TOGETHER - POSITIVELY AWARE MARCH+APRIL 2022

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TOGETHER - POSITIVELY AWARE MARCH+APRIL 2022
HIV TREATMENT, PREVENTION + HEALTH FROM TPAN

                                               POSITIVELY AWARE
                                               MARCH+APRIL 2022

                                                                  APART, BUT
                                                                  THE 26TH ANNUAL HIV DRUG GUIDE

                                                                  TOGETHER
                                                                  Separated and isolated by a pandemic,
                                                                    we still reach out for community
TOGETHER - POSITIVELY AWARE MARCH+APRIL 2022
CONTRIBUTORS

THE PHARMACIST                 THE DOCTOR                      THE ACTIVIST                  THE ASSOCIATE EDITOR            THE EDUCATOR

Eric K. Farmer, PharmD,        Melanie Thompson, MD’s          Michael Broder                Enid Vázquez has been           Carla Blieden, PharmD,
BCPS, AAHIVP, is an            career of over three            is a 60-year-old gay male     Associate Editor of             MPH, AAHIVP, completed
HIV clinical pharmacist        decades has focused on          who tested positive           POSITIVELY AWARE                her Doctor of Pharmacy,
at the Indiana University      ending the HIV pandemic,        for HIV in 1990. He           ever since she joined           Master of Public Health,
Health LifeCare Clinic         including conducting            grew up in Coney Island       the magazine in 1995.           and PGY1 Residency at
at Methodist Hospital          clinical research for HIV       (think: Requiem for a         She earned her B.A. in          the University of Southern
in Indianapolis, one of        treatment and prevention,       Dream). As an undergrad,      journalism from the             California. She is certified
the largest providers          advising on HIV policy at       he attended Columbia          University of Wisconsin-        as an HIV pharmacist
of HIV medical services        the local and national level,   University on a Pulitzer      Madison. She interned           and has worked as the
in the state of Indiana.       developing national and         Scholarship. He earned        at The Chicago Reporter         clinical pharmacist at
He provides pharmacy           international HIV treat-        an MFA in poetry from         and was a cub reporter          the Maternal, Child, and
services that include          ment and care guidelines,       NYU in 2005, and a PhD        for The Hartford Courant,       Adolescent/Adult Center,
medication adherence           and providing medical           in Classics from CUNY in      the oldest continuously         a family-centered HIV
counseling and patient         care for people with HIV.       2010. His dissertation        published newspaper             clinic in Los Angeles, for
education, drug                Between 1988 and 2020,          was on queer kinship          in the United States.           over a decade. She works
information services,          she conducted over 400          and camp aesthetics in        Her freelance work has          directly with patients
medication procurement,        studies in the areas of HIV     Roman satire. He loved        appeared in publications        focusing on adherence to
medication therapy             treatment, prevention and       three men who died of         around the country. She         HIV medication, managing
management, and                diagnostics; viral hepatitis    AIDS—Randy Snyder,            became interested in            other chronic diseases,
medical care coordination      treatment and diagnostics;      universally beloved ACT       health reporting because        and analyzing HIV
services. He is on the         and sexually transmitted        UP activist; Tony Salinas,    of the importance it has        medication resistance.
Board of Directors for         infection diagnostics as        who played bass with the      on people’s lives. It is a      Dr. Blieden has been
the American Academy of        Principal Investigator          rock band Mountain; and       privilege to work on behalf     working closely with
HIV Medicine and serves        of the AIDS Research            Marcos Betancourt, who        of people living with           City of Los Angeles
as clinical faculty for the    Consortium of Atlanta           was on track to ignite the    HIV/AIDS, Enid says.            officials and the Los
Midwest AIDS Training          (ARCA). She saw her first       world. He married the         She believes that HIV is as     Angeles Fire Department
and Education Center. Dr.      patient with HIV in 1982        poet Jason Schneiderman       much a condition fueled         on deployment of the
Farmer graduated from          and has cared for thou-         in 2004, in Provincetown,     by societal discrimination      influenza and COVID
Butler University with his     sands of people with HIV in     Massachusetts, one of         as it is by a virus. As such,   vaccinations. Dr. Blieden
Doctor of Pharmacy in          Atlanta since that time.        the first few hundred gay     it makes her reporting          is Assistant Professor
2007. He then completed            She currently               men to get legally civilly    socio-political as well         of Clinical Pharmacy
an ASHP-accredited             co-chairs the HIV               married in the United         as medical. She enjoys          and Director of Student
PGY1 pharmacy                  Medicine Association            States. Currently getting     reporting on medical            Outreach and Community
residency at Eskenazi          (HIVMA) HIV Primary             same-sex divorced, he         updates and making              Health at the USC
                                                                                                                                                            FARMER AND VÁZQUEZ: JOHN GRESS • BLIEDEN: ISAAC MORA

Health in Indianapolis,        Care Guidance Panel that        lives in historic Bed-Stuy,   them relatable to readers’      School of Pharmacy.
and subsequently an            recently published its          Brooklyn, with a number       lives. Enid has a special       She reviewed the DHHS
ASHP-accredited PGY2           2020 recommendations            of feral cats, and the        interest in sexual violence     guidelines for this guide.
HIV specialty pharmacy         for the clinical care of        best roommate ever. His       and sexual freedom, and
residency at the Center        people with HIV in Clinical     book of poems, This Life      in serving the sex trade
for HIV/AIDS Care and          Infectious Diseases in          Now, was a finalist for the   worker and transgender
Research at Boston             November.                       Lambda Literary Award         communities.
Medical Center.                    Dr. Thompson’s              for gay poetry in 2015.
                               passion is to contribute to
                               an end to the HIV epidemic
                               through patient-centered
                               medical care, prevention
                               and treatment research,
                               and evidence-based
                               guidelines and policy
                               with a focus on health
                               inequities.

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TOGETHER - POSITIVELY AWARE MARCH+APRIL 2022
EDITOR’S NOTE
                               JEFF BERRY
                               @PAeditor

                               Gratitude

T
                   his is the 26th Annual POSITIVELY AWARE HIV Drug Guide. I’m incredibly honored
                   to have served as editor on 18 of these incredible resources for people living
                   with HIV and those who care for them. This HIV Drug Guide has some changes
                   to it that we think you’ll like. For the first time we’ve added HIV PrEP to the HIV
                   Drug Chart that’s in the middle of this issue (we added the PrEP drug pages to
                   the guide itself a few years ago). We’ve included a statement on Paxlovid from
                   our amazing physician for this year’s guide, Dr. Melanie Thompson. Paxlovid
                   is the latest oral medication (under emergency use authorization and not yet
                   approved) to treat mild to moderate COVID for those at highest risk for severe
                                                                                                                               I’m grateful to
                   disease. It contains an old HIV drug (Norvir) that has a lot of interactions with
                                                                                                                               have lived to see
                   other drugs, so see the statement on page 17 for more information.                                          the day where
    Treatment and prevention for HIV continues to            Vázquez and Rick Guasco. You know I love you guys!                this revolution in
evolve with long-acting injectable medications now or        We drive each other crazy as we get down to the wire              treatment is now
soon to be on the market. As this issue went to press,       to meet our deadline, but it’s all worth it because of            upon us, because
Cabenuva, the first long-acting injectable regimen           the end result. We do it for all for you, the people who          this is only the
for treatment of HIV, was approved for dosing every          are reading this right now!
other month—that’s six doses a year. Wow! What a                 Enid wanted to make sure that we gave a special
                                                                                                                               beginning.
long way we’ve come from handfuls of pills two or            shout out and thank you to all of the scientists and
three times a day with dreadful side effects—some of         providers who make her sister’s continued life and
which weren’t all that effective. I’m grateful to have       well-being possible. That goes for all of us living with
lived to see the day where this revolution in treatment      HIV—we all thank you for making our lives your life’s
is now upon us, because this is only the beginning.          work. We wouldn’t be here (literally) if it wasn’t for you.
Monoclonal antibodies, gene-editing technology,                  Wherever life leads us, let’s continue to express
mRNA vaccines for HIV, implants, etc.—all of these           gratitude to each other and for what each of us brings
advances are mind-blowing and moving at a rapid              to the table. I’m grateful for my postal carrier who
pace, and will result in this guide having to evolve         delivers the mail (almost) every day. I’m grateful for
as well. A pill chart may soon become a relic of the         my therapist who encourages me to keep working
past in the not-too-distant future. We’ll have to come       on getting in touch with my best self (and letting go
up with a lot of new categories, symbols, icons—but          of the rest). I’m grateful for my coworkers who make
it’s all good, and it will be exciting to be a part of the   me laugh and teach me new things every day (at least
future of the HIV treatment and prevention landscape.        when I’m in the office). I’m grateful for family and
    This is where I have to stop and point out once          friends who help me feel connected and keep me
again (I know, I sound like a broken record) that none       grounded. And above all I’m grateful to the universe
of it will lead us to the end of the HIV epidemic unless     for providing—always.
people have access to these new therapies. We have               Thanks to you, our readers, for subscribing to the
to ensure health equity for our Black and Brown              magazine, for reading my ramblings, and for joining
brothers and sisters and for all communities that are        along with us for this wild ride. Last but not least,
disproportionately affected by HIV. Pricing of these         we’re grateful to the frontline workers who are doing
drugs cannot continue to grow exponentially by leaps         the work each and every day on behalf of people living
and bounds as the advances in research have—it is            with and affected by HIV. Our community has never
just not sustainable, not for our health systems, and        been stronger, and I’m so grateful to have been wel-
not for our pocketbooks. Will these new modes of             comed into it with open and loving arms.
delivery and novel therapies only be accessible for the
privileged few, while the rest of us are left to swallow        Always take care of yourself, and each other.
generic versions of old HIV pills because that’s all our
plans will cover or that we can afford? Let’s hope not.
    I’m also honored to work with a great team that
puts this behemoth together year after year, Enid

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TOGETHER - POSITIVELY AWARE MARCH+APRIL 2022
BEING BRIDGETTE
                       BRIDGETTE PICOU

                       The problem is how
                       you see the problem
                       I have a question: Is your HIV a problem for you?                                Another good example is
                       Why or why not? If I asked you to identify the biggest                       love. I hear women say pretty
                                                                                                    often “he loves me even with
                       problem it causes for you—could you? Is it stigma?                           HIV” or “he loves me in spite
                       Internalized stigma? Medication adherence? Is it navigating                  of HIV.” In my head I’ve also
                       relationships (including the one with yourself)?                             reframed that idea of being loved
                                                                                                    in spite of HIV and changed it to
                         Next questions: How long             using your skills to facilitate       being loved with HIV. When we
                     have you been living with HIV            change.                               do things “in spite of,” it implies
                     and the same problem(s)? Have                All too often in HIV we let the   a certain disdain for the thing
                     your coping skills evolved? Has          virus—and other people—define         in question. It’s that you don’t
                     your “problem” changed face              us. They label us and come to         like it, but you’ll tolerate or live
                     over the years, or is it the same        conclusions about a life they’ve      with it anyway. The problem with
                     one or two on repeat?                    never lived—and we let them.          allowing that is it’s an insidious
                         Which leads me to this: What         We get caught in endless cycles       and subtle kind of stigma, both
Problem solving      skills do you use to cope with           of what we know life could or         external and internalized. You’ll
involves looking HIV as a concept, lifestyle, and             should be, and yet let stigma and     settle for less than you deserve
                     life process? Don’t worry, I’m           shame corner us into feeling dif-     in a relationship because after all,
  at the problem, not about to tell you what to do            ferently. For example, sometimes      you do have this thing that needs
    defining and or how to do something about it;             I would resent taking a pill every    to be worked around.
   analyzing the I’m not a therapist, and I damn              day because I didn’t want to          I don’t want to be tolerated on
       underlying sure don’t have all the answers.            depend on a thing for my health.      any level, and in a relationship,
  concerns, then I am, however, working on me                 I’ve reframed the problem—it’s        we better be working through,
using your skills and how I see myself, and I just            now my opportunity each day to        not around, issues that arise.
      to facilitate wanna make you take stock of              ensure I’m here to do what my         Love the whole imperfect
                     your life with HIV for a second          purpose says I need to do and         package or leave me alone. The
           change. and do the same.                           I’m more grateful and gracious                  problem isn’t HIV makes
                         Consider this notion—which           about it.                                           love and relationships
                     is actually one of my personal                                                                 hard. The problem
                     affirmations: The problem is                                                                     is my relationship
                     how you see the problem. The                                                                        with those
                     Google definition of                                                                                 things and HIV.
                     problem is “a matter                                                                                      So, let me
                     or situation regarded                                                                                 ask again:
                     as unwelcome or                                                                                       Is your HIV
                     harmful and needing                                                                                   a problem,
                     to be dealt with and                                                                                   or is how
                     overcome.”                                                                                             you see the
                         Just reading the words                                                                              problem your
                    “harmful” and “overcome”                                                                                 problem?
                     invokes some angst, right? I                                                                                Be well.
                     came across a definition once                                                                           You matter.
                     that seems less negative as it
                     processes through the brain’s
                                                                                                                                            PICOU: CHAD SAIN • WOMAN: SZEFEI-ISTOCK

                     gray matter: A problem is the
                     difference between what is and
                     what could or should be.
                         How about that for seeing a
                     problem differently? I don’t know
                     about you, but “what could or
                     should be” makes me feel a little
                     optimistic as opposed to putting
                     me in the struggle mindset of
                     having to overcome. Problem
                     solving involves looking at the
                     problem, defining and analyzing
                     the underlying concerns, then

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TOGETHER - POSITIVELY AWARE MARCH+APRIL 2022
T H E 2 6 TH A N N U A L H I V D R U G G U I D E

                                                        MARCH+APRIL 2022
POSITIVELY AWARE                                    P O S I T I V E LY AWA R E • VO LU M E 32 N U M B E R 2 • posi tivel yaware.com • @pos aware

Jeff Berry
E D I T O R- I N - C H I E F
@PAeditor
                                                                                         EVERY ISSUE

Enid Vázquez
A S S O C I AT E E D I T O R
@enidvazquezpa
                                                        3
                                                  EDITOR’S NOTE
                                                                                   4
                                                                          BEING BRIDGETTE
                                                                                                                6
                                                                                                       BEHIND THE COVER
                                                                                                                                         65
                                                                                                                                    POZ ADVOCATE
                                                    Gratitude              The problem is             Apart, but together            The agony of
Andrew Reynolds                                                            how you see the            Seeking community.              defeat—and
H E PAT I T I S C E D I T O R                                                 poblem                    BY RICK GUASCO               delayed drug
@AndrewKnowsHepC                                                         BY BRIDGETTE PICOU                                          development
                                                                                                                                BY SCOTT SCHOETTES
Rick Guasco

                                                                                          21–61
C R E AT I V E D I R EC T O R
@rickguasco

C O LU M N I S T S                                              THE 26TH ANNUAL HIV DRUG GUIDE
Bridgette Picou                                                   A handbook of the medications used for treating HIV.
Scott Schoettes                                                      BY ERIC K. FARMER, PharmD, AND ENID VÁZQUEZ
                                                            WITH COMMENTS BY MELANIE THOMPSON, MD, AND MICHAEL BRODER
PROOFRE ADER
Jason Lancaster

PHOTOGR APHERS
                                                                   10
                                                        12 THINGS TO KNOW
                                                                                                                               17
                                                                                                           INVESTIGATIONAL NEW DRUGS
Habeeb Mukasa
John Gress                                             ABOUT HIV TREATMENT                                   This is why clinical trials are done.
Chris Knight                                     When you should start HIV treatment,

ADVERTISING MANAGER
Lorraine Hayes
                                                 what does HIV treatment do, and other
                                                     essential questions answered.                                             17
                                                                                                                       HIV & COVID-19

                                                                 12
L.Hayes@tpan.com                                                                                             Statement on Paxlovid for people
                                                                                                             with HIV on antiretroviral therapy.
DISTRIBUTION MANAGER
Denise Crouch                                               HIV LIFE CYCLE
distribution@tpan.com

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                                                   Different drug classes interrupt the
                                                 virus from replicating at various stages.                                     20
                                                                                                                         CLASS LIST
positivelyaware.com/subscribe
                                                              13
                                                     DHHS RECOMMENDATIONS
                                                                                                           An A-to-Z listing of the medications
                                                                                                                    in the drug guide.

LIVE LIFE POSITIVELY AWARE.                           Guidelines for people starting
                                                      HIV therapy for the first time.                                          62
                                                                                                                    HELP IS OUT THERE
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                                                                16
                                                            LOOKING AHEAD
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TPAN was founded in 1987
in Chicago as Test Positive Aware
Network, when 17 individuals living
with HIV gathered in a living room
to share information and support
                                               ‘As a Black trans woman who has been living with HIV
in response to the HIV/AIDS                     for over 10 years, I just want to say it’s okay to be
epidemic. POSITIVELY AWARE is                   nervous and overwhelmed, but dig deep and find that
the expression of TPAN’s mission to
share accurate, reliable, and timely            determination and tenacity to survive and thrive so
treatment information with anyone               you, too, can motivate and inspire others.’
affected by HIV.
                                               —MALLERY JENNA ROBINSON (SECOND FROM RIGHT, WITH CARLOS MORENO,
          BE GREEN.                            ANDREA DE LANGE, DAMONE THOMAS, AND OLIVER WONG, PAGE 3
          SHARE OR RECYCLE
          THIS MAGAZINE.

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TOGETHER - POSITIVELY AWARE MARCH+APRIL 2022
BEHIND THE COVER

FROM LEFT: ANDREA DE LANGE, DAWN McCLENDON, OLIVER WONG, ALFREDO “FREDDY” FAVELA, CARLOS MORENO, DANIELLE M.
CAMPBELL, MPH, DAMONE THOMAS, MALLERY JENNA ROBINSON, ALICIA MOREHEAD-GEE, MD, JOSÉ MAGAÑA, AND NICHOLAS SNOW.

 Apart, but together

F
BY RICK GUASCO

     rom the AIDS epidemic of the 1980s through                     of African descent globally, the     are HIV negative to remain
     today’s COVID pandemic, people living with                     decision to pursue this work         HIV negative.
                                                                    was a logical conclusion. So            “My turning point in
     HIV have endured isolation in one form or                      many of my people were being         facing life with HIV came in
     another while reaching for community to find                   affected, I couldn’t resist join-    September 2011,” he says.
     support, information, and hope. We might be                    ing the ranks alongside others      “I decided I wanted to live,
alone, but we’re also together.                                     doing this work,” she adds.          because there is so much to
                                                                                                         gain. Today, I thrive above HIV.”
                                                                    At 34, Damone Thomas’
    That was the theme behind “I have been an HIV advocate          HIV journey has taken him           As an undergrad at California
the Los Angeles photo shoot      since first volunteering in the    from Kingston, Jamaica,             State University, Northridge,
for the cover (and additional    food pantry of an HIV service      where he tested HIV positive        Alfredo “Freddy” Favela, MPH,
photos) of the 26th annual HIV   organization, nearly eight         in January 2008, to L.A, where      was passionate about sexual
Drug Guide, which brought        years ago,” says Danielle M.       he is now a health care worker      health, often advocating on
together people living with      Campbell, MPH, an activist         and a retention specialist.         campus for safer-sex practices.
HIV—both recently diagnosed      and faculty member of the             “I learned of my status          Pursuing his master’s degree
and long-term survivors—and      Charles R. Drew University of      when I decided to get tested,       in public health with an
care providers in the HIV field, Medicine and Science, a his-       despite the fear of being gay       emphasis in epidemiology at
all passionate about their work, torically Black college, as well   in Jamaica,” he says. “Living       Los Angeles Pacific University,
                                                                                                                                             MARK HARVEY

and some living with HIV as      as at UCLA and the University      with HIV motivates me to work       he began focusing on com-
well. They each make a unique    of California at San Diego.        in the field, to be at the table    munities of color. Favela is
contribution, finding a place in    “Learning how HIV dispro-       to help others living with HIV,     now community outreach
the communities they serve.      portionately impacted women        and try to help people who          supervisor and community

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TOGETHER - POSITIVELY AWARE MARCH+APRIL 2022
engagement lead          diagnosed, it’s important to       but she was already in                A young single mother of two,
             at UCLA’s CARE           talk with someone who has          another abusive relationship.         struggling to work and go to
             Center.                  been living with HIV for a lon-   “Starting a year before I was          school, Dawn P. McClendon
                                      ger time,” he says. “Hearing       diagnosed, he treated me              shifted gears from becoming
              In 2011, Mallery        firsthand experiences from a       like a leper after I told him         a lawyer to promoting public
              (“Mally”)Jenna          long-term survivor can give        my status,” she says. “I let          health and to become part of
              Robinson was            you assurance that HIV is          him live with me and treat            something larger than her-
              studying for a          manageable.”                       me that way for another               self. Now 48, she is assistant
              double bachelor’s                                          two years because I was so            director of the Los Angeles
              degree in biology       Carlos Moreno, 31, came            unempowered and thought               County Commission on HIV.
              and history in          out to his family, friends and     I’d never be in a better                 “I am eternally changed by
              Montgomery,             coworkers by telling his story     relationship.”                        the relationships I have built
              Alabama, when           onstage during a concert by            Today, de Lange has been          with people living with and
              she collapsed           the Reveille Men’s Chorus in       happily married for more              impacted by HIV as well as
              at the restau-          Tucson, Arizona, in May 2015.      than 19 years, “to an HIV-            those who are a part of this
              rant where she             “My entire life changed         negative guy, who totally             workforce, and I am forever
              worked. Two             after that,” says Moreno,          loves and accepts me, HIV             grateful,” she says.
              weeks later, she        whose pronouns include he          and all,” she says.
              learned she was         and they. “I no longer carried                                           José Magaña’s love of help-
              living with HIV.        the heavy burden of secrecy.       After decades of practicing           ing people helped him to
                 “I was               This opened up many doors          safer sex, Nicholas Snow              overcome stigma. He learned
              completely              for me, and just a couple          says it was one moment that           of his HIV status about six
              overwhelmed as          months after coming out, I         led to him acquiring HIV in           years ago while getting test-
              a then-21-year-         moved to Los Angeles to            August 2007. “I remind myself         ed to get onto PrEP.
              old Black trans         continue expanding my              that I am human, and this                “I told my sexual partner,
              woman, but I was        advocacy.”                         was a human experience,” he           and they did not want any-
              determined to not           For him, being visible         says. “I don’t beat myself up         thing to do with me,” he says.
              let this diagnosis      means representing. “Folks         for it, and I am loving and for-     “It took me a year of therapy
              deter me from           needed to see people like          giving of myself. My greatest         to learn to love myself
              living my best life,”   myself living well, working,       power is my ability to live and       regardless of my status,
              she says. Today,        and thriving with HIV, as well     express my truth.                     whether people choose to
              she advocates           as contributing to the field of       “My personal mission               accept me or not. Since then,
              for women of all        service delivery for margin-       statement is to honor and             I decided to educate and
              trans identities        alized populations. This was       express my creativity in a            share my story with others to
              and is a mem-           something that I struggled         way that makes a difference,”         get rid of HIV stigma.”
              ber of the Los          to see in the early years of       says Snow, producer and host              At 39, public service has
              Angeles County          my diagnosis.                      of PromoHomo.TV, an LGBTQ             always been part of José
 Commission on HIV.                       “Not everyone gets the         online platform.                      Magaña’s life. He’s been in
    “As a Black trans woman           chance or has the privilege to        “My status doesn’t weigh           the Army National Guard for
 who has been living with HIV         be out about their status, or      on me personally, except that         17 years, having spent over a
 for over 10 years, I just want       to be a community advocate,”       stigma and ignorance are still        year and half on deployment
 to say it’s okay to be nervous       they acknowledge, “but know        pervasive within the gay male         assisting hospital workers
 and overwhelmed,” she says,          the rest of us do what we do       community, which makes it             during the COVID-19 pandem-
“but dig deep and find that           because we love and honor          challenging to find love, but         ic. He’s now a community
 determination and tenacity           you, and carry you with us.”       I haven’t given up,” he adds.         organizer for The Wall Las
 to survive and thrive so you,                                          “What about U=U [undetect-             Memorias Project, focusing
 too, can motivate and inspire        It was 1987, and Andrea de         able equals untransmittable,          on substance abuse and men-
 others.”                             Lange didn’t fit “the type”        the message that a person             tal health, and facilitates a
                                      who would have HIV. She had        with undetectable viral load          virtual group for people living
 Being public about his status        swollen lymph nodes, and           is not able to transmit HIV           with HIV that meets every
 helped Oliver Wong, 30,              her new doctor was trying          to a sexual partner] don’t            Wednesday night via Zoom.
 overcome isolation and stig-         to rule out possible causes.       they understand?”                        “I love to help people in
 ma. Diagnosed barely a year          A cancer screening three                                                 the community that I am part
 ago, he’s even made it part          years earlier had turned out        In medical school, Alicia            of,” he says. “Everyone has a
 of schtick. “As a stand-up           negative.                          Morehead-Gee, MD, MS, 34,             different story to tell and it’s
 comedian, I also talk about             “My doctor never thought        was fascinated by the global          important to share those sto-
 being HIV positive,” he says.        I could be HIV positive when       impact of HIV/AIDS. At UCLA,          ries so that others can learn
“It helps me to share my              I got the biopsy, because I        her work focuses on HIV               and grow from them.”
 experience onstage. It’s very        didn’t fit the stereotypes of      prevention and Black women.
 therapeutic, empowering,             who was HIV positive, and          Today, she’s medical director         ABOUT THE PHOTOGRAPHER
 and freeing to talk about it.        he also didn’t know about          of HIV prevention for AltaMed         Mark Harvey is a visual artist,
 If you’re living with HIV and        my past history with the           Health Services to expand             designer, photographer, and
 turn your experience into art        boyfriend,” she says.              PrEP (pre-exposure prophy-            educator living in Los Angeles.
 and share it with the world,            “The boyfriend,” an injec-      laxis) awareness and access.          He also teaches a variety of
 it’s gonna not only help             tion drug user, had turned        “My team trains primary                topics in graphic design and
 you, but also help the world         her on to crystal meth, telling    care providers, pharmacists,          photography at the Art Center,
 understand HIV and remove            her that she needed to lose        and staff on PrEP and PEP             Pasadena City College,
 stigma.                              weight. The relationship           (post-exposure prophylaxis),”         Glendale College, and at
    “If you are newly                 lasted from 1981 to 1985,          she says.                             Los Angeles City College.

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TOGETHER - POSITIVELY AWARE MARCH+APRIL 2022
THE BASICS

            12 things to know about HIV
            1. When should                          “antiretrovirals” (ARVs). To
            HIV treatment start?                     quickly find your drug, go to
                                                    “Getting Around” in this issue. A
            It is recommended that every-            single-tablet regimen (STR) con-
            one living with HIV be on HIV            sists of two or more ARVs which
            treatment, and as soon as pos-           represent at least two drug
            sible after diagnosis. So say the        classes, and form a complete
            HIV treatment guidelines from            HIV treatment in one pill taken
            the U.S. Department of Health            once daily. STRs are widely used
            and Human Services (DHHS).               by people taking HIV treatment
                                                     for the first time (called “treat-
            2. What does                             ment naïve”), but they are not
            HIV treatment do?                        for everybody, including some
                                                     people who are treatment-expe-
             The goal of therapy is to sup-          rienced or have multi-drug resis-
             press the amount of virus (called       tance. A fixed-dose combination
            “viral load”) to an undetectable         (FDC) combines two or more
             level (meaning that the amount          ARVs in one pill but is not always
             of virus in your blood is so low, it    an entire regimen (an STR is a
             cannot be detected by normal            type of fixed-dose combination).
             tests). This will keep you healthy,     We now have a long-acting
             and the sooner you start ther-          injectable regimen (Cabenuva),
             apy, the less damage the virus          which at press time consists of a
             can do to your immune system            one-month oral lead-in followed
             so you’ll stay healthier longer. It     by two intramuscular injections
             also means you can’t transmit           administered every four weeks.
             HIV to your partner through sex         Other long-acting drugs are
             when you are on antiretroviral          in development; for one that’s
             treatment (ART) and undetect-           expected to be approved this
             able at less than 200 copies for        year, see lenacapavir, page 32.
             at least six months (undetect-
             able equals untransmittable,           6. How should HIV
             or U=U; also called “treatment         treatment be taken?
             as prevention,” or TasP). HIV
             treatment should also raise the        Getting to and staying undetect-
             number of your CD4+ T cells, a         able requires adherence: taking
             measure of the immune system.          your medication as prescribed
                                                    (for example, with or without
            3. What tests are needed                food) and not missing doses.
            before starting HIV therapy?            Discuss any concerns with your
                                                    doctor, nurse, or pharmacist.
            You will be tested for STIs,            Reach out for support at your
            hepatitis B and C virus, and HIV        local HIV organization or support
            drug resistance. With the “Rapid        network. That includes housing
            Start” strategy recommended             and job opportunities if you need
            by DHHS, you will begin treat-          them. Anti-stigma efforts are
            ment while awaiting test results.       also important for HIV care.
            Not all HIV meds are recom-
            mended for Rapid Start.                 7. What is drug resistance?
            4. Is HIV treatment a cure?             If treatment is not taken
                                                    correctly or is unable to com-
            Treatment does not cure HIV,            pletely suppress the virus, it
            but maintains health and, if            might mutate (make changes
            you’re undetectable, prevents           in its viral genetic structure).
            transmission.                           This can make therapy less
                                                    effective or even ineffective.
            5. What does HIV                        This drug resistance occurs
            treatment consist of?                   mostly through missed doses.
                                                    Fortunately, many of the widely
            HIV therapy consists of medi-           used HIV drugs today have a
            cations from at least two drug          high barrier to resistance, are
            classes. HIV drugs are called           easier to take, and have few if

10   M A R CH+A PRIL 202 2   | positivelyaware.com/subscribe
TOGETHER - POSITIVELY AWARE MARCH+APRIL 2022
treatment
                          any side effects. However, it is            contact information and
                          better to avoid missing doses.              their preferred method of
                          Drug resistance may lead to                 communication.
                          the need for more complicated           n   Remember that nurses and
                          therapy (such as more pills).               pharmacists are also good
                                                                      sources of information.
                          8. Which drugs should I use?
                                                                 10. What is AWP?
                          HIV treatment is based on
                          considerations such as health           The Average Wholesale Price
                          status (for example, kidney or          (AWP) on each drug page is a
                          liver disease) and lifestyle. See       way to compare costs of drugs.
                          considerations for therapy in           It is not what you would pay if
                          the DHHS guidelines.                    you were to pay the full retail
                                                                  price. (That’s why it’s commonly
                          9. How can I                            referred to as “ain’t what’s
                          address my concerns?                    paid.”) The drug cost-sharing
                                                                  and patient assistance program
                          You can play an active role in          charts (beginning on page 62)
                          your health care by talking to          include information on how to
                          your doctor. Clear and honest           access programs that can help
                          communication between you               cover all or part of the costs of
                          and your physician can help             many of these medications.
                          you both make smart choices
                          about your health. It’s import-        11. What are PEP and PrEP?
                          ant to be honest and upfront
                          about your symptoms even if             PEP and PrEP are not HIV treat-
                          you feel embarrassed or shy.            ment, but are HIV medications
                          Have an open dialogue with              used by HIV-negative people to
                          your doctor—ask questions to            prevent infection with the virus.
                          make sure you understand your          “PEP” stands for “post-exposure
                          diagnosis and treatment. While          prophylaxis” and is taken for
                          ARV regimens are usually well           28 days following a potential
                          tolerated, each ARV can have            exposure to the virus; PEP must
                          side effects. Some may be seri-         be started within 72 hours after
                          ous. Refer to the drug page for         a recent possible exposure.
                          each individual drug. Each per-        “PrEP” stands for “pre-exposure
                          son is different; you and your          prophylaxis” and is taken daily
                          health care provider will have to       to prevent someone from get-
                          decide which drugs to use.              ting HIV. “Prophylaxis” means
                             Here are a few tips that            “preventative.”
                          can help you talk with your
                          doctor to make the most of your        12. More information online
                          appointment:
                                                                  See considerations for therapy,
                          n   Write down a list of ques-          including information on COVID,
                              tions and concerns before           and drug factsheets from DHHS
                              your appointment.                   at HIVinfo.nih.gov. DOWNLOAD
                          n   Consider bringing a close           iPhone and Android apps that
                              friend or family member             provide drug info, guidelines,
                              with you.                           and a glossary: clinicalinfo.hiv.
                          n   Take notes about what the           gov/en. The International AIDS
                              doctor says, or ask a friend        Society also produces HIV
                              or family member to take            treatment guidelines. GO TO
                              notes for you.                      iasusa.org/resources/guidelines.
                          n   Learn how to access your            To see if your HIV drug interacts
                              medical records, so you can         with another medication, either
                              keep track of test results,         prescription or over-the-counter,
                              diagnoses, treatment                GO TO hiv-druginteractions.org.
            MARK HARVEY

                              plans and medications,              Among the good community-
                              and prepare for your next           based sources of information,
                              appointment.                        besides POSITIVELY AWARE,
                          n   Ask for the doctor’s                is aidsmap.com.

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TOGETHER - POSITIVELY AWARE MARCH+APRIL 2022
POSITIVELY AWARE 2022 HIV DRUG GUIDE
HOW HIV DRUGS WORK

                                                                           HUMAN
                                                                           IMMUNODEFICIENCY
                                                                           VIRUS (HIV)

HIV life cycle
Different drug classes interrupt the virus
from replicating at various stages
                                                                                    CD4
                                                                                    RECEPTOR
ANTIRETROVIRAL THERAPY works by
                                                                                                    CCR5
targeting more than one stage in the                                                                CO-RECEPTOR
HIV life cycle. Combining certain drugs
from more than one drug class will
achieve this goal, and suppress the virus
to undetectable levels in the blood. The
compounds listed under the stages below
are new drugs in development.
                                                                       1

                                                                                                    2
                                                                    CD4 CELL
     ➊ BINDING                                                                                  3
     HIV binds to the surface of a host cell.
     ENTRY INHIBITORS

     ➋ FUSION                                                                  4
     HIV’s RNA reverse transcriptase,
     integrase, and other viral proteins
     fuse to the host cell.
     FUSION INHIBITOR
     MONOCLONAL ANTIBODIES (mAb)
     in development:
     • UB-421 (CD4 receptor)
     • VRC01 (CD receptor)
     • 3BNC117/LS and 10-1074/LS                                       5
     • PGDM1400 and PG121
       10E8.4, etc.
     • PRO-140 (CCR5 receptor)                                                              6
     • albuvirtide
                                                                7
     ➌ REVERSE TRANSCRIPTION
     Viral DNA is formed by reverse
     transcription.
     NRTIs and NRTTIs (nukes), including                                       ➏ ASSEMBLY
                                                                                                                       SOURCES: PUBLIC HEALTH LIBRARY/CDC AND HIV i-BASE (i-BASE.INFO)
     these in development:                                                     New viral RNA and proteins move to
     • islatravir                                                              the cell’s surface; a new, immature
     NNRTIs, including these in                                                (and non-infectious) virus forms.
     development:                                                              PROTEASE INHIBITORS, including
                                                                                                                       ILLUSTRATION BY ABBEY DENLINGER ©POSITIVELY AWARE

     • elsufavirine                                                            this one in development:
                                                                               • GS-1156
     ➍ INTEGRATION                                  NEW
     Viral DNA is transported into the host         COPIES                     ➐ BUDDING
     cell’s nucleus and integrates into the         OF HIV                     The virus becomes infectious when
     host’s DNA.                                                               protease breaks up proteins in the
     INTEGRASE INHIBITORS                                                      immature virus to create the mature
     • GS-9883                                                                 virus that goes on to infect other
                                                                               CD4 cells.
                                                                               * CAPSID INHIBITOR in development:

     ➎ REPLICATION
                                                                               • lenacapavir
                                                                               MATURATION INHIBITOR
     New viral RNA is used as genomic                                          in development:
     RNA and to make viral proteins.                                           • GSK3640254
                                                                             * IN MARCH 2021, RESEARCHERS ACCEPTED
                                                                              THAT THE CAPSID UNCOATS IN THE NUCLEUS

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POSITIVELY AWARE 2022 HIV DRUG GUIDE
DHHS RECOMMENDATIONS

 DHHS Guidelines for people starting HIV therapy for the first time
        The expert panel of the U.S. Department of Health and Human Services recommends starting antiretroviral
        therapy (ART) as soon as possible after HIV is diagnosed, regardless of CD4 count. Most people starting
        HIV treatment for the first time (treatment-naïve) should take one of the following: Biktarvy, Dovato, Triumeq,
        or Tivicay plus Descovy or Truvada. GO TO hivinfo.nih.gov for more information.

                                ★ Recommended initial regimens for most people with HIV
                                      Recommended regimens are those with demonstrated durable
                               virologic efficacy, favorable tolerability and toxicity profiles, and ease of use.

                             INSTI + 2 NRTIs                                                            INSTI + 1 NRTI
                                                                                                                 Except for individuals
                                                                                                                 with pre-treatment HIV
                                                                                                                 viral load greater than
                                                                                                                 500,000 copies/mL,
                                                                                                                 who are known to have
                                                                                                                 active hepatitis B virus
                                                                                                                 (HBV) co-infection,
                                                                                                                 or who will start ART
                                                                                                                 before results of HIV
                                                                                                                 genotype testing for
            Biktarvy                                  Triumeq                                 Dovato             reverse transcriptase
          BIC / FTC / TAF                           DTG / ABC / 3TC                          DTG / 3TC           or HBV testing are
                 A1                            (if HLA-B*5701-negative)                         A1               available.
                                                           A1

                                                                INSTI + 2 NRTIs

                                                      WITH                           OR

                                       Tivicay                     Descovy                      Truvada
                                        DTG                        FTC / TAF         A1         FTC / TDF

                              ✔ Recommended initial regimens in certain clinical situations
                      These regimens are effective and tolerable, but have some disadvantages when compared
                      with the regimens listed above, or have less supporting data from randomized clinical trials.
                            However, in certain clinical situations, one of these regimens may be preferred.

                                                                INSTI + 2 NRTIs

                                         OR                         WITH                           OR

                        Isentress HD (two tablets once daily)                   Descovy                        Truvada
                          or Isentress (1 tablet twice daily)                   FTC / TAF                      FTC / TDF
                                              RAL                                  B2                             B1

RATING OF RECOMMENDATIONS                                           THE FOLLOWING ARE AVAILABLE AS CO-FORMULATED DRUGS
A: Strong B: Moderate C: Optional                                   (NOT A COMPLETE LIST)

RATING OF EVIDENCE                                                  Atripla: EFV/FTC/TDF Biktarvy: BIC/FTC/TAF Cimduo or Temixys: 3TC/TDF
1: Data from randomized controlled trials. 2: Data from well-       Complera: RPV/FTC/TDF Delstrigo: DOR/3TC/TDF Descovy: FTC/TAF
designed non-randomized trials, observational cohort studies        Dovato: DTG/3TC Epzicom: ABC/3TC Evotaz: ATV/c
with long-term clinical outcomes, relative bioavailability/         Genvoya: EVG/c/FTC/TAF Odefsey: RPV/FTC/TAF Prezcobix: DRV/c
bioequivalence studies, or regimen comparisons from                 Stribild: EVG/c/FTC/TDF Symfi: EFV 600 mg/3TC/TDF
randomized switch studies. 3: Expert opinion.                       Symfi Lo: EFV 400 mg/3TC/TDF Symtuza: DRV/c/FTC/TAF
                                                                    Triumeq: DTG/ABC/3TC Truvada: FTC/TDF

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POSITIVELY AWARE 2022 HIV DRUG GUIDE
DHHS RECOMMENDATIONS

                      ✔ Recommended initial regimens in certain clinical situations (continued)
                                                             Boosted PI + 2 NRTIs
                                             (In general, boosted DRV is preferred over boosted ATV.)

                                                                                OR                             +

                                                        Prezcobix                            Prezista                     Norvir
                                                        DRV / COBI                          DRV 800 mg                       RTV

                                                                              WITH

               Symtuza
         DRV / COBI / FTC / TAF
                  B1                                                            OR

                                                           Descovy                      Truvada
                                                           FTC / TAF                    FTC / TDF
                                                                                A1

                         OR                              +                              WITH                            OR

      Evotaz                           Reyataz                         Norvir                           Descovy                    Truvada
     ATV / COBI                             ATV                         RTV                             FTC / TAF                  FTC / TDF
                                                                         B1

                                       OR                               +                               WITH

             Prezcobix                                Prezista                       Norvir                          Epzicom
             DRV/ COBI                               DRV 800 mg                       RTV                            ABC / 3TC
                                                                        B2                                     if HLA-B*5701 negative

                                                               NNRTI + 2 NRTIs

                                                                                         WITH

                                Delstrigo                               Pifeltro                         Descovy
                              DOR / 3TC / TDF                             DOR                            FTC / TAF
                                    B1                                                      B3

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✔ Recommended initial regimens in certain clinical situations (continued)
                                                                    NNRTI + 2 NRTIs
                                                       3TC may substitute for FTC and vice versa

                                                                                                                          WITH

      Atripla                              Symfi                       Symfi Lo                        Sustiva                           Descovy
EFV 600 mg / FTC / TDF          EFV 600 mg / 3TC / TDF           EFV 400 mg / 3TC / TDF               EFV 600 mg                         FTC / TAF
                                                                                                                            B2
         B1                                  B1                           B1

                If viral load is less than
                100,000 copies/mL                    Odefsey                               Complera
                and CD4 count is more             RPV / FTC / TAF                     RPV / FTC / TDF
                than 200 cells/mm3                      B2                                      B1

                                                             Boosted INSTI + 2 NRTIs

                                                    Genvoya                                  Stribild
                                             EVG / COBI / FTC / TAF                 EVG / COBI / FTC / TDF
                                                       B1                                        B1

                ✔ Regimens to consider when ABC, TAF, and TDF cannot be used or are not optimal
 Except for individuals
 with pre-treatment HIV
 viral load greater than
 500,000 copies/mL,
 who are known to have
                                                                                           +                              WITH

 active hepatitis B virus
 (HBV) coinfection, or
 who will start ART before
 results of HIV genotype           Dovato                               Prezista                         Norvir                        Isentress
 testing for reverse
                                  DTG / 3TC                            DRV 800 mg                          RTV                (one tablet twice daily)
 transcriptase or HBV
 testing are available                A1                                            If viral load is less than 100,000 copies/mL        RAL
                                                                                    and CD4 count is more than 200 cells/mm3
                                                                                                           C1

                                                             +                               WITH

                                       Prezista                         Norvir                                  Epivir
                                      DRV 800 mg                         RTV                                      3TC
                                                                          C1

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Looking ahead
                                                         What’s on the horizon—new drugs in development

                                                         RECENTLY APPROVED                      PHASE 2

                                                         Cabenuva                               GSK3640254
                                                         (cabotegravir LA/rilpivirine LA)       A maturation inhibitor with Phase 2a
                                                         Two long-acting drugs from INSTI       results in HIV-positive participants.
                                                         and NNRTI families that are given      From ViiV.
                                                         by intramuscular injection and that
                                                         have very long half-lives—detect-      PHASE 1–3 and PRE-CLINICAL
                                                         able after more than one year
                                                         following single dose. CAB LA +        3BNC117, 10-1074, PGDM1400,
                                                         RPV LA injections were studied         PGT121, 10E8, UB-421, etc.
                                                         for treatment, and CAB LA is being     Many bNAbs (broadly neutralizing
                                                         studied for prevention as single       antibodies) are in development
                                                         INSTI injection. From ViiV/Janssen.    for HIV prevention, treatment,
                                                         See page 31.                           and cure, often in dual or triple
                                                                                                combination (see “Scenes from
                                                         PHASE 3                                the bNAb Revolution” in the
                                                                                                January+February 2020 issue).
                                                         islatravir/3TC/doravirine              Potential as switch option without
                                                         Fixed-dose combination of the          ART and in current studies for use
                                                         NNRTI doravirine plus generic 3TC      as PrEP.
                                                         and NRTI islatravir (EFdA). From
                                                         Merck. On partial clinical hold (see   Albuvirtide + 3BNC117
                                                         sidebar).                              Albuvirtide is a fusion inhibitor,
                                                                                                approved in China, that is being
                                                         islatravir/doravirine                  developed in the U.S. by Frontier
                                                         Dual FDC with NNRTI doravirine.        Biotechnologies in combination with
                                                         From Merck. On clinical hold (see      the bNAb 3BNC117 for use in treat-
                                                         sidebar).                              ment-experienced patients.

                                                         leronlimab (PRO 140)                   GS-1156
                                                         Monoclonal antibody CCR5 target.       Once-daily unboosted protease
                                                         Once-weekly (350–700 mg) subcu-        inhibitor; high potency, long half-life,
                                                         taneous injection being studied in     potential for fixed-dose combination
                                                         addition to oral ART for multi-drug    single-tablet regimen. From Gilead.
                                                         resistance and as monotherapy
                                                         maintenance therapy (without oral      GS-9883
                                                         ART). From CytoDyn.                    Long-acting formulation of the
                                                                                                integrase inhibitor bictegravir. From
                                                         PHASE 2/3                              Gilead.

                                                         islatravir (EFdA)
                                                         A new NRTI, highly potent, low dose,   ADAPTED in part from HIV Pipeline
                                                         active against NRTI resistance. Long   2021: New Drugs in Development,
                                                         half-life, potential as oral (daily,   published by HIV i-Base, September
                                                         weekly dose for treatment; perhaps     2021. Accessed online January 27,
                                                         monthly for PrEP) and implant          2022. For the full report, GO TO i-base.
                                                         (annual implant for PrEP). From        info/htb/41142.
                                                         Merck. On full and partial clinical
                                                         hold (see sidebar).                    ALSO SEE HIV life cycle on page 12.

                                                         lenacapavir (GS-6207)
                                                         New drug class (capsid inhibitor)
                                                         with activity at multiple stages of
                                                         viral lifecycle. Subcutaneous injec-
                                                         tion every six months. It is being
                                                         studied simultaneously for treat-
                                                         ment and prevention. From Gilead.
                                                                                                                                           MARK HARVEY

                                                         Submitted for approval in U.S. in
                                                         July 2021 (see page 32). On clinical
                                                         hold (see sidebar).

16   M A R CH+A PRIL 202 2   | positivelyaware.com/subscribe
HIV & COVID-19

                                                                                                     Statement about
                                                                                                     Paxlovid for
                                                                                                     people with HIV on
                                                                                                     antiretroviral therapy
Investigational new drugs                                                                            Paxlovid is approved under
                                                                                                     Emergency Use Authorization
BY MELANIE THOMPSON                                                                                  to treat COVID-19 in persons
                                                                                                     at high risk for serious out-
At the end of 2021, clinical trials of two promising agents screeched to a halt,                     comes. It is a two-drug regi-
disappointing many who were excited about the prospects for long-acting HIV                          men of the protease inhibitors
treatment and prevention with islatravir and injectable lenacapavir. This is                         nirmatrelivir and ritonavir and
why we do clinical trials, though, and they did their jobs correctly. Shout out                      is given twice daily for five
also to independent Data Monitoring Committees.                                                      days, beginning as soon as
                                                                                                     possible after diagnosis of
    On November 16, Merck stopped its study of once weekly oral islatravir                           COVID-19. As we know from
and MK-8507, an investigational long-acting NNRTI, because the external                              decades of use in HIV treat-
Data Monitoring Committee (eDMC) detected a decrease in total lympho-                                ment, ritonavir has many drug
cytes and T cell counts with the combination. At the time, the changes                               interactions that should be
seemed to be related to the dose of MK-8507. The next week, Merck and                                carefully considered before
Gilead temporarily paused enrollment into the much-anticipated trial of                              starting Paxlovid. A state-
once-weekly oral islatravir and lenacapavir. On December 6, at the recom-                            ment from the HIV Medicine
mendation of its eDMC, Merck paused enrollment in its two IMPOWER trials                             Association of the Infectious
of once-monthly oral islatravir for PrEP. Just a week later, the FDA placed a                        Diseases Society of America
partial clinical hold on seven oral islatravir/doravirine trials (no new enroll-                     recommends that people with
ment, but existing participants continue to get medication) and a complete                           HIV can take Paxlovid even
hold on six other islatravir treatment and prevention trials, including oral,                        if they are on a regimen con-
injectable, and implant formulations. At the same time, Merck and Gilead                             taining ritonavir or cobicistat,
also stopped dosing in a study of oral islatravir and lenacapavir. This may not                      but monitor for side effects.
portend the death of islatravir, but it is too soon to tell.                                         This is reiterated in the EUA
                                                                                                     package insert for Paxlovid.
    Lenacapavir, Gilead’s first-in-class capsid inhibitor, was being studied                         However, Paxlovid may
for treatment and prevention via subcutaneous injection every 6 months.                              interfere with other drugs
Obviously, it needed a suitable partner for treatment, and islatravir appeared                       you are taking, which would
to be an excellent choice. Gilead quickly submitted a New Drug Application                           require holding other drugs
for lenacapavir based on promising 26-week results of the phase 2/3                                  temporarily or changing their
CAPELLA trial in heavily treatment-experienced patients with multidrug                               dosage or, possibly, not taking
resistant virus. As with the pivotal trial of fostemsavir, the primary endpoint                      Paxlovid. If you are going to
was change in HIV RNA after 14 days of functional monotherapy, followed                              take Paxlovid for COVID-19,
by optimization of the background therapy (OBT) and open label lenacapavir.                          be sure to tell your care pro-
There was also a separate nonrandomized cohort who started LEN and OBT                               vider about all the medicines
from Day 1. These data were presented last July at the IAS Conference. The                           you take, including those that
combination of injectable lenacapavir and an injectable version of islatravir                        are over the counter.
was on the horizon until the FDA hold on islatravir stopped the phase I trial of
the injectable formulation.                                                                          Statement from
                                                                                                     HIVMA and IDSA
   For an even worse end to 2021, on December 21, Gilead announced that                              idsociety.org/globalassets/
the FDA had placed a clinical hold on injectable lenacapavir in all ongoing                          covid-19-real-time-learning-
studies for treatment and prevention, due to concerns about the safety of                            network/patient-populations/
the borosilicate glass vials. Both enrollment and dosing were stopped in 10                          hiv/oral-covid-tx-
ongoing trials. If there is good news here, it is that there was no concern                          considerations-for-people-
expressed about lenacapavir itself, so one hopes that Gilead will quickly solve                      with-hiv-and-hcv.pdf
this problem and continue on with the trials. However, if problems with isla-
travir are not solved, it will also be a setback for lenacapavir and LEN will be                     Statement from the
looking for another date to the prom.                                                                COVID19 Treatment
                                                                                                     Guidelines
   Still in the pipeline are ViiV’s maturation inhibitor GSK-3640254 (called                         covid19treatmentguidelines.
GSK-254); albuvirtide, a fusion inhibitor being developed by Frontier                                nih.gov/therapies/statement-
Biotechnologies; and a host of broadly neutralizing antibodies (bnAbs)                               on-paxlovid-drug-drug-
being studied alone and in combinations for treatment, prevention, and                               interactions/
cure. It’s clear that 2022 will be an interesting year in HIV drug development.
Get your popcorn!                                                                                    FDA Emergency Use
                                                                                                     Authorization Fact Sheet
                                                                                                     about Paxlovid
                                                                                                     fda.gov/media/155050/
                                                                                                     download

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POSITIVELY AWARE 2022 HIV DRUG GUIDE

                                                           Class list
                                               In this guide, HIV drugs are grouped into nine categories
                                             —plus, additional categories for select non-HIV drugs and PrEP

       STR                LA                CAI              INSTI             PI              PKE              NRTI            NNRTI             EI/AI
  SINGLE-TABLET       LONG-ACTING        LONG-ACTING    INTEGRASE STRAND    PROTEASE      PHARMACOKINETIC    NUCLEOSIDE     NON-NUCLEOSIDE   ENTRY INHIBITOR/
     REGIMEN           INJECTABLE      CAPSID ASSEMBLY TRANSFER INHIBITOR   INHIBITOR        ENHANCER          REVERSE           REVERSE       ATTACHMENT
    (MULTIPLE           REGIMEN           INHIBITOR         (INTEGRASE                       (BOOSTER)      TRANSCRIPTASE    TRANSCRIPTASE      INHIBITOR
  DRUG CLASSES)                                              INHIBITOR)                                       INHIBITOR         INHIBITOR
                                                                                                               (“NUKE”)       (“NON-NUKE”)

PAGE         BRAND NAME                  CATEGORY               GENERIC NAME
29           Atripla                         STR                efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF)
21           Biktarvy                        STR                bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)
31           Cabenuva                         LA                cabotegravir/rilpivirine long-acting (CAB LA/RPV LA) injectable
41           Cimduo                         NRTI *              lamivudine/tenofovir DF (3TC/TDF)
28           Complera                        STR                rilpivirine/emtricitabine/tenofovir DF (RPV/FTC/TDF )
26           Delstrigo                       STR                doravirine/lamivudine/tenofovir DF (DOR/3TC/TDF)
39           Descovy                        NRTI *              emtricitabine/tenofovir alafenamide (FTC/TAF)
23           Dovato                          STR                dolutegravir/lamivudine (DTG/3TC)
47           Edurant                       NNRTI                rilpivirine (RPV)
43           Emtriva                        NRTI                emtricitabine (FTC)
44           Epivir                         NRTI                lamivudine (3TC)
42           Epzicom                        NRTI *              abacavir/lamivudine (ABC/3TC)
36           Evotaz                       PI / PKE              atazanavir/cobicistat (ATV/COBI)
27           Genvoya                         STR                elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF)
50           Intelence                     NNRTI                etravirine (ETR)
34           Isentress HD                   INSTI               raltegravir (RAL)
32           lenacapavir                     CAI                lenacapavir (LEN )—NOT YET APPROVED AT PRESS TIME
24           Juluca                          STR                dolutegravir/rilpivirine (DTG/RPV)
37           Norvir                          PKE                ritonavir (RTV)
28           Odefsey                         STR                rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF)
48           Pifeltro                      NNRTI                doravirine (DOR)
35           Prezcobix                    PI / PKE              darunavir/cobicistat (DRV/COBI)
35           Prezista                         PI                darunavir (DRV)
36           Reyataz                          PI                atazanavir sulfate (ATV)
53           Rukobia                          AI                fostemsavir (FTR)
51           Selzentry                        EI                maraviroc (MVC)
27           Stribild                        STR                elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/FTC/TDF)
49           Sustiva                       NNRTI                efavirenz (EFV)
30           Symfi/Symfi Lo                  STR                efavirenz/lamivudine/tenofovir DF (EFV//3TC/TDF)
25           Symtuza                         STR                darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/COBI/FTC/TAF)
41           Temixys                        NRTI *              lamivudine/tenofovir DF (3TC/TDF)
33           Tivicay                        INSTI               dolutegravir (DTG)
22           Triumeq                         STR                dolutegravir/abacavir/lamivudine (DTG/ABC/3TC)
52           Trogarzo                         EI                ibalizumab-uiyk (IBA)
40           Truvada                        NRTI *              emtricitabine/tenofovir DF (FTC/TDF)
38           Tybost                          PKE                cobicistat (COBI)
45           Viread                         NRTI                tenofovir disoproxil fumarate (tenofovir DF, or TDF)
46           Ziagen                         NRTI                abacavir sulfate (ABC)
                                                                                        * Fixed-dose combination of two drugs from the same drug class.

HIV PRE VENTION
57       Apretude for PrEP PrEP cabotegravir extended-release injectable suspension (CAB LA)
58       Descovy for PrEP  PrEP emtricitabine/tenofovir alafenamide (FTC/TAF)
59       Truvada for PrEP  PrEP emtricitabine/tenofovir DF (FTC/TDF)

NON-HIV DRUGS
60      Egrifta SV tesamorelin for injection for HIV-related hard belly fat
60      Mytesi          crofelemer           for HIV/AIDS-associated diarrhea
61      Serostim   somatropin for injection  for HIV-related wasting

20     M A R CH+A PRIL 202 2        | positivelyaware.com/hiv-drug-guide
POSITIVELY AWARE 2022 HIV DRUG GUIDE

                                         Biktarvy                               bictegravir/emtricitabine/tenofovir alafenamide
                                                                                BIC/FTC/TAF

                                                Single-tablet regimen
                                          STR   containing an INSTI and two NRTIs          ★ Recommended initial regimen for most people

n STANDARD DOSE                                                                            DR. MELANIE THOMPSON:                avoided by the switch, address-
One tablet once daily without regard to food for people taking HIV                          Small and potent, Biktarvy          ing a common polypharmacy
treatment for the first time (treatment-naïve) or individuals with sup-              is a popular “go-to” initial               issue in older persons who have
pressed viral load on a stable HIV regimen with no history of treat-                 therapy, including for same-               multiple comorbidities. Never
ment failure and no known resistance to components of the regimen:                   day HIV treatment start. It has            take Biktarvy with dofetilide, a
bictegravir, emtricitabine, or tenofovir. Tablet contains 50 mg of the               a high resistance barrier. A               heart rhythm medicine, as levels
INSTI bictegravir plus 200 mg emtricitabine and 25 mg TAF.                           recent randomized open label               of defetilide are increased and
                                                                                     study, GS-380-4030, found that             serious rhythm disturbances
   For adults and children weighing at least 55 pounds (25 kg), use                  individuals with suppressed                could occur. Biktarvy increases
standard dose above or see package labeling. New pediatric formula-                  virus on DTG + TDF/FTC or TAF/             metformin levels and the metfor-
tion available for children at least 2 years old and weighing 30.8–55                FTC could safely switch to                 min dose may need to be adjusted
pounds (14–25 kg), Biktarvy Low Dose—use one tablet daily with or                    Biktarvy even in the presence of           if there are side effects. Several
without food. Each Biktarvy Low Dose tablet contains BIC 30 mg/FTC                   some previous NRTI resistance,             medications for seizures or tuber-
120 mg/TAF 15 mg. Take missed dose as soon as possible, unless it is                 including the M184V mutation               culosis cannot be taken with
closer to the time of your next dose. Do not double up on your next dose.            associated with resistance to              Biktarvy. St. John’s wort decreas-
Biktarvy is not recommended for people with CrCl less than 30 mL/min                 FTC and 3TC. Weight gain can be            es Biktarvy levels and should be
or people with severe liver impairment. Biktarvy may be used for people              associated with INSTIs and TAF,            avoided. Take aluminum- or mag-
with an undetectable viral load and CrCl less than 15 mL/min who are                 and among INSTIs, bictegravir              nesium-containing supplements,
also receiving hemodialysis.                                                         and dolutegravir were associ-              vitamins, or antacids at least 2
                                                                                     ated with more weight gain than            hours after or 6 hours before
                                                                                     elvitegravir/COBI, NNRTIs, and             Biktarvy, although iron- and
➤ SEE ALSO DESCOVY, which                aching, or tenderness on the right          PIs in several studies. In an              calcium-containing compounds
   is contained in this drug             side below the ribs.                        analysis of 8 randomized trials,           can be taken with Biktarvy and
   (bictegravir is not available                                                     the average weight gain for BIC-           a meal. I have seen lots of “low-
   separately).                          n POTENTIAL DRUG INTERACTIONS               and DTG-containing regimens                level viremia” cured by adjusting
➤ SEE PACKAGE INSERT for more                Do not take with rifampin or            was 3.5 kg (7.7 lbs.) at 96 weeks.         supplements. Don’t take Biktarvy
   complete information on poten-        dofetilide. Not recommended to              It’s important to watch your diet          if you are planning to become
   tial side effects and interactions.   be taken with Cimduo or Temixys,            and exercise regardless of what            pregnant because of lack of data
                                         Descovy, Emtriva, Epivir-HBV,               you are taking, but that can               for safety in pregnancy. If you
n POTENTIAL                              Hepsera, Truvada, Vemlidy, or               be especially true with a TAF +            are already pregnant and taking
SIDE EFFECTS AND TOXICITY                Viread, all for treatment of hepatitis      INSTI combo. All INSTIs have               Biktarvy, talk with your HIV care
Most common side effects (rarely         B, as the emtricitabine and tenofo-         the potential for insomnia or,             provider about whether it’s advis-
experienced) include headache,           vir components of Biktarvy already          rarely, worsening of depression            able to continue the drug.
nausea, and diarrhea. INSTIs and         treat HBV. Biktarvy can be taken at         or suicidal ideation, particularly
TAF are associated with weight           least two hours before or six hours         if there are pre-existing mental                ACTIVIST MICHAEL BRODER:
gain. Serum creatinine, estimated        after taking laxatives or antacids,         health issues. INSTIs have fewer                 Most people taking
creatinine clearance, urine glucose,     sucralfate, oral iron or calcium            drug-drug interactions than                Biktarvy (approved in 2018) have
and urine protein should be              supplements (but either of these            most NNRTIs and PIs. A Gilead-             no side effects. Concerns have
obtained before initiating Biktarvy      two can be used with Biktarvy if            sponsored chart review study in            emerged about weight gain on
and should be monitored. BIC can         taken with food at the same time),          350 persons who were at least              INSTI-containing regimens. As
cause a small, reversible increase       or buffered medications. Start met-         50 years old who had switched              always, your provider should
in serum creatinine within the first     formin at lowest dose and titrate           to Biktarvy found that 140 drug            help you weigh the benefits
few weeks of treatment that does         based on tolerability and clini-            interactions in 121 people were            against the risks.
not affect actual kidney function.       cal effect. Monitor for metformin
There have been rare reports of          adverse effects. When starting
depression and suicidal ideation         or stopping Biktarvy in people on           have detectable virus when they
with INSTIs, primarily among             metformin, dose adjustment of met-          switch to it from another regimen
people with a history of psychiatric     formin may be necessary to main-            (having experienced virologic failure
illnesses. DHHS guidelines               tain optimal glycemic control. Not          on their previous regimen). At this
recommend closely monitoring             recommended with St. John’s wort.           time, there aren’t sufficient data to
people with pre-existing psychiatric     Can be taken with Epclusa, Harvoni,         support the use of Biktarvy during
conditions. Prior to initiation,         Sovaldi, and Vosevi. Tell your pro-         pregnancy. Pregnant individuals can
test for hepatitis B virus (HBV).        vider or pharmacist about all medi-         voluntarily enroll in the Antiretroviral
Severe exacerbations of HBV have         cations, herbals, and supplements           Pregnancy Registry through their
been reported in people with             you are taking or thinking of taking,       provider; go to apregistry.com.
co-infection who have discontinued       prescribed or not, as there are other
Biktarvy (due to elimination of the      drug interactions which are not             n MANUFACTURER
emtricitabine and TAF components,        listed here.                                Gilead Sciences, Inc.
which also treat HBV). Monitor liver                                                 gilead.com; biktarvy.com
enzymes closely. Initiation of HBV       n MORE INFORMATION                          (800) GILEAD-5 (445–3235)
therapy may be warranted upon            New pediatric formulation, Biktarvy
discontinuation of Biktarvy. Call        Low Dose, became available                  n AVERAGE WHOLESALE PRICE
your health care provider right away     late last year. Biktarvy is widely          $4,300.56/month
if you develop any of the following      prescribed because of its efficacy
signs of hepatitis: yellowing of the     and safety profile as well as relative
skin or whites of the eyes; dark         lack of resistance emerging from
or tea-colored urine; pale-colored       use of this treatment in clinical trials.
bowel movements; nausea or               Data are accumulating that show
vomiting; loss of appetite; or pain,     Biktarvy works for people who

                                                                                              positivelyaware.com/biktarvy | M A R C H + A P R I L 2 0 2 2      21
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