TOGETHER - POSITIVELY AWARE MARCH+APRIL 2022
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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
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. 2 M A R CH+A PRIL 202 2 | positivelyaware.com/subscribe
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 positivelyaware.com/subscribe | M A R C H + A P R I L 2 0 2 2 3
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 4 M A R CH+A PRIL 202 2 | positivelyaware.com/subscribe
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 SUBSCRIBE OR ORDER COPIES 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 S I N C E 1 9 9 0 , P U B L I S H E D BY 16 LOOKING AHEAD HIV treatment can be costly, but there’s help. 5537 N. BROADWAY New drugs in development. CHICAGO, IL 60640-1405 (773) 989-9400 2022 PULL-OUT HIV DRUG CHART SPONSORED BY fax : (773) 989-9494 inbox@tpan.com positivelyaware.com @PosAware FOR A LIST OF WALGREENS HIV SPECIALTY PHARMACIES, AND OTHER RESOURCES, GO TO HIV.WALGREENS.COM 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. positivelyaware.com/subscribe | M A R C H + A P R I L 2 0 2 2 5
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 6 M A R CH+A PRIL 202 2 | positivelyaware.com/subscribe
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. positivelyaware.com/subscribe | M A R C H + A P R I L 2 0 2 2 7
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
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. positivelyaware.com/subscribe | M A R C H + A P R I L 2 0 2 2 11
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 12 M A R CH+A PRIL 202 2 | positivelyaware.com/subscribe
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 positivelyaware.com/subscribe | M A R C H + A P R I L 2 0 2 2 13
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 14 M A R CH+A PRIL 202 2 | positivelyaware.com/subscribe
✔ 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 positivelyaware.com/subscribe | M A R C H + A P R I L 2 0 2 2 15
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 positivelyaware.com/subscribe | M A R C H + A P R I L 2 0 2 2 17
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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