Long-acting PrEP with cabotegravir could be around the corner

HIV prevention with just one injection a month could be here soon.

The U.S. Food and Drug Administration (FDA) has granted priority review to a New Drug Application (NDA) for the long-acting medication cabotegravir to be used once a month as prevention against HIV. The FDA has set a target approval date of January 24, 2022.

“In the United States, fewer than 25% of those who could benefit from PrEP [pre-exposure prophylaxis] are currently taking it, which points to the need for additional HIV prevention options. We believe new options like investigational cabotegravir long-acting for PrEP will help play a significant role in our collective efforts to end the HIV epidemic,” said Kimberly Smith, MD, MPH, head of Research & Development for ViiV Healthcare, in a company press release September 28, the day that the FDA granted the priority review.

The NDA was based on good results from studies HPTN 083 and HPTN 084. Those studies demonstrated safety and also declared superiority in preventing HIV compared with a daily tablet of Truvada for PrEP.

Long-acting cabotegravir is currently used for the treatment of HIV, in combination with another long-acting injectable medication (LA rilpivirine). The two injections are taken once monthly. There are hopes of being able to use the combination every other month for the treatment of HIV.

ANCHOR study: Stopping anal cancer in its tracks in HIV

Treating pre-cancerous anal lesions is better at preventing anal cancer than aggressive monitoring, according to a large, Phase 3 multi-center study in people living with HIV.

“ANCHOR data show for the first time that, like cervical cancer, anal cancer can be prevented even in high-risk populations, such as people living with HIV, who often have HSIL [high-grade squamous intraepithelial lesions] that can be difficult to treat,” said lead investigator Joel Palefsky, MD, a professor of medicine at the University of California San Francisco, in a press statement. “Although the study was performed in people living with HIV, the results suggest that anal cancer prevention could be similarly possible in other groups known to be at increased risk of anal cancer, including women with a history of vulvar or cervical cancer, men who have sex with men who are HIV-negative, and men and women who have immunosuppression for reasons other than HIV infection.”

The study results were released early, in October, because of their public health importance. There were 4,446 participants in the ANCHOR study (Anal Cancer/HSIL Outcomes Research study). 

ANCHOR was conducted through the AIDS Malignancy Consortium through the National Cancer Institute.

Volunteers sought for clinical studies

The UCLA Center for Clinical AIDS Research and Education (CARE) is currently seeking volunteers for these research studies:

A5359—This study is investigating if long-acting injectable antiretroviral therapy (ART) as a monthly shot will be more successful for people who have trouble taking daily, oral HIV medication. 

A5391—The Do IT Study is looking for people living with HIV who have experienced weight gain from taking a treatment regimen that contains both an integrase inhibitor (such as bictegravir, dolutegravir, or raltegravir) and “new” tenofovir (TAF, tenofovir alafenamide). This study will assess whether the new combinations reduce weight gain or possibly reverses the weight gain over 48 weeks compared to people who remain on their current ART.

CARE provides primary HIV care and HIV prevention clinical services and conducts DAIDS network sponsored research in HIV treatment and prevention.

For more information, go to uclahealth.org/care-center or contact the UCLA study team at (310) 843-2015 or careoutreach@mednet.ucla.edu

Other sites around the country, including Northwestern Universityin Chicago and the University of Pittsburg, are also conducting these trials. Go to actgnetwork.org/studies/a5359-the-latitude-study and to actgnetwork.org/studies/a5391-doravirine-for-persons-with-excessive-weight-gain-on-integrase-inhibitors-and-tenofovir-alafenamide-the-do-it-study.

Home HIV testing program reaches out to Black, Latinx LGBTQ folk

The Human Rights Campaign (HRC) Foundation in August announced the first national home HIV testing program focused on reaching Black and Latinx gay and bisexual men and transgender women of color. 

The foundation is working in partnership with Us Helping Us, in Washington, DC, an organization founded in 1985 as a Black-led, community-based HIV services organization. 

“Today, Black and Latinx gay men and transgender people are still dying of HIV and dying at disproportionately high rates,” said HRC president Alphonso David in a press release. “Although we have made significant advances in addressing HIV, some of our communities remain ravaged by it.” 

HRC is the largest LGBTQ civil rights organization in the country, and the foundation represents its educational arm.

The home testing kits, supported by HIV drug maker Gilead Sciences, are part of the My Body, My Health education campaign. The 5,000 kits will include the OraQuick oral swab, condoms and lubricant, a referral to providers for HIV prevention medicine, and an online services page for local HIV prevention and treatment services. 

Home HIV testing kits can be ordered at mybodymyhealth.org.

Making sure that insurers, providers know that PrEP is free

As of last year, preventing HIV with the use of PrEP (pre-exposure prophylaxis) should be covered by insurers without co-pays or any other cost-sharing. But some medical groups may not understand that this also includes the services associated with the HIV prevention pills (Descovy and Truvada). These services, for example, include testing for hepatitis B and C and screening for STIs. To clarify these issues, three government departments (Labor, Health and Human Services, and the Treasury) issued an FAQs (frequently asked questions) document in August. Aimed at service providers, the document is technical. The points made include the fact that insurance companies can request that generic Truvada be used in order for the PrEP to be cost-free to the individual. Go to bit.ly/dol-FAQ-ACA-part47.

New infections down globally, but not enough

The World Health Organization (WHO) reported that a decline in new HIV infections across the globe from 2010 to 2020 was smaller than expected, and downward movement has actually stalled. 

While declines were greatest in sub-Saharan Africa and the Caribbean, “too few” countries were using a combination of structural, behavioral, and biomedical interventions focused on groups of people with the greatest risk as needed for greater declines. 

According to the announcement, “While the global rollout of HIV treatment has saved millions of lives, efforts to prevent new infections have been less successful. The annual number of new HIV infections among adults globally has hardly changed over the last four years, and total new infections have declined by just 31% since 2010, far short of the 75% target for 2020 that was set by the United Nations General Assembly

in 2016.”

Read the September report at bit.ly/UNreportSEP2021.

HIV information en español 

POZ magazine, a national publication that, like Positively Aware, is devoted to serving people living with HIV and their allies, has added posters in Spanish to its repertoire of information in that language. Started in 1994, POZ produced its first issue in Spanish in 1997. Since then, POZ has continued to add more information in Spanish, both online and in print. POZ Basics in Spanish, for example, was rolled out in 2006. There is also a Spanish language sister site, Tu Salud (Your Health), which is devoted to health care in general and produces bilingual issues. This year, Tu Salud issued a new digital issue specifically on sexual health. The POZ Health Information Posters come in silver frames, and are meant to “empower your clients with the information they need to actively engage in their health care.” Go to poz.com/posters. ¡Googlelealo!

Latinx LGBTQ health series debuts online

Latino Alternative TV (LATV) in October kicked off an online digital series for the LGBTQ+ community, My Health Agenda. The October 6 premiere featured Erick Velasco from The Homo Homie podcast. Others telling their stories in the series through the month of November include trans recovery advocate Jennifer Rodriguez; influencer Curly Velasquez; and artist, filmmaker, and HIV activist Vasilios Papapitsios. Dr. Ariel Ourian, a plastic surgeon who works with many individuals in the LGBTQ+ community, leads the conversations with the featured guests. In addition to talking about their journeys, they also address myths, stigmas, and fears around health. 

The series, part of LATV’s Proud initiative, takes a creative approach with artwork from members of the LGBTQ+ community, including illustrator Tevy Khou and trans visual artist Ledesma Vazquez.  

The series began airing in October to coincide with Hispanic Heritage Month and in observance of National Latinx AIDS Awareness Day on October 15. It aims to help people “feel seen and empowered,” especially to take steps towards their own vision of health, according to a press release from LATV.

“We empowered incredibly talented creators from our community to bring a unique series to life that gives visibility and representation to members of our community who make us proud in a way that is genuine, creative, and original,” said Andres Palencia, creator and director of My Health Agenda, in the release. “As Latinos, it can be difficult to bring up health-related conversations for a number of reasons. We decided to create this series as a loving and creative ‘ice breaker’ of sorts so we can normalize health-related conversations for LGBTQ+ people—especially Latinos.” 

Vaya. Go to latv.com.

Love (photo by Ahron R. Foster)

Black playwright living with HIV creates prize to support new talent

Donja R. Love, an African American playwright living with HIV, has expanded his Write It Out! program for other positive playwrights to include award money. 

On his Facebook page, Love wrote, “With the support of Billy Porter and GLAAD, I’ve created a new prize for playwrights living with HIV. I’m actually about to cry! On top of the 10-week playwright’s course, Write It Out! now has a prize which consists of $5,000 and a year of dramaturgical support. Our lives and our stories matter!”

Love is also the creator of Youth Write Now for LGBTQ youth ages 14–18, and Learning to Love, which pairs playwrights ages 18–35 with an older playwright. 

Love, writer of Sugar in Our Wounds, Fireflies, soft, one in two, and The Trade, won the 2021 Terrence McNally Award for What Will Happen to All That Beauty? from the Philadelphia Theatre Company. The company reported, “A Philly native, his work examines the forced absurdity of life for those who identify as Black, Queer, and HIV-positive—a diverse intersection filled with eloquent stories that challenge the white supremacist, heteronormative structures that exist in American culture.”

Matt Cameron (left) gets wet with Damon Jacobs

Tub Talks with Damon Jacobs

HIV prevention advocate Damon L. Jacobs, founder of the Facebook page PrEP Facts, shows a fun side to serious conversation with Tub Talks, which he started uploading in September to his YouTube channel. In Tub Talks, Jacobs has a one-on-one conversation with men working in HIV treatment and prevention, and other interesting work—while they’re in a bathtub together. Think of bubbles as part of a celebration of life and add love of self and community. Jacobs is a licensed marriage and family therapist in New York state and author of Absolutely Should-less: The Secret to Living the Stress-Free Life You Deserve. Go to youtube.com/user/DamonLJacobs/videos?app=desktop.

Bushe (photo: LoganAir)

Documentary shows positive pilot achieving his dream

James Bushe only ever wanted one career—to be a pilot. Then HIV discrimination changed his course. Bushe, from Stoke-on-Trent, England, discusses his journey in the new short documentary, The Tyranny of Petty Things. 

“The only thing I could think about was, This is the only thing you’ve ever wanted to do. You cannot let this go,” Bushe says in the film. 

“All of the evidence—all of the medical evidence—that was used to justify the authorities’ position on HIV at the time was outdated,” he continued. “And it didn’t know, or didn’t recognize, that somebody that’s on successful treatment had the virus suppressed in the body so you weren’t going to become incapacitated at any point in time. There was blatant discrimination based on somebody’s HIV status and … that didn’t make any sense to me … and it needed to be challenged.” 

His success at changing the regulations, with the support of the news media, community, and politicians, came with scars, and he also confronted self-stigma. In January 2020, he became the first HIV-positive commercial pilot in Europe, based in Glasgow, Scotland, and flying for Loganair.

“Flying, to me, has always felt very therapeutic,” said Bushe.

Terrence Higgins Trust, a British charity that provides services related to HIV and sexual health, premiered the film August 17 as part of its Life Really Changed campaign. Said Chief Executive Ian Green, “The incredible progress we’ve made in the fight against HIV means a diagnosis doesn’t have to be a barrier to success.”

“There’s no place for discrimination based on status in 2021,” he added. “Tell everyone.”

The film was directed and produced by Cameron Nicoll. Read the story and watch the film at tht.org.uk/news/pilot-launches-film-about-his-campaign-overturn-hiv-training-ban.

Stories of recovery told in new National AIDS Memorial documentary

The National AIDS Memorial in August released another in its series of mini-documentaries, Surviving Voices. 

In Substance Users, the Recovery Community & AIDS, several members of the LGBTQ community who are living with HIV tell their stories. They talk about how they started using drugs, how they suffered from that, and how they got better. They examine fears, stigma, and resilience. Insights from professionals working in the field are also included. 

“People who use drugs have been integral to the fight against AIDS,” says one person.

“Being sober is not always fun and pretty, pink skies,” another person admits. 

The National AIDS Memorial said its multi-year oral history was created to “ensure the myriad stories and lessons of the epidemic are captured, curated, and retained for current and future generations.” 

Other mini-documentaries from Surviving Voices include The Transgender Community & AIDS, The A&PI Community & AIDS, Women & AIDS, The National Hemophilia Community & AIDS, and The San Francisco Leather Community & AIDS. The films are produced and directed by Jörg Fockele and funded through a grant by Chevron, a long-standing partner of the National AIDS Memorial. Community partners include the San Francisco AIDS Foundation, The Elizabeth Taylor 50-Plus Network, Stonewall Project, and the Castro Country Club.

“We believe in the power of storytelling and the lessons it can teach current and future generations,” said Huma Abbasi, general manager, Health & Medical at Chevron, in a press release from the memorial. 

Go to aidsmemorial.org/surviving-voices. Other oral history sites collecting stories from the epidemic are listed.

Boston Planning Council unveils anti-stigma video

Boston’s Ryan White HIV Planning Council unveiled a short video as part of an anti-stigma campaign, Someone You Know and Love. In the film, council members talk about a diagnosis, and the conversations they’ve had with parents, children, partners, and friends. They discuss experiences of living with HIV, both personal and within the overall epidemic.

Catherine Joseph talks about the experiences of her partner, Shirley, who appears in the video. “They didn’t invite us to the house anymore,” she says of some family members. 

“People are afraid of what they don’t know,” council member Larry Day says in the video, “and most folks didn’t really know, didn’t really understand, what HIV was [in the beginning of the epidemic].”

At the video’s debut in August, the city’s Chief of Health and Human Services, Marty Martinez, formerly of the Boston AIDS Consortium, said, “The fact that there is this video related to stigma and wanting to break down stigma, especially at a time like now, is remarkable, and important.” He said there’s a need for creating access to care and services by breaking down barriers, to help people “not just survive but to thrive,” as council committee chair Tim Young proclaims.

Go to youtube.com/watch?v=_lL0-vtGodw.

New podcasts from International AIDS Society, NMAC

“We now live in a world where AIDS has become old news: the forgotten pandemic,” said the International AIDS Society (IAS) of the podcast it debuted earlier this year, HIV unmuted.

Speakers lending their voice and expertise to shake that up start with Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), with Back to the beginning: AIDS and the elusive vaccine. 

Others speaking with Femi Oke, British television presenter and journalist, and podcast host, include Michael Gottlieb, MD, who reported the first case of HIV in the U.S., and long-time activist and epidemiologist Gregg Gonsalves, PhD. Advocates discussing vaccine research and vaccine myths are Vincent Basajja (Uganda), Udom Likhitwonnawut (Thailand), and Maureen Luba (Malawi).

In the second podcast, French virologist Francoise Barre-Sinoussi talks about her co-discovery of HIV back in 1983. Also speaking up are Australia’s health minister Neal Blewett; long-term survivor and Pacific Islander Vince Crisostomo on facing fear and stigma; and Vuyiseka Dubula, of South Africa, on the myths that led her to activism.

Subscribe to HIV unmuted for free wherever you listen to podcasts. “Join us as we journey through four decades marked by resilience in the face of adversity,” IAS said in September with a release of its first three episodes.

NMAC (formerly the National Minority AIDS Council) has launched its own podcast, Real Talk with NMAC. The first episode introduced the podcast’s hosts. The second episode observes National Latinx AIDS Awareness Day featuring NMAC’s treatment manager Damián Cabrera, and is entirely in Spanish. The podcast is available at nmac.org/resource-library/podcasts and through Apple Podcasts, Google Podcasts and Spotify.

Morrison (photo: Heidi Gutman-ABC)

Young TV producer publicly discloses his HIV status

ABC news producer Tony Morrison writes about living with HIV on the eighth anniversary of his diagnosis, on the Good Morning, America website. He was only 23 when he learned of his status. Morrison writes about being overwhelmed with negative emotions, some of them resulting from comments by people around him, not by living with the virus. It made living fully more difficult. He writes about feeling alone, until his doctor explained that he was not alone, and that he could look forward to a long and normal life. She also explained U=U—telling him that his undetectable viral load means “there would be virtually no risk of me passing the virus to anybody else.” 

“My reality is that I am not only alive, I am thriving,” Morrison writes.

“But learning to thrive has been and continues to be a process.

“And thriving, I’ve found too, is a choice.” 

He concludes, “I’ve found that living is a duty. I’m choosing to celebrate life as long as I have life to live.”

Read the essay: goodmorningamerica.com/living/story/personal-essay-learned-living-hiv-secret-years-79392051.

L’Art de Rue Bonaparte, from the ArtPositive exhibit (courtesy of Bóre Ivanoff)

Artists living with HIV say ‘no’ to stigma with Paris exhibit 

Artists from across Europe who are living with HIV worked together to fight stigma and discrimination with ArtPositive, an exhibit held in Paris in September at the Galerie Marie Holmsky.

“Although science has made great strides, discrimination against people living with HIV has largely remained,” they write in an artist statement. “Fear and prejudice are deeply rooted in people for no good reason. However, some people with HIV also self-stigmatize and many cannot, because of public pressure, reveal their status.

“ArtPositive is an artistic project, the culmination of which will be an international exhibition by visual artists living with HIV. 

“The objective of this initiative is to combat, through art, the stigma, discrimination, and isolation some people still face living with the virus.

“We are HIV-positive artists from different countries and we want to say NO to HIV stigma! We want to show through our artistic creations, exhibited in a high-class art gallery (located in the artistic epicenter of Paris, the Saint-Germain-des-Pres quartier), that we are people and artists like all the others in the world.

“The virus in the blood is apparently easier to eliminate than stigma in the mind.

“We want people to know that everyone has the same rights, duties, and opportunities whether you live with or without HIV.”

The statement is signed by the four artists: Nacho Hernandez Alvarez, of Barcelona, Spain; Bóre Ivanoff, of Paris, France and Bulgaria; Adrienne Seed, of Manchester, UK; and Philipp Spiegel, of Vienna, Austria.

In an email to Positively Aware, Ivanoff wrote that visibility and popularity “will be a great help and encouragement to fight HIV-related stigma and discrimination and to encourage other people living with HIV to organize similar activities, to go out in public and not be ashamed of HIV.”

ArtPositive was produced in partnership with Elus Locaux Contre le SIDA; EACS (European AIDS Clinical Society), Brussels; Visual AIDS, New York City; and Forum Culturel Autrichien, Paris.