The national Treatment Action Group (TAG), based in New York and born of the city’s early ACT UP struggles, has released five of its annual research pipeline reports online.
Comprehensive yet readable, the TAG reports take you step-by-step through some of the most important research being conducted today. They cover far more than is possible in your average newspaper or magazine story.
Frustrated by the lack of an HIV vaccine? Get a deeper understanding of the process in the vaccine update. (Yes, there’s still hope for a vaccine, but not in the near future. We probably have at least a decade to go before testing for efficacy in a trial begins, the report tells us.)
- The Antiretroviral Therapy Pipeline report covers the clinical research for new antiretroviral drugs for treating HIV that are on the way
- The HIV Vaccines and Passive Immunization Pipeline report covers progress toward designing vaccines capable of inducing broadly neutralizing antibodies (bNAbs) and plans for a new efficacy trial of passive immunization (direct antibody infusion) involving a triple bNAb combination
- The PrEP and Microbicides Pipeline report provides an update on the latest PrEP efficacy results with the long-acting drug lenacapavir (Sunlenca) and covers newly initiated trials of microbicide inserts for vaginal or rectal use
- The Research Toward a Cure and Immune-Based Therapies Pipeline report highlights the recent launching of large phase 2 clinical trials for several candidate approaches and documents an increase in the number of new cure-related studies with sites in Africa
- The Long-Acting Therapies Trials Tracker for Hepatitis C, Opioid Use and Overdose Prevention Therapy, and Malaria covers how long-acting therapies offer a choice and an opportunity, and address pill fatigue
TAG dedicates itself “to ensure that all people living with or impacted by HIV, TB or HCV—especially communities of color and other marginalized communities experiencing inequities—receive life-saving prevention, diagnosis, treatment, care and information.”
A tuberculosis report is scheduled for release this fall. To view the reports, GO TO treatmentactiongroup.org.
Ryan White program may now cover security deposits
The Ryan White HIV/AIDS Program (RWHAP) for the first time will be able to cover the cost of a housing security deposit. Not all program recipients will be eligible for deposit funds, and the money will have to be returned to the program, not the individuals. The Health Resources and Services Administration (HRSA) announced its new policy action in June.
According to HRSA, the Ryan White program provides care and treatment services to more than 560,000 low-income people living with HIV, “addressing factors like access to housing and transportation that directly affect clients’ ability to enter and stay in care.”
To read HRSA’s statement on the policy update, GO TO bit.ly/46APLt4. The statement links to the HRSA letter explaining the policy to RWHAP agencies.
Between the lines of TAG’s reports on new drugs for HIV treatment and prevention
Richard Jefferys, a long-time member of TAG and the group’s Basic Science, Vaccines and Cure project director, shared his thoughts about the reports and HIV drug development during a Zoom conversation with POSITIVELY AWARE.
“Our ideal world is one where people have maximum choice,” Jefferys said. “I think advocates think that there’s still room for better or daily oral drugs. We don’t really want to see development of those completely stop, but the [pharmaceutical] industry has shifted to these more kind of intermittent types of [long-acting injectable] regimens.
“There is obviously interest out there in the community for long-acting options, where people don’t have to worry so much about daily adherence. There’s also the fact that for some people, it’s a reminder, they don’t want to have to think about it every day.
“The longest-acting drug is lenacapavir [an injection that’s every] six months,” he said. Jefferys added that the search is on to find a partner for lenacapavir, another antiretroviral drug or a different strategy that, combined, could become a new, long-acting complete regimen. Among the candidates are broadly neutralizing antibodies (bNAbs), a type of antibody that can identify and block different strains of HIV from infecting healthy cells.
But bNAbs are not without their own issues. Y-shaped antibodies are best at neutralizing a virus. The surface of a virus is covered with “spikes” of proteins. To block infection, both arms of an antibody’s “Y” have to be able to bind to and block two protein spikes at more or less the same time. A bNAb’s “arms,” though, don’t always have enough reach.
“And so I think ideally, that [researchers] are hoping to get to a point where you can have maybe two or three antiretrovirals that are given every six months [as a complete regimen], and lenacapavir will be one of them,” Jefferys said. “But they’re not quite there yet. I think it’s going to be another year or two at least. I don’t think there’s an obvious antiretroviral candidate out there at the moment.”
Still, the recent announcement that lenacapavir was 100% effective in preventing HIV among a group of cisgender women in the phase 2 of the PURPOSE 1 clinical study was a game changer. “We had to rewrite this year’s PrEP pipeline report because the news came out in June, which was a pretty amazing and historic result,” he said.
“I think now it’s a case of waiting for the PURPOSE 2 results. It’s a large study of cisgender men who have sex with men plus transgender and nonbinary people, to make sure that efficacy also is there. If it is, they [Gilead, the maker of lenacapavir] will be looking to file for approval, and have some kind of access plan, which is still a bit vague for now.”
Jefferys is hopeful that more effective treatments and a vaccine will be developed but believes it will take more time than people realize.
“I’m still optimistic that a highly effective vaccine is possible, if a way of inducing bNABs can be figured out. I doubt it’s going to happen within the next five years. Hopefully we’re going to see an efficacy trial of a bNAb-inducing vaccine sometime over the next decade.”
—Rick Guasco
NMAC’s Get Out The Vote campaign
November’s elections could be key to sustaining the federal Ending the HIV Epidemic (EHE) Initiative, says NMAC, a national organization advocating for people living with HIV that “leads with race.” As such, NMAC has launched its Get Out The Vote (GOTV) campaign.
GOTV kicks off a tour of historically Black colleges and universities (HBCUs) this fall as part of its focus on people of color but particularly young people ages 18–35. NMAC reported that youth are “increasingly disengaged and uninterested” in this year’s choices. One survey found that nearly two-thirds of respondents in this age group were unsure if they would vote at all. Young people make up nearly 40 million potential voters.
NMAC also reported a growing racial gap in voting since 2012 resulting from voter suppression laws. These included nearly 100 restrictive voting laws in 29 states since 2013 that put barriers to voting in place that primarily affect people of color.
GOTV is working with several other national advocacy groups: the National Action Network (civil rights organization), the Human Rights Campaign (LGBTQ+ advocacy), Advocates for Youth, LGBTQ+ Task Force, LGBTQ+ Victory Fund, the National Urban League and HBCUs.
The campaign also focuses on people living with HIV and their allies. To help mobilize the vote, GO TO nmac.org. The NMAC Coalition for Justice and Equality will gather for its annual meeting after the November 5 elections to explore the question, “Where Do We Go from Here After the 2024 Election?”
Frequent cannabis use associated with heart attacks and strokes
According to a study of 435,000 individuals, frequent cannabis smoking may significantly increase the risk of heart attack or stroke. Cannabis, in several forms, is used for treating many debilitating symptoms of illness, including those found with HIV/AIDS and chronic hepatitis.
The study reported a 25% greater likelihood of heart attack and 42% greater possibility of stroke with daily use of cannabis, predominantly smoking. Weekly use was associated with a much smaller increased risk, 3% for heart attack and 5% for stroke. About 75% of respondents said they usually smoke it.
“We’ve known for a long time that smoking tobacco is linked to heart disease, and this study is evidence that smoking cannabis appears to also be a risk factor for cardiovascular disease, which is the leading cause of death in the United States,” lead author Abra Jeffers, PhD, of Massachusetts General Hospital in Boston, said in a press release issued by the primary funder of the study, the National Heart, Lung and Blood Institute (NHLBI).
She said toxins released by weed smoking are similar to those found with tobacco smoking. Research has also found that THC, the main psychoactive ingredient in cannabis, attaches to receptors of cells which are widely distributed throughout the cardiovascular system.
The study, published February 28 in the Journal of the American Heart Association, was based on 2016–2020 data from the Behavioral Risk Factor Surveillance Survey of the Centers for Disease Control and Prevention (CDC). The report took into account other potential risk factors such as age, race and obesity.
To read the press statement, GO TO bit.ly/3WP4Aoo. GO TO bit.ly/4d7GH1c.
HUD awards $26 million to EHE
The U.S. Department of Housing and Urban Development (HUD) announced in June a $26 million award for Housing Interventions (HINT) to End the HIV Epidemic (EHE). Housing is a key element to ending the epidemic, says HUD. The money will go to 11 communities around the country. Programs and organizations will receive a one-time funding award supporting housing assistance and supportive services for families and individuals. HINT is part of HUD’s Housing Opportunities for Persons with AIDS (HOPWA) program. Earlier this year, HUD provided $455 million to 130 grantees through HOPWA. To read the press statement, with a list of grantees, GO TO bit.ly/3SEPGi7.
Mini-grants for women: NMAC
NMAC’s community-driven GLOW (Growing Leadership Opportunities for Women) continues its rounds of training and engagement gatherings around the country with a session in the Bronx, New York, October 3–6. Most women registered will be local, but travel can be arranged for women from nearby states and locales. All will receive hotel accommodations. GLOW aspires to help women of color learn about sexual health and wellness and explore their experiences in life in a safe space. Other training topics will cover financial health, holistic care and entrepreneurship. Participants will have the opportunity to apply for mini-grants for projects providing women with tools and resources to support their leadership capabilities. “Women” means women—cis and trans. The Bronx forum is in Spanish. For a list of GLOW opportunities, GO TO nmac.org.
Overdose and suicide prevention with HIV care: NIDA
Earlier this year, the New York City Department of Health and Mental Hygiene published a study showing that people living with HIV in the city had twice the rate of overdose than NYC’s general population.
In response to the findings, the director of the National Institute of Drug Abuse (NIDA) and the director of the National Institute of Allergy and Infectious Diseases (NIAID) published a blog entry over the summer on combatting overdose and suicide among people living with HIV (PLWH).
Because the majority of PLWH in both New York City and across the country are in HIV care, both reports point to the failure of the health care system to save lives by providing simple and inexpensive interventions.
The New York City report showed that nearly all of the PLWH (98%) who died from overdose had been connected to HIV care and three-quarters of them (75%) had remained in care, with more than half of them virally suppressed (had undetectable viral load).
That finding is “shocking,” write NIDA director Nora D. Volkow, MD, and NIAID director Jeanne Marrazzo, MD.
“In other words, the victims of fatal overdose were not unreached, or on the margins of the system—the stereotype of people with addiction,” the doctors wrote on July 22. “They were engaged in care. Their drug use put them at greatly increased risk of overdose death, but because they were living with HIV, they were engaged with healthcare settings where preventive interventions could have been provided.”
They note that resources from federal agencies like the Substance Abuse and Mental Health Services Administration (SAMHSA) can facilitate the supply of Narcan (naloxone), an opioid overdose reversal medication, that is administered as a nasal spray, and many cities and states provide it for free.
“Delivering naloxone and overdose education in HIV care settings is an obvious and relatively easy way to prevent overdose deaths,” the doctors write. “Readily available both as a nasal spray and in an injectable formulation, naloxone quickly and safely reverses the respiratory depression caused by opioids including fentanyl. Although it is not a magic bullet—someone must be nearby to administer it—dispensing naloxone to people at risk of overdose is now a core harm-reduction strategy, and clinics delivering HIV care are settings where this strategy could and should be implemented. Even if a given person does not use substances, they may know people who do, so giving them naloxone and instruction in how to use it could save a life.”
In their blog entry, We Should Leverage the Successes of HIV Care to Prevent Overdose Mortality, the doctors point out that:
- Drug overdoses in New York City claimed more lives of PLWH than did HIV-related illness
- Nearly one in five PLWH had a substance use disorder, according to the National Survey on Drug Use and Health data (2015–2019)
- Other studies show that PLWH have a high prevalence of prescription opioid use and are at increased risk for drug overdose
- 81% of people diagnosed with HIV in the U.S. in 2019 were linked to HIV care within a month, two-thirds (66%) received care and half remained in care, according to the Centers for Disease Control and Prevention (CDC)
“Enormous strides have been made in screening and treating people with HIV with antiretroviral drugs and then retaining them in care long-term. Now, overdose is among the greatest threats to people with HIV,” Volkow and Marrazzo said in their conclusion. “Especially in a drug landscape now dominated by deadly fentanyl, clinicians serving people living with HIV have a critical role to play in preventing overdose deaths with a relatively simple and extremely effective harm-reduction measure.”
To read the blog, GO TO bit.ly/3yoLc8m.
The NYC study, which examined data from 2007 to 2017, was published in the February 1 issue of the Journal of Acquired Immune Deficiency Syndrome (JAIDS). In its conclusion, the authors note that, “A sizeable number of [PLWH] died of OD during 2007–2017, and OD death rates in recent years increased. Predeath care patterns reveal frequent interaction with the health care system, underscoring missed opportunities for harm-reduction and suicide prevention interventions for [PLWH].” To read the New York study abstract (brief report), GO TO bit.ly/4cdIaS6.
Treatment behind bars
“It remains a common belief that simply stopping someone from taking drugs while in jail or prison is an effective approach to treatment. But that belief is inaccurate and dangerous,” Dr. Volkow writes in a separate edition of Nora’s Blog, along with co-author Tisha Wiley, PhD, associate director for social justice at NIDA. They lay out statistics and report on one successful model for preventing overdose in people after they’ve been incarcerated—including the use of all three FDA-approved opioid use disorder medications during incarceration (Franklin County, Massachusetts). Everyone deserves addiction treatment that works—including those in jail was published online on July 15. GO TO bit.ly/3A72Caf. The article was originally published online July 9 on STAT. The three opioid use disorder medications are methadone, buprenorphine and naltrexone.
Curing and eliminating hepatitis B
Listen to Jeanne Marrazzo, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), as she helps open the meeting of the Coalition for Global Hepatitis Elimination during a webinar August 8. In her short presentation, Dr. Marrazzo provides a quick review of the current global state of hepatitis B and lists medications in new drug classes in development for its treatment and cure. These include long-acting therapies for both hepatitis B and C, pediatric formulas and vaccine work. She also mentioned the tests in development to achieve a faster and simpler diagnosis. U.S. research includes speeding up the search for a cure for people living with both HIV and hepatitis B. “So, exciting areas,” said Dr. Marrazzo. “Lots of promise, but also lots of work.” GO TO bit.ly/3YCIYgc.