Long-awaited results have come out from two large-scale clinical trials of a long-acting, injectable HIV prevention drug that only needs to be taken every six months.
They are sensational.
Excited News Thursday Lenacapir is 89% more effective at preventing HIV than daily oral preventive medications in gay, bisexual, and transgender people, and Previous News With reports that the injectable drug is 100% effective in cisgender women, HIV advocates are looking to the future: They hope that with widespread and equitable rollout, lenacapavir could become the breakthrough drug the country desperately needs.
“These results are unprecedented,” said Dr. Jared Baeten, senior vice president of virology clinical development at Gilead Sciences, which makes lenacapavir. “I really have a moment of speechlessness. What this means for the trajectory of the HIV epidemic is something the world has imagined for years: we can actually stop new infections.”
But battle-weary public health advocates on the front lines of the more than 40-year effort to finally curb the U.S. HIV epidemic are confronted with a cold truth: lenacapavir is extraordinarily expensive.
Jen Cates, director of global health and HIV policy at the nonpartisan health nonprofit KFF, called the lenacapavir clinical trial results “alarming” and said, “This news underscores the importance of getting this new tool into the hands of everyone who needs it, in the U.S. and around the world. Unfortunately, the track record so far has not been good.”
Gilead also makes two daily oral tablets approved for pre-exposure prophylaxis (PrEP): Truvada and Descovy. The pharmaceutical giant has already Secure Approval As an injectable drug to treat highly drug-resistant HIV.
The current list price for the HIV drug lenacapir is $3,450 per month. Gilead Not yet shown The company is considering whether to set a separate price for its PrEP use, but a company spokesperson told NBC News on Thursday that the price of lenacapavir for PrEP is not based on its current use as a treatment. It is unclear whether the statement indicates the pharmaceutical giant intends to lower the price of the injectable drug to a more realistic level for its use as an HIV prevention drug.
Truvada has been available as a generic drug since 2020 and can now be purchased for as low as $20 per month (Descovy remains under patent, $2,200 Despite the potential cost of lenacapavir (at list price), absent perhaps new forms of government intervention, it is unclear whether insurers will actually make lenacapavir widely available and have the widespread public health impact that epidemiologists predict.
Another injectable drug, ViiV Healthcare’s Apretude, is administered every eight weeks and has a monthly list price of $1,965, but has not been widely available in the U.S. since coming to the market in December 2021.
Gilead plans to apply for Food and Drug Administration approval of lenacapavir for use as PrEP by the end of the year, meaning this powerful new HIV prevention tool could be on the U.S. market in mid-to-late 2025.
There is an urgent need to strengthen HIV prevention efforts. Truvada was approved The drug, which first appeared as PrEP 12 years ago, has failed to achieve results in the United States that match the staggering impact it has had on HIV infection rates among gay and bisexual men in wealthy Western countries such as Australia and the United Kingdom, which boast streamlined sexual health systems that are lacking in the fragmented U.S. health care system.
“All this talk about PrEP is a missed opportunity,” said Amy Killelea, a health consultant and prominent HIV advocate in Arlington, Virginia.
Unprecedented clinical trial results
of Advanced Clinical Trials Clinical trials of lenacapavir in gay men began in 2021 at 88 sites in the United States, Latin America, South Africa, and Thailand. More than 3,250 cisgender men, transgender, and non-binary people who have sex with male partners were enrolled.
Participants were randomly assigned to receive either lenacapavir or Truvada in a placebo-controlled, double-blind fashion, meaning neither participants nor researchers knew who was getting which drug. Participants returned for injections every six months and were instructed to take the provided pills once a day.
A planned interim independent analysis of the trial results showed that 2 of 2,180 participants who received lenacapavir during the trial became infected with HIV, compared with 9 of 1,087 who received Truvada. In the lenacapavir group, this represented an 89% lower HIV infection rate than in the Truvada group, which Gilead estimated was 96% lower than the infection rate if neither drug was given.
Because lenacapavir is clearly statistically superior to Truvada, the blinded phase of the study will end several months early, and participants will be informed of which drug they received and will be offered the choice to receive either drug going forward.
According to Gilead, lenacapavir was found to be safe and well tolerated, with no major safety concerns. The only drawback is that subcutaneous injection into the abdomen leaves small visible deposits in people with low body fat, which some may find unpleasant or stigmatizing in practice.
When taken as prescribed, Truvada It’s over 99% effective It is effective in preventing HIV. Relatively effectiveHowever, poor adherence to daily oral PrEP therapy undermines its effectiveness, and gay and bisexual black men, the group with the highest rates of HIV infection, often show particularly low adherence in oral PrEP studies.
Centers for Disease Control and Prevention Estimated in May Between 2018 and 2022, the number of annual HIV infections in the United States fell by just 12%, from 36,200 to 31,800. About 7 in 10 new HIV infections are among gay and bisexual men, and within this group, Black and Latino people are much more likely to contract the virus than white people. Transgender women, particularly women of color, are also at high risk of contracting the virus.
A problem that has vexed the CDC and HIV advocacy groups for more than a decade is that black and Latino gay and bisexual men have never adopted PrEP in the critical mass needed to truly curb the U.S. HIV epidemic among them, despite disproportionately high rates of viral infection in each demographic group. Meanwhile, PrEP has accelerated long-term declines in white HIV infections, exacerbating disparities between the groups.
HIV advocacy groups worry that lenacapavir may only widen these racial disparities.
“Oral PrEP has been around since 2012. Look at our failure,” said Jirair Latevosian, an associate research scientist at the Yale School of Nursing. “How can we learn from the past so we don’t squander opportunities?”
Hopes for the potential of lenacapavir
Dr. Hansel Tookes, a professor of infectious diseases at the University of Miami Miller School of Medicine, was the most bullish HIV expert to speak about lenacapavir’s prospects in an interview with NBC News.
“I’m borderline delusional,” Tookes said, excited about how lenacapavir could benefit gay men of color, particularly in the South, whom he is tasked with protecting against HIV infection.
In the South, HIV treatment and prevention efforts 7 out of 11 states Medicaid expansion under the Affordable Care Act accounts for half of new HIV infections; According to CDC.
“The challenge now is getting people to take a pill every day to prevent something they don’t have,” Tookes said of the difficulty of getting people, especially young people, to adopt such a mundane, progressive habit. “It’s easier to convince them if they have to get a shot twice a year.”
Dr. Bogma Titanzi, an infectious disease specialist at Emory University, said new HIV diagnoses are occurring frequently in Atlanta, where the university is located, especially among young black and Latino men who have sex with men.
“These groups often have less access to or information about existing PrEP options,” she said. “Lenacapavir will be a valuable addition to our toolkit, but to reach its full potential, it must be made available to those who would benefit most from its effectiveness.”
After Gilead published initial results from its clinical trial of lenacapavir in cisgender women and girls in sub-Saharan Africa in June, HIV advocacy groups immediately pressured the company to make the drug available to low-income countries at a scalable price. Now that lenacapavir is officially recognized as highly effective in protecting gay and bisexual men and transgender people, that chorus is sure to grow louder. Results from the drug’s ongoing clinical trials have yet to be released. People who inject drugs and Cisgender women in the United States.
Gilead said in a press release Thursday that it is committed to “rapidly and sustainably providing lenacapavir in sufficient quantities, if approved, to countries with high infection rates and limited resources, primarily low- and lower-middle-income countries.” The company is “actively consulting with the HIV community” about these plans.
“If the cost of lenacapavir or other structural challenges prevent access nationally or globally, that’s not progress,” said Tim Horn, director of medicines access at the public health nonprofit NASTAD. “The results of this drug’s clinical trials must benefit all people at risk of HIV infection, including those who face cost-related hurdles to cutting-edge prevention and treatment.”
Correction (Sept. 12, 2024, 3:15 p.m. ET): A previous version of this article incorrectly stated the monthly list price of ViiV Healthcare’s injectable drug Apretude. The monthly list price is $1,965, not $3,930. The price per injection, administered every two months, is $3,930.
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