Twice-yearly injections of the drug lenacapavir could offer complete protection from HIV, according to new research published this week in the New England Journal of Medicine.
The paper reports the findings of a randomized trial of over 5,000 cisgender girls and young women in South Africa and Uganda, dubbed the “PURPOSE 1” trial by the drug’s developer, Gilead Sciences. Researchers found that of the 2,134 participants who received shots of lenacapavir every 26 weeks, none of them acquired an HIV infection by the end of the trial. In contrast, 55 infections in total were reported in other groups who received two different forms of pre-exposure prophylaxis, or PrEP, instead (tenofovir alafenamide and tenofovir disoproxil fumarate, commonly abbreviated TAF and TDF). The results were presented at the 2024 International AIDS Conference in Munich, where it was also announced that a seventh person has likely been cured of HIV through stem cell therapy. The injection has been hailed as a potentially game-changing measure in the fight to end the HIV epidemic.
“This appears to be a new breakthrough for HIV prevention,” said Sarah Palmer, co-director of the Center for Virus Research at the Westmead Institute for Medical Research in Sydney, in comments to the Washington Post on Thursday. (Palmer was not involved with the PURPOSE 1 trial.) “If these injections can be widely distributed at low cost, it would dramatically reduce the risk of new HIV infections worldwide [...] It is especially encouraging [that] this research focused on young women in Africa who are so highly at-risk for HIV infection.”(Globally, cis women and girls accounted for 44% of new HIV infections in 2023, with that rate rising to 62% in sub-Saharan Africa, according to data from UNAIDS.)
Heralding the study’s top-level results in a press release last month, Gilead called their lenacapavir trials “the most comprehensive and diverse HIV prevention trial program ever conducted.” Multiple trials of the drug’s HIV efficacy are currently underway in the U.S.
“These stellar results show that twice-yearly lenacapavir for PrEP, if approved, could offer a highly effective, tolerable and discreet choice that could potentially improve PrEP uptake and persistence, helping us to reduce HIV in cisgender women globally,” said Linda-Gail Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town, in a Gilead press release this week.
Gilead representatives in June laid out a “two-pronged access strategy” to distribute lenacapavir in countries with few resources and high rates of HIV. The company intends to establish a “dedicated Gilead supply” of lenacapavir in those countries until a “high-quality, low-cost” version is made available via a “direct voluntary licensing program.”
Lenacapavir is already on the market, but is approved for treatment rather than prevention, and is being sold by Gilead under the brand name “Sunlenca” at over $42,000 for the first year of treatment. At the International AIDS Conference, experts reported that lenacapavir could likely be sold for just $40 per year instead while still maintaining a 30% profit margin, as The Guardian reported this week.
Over the past few years, Gilead has been the target of increasing legal and activist pressure, over allegations that the company for years delayed HIV/AIDS treatment research and engaged in price gouging. In 2023, the U.S. government lost its legal case against Gilead, failing to prove the company violated drug patents held by the CDC; government officials had argued that Gilead used CDC research to sell Truvada (a TDF treatment) at price points up to $2,000 a month, “a price that makes the drug unaffordable for many Americans.” But in January, the California First District Court of Appeals ruled that Gilead could be held liable for negligence in a class-action suit that alleged Gilead delayed its development of TAF in order to continue profiting from TDF, a less effective drug with more side effects. Gilead settled with the complainants in June to the tune of $40 million, without admitting fault.
HIV activists from the AIDS Healthcare Foundation organized a campaign against Gilead earlier this year, protesting the company at multiple scientific conferences in the U.S. The protests were part of a plan “to draw attention to Gilead’s quiet campaign to undermine safety net providers and illegally restrict access to lifesaving HIV and Hepatitis C treatments,” said AHF president and cofounder Michael Weinstein in March. “By highlighting the greed and hypocrisy of Gilead and CEO Daniel O’Day, we hope to force some measure of accountability for both in the public eye.”
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