Activists demand access to groundbreaking HIV prevention tool

Activists stormed the Gilead exhibition at the 25th International AIDS Conference in Munich, Germany, yesterday following the release of a new study showing that a year’s supply of an emerging preventive HIV injection, lenacapavir, can be manufactured for $40. The U.S. pharmaceutical giant controls the patent over the twice-yearly injection, which showed 100% efficacy in recent trials conducted among women and adolescent girls in Uganda and South Africa. But the company currently charges over $40,000 for the first year of access to lenacapavir in the United States, where it is only available as a form of HIV treatment at the moment. Activists demanded that Gilead immediately begin the process of issuing voluntary licenses that would allow for affordable, generic production of the tool for preexposure prophylaxis, or PrEP, or that more countries take steps to break the patents that guard the intellectual property. “100% effectiveness demands 100% access,” Health GAP’s Asia Russell said in a statement. “Lenacapavir for HIV prevention is a potentially pandemic defeating intervention.” The prevention method is seen as particularly critical in communities where people have been hesitant to take oral versions of PrEP because of the difficulty of maintaining discretion and avoiding stigma when using a daily pill. In the PURPOSE 1 trial, which compared the method to two oral versions of PrEP, Truvada and Descovy, the injection proved most effective. Sixteen of the more than 1,000 women who took Truvada on the trial contracted HIV, and 39 of the more than 2,100 women who took Descovy also contracted the virus. At the AIDS conference, the researchers confirmed that, though more than two-thirds of injection recipients reported some reactions at the site of the shot, they were minor and the injection was deemed safe and well tolerated. “If it’s patented, the poor person cannot afford it. … We are not against big pharma. But [their medicines] have to be accessible.” -- — Loon Gangte, founder and president, Delhi Network of Positive People In pushing for countries to break the lenacapavir patents and issue compulsory licenses, Russell accused the drug company of excluding middle-income countries from voluntary licensing deals in the past. That has raised fears that even if Gilead does take steps to make the prevention tool affordable in some settings, it will still exclude tens of thousands of people who would also benefit from it. Following the release of the findings last month from the PURPOSE 1 trial, the company said it was “developing a strategy to enable broad, sustainable access globally.” The company said it would prioritize providing lenacapavir “sustainably and in sufficient volumes” to low- and lower-middle-income countries. Gilead also said it was developing a voluntary licensing platform to expedite access “in high-incidence, resource-limited countries.” Representatives from Gilead did not respond to a request from Devex for comment in response to the demonstration. The company’s existing commitments have not allayed the fears of activists, who warn that communities in middle-income countries might be left out. Instead, they are calling for steps to ensure universal access. Already HIV community organizations in India, Argentina, Thailand, and Vietnam have filed oppositions against Gilead patent applications. And activists are calling for more countries to consider issuing compulsory licenses if Gilead will not take steps to make the prevention tool universally available. “If it’s patented, the poor person cannot afford it,” Loon Gangte of the Delhi Network of Positive People told Devex. “We are not against big pharma. But [their medicines] have to be accessible. Once it becomes cheap, my government can buy it.” Andrew Hill, one of the authors of the pricing study released Tuesday in Munich, said experts have already been in touch with generic manufacturers to confirm the costs and to ensure generic lenacapavir could be produced at the scale needed. According to the study, 1 million generic versions could be launched the first year at a cost of $93 per patient per year. As production ramps up to 10 million, the cost would fall to $40 per patient per year. Even as the pricing debate continues, the activists are also frustrated that Gilead had not already taken steps to get regulatory approval to expedite the rollout of lenacapavir in low- and middle-income countries as soon as efficacy data became available. Gilead has said it is waiting to file for regulatory approval of lenacapavir for PrEP when they have the results from PURPOSE 2, which is investigating the drug’s efficacy in cisgender men, transgender women, transgender men, and nonbinary individuals who were assigned male at birth. “We already know it works in women,” Hill told Devex. “Just treat the women,” he said, and when efficacy information becomes available from PURPOSE 2, the company could decide whether to expand access.