ViiV signs agreement to allow generics of long-acting HIV PrEP in 90 countries
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Announcements made at the International AIDS Conference indicate growing momentum to expand global access to long-acting cabotegravir for HIV prevention.
“Long-acting PrEP could play a major role in ending the HIV pandemic, but right now, very few people can access it,” International AIDS Society (IAS) President Adeeba Kamarulzaman, MBBS, FRACP, FASc, said during a press conference.
She said scaling up affordable access to this “game-changing prevention tool” must be a top priority.
This is especially important in the context of new data showing that there were 1.5 million new HIV infections in 2021, with high-risk populations who could benefit from improved PrEP options and access — including sex workers, men who have sex with men, people who inject drugs and transgender people — accounting for 70% of these new infections.
In the decade since oral PrEP was first approved, experts have attributed the sluggish uptake and adherence to the medication to stigma, problems taking a daily pill and issues regarding access. Long-acting cabotegravir (CAB-LA) — which is administered by injection once every 2 months and has been shown to be a safe and effective alternative to oral PrEP — has emerged as an alternative.
Although CAB-LA is currently approved for PrEP only in the United States, ViiV Healthcare has submitted marketing applications in additional countries and announced plans to allow generics of the medicine to be made by manufacturers in lower income countries.
During a press conference at the International AIDS Conference, ViiV CEO Deborah Waterhouse announced that ViiV and the Medicines Patent Pool have signed a voluntary licensing agreement for patents relating to CAB-LA for HIV PrEP, which will help enable access in low-income, lower middle-income and sub-Saharan African countries.
According to a press release from the IAS, the agreement will grant selected generic manufacturers the opportunity to develop, manufacture and supply generic versions of CAB-LA in 90 countries.
Following the licensing agreement, next steps include opening an online portal for potential manufactures to apply, according to Waterhouse. This will remain open for 4 weeks and will be followed by a thorough assessment of applicants to ensure they have the capacity to develop generic CAB-LA quickly and make it available at affordable prices.
“This is a potentially game-changing moment in HIV prevention,” Waterhouse said. “Enabling at-scale access to generic CAB-LA for PrEP could play a significant role in averting the transmission of HIV.”
Additionally, WHO released its first guidelines for CAB-LA as HIV PrEP, which will also help facilitate access and use.
The new guidance recommends that CAB-LA be offered as an additional prevention choice for people at “substantial risk” for HIV as part of combination prevention approaches.
“We hope these new guidelines will help accelerate country efforts to start to plan and deliver CAB-LA alongside other HIV prevention options, including oral PrEP and the dapivirine vaginal ring,” Meg Doherty, MD, MPH, Director of WHO’s Global HIV, Hepatitis and STI Program, said in a press release.
“To achieve UN prevention goals, we must push for rapid, equitable access to all effective prevention tools, including long-acting PrEP,” Rachel Baggaley, MBBS, MSc, who heads the WHO Global HIV, Hepatitis and STI Program testing, prevention and populations team, said in a press release. “That means overcoming critical barriers in low- and middle-income countries, including implementation challenges and costs.”
References:
WHO recommends long-acting cabotegravir for HIV prevention. https://www.who.int/news/item/28-07-2022-who-recommends-long-acting-cabotegravir-for-hiv-prevention. Published July 28, 2022. Accessed July 28, 2022.
WHO. Guidelines on long-acting injectable cabotegravir for HIV prevention. https://www.who.int/publications/i/item/9789240054097. Accessed on July 28, 2022.
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