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What next after the success of the twice-yearly HIV injectable pre-exposure prophylaxis (PreP) study whose results were released last month? 

This is the question that key stakeholders in the HIV fight are asking after the release of results of a study that showed that lenacapavir, a once-in six months’ injection was 100% effective in preventing HIV infection. The study, which is sponsored by Gilead sciences, was also known as Purpose 1 and it was conducted among 5,345 adolescent girls and young women aged 16–26 years at 25 sites in South Africa and three in Uganda.

Speaking to journalists from eastern and southern Africa on July 31, 2024, Elizabeth Irungu, the regional technical advisor for Implementation Science Jhpiego, said the team is waiting for the results of another study called Purpose 2 that is being conducted among men.

Elizabeth Irungu. (courtsey Photo)

“We have a study for men called Purpose 2. The results may come before the end of the year. Once we get results from Purpose 2, which may happen before the end of the year. Once we get results for that study plus this one of purpose 1, then Gilead will submit the results for approval by the Food and Drug Administration (FDA),” she said during an online session.

Irungu said once the US-based FDA approves the drug, it will be reviewed by the World Health Organisation before being cascaded to individual countries for national approvals before the drug is made available for everyone to use.

“How long it will take, I don’t know… probably two years,” she told journalists from Uganda, Kenya, Tanzania, Zambia, Malawi, Zimbabwe and South Africa.

Lenacapavir was approved for use for HIV patients in US and the European Union in 2022. It is available from around $40,000 a year in the US.

It is also being tested for pre-exposure prophylaxis (PrEP) use.

Following the release of the Purpose 1 study, agitation to make the drug affordable has gained pace. For instance, during the recent 25th International AIDS Conference in Munich, Germany, leading stakeholders urged pharmaceutical companies like Gilead Sciences to ensure that the twice-yearly lenacapavir is affordable.

“Lenacapavir could be a game-changer but only if all who would benefit have access. That is why I joined the call for Gilead Sciences to license a generic version to all low- and middle-income countries through the Medicines Patent Pool,” United Nations Programme on HIV/AIDS (UNAIDS) executive director Winnie Byanyima said during the conference in Germany.

"Gilead has an opportunity to save the world. To save the world, literally,” she said.

Dr Flavia Matovu Kiwewa and Linda-Gail Bekker, the director of the Desmond Tutu HIV Center at the University of Cape Town welcomed the new study.

Charles Brown, the executive director of Preventive Care International, a non-government organisation based in Kanyanya in Kampala, called for more sensitisation of people about the different PREP choices if new HIV infections are to be stopped.

Brown, who launched a campaign dubbed PREP=Prevention (P=P) during the conference in Germany, said: “We launched this campaign after talking to people within the community, we realised that they did not understand Prep, which was affecting uptake and leading to new infections. It is affecting adherence”.

“We know that adherence to anything is more challenging for younger people and that’s because they’re busy, their lives are full, they have things to do, places to be,” Bekker said.

According to the WHO, 1.3 million people were newly infected with HIV last year. In Uganda, according to the health ministry estimates 2020, the HIV prevalence among adults (15-49 years) in Uganda is 5.4%. The prevalence is higher among females. According to the Uganda Aids Commission, annual new HIV infections reduced from 94,000 in 2010 to 38,000 in 2020.