The drug that helps prevent HIV found to be 100% effective in clinical trial
Lenacapavir, a new pre-exposure prophylaxis drug, has been shown to provide complete protection against HIV infection in a large clinical trial conducted in South Africa and Uganda. The trial compared the efficacy of lenacapavir, administered as a twice-yearly injection, to two other pre-exposure prophylaxis medications taken daily. Notably, the six-monthly injection of lenacapavir demonstrated better protection against HIV infection than the daily pill regimens. This is reported by SSP.
The Purpose 1 trial involved 5,000 participants across multiple sites in South Africa and Uganda. The study aimed to evaluate the effectiveness of lenacapavir and the two other drugs. Lenacapavir is a fusion capside inhibitor that targets the HIV capsid, the protective protein shell surrounding the virus' genetic material. It is administered via subcutaneous injections once every six months.
The trial compared the safety and efficacy of lenacapavir with Truvada F/TDF, a well-established daily PrEP pill, and Descovy F/TAF, a newer daily pill with improved pharmacokinetic properties. Among the young women participating, who face a higher risk of new HIV infections in eastern and southern Africa, lenacapavir demonstrated remarkable results. None of the women receiving lenacapavir contracted HIV during the trial, showcasing 100% efficacy. In contrast, a small percentage of women receiving Truvada or Descovy experienced HIV infections.
The promising results from an independent data safety monitoring board review prompted the recommendation to halt the blinded phase of the trial. Now, all participants will be given the option to choose their preferred PrEP method. This represents a major breakthrough in HIV prevention, offering a highly effective tool for individuals at risk.
While this breakthrough is significant, it's essential to recognize that PrEP is not the sole prevention strategy. It should be accompanied by HIV self-testing, condom access, sexually transmitted infection screening and treatment, and contraceptive availability for women of childbearing potential. Factors such as the challenge of daily adherence, particularly for young people, highlight the importance of feasible prevention options.
Moving forward, the Purpose 1 trial will transition to an open-label phase where participants will be informed of their assigned intervention (injectable or oral PrEP). The study will continue, allowing individuals to choose their preferred method. Another ongoing trial, Purpose 2, focuses on cisgender men, transgender individuals, and nonbinary people who have sex with men in various regions, including Africa. These diverse trials aim to assess effectiveness across different populations and consider the impact of specific sexual contexts.
Upon completion of the trial, Gilead Sciences, the drug developers, will compile the data and submit it to country regulators, including those in Uganda and South Africa. The World Health Organization will also evaluate the findings to potentially issue recommendations. Access to the drug at an affordable price will be crucial for widespread distribution, particularly in the public sector where it is most needed. Gilead Sciences has expressed intentions to offer licenses to generic drug manufacturers to ensure affordability.