Gilead’s Experimental HIV Prevention Shot Shows 100% Effectiveness in Trial

Gilead Sciences, a pharmaceutical company, announced that its experimental twice-yearly medicine to prevent HIV was 100% effective in a late-stage trial. The trial involved approximately 2,000 women who received the lenacapavir shot, and none of them contracted HIV. This promising result prompted the independent data monitoring committee to recommend expanding the study and offering the treatment to all participants. Gilead’s shares rose about 7% following the announcement.

The success of this trial brings Gilead one step closer to introducing a new form of pre-exposure prophylaxis (PrEP) and expanding its HIV business. Jared Baeten, Gilead’s vice president of clinical development for HIV, emphasized the importance of providing more PrEP options to individuals so they can choose what works best for them.

Before seeking approval from the FDA, Gilead will need to replicate these results. The company expects to share data from an ongoing Phase 3 study of men who have sex with men later this year or early next year. If the results are positive, lenacapavir could be available for PrEP as early as late 2025.

Gilead’s previous PrEP drug, Truvada, became the first approved medication for people without HIV at high risk of acquiring it over a decade ago. However, daily pills dominate the market, and there is a need for longer-acting options. PrEP is highly effective, reducing the risk of acquiring HIV from sex by 99% and from injected drug use by 74% when taken correctly. However, only about one-third of individuals in the U.S. who could benefit from PrEP currently take it.

Health policymakers and advocates hope that longer-acting options like lenacapavir can reach individuals who may not want to take a daily pill or have difficulty accessing healthcare. Bruce Richman, the founding executive director of the nonprofit Prevention Access Campaign, emphasized the importance of providing options that fit with people’s lifestyles to better prevent the spread of HIV.

The FDA approved the first injectable PrEP, Apretude, in 2021. Apretude is administered every other month by a medical professional. While some individuals like Tim Oliver, a public health worker in New York, don’t mind going to the doctor for injections, others prefer the convenience of a daily pill. Therefore, a longer-acting option like lenacapavir could be more attractive to patients.

Analysts predict that Gilead’s shot could significantly increase the number of people interested in preventive HIV medicine, estimating peak sales of nearly $2 billion. Gilead’s newer PrEP pill, Descovy, generated about $2 billion in revenue last year.

However, activists have raised concerns about access to lenacapavir in low- and middle-income countries where HIV incidence rates are high. Gilead has faced criticism in the past regarding the pricing of its HIV medicines. The company has stated that it plans to address access in these countries but has not provided specific details.

In conclusion, Gilead’s successful trial of lenacapavir as a twice-yearly HIV prevention medicine brings hope for expanding PrEP options. Longer-acting options like lenacapavir could be crucial in reaching individuals who cannot or do not want to take a daily pill. However, ensuring access to these medications in low- and middle-income countries remains a concern. The future availability of lenacapavir for PrEP will depend on further replication of positive results and regulatory approval.