Recent excitement over lenacapavir's 100% success rate in preventing HIV among young African women is tempered by concerns about access to the drug. While the twice-yearly injectable offers a promising prevention method, Gilead's lack of a clear timeline for affordable access in Africa raises questions about equitable distribution.
Delayed Access to Life-Saving Drugs
Lenacapavir, with an estimated manufacturing cost of $40 per year, is currently licensed as an HIV treatment in the United States for over $42,000 annually. This disparity highlights the potential for delayed access in regions where healthcare expenditures are significantly lower. Advocates are urging Gilead to make the drug swiftly available in sub-Saharan Africa at an affordable price, especially given the high rate of new HIV infections in the region.
Cabotegravir, another HIV prevention drug administered every two months, showed similar efficacy in trials conducted in Africa from 2017-2020. However, it remains largely unavailable in the region, with widespread access not expected until at least 2027. This delay could result in an estimated 1.4 million preventable HIV infections in young women.
Ethical Concerns and Trial Locations
Pharmaceutical companies often conduct HIV prevention studies in Africa due to the region's high infection rates, which expedite trial results and reduce costs. However, this practice raises ethical concerns about ensuring that the populations involved in these trials benefit from the resulting therapies.
The Helsinki Declaration mandates that trials should benefit the communities where they are conducted, but this is often narrowly interpreted. Drug companies typically only ensure drug access to trial participants themselves, and for a limited time.
Proposed Solutions for Equitable Access
To address these issues, experts propose a new mandate for global drug and vaccine development research in low- and middle-income settings. This mandate would require a licensing, manufacture, pricing, and distribution plan prior to the conduct of trials. If a trial shows benefit, the local population would be ensured access on a pre-specified timeline.
This policy could be implemented by regional regulatory bodies and added to clinicaltrials.gov reporting requirements for all Phase 3 trials of unlicensed drugs in such regions. Such a change would help balance the power dynamic between drug manufacturers and trial participants, ensuring that those who volunteer for studies also benefit from their participation.
