Infectious Disease

Gilead applies for FDA approval for lecapavir, a long-acting HIV treatment

Melanie A. Thompson, MD

Melanie Thompson

Treating MDR HIV remains challenging, and we need new drugs with new mechanisms of action to win this battle. As the first capsid inhibitor, lecapavir has the potential to fit well into this niche. In addition, it is given by subcutaneous injection, which means it could actually be self-administered by the patients, and it has a very long half-life that supports dosing every 6 months.

Preliminary data from 36 patients presented at CROI 2021 was encouraging in terms of virus suppression, and it’s good news that 6-month follow-up data will be presented at the IAS conference in July. As always, when announcing a press release, we have to wait for the data. And it is imperative that we have longer-term data beyond 6 months for a larger number of patients, especially if it is a long-acting drug. One concern is that early studies have shown some incidence of capsid mutations.

To minimize the risk of resistance, it is very important to pair lenacapavir with robust partners. Ideally, these partners should act for a long time in order to benefit from this quality. Islatravir, an investigational long-acting nucleotide reverse transcriptase translocation inhibitor, could be a great partner for lecapavir, and Merck and Gilead are already working together to explore this combination. Lenacapavir with suitable partners may also be attractive for early treatment and is being studied as a solo drug for prevention.

Today’s pipeline of HIV treatments has a high bar to meet because it must be effective, safe, tolerable, easy to administer, forgiving of non-compliance and, increasingly, affordable. If Gilead gets lenacapavir approval, I hope it will lower the price bar and really become the game changer it could be.

Melanie A. Thompson, MD

former chairman,

Society for HIV Medicine

Chief investigator,

Atlanta AIDS Research Consortium

Disclosure: Thompson does not disclose any relevant financial information.

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