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Lenacapavir (GS-6207) Long-Acting HIV Treatment


Jim Allen:
An update and good results from the Lenacapavir Capella trial. full writeup

In Short:

--- Quote ---Lenacapavir, the first HIV capsid inhibitor, led to viral load reductions in 88% of people who had received several prior antiretroviral medications and had multidrug-resistant virus, according to Gilead Sciences.

Researchers are also evaluating lenacapavir as a twice-yearly injectable for HIV pre-exposure prophylaxis (PrEP), which could expand the armamentarium of long-acting prevention options.

The Phase II/III CAPELLA trial included 36 adults with resistance to multiple antiretroviral drug classes who had a detectable viral load on their current treatment regimen. About two thirds of those who received lenacapavir had advanced immune suppression with a CD4 count below 200.

The participants were randomly assigned to add either lenacapavir or a placebo given by subcutaneous injection to their failing regimens for 14 days—that is, lenacapavir was essentially functioning as monotherapy. At that point, all participants were offered open-label lenacapavir plus an optimized background regimen designed to work as well as possible based on resistance testing. They will receive lenacapavir injections every six months as maintenance therapy.

At the end of the two-week period, 88% of those assigned to lenacapavir experienced at least a half-log reduction in viral load, compared with just 17% in the placebo group. Despite the small numbers, the difference was highly statistically significant, meaning it was probably not attributable to chance. What’s more, people in the lenacapavir group saw a significantly greater average change in viral load compared with the placebo group (-1.93 versus -0.29 log).
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A previous posting on this drug 2019: Early Trial of Gilead’s HIV Capsid Inhibitor Supports 3-Month


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