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Lenacapavir capsid inhibitor (GS-6207) - CAPELLA trial

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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 phase 1 safety testing: Early Trial of Gilead’s HIV Capsid Inhibitor Supports 3-Month

FOSTER CITY, Calif.Gilead Sciences, Inc. (Nasdaq: GILD) today announced new one-year results from the ongoing Phase 2/3 CAPELLA trial evaluating lenacapavir, the company’s investigational, long-acting HIV-1 capsid inhibitor, in heavily treatment-experienced people living with multi-drug resistant HIV. The findings demonstrated that lenacapavir, administered subcutaneously every six months in combination with other antiretrovirals, achieved high rates of virologic suppression and clinically meaningful increases in CD4 counts in people living with HIV whose virus was no longer effectively responding to their current therapy.

I read they also fid some other trails on treatment naive patients with other drugs and found the results to be good. Hoping they can find something to use in combination to lencapavir, so that we can get to twice a year dosing instead of daily pills

Jim Allen:
May 12th 2022 - In full: I-base:
Lenacapavir in MDR HIV: phase 3 results of CAPELLA study published

In Brief:

--- Quote ---Notably, lenacapavir is given by subcutaneous injection every six months, but it still needs to be used in combination with other active drugs. This is likely to include oral dosing, until other long-acting options become available.

Without this support, resistance to lenacapavir can develop easily if viral load remains unsuppressed or if adherence to other drugs in the combination is not high Viral failure was reported in 8/72 participants in CAPELLA, generally early, and with 4/8 linked to low adherence.

Lenacapavir has so far been associated with few side effects, other than injection site reactions which are generally mild; only two participants reported grade 3 events, both of which resolved. None of the serious events reported in seven participants were judged related to lenacapavir.
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Jim Allen:
The Phase III CAPELLA + CALIBRATE II trial & FDA Lifts Clinical Hold on Long-Acting Lenacapavir

In Brief:

--- Quote ---Clinical Hold

In late December 2021, Gilead announced that the FDA had put a clinical hold on trials of lenacapavir due to concerns about the type of glass vial used for the injectable formulation, which resulted in tiny glass particles in the medication.

This week, Gilead announced that the FDA has lifted the clinical hold on the company’s Investigational New Drug application, allowing trials of injectable lenacapavir for treatment and PrEP to continue.
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