Approved Medications Research

Lenacapavir Sustained Delivery Formulation Supports 6-Month Dosing Interval

♦ Single LEN SC doses up to 900 mg were generally safe and well tolerated – Injection-site reactions were common, but all were mild ♦ LEN 900 mg SC maintained target concentrations for 26 wk (6 mon), supporting its use as a q6mon antiretroviral agent ♦ PK simulations support LEN regimen with oral PK loading,

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Tail-phase safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in HIV-uninfected adults: a secondary analysis of the HPTN 077 trial

This study assess the terminal phase pharmacokinetics and safety of long-acting injectable cabotegravir in participants included in the HPTN 077 trial.

Tail-phase safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in HIV-uninfected adults: a secondary analysis of the HPTN 077 trial Read More »

Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression.

This is a phase 3, open-label, multicenter, noninferiority trial involving patients who had had plasma HIV-1 RNA levels of less than 50 copies per milliliter for at least 6 months while taking standard oral antiretroviral therapy. The primary end point was the percentage of participants with an HIV-1 RNA level of 50 copies per milliliter

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Acceptability of Long-Acting Injectable Cabotegravir (CAB LA) in HIV-Uninfected Individuals: HPTN 077

Long-acting injectable PrEP acceptability was high, especially at non-U.S. sites. Preferences for a LAI PrEP product compared to other methods was higher among males, many who were MSM, in the U.S., and higher among females in non-U.S. compared to U.S. sites, where both the need for new HIV prevention methods is greatest and contraceptive injectable

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Lenacapavir Resistance Analysis in a Phase 1b Clinical Proof-Of-Concept Study

In this Phase 1 study, single SC doses of LEN resulted in potent antiviral activity over 10 days ♦ Rare low-level resistance to LEN via a single mutation (Q67H) emerged only at LEN exposures below the expected exposure in Ph2/3 studies ♦ Previous in vitro characterization identified that Q67H mutation had the least impact on

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Evaluating cabotegravir/rilpivirine long-acting, injectable in the treatment of HIV infection: emerging data and therapeutic potential.

This study evaluates the clinical evidence to date and efficacy and challenges of cabotegravir/rilpivirine long-acting, injectable in the treatment of HIV infection in selected populations.

Evaluating cabotegravir/rilpivirine long-acting, injectable in the treatment of HIV infection: emerging data and therapeutic potential. Read More »

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