Drugs

Gilead’s Single-Tablet HIV Regimen Meets Trial Endpoint

Gilead Sciences says its investigational single-tablet regimen combining bictegravir and lenacapavir met its primary endpoint in a pivotal Phase 3 trial, marking a potential advance for people with HIV who rely on complex, multi-pill treatments. The open-label ARTISTRY-1 study tested the once-daily tablet, which combines the integrase inhibitor bictegravir and the long-acting capsid inhibitor lenacapavir, in adults with HIV-1 who are virologically suppressed on multi-drug antiretroviral regimens, according to the company. It says the regimen was statistically non-inferior to existing multi-tablet therapy in maintaining viral suppression at 48 weeks, the study’s primary endpoint, and no new or significant safety issues emerged in the trial.

The findings could expand treatment options for people with HIV who cannot take current single-tablet regimens because of resistance, tolerability, or drug–drug interactions — factors that often lead to high pill burdens and complicated dosing schedules, according to Gilead. At the start of ARTISTRY-1, participants were taking between two and eleven HIV pills daily, with about 40% dosing more than once a day.

The company notes that the results from ARTISTRY-1 and a companion study, ARTISTRY-2, will form the basis of Gilead’s regulatory submissions. ARTISTRY-2 is an ongoing double-blind Phase 3 trial testing the same fixed-dose combination in people switching from Gilead’s marketed single-tablet regimen Biktarvy. Topline data from that study are expected by the end of the year.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome