Health Care

First Complete 2-Drug HIV Regimen Gets FDA Approval

First Complete 2-Drug HIV Regimen Gets FDA Approval”

Juluca combines dolutegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), and rilpivirine, a non-nucleoside reverse transcriptase inhibitor.

The approval puts GSK ahead of rival Gilead Sciences in the race to market with two-drug combinations for HIV treatments, although uptake could be slow because rilpivirine has the downside that it must be taken with a meal at the same time every day.

"This is the start of a new era in HIV treatment".

Reaching and maintaining suppression of viral load is a key treatment goal for people living with HIV. The proportion of patients with HIV-1 RNA ≥50 copies/mL (virologic failure) at Week 48 was 0.6% and 1.2% for the Juluca group and the current antiretroviral regimen groups, respectively (treatment difference -0.6%, 95% CI: -1.7%, 0.6%). The most common AEs leading to discontinuation were psychiatric disorders in 2% receiving DTG+RPV and less than 1% on the vehicle.

Diarrhea and headache were the most commonly reported adverse effects of Juluca; serious effects included skin rash, allergic reactions, liver problems, depression, or mood changes.

Switching to the two-drug regimen of JULUCA showed a neutral effect on lipids - at 48 Weeks, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, and total cholesterol to HDL ratio were similar between the treatment arms. Participants were randomly assigned to continue their current anti-HIV drugs or to switch to Juluca. Future long-term data and analyses will be presented at upcoming medical congresses.

Juluca belongs to GlaxoSmithKline Plc's majority-owned ViiV Healthcare, in which Pfizer Inc and Shionogi also have small stakes.

"Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients", said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research.



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