FDA approves daily HIV pill from Gilead designed to simplify treatment for some patients
The new pill is also aimed at people who are doing well on a single-tablet regimen, including Biktarvy, and want to switch to a new treatment.
TL;DR
- FDA approved Gilead's once-daily HIV pill, Bixlenvo.
- Bixlenvo combines bictegravir and lenacapavir, targeting adults with suppressed virus on complex regimens or seeking new options.
- It's the first single-tablet regimen for adults with suppressed HIV who cannot use current one-pill options.
- The list price is $4,595 for a 30-day supply, in line with other daily single-tablet HIV treatments.
- Patient assistance programs are available for uninsured or co-pay support for commercially insured patients.
- The drug aims to simplify care, particularly for older patients with long treatment histories and potential drug resistance.
- Approval is based on two Phase 3 trials showing maintained viral suppression and good tolerability.
- Common side effects reported were headache, nausea, and diarrhea.