Gilead Sciences said Wednesday its experimental single-tablet HIV drug shows low discontinuation rates and strong viral suppression in late-stage trials, positioning the regimen as a potential switch option for patients whose virus is already controlled.
The company released detailed results from one late-stage study at a medical conference in Denver and said it is preparing regulatory filings for the experimental combination therapy.
Trial Data Show Low Dropout Rates And Strong Viral Control
In one trial, discontinuation rates due to adverse events were 1.6% and 0.5% in the two treatment arms, respectively. Company officials described both figures as low and consistent with established HIV therapies.
After 48 weeks, 0.8% of patients who switched to the experimental combination pill had detectable levels of the virus in their blood, compared with 1.1% of those who remained on multi-tablet regimens.
The study enrolled patients whose HIV was already suppressed. Participants included those switching from complex multi-tablet regimens and those transitioning from a guideline-recommended single-tablet treatment.
“These data show that the regimen maintains viral suppression with a low rate of treatment discontinuation,” a Gilead spokesperson said in a statement released Wednesday.
Patients Report Higher Satisfaction After Switching
Participants who switched to the experimental pill reported higher treatment satisfaction compared with their previous regimens, according to findings published in The Lancet.
Researchers measured patient-reported outcomes as part of the study, assessing convenience, tolerability, and overall satisfaction. The single-tablet HIV drug design aims to simplify treatment for people living with HIV, many of whom take daily medication for life.
Dr. Karen Whitfield, an infectious disease specialist not involved in the study, said simplified regimens can improve adherence. “When patients have fewer pills to manage, it can reduce treatment fatigue over time,” she said.
Gilead did not disclose pricing details or a potential launch timeline. The company said the combination therapy has not been approved by any regulatory authority.
Company Prepares Regulatory Filings For Experimental Combination
Gilead said it plans to submit data from both late-stage trials to health regulators in the coming months. Regulatory review will determine whether the therapy can be approved as a switch option for patients with already suppressed virus.
The company has long been a major player in the HIV treatment market, with several approved antiviral therapies. Analysts say new combination options could help maintain its position as patents expire on older drugs.
The single-tablet HIV drug regimen is designed as a complete, once-daily combination. If approved, it could offer an alternative for patients seeking to move away from multi-pill regimens without compromising viral control.
Health experts caution that long-term data and regulatory review will be key in determining the treatment’s role in care guidelines.
For now, the therapy remains investigational, and approval will depend on regulators’ assessment of safety and efficacy data submitted by the company.
