These 96-week data, which follow on from the earlier 48-week results, reinforce the long-term safety, efficacy and tolerability profile of SYMTUZA as a treatment for antiretroviral treatment naïve adults with HIV. Results demonstrated that a high proportion of ART-naïve adults with HIV-1 achieved virologic suppression at 96 weeks when treated with SYMTUZA.
There was a low virologic failure rate (6%) in patients treated with SYMTUZA and no darunavir, primary protease inhibitor or tenofovir resistance-associated mutations emerged in any patient.
As previously reported, only 1 patient receiving SYMTUZA developed a nucleoside reverse transcriptase inhibitor resistance-associated mutation (M184I/V) through week 48.
In the current analysis through 96 weeks, only 1 additional patient receiving SYMTUZA developed a nucleoside reverse transcriptase inhibitor resistance-associated mutation to emtricitabine.
"The 96-week AMBER data further demonstrate the importance of SYMTUZA as a treatment option for adults new to HIV therapy who may benefit from a single-tablet regimen that offers the protective barrier to resistance of darunavir along with the tolerability profile of TAF," said Joseph Eron, M.D., Professor of Medicine and Director, Clinical Core, University of North Carolina Center for AIDS Research, Chapel Hill, NC.
"Based on the DHHS guidelines, darunavir-based regimens are a recommended option in situations where clinicians may not have all genotypic resistance test results, when patients may be at risk for sub-optimal adherence or in rapid initiation scenarios."
The U.S. Department of Health and Human Services (DHHS) guidelines recommend darunavir for patients who may have suboptimal adherence and face the risk of developing HIV drug resistance.
SYMTUZA was approved by the U.S. Food & Drug Administration (FDA) in July 2018 for treatment-naïve and certain virologically suppressed adults.
SYMTUZA has also been approved by the European Commission (EC) and Health Canada for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older with body weight of at least 40 kg.