First Complete Darunavir-Based Single-Tablet Regimen for HIV Sees Positive Results at 96 Weeks

Results for the combination of darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF, SYMTUZA, Janssen) for the treatment of HIV-1, continue to be positive as the latest data indicate that 85% of study participants (308/362) achieved virologic suppression (viral load <50 copies/mL) at week 96. A total of 6% of participants (20/362) had virologic failure (viral load >50 c/mL) when treated with D/C/F/TAF. Furthermore, none of the patients experienced darunavir, primary protease inhibitor, or tenofovir resistance-associated mutations, according to a statement from Janssen on the newest HIV treatment.

“The 96-week AMBER data further demonstrate the importance of [D/C/F/TAF] 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, MD, professor of medicine and director, Clinical Core, University of North Carolina Center for AIDS Research, Chapel Hill, North Carolina in the statement. “Based on the US Department of Health and Human Services guidelines, darunavir-based regimens are a recommended option [for patients with HIV] 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 US Food and Drug Administration (FDA) approved D/C/F/TAF in July 2018 as the first and only complete, darunavir-based single-tablet regimen for the treatment of HIV in treatment-naïve and certain virologically-suppressed adults based on the AMBER and EMERALD trial results.

One patient who was receiving D/C/F/TAF developed a nucleoside reverse transcriptase inhibitor resistance-associated mutation (M184I/V) through week 48. Through 96 weeks, 1 additional patient developed this mutation.

Through 96 weeks, a total of 3% of study participants (10/362) receiving D/C/F/TAF for HIV treatment experienced adverse event-related discontinuations and 3% (11/362) experienced a grade 3 or grade 4 drug-related adverse event. Diarrhea, rash, and nausea were the most common drug-related adverse events of all grades, occurring in 5% or more of study participants. According to the Janssen statement, “bone, renal, and lipid safety results were consistent with known tenofovir alafenamide and cobicistat profiles.”

Earlier this year, Bruce Rashbaum, MD, from Capital Medical Associates, shared week 48-results from the AMBER trial which demonstrated that patients taking D/C/F/TAF for HIV treatment achieved high virologic response rates that were overall noninferior to the control population. Patients also had favorable bone and renal outcomes. These results were consistent across subgroups of participants by age, gender, and race.