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

New trial results presented at HIV Glasgow in Scotland indicate that the combination of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide (D/C/F/TAF, SYMTUZA, Janssen) is a safe and effective treatment for HIV-1 infection in treatment-naïve and certain virologically suppressed adults.

The combination of darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg was approved 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 results of the AMBER and EMERALD trials.

A total of 85% of AMBER study participants (308/362) achieved virologic suppression (viral load <50 copies/mL) at week 96 when treated with D/C/F/TAF for HIV infection, according to a statement from Janssen. Six-percent of participants (20/362) had virologic failure (viral load >50 c/mL); however, none of the participants experienced darunavir, primary protease inhibitor, or tenofovir resistance-associated mutations.

Darunavir-based regimens are recommended in the US Department of Health and Human Services guidelines for patients with HIV who require a rapid initiation of antiretroviral therapy before bloodwork results are available, as well as those who are at risk of developing resistance and who may not optimally adhere to their HIV treatment regimens. The International Antiviral Society-USA guidelines indicate that darunavir-based regimens are recommended in rapid initiation scenarios.

“Long-term AMBER results further build on the growing clinical data set that provides additional support for [D/C/F/TAF] as a treatment option for patients who are starting therapy,” said Richard Nettles, MD, vice president, Medical Affairs, Janssen Therapeutics, Janssen Scientific Affairs, LLC, in a statement.

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.

A total of 3% of study participants (10/362) experienced adverse event-related discontinuations, through week 96, 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.”

An earlier version of this article appeared on ContagionLive.com as, “First Complete Darunavir-Based Single-Tablet Regimen for HIV Sees Positive Results at 96 Weeks.”