NEW YORK (Reuters Health) – The single-tablet combination of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) is effective for long-term viral suppression in previously untreated patients with HIV-1 infection, according to 96-week results from the AMBER trial.

Week 48 primary analyses of the AMBER trial and the companion EMERALD trial showed that D/C/F/TAF had high, noninferior antiviral efficacy with better outcomes for bone and renal safety parameters, compared with D/C plus F/tenofovir disoproxil fumarate (TDF), in adults infected with HIV-1.

Dr. Chloe Orkin from Royal London Hospital and Queen Mary University and colleagues from 121 sites across 10 countries in North America and Europe reported efficacy, safety, and resistance results for D/C/F/TAF through week 96 in AMBER, online in AIDS.

In the D/C/F/TAF group, 85.1% (308/362) had virologic suppression at week 96, compared with 83.7% (304/363) in the control group.

Viral failure rates at week 96 were 5.5% in the D/C/F/TAF group and 4.4% in the control group.

Mean increases in CD4 cell counts from baseline to week 96 were similar in the D/C/F/TAF group (228.9 cells/mm3) and control group (226.5 cells/mm3).

One patient in each treatment group developed resistance-associated mutations.

D/C/F/TAF was well-tolerated through week 96, and safety findings at that point were consistent with those at week 48.

The superior outcomes for estimated GFR, proteinuria, and bone mineral density (BMD) at week 48 persisted at week 96. Fasting lipid parameters showed stable to small increases from week 48 to week 96.

“The results of the AMBER phase 3 trial through 96 weeks confirm the efficacy and high genetic barrier to resistance and bone/renal safety advantages of D/C/F/TAF for antiretroviral therapy-naïve patients,” the researchers conclude. “D/C/F/TAF may have an important role for treating patients with uncertain adherence or who plan to start treatment prior to the availability of resistance testing results.”

The U.S. Food and Drug Administration approved D/C/F/TAF for the treatment of HIV-1 in treatment-naïve and certain virologically suppressed adults in July 2018.

Janssen sponsored the study, employed five of the 11 authors of this report, and had various relationships with the other six authors.

Dr. Orkin was not available for comments.

SOURCE: http://bit.ly/2F9vrDc AIDS, online December 10, 2019.