TAF-based Regimens Demonstrate Non-inferiority in HIV

Two studies published in the Lancet HIV support guidelines recommending tenofovir alafenamide (TAF)-based regimens for the treatment of HIV.

In the first study, investigators examined the safety and efficacy of a single-tablet combination of rilpivirine, emtricitabine, and TAF compared with a rilpivirine, emtricitabine, and tenofovir disoproxil fumarate (TDF) regimen.

Included in the study were 630 patients with HIV who were randomized to receive either a TAF-based regimen or a TDF-based regimen. The results of the study showed that by week 48—–in both groups––94% of patients maintained <50 copies per mL HIV-1 RNA, which indicated there was no inferiority of TAF to TDF.

The second study sought to examine the safety and efficacy of switching to combination rilpivirine, emtricitabine, and TAF compared with remaining on regimen efavirenz, emtricitabine, and TDF.

There were 875 participants included in the study who were randomized to receive either the TAF-based regimen or the TDF-based regimen. By week 48, the results of the study showed that 90% of patients in the TAF group and 92% in the TDF group maintained viral suppression, which indicated non-inferiority. Treatment-induced adverse events occurred in 13% of TAF patients and 10% of TDF patients.

“These findings support guidelines recommending tenofovir alafenamide-based regimens, including coformulation with rilpivirine and emtricitabine, as initial and ongoing treatment for HIV-1 infection,” the authors wrote.

Switching from TAF-based regimens to TAF-regimens in the treatment of HIV has also shown promise in other clinical trials. Gilead announced positive results from a 96-week, phase 3 trial evaluating the safety and efficacy of switching from regimens containing Truvada (TDF-based) to those containing Descovy (TAF-based).

The findings from the trial found that overall, the regimens that included Descovy demonstrated non-inferiority to those containing Truvada. Furthermore, patients administered Descovy had improvements in renal and bone laboratory parameters.