FDA accepts two new drug applications for new NNRTI doravirine

The Food and Drug Administration has accepted two new drug applications (NDAs) for the HIV medication called doravirine. Doravirine is a new NNRTI or non-nucleoside reverse transcriptase inhibitor that completed two 48-week studies in 2017. If both NDAs are approved, doravirine could be available this year as a one-drug pill and in combination with other meds as a single tablet regimen.

The first study, DRIVE-FORWARD, compared doravirine to the boosted protease inhibitor darunavir (Prezista) in 769 people who were new to treatment. All participants also took either emtricitabine/tenofovir (Truvada) or abacavir/lamivudine (Epizcom).

At 48 weeks, those at undetectable levels were similar in both groups (84% doravirine vs. 80% darunavir). CD4 gains were also similar (198 vs. 188, respectively). Both regimens were safe and well tolerated with similar rates of side effects.

The second study, DRIVE-AHEAD, compared a single table regimen of doravirine + lamivudine + tenofovir against efavirenz/emtricitabine/tenofovir (Atripla) in 364 people who were new to treatment.

At 48 weeks, those at undetectable levels were similar in both groups (84% doravirine vs. 81% efavirenz). CD4 gains were also similar (193 vs. 186, respectively). Fewer people quit the doravirine regimen (9.6%) than those on efavirenz (13.7%) for reasons other than virologic failure. Both regimens were safe and well tolerated with similar rates of side effects.

Results from both of these studies are included in the NDAs to the FDA. A third study, DRIVE-SHIFT, is currently looking at moving people from a regimen with stable control of HIV over to the single tablet regimen doravirine/lamivudine/tenofovir. Two other studies are evaluating doravirine in people new to treatment but with transmitted resistance to NNRTIs and in people who want to switch from an efavirenz regimen due to side effects. Therefore, more data will be released over the next couple of years that will provide more guidance on how to best use doravirine among the current toolbox of treatment options.

Read Project Inform’s previous coverage of released study data on doravirine from the 2017 CROI.