FDA expands indication for doravirine in the US as switch option
Simon Collins, HIV i-Base
On 20 September 2019, the US FDA expanded the indication for the NNRTI doravirine to also include people currently on effective ART with undetectable viral load. 
Similar approval was also announced for the fixed dose combination (FDC) of doravirine/TDF/3TC.
Previously, doravirine was indicated as first-line ART for people who were treatment-naive.
Approvals were based on results from the phase 3 DRIVE-SHIFT trial that switched people on stable ART to the fixed dose combination (FDC) of doravirine/3TC/TDF (Delstrigo).
This study was published as an open access paper in the 1 August 2019 edition of JAIDS. 
- Merck PR. Merck’s doravirine (Pifeltro) and doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo) receive US FDA approval for use in appropriate adults living with HIV-1 who are virologically suppressed. 20 September 2019).
- Johnson M et al. Switching to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) maintains HIV-1 virologic suppression through 48 weeks: results of the DRIVE-SHIFT trial. JAIDS: 81(4); 463–472. doi: 10.1097/QAI.0000000000002056.