FDA expands indication for doravirine in the US as switch option

30 September 2019. Related: Antiretrovirals.

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. [1]

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. [2]

Reference

1. 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).
   https://www.mrknewsroom.com/news-release/prescription-medicine-news/mercks-pifeltro-doravirine-and-delstrigo-doravirinelamivudin
   
2. 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.
   https://journals.lww.com/jaids/Fulltext/2019/08010/Switching_to_Doravirine_Lamivudine_Tenofovir.15.aspx