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Doravirine  Investigational

Other Names: MK-1439
Investigational Treatment. This treatment has NOT been approved by the FDA.
Table of Contents

Drug Summary

Doravirine is an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) that is dosed once daily and appears to be well tolerated. Doravirine is active in vitro in the presence of common NNRTI drug-resistant mutations and thus may have clinical utility for individuals with resistance to other NNRTI’s. Clinical trials involving treatment-naïve participants have compared doravirine with efavirenz and with boosted darunavir, all in combination with two nucleoside reverse transcriptase inhibitors (NRTI’s). In these studies, doravirine-associated rates of central nervous system side effects have been lower than with efavirenz and rates of diarrhea have been lower than with darunavir plus ritonavir. Doravirine is also under development coformulated with tenofovir disoproxil fumarate (DF) and lamivudine as a single-tablet regimen.

Guidelines for use in Antiretroviral-Naïve Patients

Doravirine is an investigational antiretroviral medication and therefore not included in the HHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.

Key Clinical Trials

In a phase 2 trial, 216 treatment-naïve adults were randomized 1:1 to doravirine or efavirenz, each with two NRTI’s, and at 48 weeks an equivalent proportion had suppressed HIV RNA level (77.8% in the doravirine arm and 78.7% in the efavirenz arm) []. Side effects were less frequent with doravirine, particularly central nervous system side effects. In a phase 3 study, doravirine was compared to ritonavir-boosted darunavir as initial antiretroviral therapy, each with two NRTI’s []. Three-hundred twenty seven individuals were randomized to the doravirine arm and 312 to the darunavir arm; at 48 weeks, 84% in the doravirine arm had HIV RNA below 50 copies/mL, which was non-inferior to the boosted darunavir arm (80%). Overall rates of drug-related adverse events were similar between the two arms, though diarrhea was less common in the doravirine group.

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