Doravirine: a review.

Abstract

The current review addresses the role of doravirine (DOR), a novel once-daily nonnucleoside reverse transcriptase inhibitor (NNRTI) in first-line therapy at a time in which multiple options are available, and issues of antiviral efficacy, safety, simplicity and cost are critical to make informed decisions. DOR combination regimens have been tested in two large randomized double-blinded clinical trials in treatment-naïve patients, showing noninferiority to ritonavir-boosted darunavir-based and efavirenz (EFV)-based regimens. The main features of DOR are reviewed in this report including its antiviral activity, genetic barrier to resistance, safety, once-daily dosing and coformulation in a single tablet with tenofovir disoproxil fumarate and lamivudine. DOR pharmacokinetics and drug-drug interactions are also reviewed as DOR can be given without food restriction and has no interaction with proton pump inhibitors. DOR has shown a superior safety profile than EFV regarding neuropsychiatric and cutaneous adverse events. DOR is currently being investigated in treatment-experienced patients and in those with transmitted NNRTI drug resistance. DOR is a promising new NNRTI that could become the preferred drug in its class for treatment initiation. DOR has shown excellent antiviral activity in treatment-naïve patients, a better safety profile than EFV and a low potential for drug-drug interactions.