Investigational HIV Therapy Further Demonstrates Efficacy in Phase 3 Trial

Study evaluates doravirine once daily compared with ritonavir-boosted darunavir, each taken in combination with other antiretroviral agents.

Merck recently announced positive week 96 results from the phase 3 DRIVE-FORWARD study for its investigational HIV therapy doravirine (DOR), according to a press release. The data were presented at the 22nd International AIDS Conference taking place July 23 to 27, 2018 in Amsterdam.

DOR, a non-nucleoside reverse transcriptase inhibitor, is being evaluated for efficacy and safety in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history.

In the trial, 766 treatment-naïve patients were randomized and received either DOR once daily (100 mg) or ritonavir-boosted darunavir (800 mg and 100 mg, respectively) once daily, each in combination with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) selected by the investigator.

According to the data, at week 96, 73.1% of patients treated with once-daily DOR achieved viral suppression compared with 66% of patients treated with once-daily ritonavir-boosted darunavir (DVR+r). Viral suppression was measured by the proportion of patients who achieved HIV-1 RNA of less than 50 copies/mL. Results for patients with high baseline viral load were 65.4% for DR and 65.2% for DRV+r.

At week 48, once-daily DOR met its primary efficacy endpoint of non-inferiority compared with DVR+r, each in combination with FTC/TDF or ABC/3TC.

The most common adverse effects associated with DOR were diarrhea, nausea, headache, upper respiratory tract infection, and viral upper respiratory tract infection.

According to Merck, DOR is being evaluated in several ongoing clinical trials, both as a once-daily single-entity tablet in combination with other antiretroviral agents in a tailored regimen and as a once-daily fixed dose combination (DOR/3TC/TDF) in a complete single tablet regimen.

Earlier this year, the FDA accepted the new drug application for DOR and DOR/3TC/TDF for the treatment of HIV-1 infection in adults. The estimated FDA target action date is set for October 23, 2018, for both applications.

Reference

Merck Announces Week 96 Data from Pivotal Phase 3 DRIVE-FORWARD Study of Its Investigational HIV Therapy Doravirine [news release]. Merck’s website. http://www.mrknewsroom.com/news-release/research-and-development-news/merck-announces-week-96-data-pivotal-phase-3-drive-forwar. Accessed July 24, 2018.