Medication Monitor

Generic Name (Trade Name—Company)
September 26, 2019

Doravirine, doravirine/lamivudine/tenofovir disoproxil fumarate

(Pifeltro, Delstrigo—Merck)
FDA expands indication to include adults with HIV-1 who are virologically suppressed

FDA approved Pifeltro (doravirine 100 mg) in combination with other antiretroviral agents and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) as a complete regimen for treatment of adult patients with HIV-1 infection who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the drugs' individual components.

Pifeltro is a nonnucleoside reverse transcriptase inhibitor that is administered with other antiretroviral agents.

Delstrigo is a once-daily, fixed-dose combination tablet of doravirine (100 mg), lamivudine (300 mg) and tenofovir disoproxil fumarate (300 mg). The agent has a boxed warning for the risk of posttreatment acute exacerbation of hepatitis B virus infection.

The agents are contraindicated when coadministered with drugs that are strong cytochrome CYP3A enzyme inducers, as significant decreases in doravirine plasma concentrations may occur and decrease the drugs' effectiveness. Delstrigo is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

The most common adverse reactions with Pifeltro are nausea, dizziness, headache, fatigue, diarrhea, abdominal pain, and abnormal dreams. The most common adverse reactions with Delstrigo are dizziness, nausea, and abnormal dreams.