Doravirine

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1 Adverse Reaction Overview The safety assessment of PIFELTRO® in antiretroviral treatment-naïve, HIV-1-infected subjects, is based on the analyses of data through 48- and 96 Weeks from two Phase 3, randomized, international, multicenter, double-blind, active-controlled trials (DRIVE-FORWARD (Protocol 018) and DRIVE-AHEAD (Protocol 021)).

In subjects receiving PIFELTRO®, the serious adverse reactions of nausea, vomiting, asthenia, insomnia, and nightmares were reported, and these reactions were reported by <1% subjects. The most frequently reported adverse reaction with doravirine was nausea (6 %).

There were no adverse reactions of moderate to severe intensity with an incidence of greater than or equal to 2%. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the frequencies of adverse reactions observed in the clinical trials may not reflect frequencies observed in clinical practice and should not be compared to frequencies reported in clinical trials of another drug.

4) and Clinical Studies (14) ]. IDVYNSO is a two-drug combination of doravirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), and islatravir, a nucleoside analog reverse transcriptase inhibitor (NRTI), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.

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