The US FDA has approved a two-drug combination of doravirine and islatravir for the treatment of HIV-1 infection in adults. This regimen is intended to replace the current antiretroviral therapy in patients who are virologically suppressed, defined as HIV-1 RNA less than 50 copies per mL, on a stable regimen, with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. Doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor, while islatravir is a nucleoside analog reverse transcriptase inhibitor.
Clinical evidence The safety and efficacy of the doravirine and islatravir combination were demonstrated in both a double-blind trial and an open-label trial. In the double-blind trial involving 513 patients, 1% of those switched to the two-drug combination had a viral load of ≥50 copies/mL at week 48, compared with 1% of…
