Merck announced today that the US Food and Drug Administration (FDA)-approved IDVYNSO, a new, two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir, 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.

IDVYNSO is contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers and lamivudine (3TC) or emtricitabine (FTC). Co-administration with these drugs may decrease the effectiveness of IDVYNSO.

“Advances in HIV treatment mean more people living with HIV are living longer—a remarkable achievement,” said Carl Baloney, Jr. President and Chief Executive Officer, AIDS United. “People aging with HIV face additional health challenges, including managing multiple chronic conditions and medications at the same time. It is essential that management of HIV considers these factors in addition to virologic suppression when choosing an HIV treatment regimen.”

IDVYNSO is a complete regimen; co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended. Severe skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis, have been reported with doravirine-containing regimens. Drug Rash with Eosinophilia and Systemic Symptoms was reported with IDVYNSO.

Concomitant use of IDVYNSO and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of IDVYNSO and possible development of resistance, or possible clinically significant adverse reactions from greater exposures of a component of IDVYNSO.

“IDVYNSO combines islatravir, a next-generation NRTI with multiple mechanisms of action, including translocation inhibition, with doravirine, an NNRTI with an established efficacy and safety profile. As the only two-drug, non-INSTI, tenofovir-free regimen, IDVYNSO expands therapeutic diversity beyond the currently available oral treatment options,” said Dr. Eliav Barr, Senior Vice President and Chief Medical Officer, Merck Research Laboratories. “As the health needs of adults living with HIV change over time, IDVYNSO gives clinicians a new choice for HIV treatment. This approval marks an important new chapter in Merck’s long-standing commitment to research and discovery for people living with HIV.”

“IDVYNSO is the first non-INSTI, tenofovir-free, two-drug regimen to demonstrate non-inferior efficacy to standard oral antiretroviral regimens, including BIKTARVY. This makes IDVYNSO a potential alternative for people with virologically suppressed HIV who may need to switch their treatment,” said Dr. Amy Colson, Director of Research, Community Resource Initiative, Boston, Massachusetts.