Health and Me

Rachel V Thomas

US FDA Approves Merck’s Once-daily Combination Pill For Treating Adults With HIV

The US Food and Drug Administration (FDA) has approved Merck's Idvynso (doravirine/islatravir), a new, once-daily pill for the treatment of HIV-1 infection in adults.

The two-drug single tablet replaces the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA &lt;50 copies per mL). 

The single tablet contains 100 mg doravirine and 0.25 mg islatravir. The FDA has approved it for adults on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.

“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,” said Dr. Eliav Barr, senior vice president and chief medical officer, Merck Research Laboratories, in a statement.

The approval is based on data from two randomized, active-controlled, noninferiority trials. In the double-blind Trial 052, participants were randomly assigned to stay on Glilead's Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide; 171 individuals) or switch to Idvynso (342 individuals).

Results showed that 1 per cent of participants in both groups had a viral load of ≥50 copies/mL at 48 weeks. 

In the open-label Trial 051, participants were randomly assigned to stay on their oral antiretroviral therapy (ART) regimen (185 individuals) or switch to Idvynso (366 individuals). 

Results showed that 1 per cent of participants who were switched to Idvynso had a viral load of ≥50 copies/mL at week 48 versus 5 per cent who continued on ART. 

"As the only two-drug, non-integrase strand transfer inhibitor, tenofovir-free regimen, Idvynso expands therapeutic diversity beyond the currently available oral treatment options," Barr said. 

"As the health needs of adults living with HIV change over time, Idvynso gives clinicians a new choice for HIV treatment."

What Is IDVYNSO? How Does It Work?

IDVYNSO is a fixed-dose combination of two medicines, doravirine with islatravir. 

Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase. 

Islatravir is a potent, next-generation nucleoside analog reverse transcriptase inhibitor (NRTI) that blocks HIV-1 replication by multiple mechanisms, including:

<ul><li>inhibition of reverse transcriptase translocation, resulting in immediate chain termination, </li><li>induction of structural changes in the viral DNA (delayed chain termination). </li></ul>IDVYNSO is a complete regimen; co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended.

<h2>Global Burden Of HIV</h2>

According to the latest data from UNAIDS, 40.8 million people globally were living with HIV in 2024. Of these, 39.4 million were adults (15 years or older) and 1.4 million were children (0–14 years).

While 1.3 million people became newly infected with HIV in 2024, 630,000 died from AIDS-related illnesses. 

About 87 per cent of all people living with HIV knew their HIV status, and 5.3 million people did not know that they were living with HIV.

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The US Food and Drug Administration (FDA) has approved Merck's Idvynso (doravirine/islatravir), a new, once-daily pill for the treatment of HIV-1 infection in adults. The two-drug single tablet replaces the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA The single tablet contains 100 mg doravirine and 0.25 mg islatravir. The FDA has approved it for adults on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. “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,” said Dr. Eliav Barr, senior vice president and chief medical officer, Merck Research Laboratories, in a statement. How Was The Pill Approved? The approval is based on data from two randomized, active-controlled, noninferiority trials. In the double-blind Trial 052, participants were randomly assigned to stay on Glilead's Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide; 171 individuals) or switch to Idvynso (342 individuals). Results showed that 1 per cent of participants in both groups had a viral load of ≥50 copies/mL at 48 weeks.  In the open-label Trial 051, participants were randomly assigned to stay on their oral antiretroviral therapy (ART) regimen (185 individuals) or switch to Idvynso (366 individuals). Results showed that 1 per cent of participants who were switched to Idvynso had a viral load of ≥50 copies/mL at week 48 versus 5 per cent who continued on ART. "As the only two-drug, non-integrase strand transfer inhibitor, tenofovir-free regimen, Idvynso expands therapeutic diversity beyond the currently available oral treatment options," Barr said. "As the health needs of adults living with HIV change over time, Idvynso gives clinicians a new choice for HIV treatment."  What Is IDVYNSO? How Does It Work?  IDVYNSO is a fixed-dose combination of two medicines, doravirine with islatravir. Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase. Islatravir is a potent, next-generation nucleoside analog reverse transcriptase inhibitor (NRTI) that blocks HIV-1 replication by multiple mechanisms, including: inhibition of reverse transcriptase translocation, resulting in immediate chain termination, induction of structural changes in the viral DNA (delayed chain termination). IDVYNSO is a complete regimen; co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended. Global Burden Of HIV According to the latest data from UNAIDS, 40.8 million people globally were living with HIV in 2024. Of these, 39.4 million were adults (15 years or older) and 1.4 million were children (0–14 years). While 1.3 million people became newly infected with HIV in 2024, 630,000 died from AIDS-related illnesses.  About 87 per cent of all people living with HIV knew their HIV status, and 5.3 million people did not know that they were living with HIV.