New Clinical Trial Data Shows HIV Drugs in the Pipeline

New clinical trial data evaluating raltegravir (Isentress HD), doravirine, and MK-8591 are set to be presented at the upcoming annual IAS Conference of HIV Science in Paris, France.

The presentations will include late-breaker abstracts from the pivotal phase 3 clinical trials ONCEMRK and DRIVE-AHEAD, according to a press release. There are 96 weeks of data from the ONCEMRK trial and 48 weeks from the DRIVE-AHEAD trial. Additionally, a late-breaking abstract will also be presented from a phase 1 study of MK-8591.

MK-8591, formerly known as EFdA, is an investigational nucleoside reverse transcriptase translocation inhibitor designed to inhibit HIV reverse transcriptase through several mechanisms that differ from any approved anti-HIV medications.

In the ONCEMRK trial, investigators are evaluating once-daily raltegravir in combination with other antiretroviral agents in previously untreated adult patients with HIV-1 infection.

The DRIVE-AHEAD study is evaluating doravirine as part of a fixed-dose regimen containing doravirine, lamivudine, and tenofovir disoproxil (TDF) compared with efavirenz, emtricitabine, and TDF combination regimen.

“Merck has never wavered in our commitment to addressing the treatment needs of people living with HIV, and the data to be presented at IAS 2017 on our portfolio and our pipeline reflect that commitment,” Dr George Hanna, associate vice president, clinical research, Merck Research Laboratories, said in a release.

Raltegravir was approved by the FDA in May 2017, in combination with other antiretroviral agents for the treatment of adults with HIV-1, and pediatric patients weighing a minimum of 40 kg, who are treatment-naïve or virally suppressed from an initial 400 mg dose of raltegravir twice-daily.

Merck’s late-breaker abstracts at IAS 2017 include:

• Abstract #TULBPEB20: Raltegravir (RAL) 200 mg once daily versus RAL 400 mg twice daily, in combination with tenofovir disoproxil fumarate/emtricitabine, in previously untreated HIV-1 infection through week 96.
• Abstract #TUPDB0202LB: Single doses as low as 0.5 mg of the novel NRTTI MK-8591 suppress HIV for at least 7 days.
• Abstract #TUAB0104LB: Fixed dose combination of doravirine/lamivudine/ tenofovir disoproxil fumarate is non-inferior to efavirenz/emtricitabine/ tenofovir disoproxil fumarate in treatment-naïve adults with HIV-1 infection: week 48 results of the phase 3 DRIVE-AHEAD study.