July 29, 2017
Merck Presented New Data From Clinical Trials on Isentress, Doravirine, and MK-8591
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Merck, known as MSD outside the United States and Canada, shared new data from the company's HIV portfolio and pipeline at the 9th IAS Conference on HIV Science (IAS 2017).
Presentations included late-breaker abstracts from two Phase 3 pivotal clinical trials -- Week 96 data from ONCEMRK, a study evaluating once-daily ISENTRESS� HD (raltegravir) in combination with other antiretroviral agents in previously untreated adult patients with HIV-1 infection, and Week 48 data from DRIVE-AHEAD, a study evaluating doravirine (MK-1439), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) as part of a fixed dose regimen containing doravirine (DOR), lamivudine (3TC), and tenofovir disoproxil fumarate (TDF) compared to a regimen containing efavirenz, (EFV), emtricitabine (FTC), and TDF in previously untreated adult patients with HIV-1 infection.
In addition, a late-breaker abstract was presented of a Phase 1 study of MK-8591, Merck's investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI), in adult patients with HIV-1 infection.
"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 on our portfolio and our pipeline reflect that commitment," said Dr. George Hanna, associate vice president, clinical research, Merck Research Laboratories.
In the United States, once-daily ISENTRESS HD was approved by the Food and Drug Administration (FDA) on May 26, 2017, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults, and pediatric patients weighing at least 40 kg, who are treatment-na�ve or whose virus has been suppressed on an initial regimen of ISENTRESS 400 mg given twice daily.
ISENTRESS HD is administered as a 1200 mg once-daily dose, given orally as two 600 mg film-coated tablets. On May 18, 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of the once-daily dose of ISENTRESS (ISENTRESS 600 mg as it will be known outside the United States) in combination with other antiretroviral medicinal products, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. The recommendation is under review by the European Commission for marketing authorization in the European Union with a decision on approval expected in the second half of 2017.
Select Late-Breaker Abstracts at IAS 2017:
About Doravirine
Doravirine is an investigational NNRTI being evaluated by Merck for the treatment of HIV-1 infection. Doravirine is being evaluated in several ongoing studies as a once-daily fixed dose combination with 3TC and TDF or individually for use in combination with other antiretroviral agents. Phase 3 studies include DRIVE-AHEAD, a trial comparing DOR/3TC/TDF to EFV/ FTC/TDF in previously untreated adult patients; DRIVE-FORWARD, a trial comparing doravirine (DOR) to once-daily ritonavir-boosted darunavir (DRV+r), each administered in combination with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC), in previously untreated adult patients; and DRIVE-SHIFT, a trial evaluating a switch to DOR/3TC/TDF in people who are currently virologically suppressed on another antiretroviral regimen. Other ongoing Phase 2 studies include an evaluation of DOR/3TC/TDF in previously untreated patients with transmitted resistance to NNRTIs and in people switching from efavirenz due to intolerability.
About MK-8591
MK-8591 (formerly known as EFdA) is Merck's investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated in early stage clinical trials for the treatment of HIV infection. It inhibits HIV reverse transcriptase through multiple mechanisms that are different from any approved anti-HIV medicines, including traditional nucleoside reverse transcriptase inhibitors (NRTIs). MK-8591 is being evaluated for its potential to be administered as part of a daily or an extended duration dosing regimen.
About ISENTRESS (raltegravir)
Approved in 2007, ISENTRESS was the first integrase inhibitor developed for the treatment of HIV-1 infection. ISENTRESS is one of the regimen options recommended by the Department of Health and Human Services -- in combination with other antiretroviral agents -- as the first-line therapy in treatment-na�ve HIV-1 infected adults.
ISENTRESS chewable tablets and oral suspension, each in combination therapy, are approved to treat pediatric patients aged at least four weeks of age, and weighing less than 20 kg.
ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells.
ISENTRESS is approved as part of combination therapy in 112 countries for the treatment of HIV-1 infection in adult patients. ISENTRESS, in combination therapy, for use in children and adolescents with HIV-1 aged two years and older has also been approved for use in 69 countries, and ISENTRESS oral suspension for infants at least four weeks of age is approved for use in 33 countries.
