Merck & Co. Plans to File NDA for HIV Treatment Doravirine Based on Phase III Results

Published: Jul 26, 2017

Merck Plans to File NDA for HIV Treatment Doravirine Based on Phase III Results July 26, 2017
By Alex Keown, Breaking News Staff

PARIS – HIV-positive patients may soon have a new treatment option that can be taken without food restrictions and has a much lower rate of drug interference with other medications patients may be taking.

Based off two successful Phase III trials, pharma giant Merck & Co. plans to file a New Drug Application with the U.S. Food and Drug Administration for its investigational HIV treatment, doravirine.

Speaking exclusively to BioSpace from Paris, Dr. George Hanna, head of clinical research at Merck Research Laboratories , said trial data at 48 weeks shows doravirine, a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI), is slightly more effective than the commonly used drug Atripla, which is a triple cocktail of efavirenz (EFV), emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), in treatment-naïve adults infected with HIV-1.

According to trial data presented at the 9th International AIDS Society (IAS) Conference on HIV Science, Merck’s fixed dose of doravirine showed viral suppression in HIV-1 infected treatment-naïve adults. Merck’s primary endpoint in the Drive Ahead trial was to determine if the drug had an inferior efficacy to Atripla. The investigational Merck drug was effective in 84 percent of patients, compared to the 81 percent taking once-daily EFV/FTC/TDF. Data shows the drug met its primary endpoint of non-inferiority against Atripla.

Based on the Phase III Drive-Ahead study, as well as positive results from a separate Phase III trial, Hanna said Merck will file the NDA before the end of 2017.

“Atripla has been used for many years to treat HIV patients. It’s oftentimes a first-line treatment and we chose a head-to-head comparison due to its prominent use,” Hanna said.

While the drug has a similar efficacy profile to Atripla, Hanna told BioSpace that the drug has a stronger safety profile, particularly when it comes to three key areas: rashes; pre-specified neuropsychiatric events that include dizziness, muddled thinking and sleep issues; and cholesterol. When it came to the cholesterol and doravirine, Hanna said the drug did not cause an increase in LDL levels in comparison to the Atripla group.

Another key factor that Hanna said will be important for HIV-positive patients is doravirine’s design that limits a drug-drug interactions as much as possible. Citing statistics from the U.S. Centers for Disease Control and Prevention, Hanna said more than half of the people in the United States living with HIV are older than 50 years, which means they are typically taking more medicines.

“We wanted to create a drug that has minimal drug interaction with other drugs a patient may be taking. No drug has zero drug-drug interaction, but it’s important to note for doravirine, that it seems to have a limited drug-drug interaction,” he said.

Hanna added that with zero food restrictions for the medicine, patients have greater flexibility in their daily lives.

“When clinicians determine therapies (for patients) they consider efficacy, but they’re also conscious of the safety profile. Clinicians look at the big picture with a treatment like doravirine,” Hanna said.

Kathleen Squires, director of infectious diseases at Philadelphia-based Thomas Jefferson University and lead investigator of the trial, said the drug, if approved, will provide HIV patients with new options to treat and manage the disease. With the favorable safety profile for doravirine and the fact the medicine isn’t tied to food requirements, Squires said the drug will allow patients to enjoy as normal a life as possible.

With the trial results for doravirine, Squires said the “major take home message for clinicians” is that there is a “variety of options available” to determine the best regimen for a patient.

“When you have a patient sitting across from you, you have to take these things into consideration in order to come up with the best regimen that will meet the patient’s lifestyle and not let it hinder their ability to go out and achieve a normal life,” Squires, who has worked with HIV most of her career, said in a phone interview.

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