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HIV Treatment Drug Doravirine Expecting FDA Approval In 2018

Doravirine Expecting FDA Approval in 2018 After Phase 3 Results

Announced at the #AIDS2018 global conference in Amsterdam the drug is another innovation for those beginning treatment.

Photo above: Dr. Carey Hwang 

At the International AIDS conference (#AIDS2018) Merck & Company, Inc. announced the week 96 results of their Phase 3 "DRIVE-FORWARD" study on the its investigational HIV Therapy doravirine.

The drug is awaiting FDA decision with a target action date set for October 23, 2018.

Dr. Carey Hwang is the development lead of the new [MOU3] therapy and talked about some of the upsides they found with doravirine. "What we see in the Phase 3 trials to date is that doravirine is potent and has been shown to be non-inferior in two Phase 3 clinical trials against well-established comparators. I think it addresses several of the issues that have been associated with the first and second generation antiretroviral drugs in the class, such as neuropsychiatric adverse events, requirements to take with a high fat meal and some of the drug interactions. In one of our Phase 3 trials—DRIVE-AHEAD— we were able to demonstrate that doravirine had a superior and neuropsychiatric profile with far fewer neuropsychiatric adverse events compared with efavirenz, each in combination with other antiretroviral agents, through 48 weeks of treatment."

Dr. Hwang explained how the process works from the development of an innovative therapy to FDA approval. "These are large trials that we sponsor and we enlist investigators worldwide to enroll participants into the trials to evaluate doravirine against other approved antiretrovirals. The primary efficacy endpoint is looking at whether in this case — doravirine, is non-inferior to our competitor FDA-approved comparator drugs that are currently on the market."

Dr. Hwang has been working on HIV from basic science to translational to clinical research and patient care and is now developing new drugs for the treatment of HIV. Dr. Hwang attended medical school at  West Virginia University and completed his residency in internal medicine and fellowship in infectious diseases at Vanderbilt University. "I was a clinician as well, so I treated patients with HIV in the clinic, while doing translational research at Vanderbilt."

Dr. Hwang took blood samples from patients and brought it back to the lab to "to gain a better understanding of what HIV was doing in the body." Although he misses the relationships with his patients, "You develop one-on-one relationships with patients to help them on an individual level to successfully treat their HIV."  Ultimately, when the opportunity opened up to develop new antiretrovirals, it was difficult to pass up. “If you can help develop a drug that improves the lives of people living with HIV, you can potentially positively impact thousands, if not millions of lives."




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