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Merck Sharp and Dohme reports positive trial data for HIV therapy doravirine
Merck Sharp and Dohme has announced new clinical trial data that demonstrates the effectiveness of its new HIV-1 therapy doravirine.
The DRIVE-AHEAD study was the second of two pivotal phase III clinical trials evaluating the efficacy and safety of the investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infections.
After 48 weeks, results indicated that a once-daily, single-tablet, fixed-dose combination of doravirine, lamivudine and tenofovir disoproxil fumarate (TDF) delivered a non-inferior performance to a similar combination of efavirenz, emtricitabine and TDF in treatment-naive adults infected with HIV-1.
In addition, statistically significantly fewer patients taking the doravirine-based regimen reported neuropsychiatric events such as dizziness, sleep disturbance and an inability to think clearly or concentrate than patients receiving the efavirenz-based regimen.
Dr George Hanna, associate vice-president for clinical research at Merck Research Laboratories, said: "The development of doravirine is the result of a decade of Merck research. Based on our encouraging phase III study findings, we plan to file regulatory applications in Q4 2017."
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