Express Innovative HIV Combination Therapy Reached the Endpoints of Two Phase 3 Clinical Trials and Supported the Submission of Regulatory Applications

▎ WuXi AppTec content team editor October 25, 2021, Merck & Co.
(MSD) announced the combination of innovative nucleoside reverse transcriptase translocation inhibitor (NRTTI) islatravir and approved non-nucleoside reverse transcriptase inhibitor doravirine Therapy, two pivotal Phase 3 trials conducted in adult patients with HIV-1 infection yielded positive top-line results
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These patients obtained virological suppression after receiving different antiretroviral treatment regimens (ART), or a combination of bictegrair/emtricitabine/tenofovir (BIC/FTC/TAF), a common drug for the treatment of AIDS
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 They switched to receiving a fixed oral combination therapy of doravirine/islatravir (DOR/ISL) once a day, or continued to receive the original treatment for 48 weeks
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The specific results of the trial will be announced at a future medical conference and will become the basis for submitting a regulatory application
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Both trials reached the primary efficacy endpoint.
At week 48, the doravirine/islatravir combination showed comparable antiviral efficacy regardless of whether it was compared with the ART therapy group or the BIC/FTC/TAF therapy group
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To date, the safety and tolerability characteristics of doravirine/islatravir during the trial period are consistent with the previously reported Phase 2 studies
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Doravirine is an innovative once-a-day oral non-nucleoside reverse transcriptase inhibitor developed by Merck
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It binds to the reverse transcriptase of the HIV-1 virus to prevent the HIV-1 virus from converting RNA into DNA, thereby blocking the replication of the HIV-1 virus
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It has been approved in the United States for the treatment of adult HIV-1 infected patients who have not received antiviral therapy
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With the development of anti-HIV therapy, most HIV-infected people have been able to achieve the effect of controlling the virus level by taking daily anti-viral therapy
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However, statistics for 2019 show that there are still 1.
7 million new HIV infections around the world
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At present, the development of long-acting HIV therapies is one of the focuses in the field of HIV drug research and development.
Long-acting HIV therapies may improve the compliance of infected patients with medication
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 ▲The molecular structure of Islatravir (picture source: Edgar181, Public domain, via Wikimedia Commons) Preclinical studies have shown that Islatravir can inhibit the function of HIV reverse transcriptase through a variety of mechanisms.
Its mechanism of action is different from the currently approved anti-HIV therapies and Traditional nucleoside reverse transcriptase inhibitors (NRTIs)
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At present, Merck has carried out a number of clinical trials to test its effect as a single-drug pre-exposure (PrEP) therapy and in combination with other antiviral therapies to treat HIV infection
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A previous phase 1 trial proved that islatravir at a dose of 56 mg is expected to keep the drug concentration above the threshold for more than one year
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In other words, as a long-acting PrEP therapy, it may provide up to 12 months of protection with only one medication
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Dr.
Joan Butterton, Vice President of Global Clinical Development for Infectious Diseases, Merck Research Laboratories, said: "We are encouraged by the results obtained in two phase 3 clinical trials, which show that the efficacy of the doravirine/islatravir combination is comparable to some commonly used three-drug regimens.

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we will continue to study in a different HIV infected population doravirine / islatravir combination therapy, and look forward to continuing to share test data
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"references: [1] Merck Announces Positive Top -Line Results from Pivotal Phase 3 trials Evaluating Investigational, Once -Daily Oral Fixed Dose Combination of Doravirine/Islatravir for the Treatment of People with HIV-1 Infection.
Retrieved October 25, 2021, from https:// results-from-pivotal-phase-3-trials-evaluating-investigational-once-daily-oral-fixed-dose-combination-of-doravirine-islatravir-for-the-treatment-of-people-with-hiv-1/ Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
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This article is not a treatment recommendation
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