Merck issued the following announcement on July 10.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the results from studies evaluating MK-8591, an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI), are scheduled to be presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019) taking place July 21 – 24, 2019 in Mexico City.
“Building upon our proud heritage in HIV, we are excited to share these latest findings for MK-8591,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “Based upon the Phase 2B results to be presented at IAS 2019, our company plans to initiate Phase 3 trials evaluating MK-8591 with doravirine for the treatment of HIV-1.”
Abstracts to be presented at IAS 2019
MK-8591, at doses of 0.25 to 2.25 mg QD, in combination with doravirine establishes and maintains viral suppression through 48 weeks in treatment-naïve adults with HIV-1 infection. Late-breaking Oral Presentation. Wednesday, July 24, 11:00-12:30 CDT. Abstract WEAB0402LB. J-M Molina et al.
First-in-human trial of MK-8591-eluting implants demonstrates concentrations suitable for HIV prophylaxis for at least one year. Late-breaking Oral Presentation. Tuesday, July 23, 16:30-18:00 CDT. Abstract TUAC0401LB. R. Matthews et al.
Tolerability, safety and efficacy of MK-8591 at doses of 0.25 to 2.25 mg QD, in combination with doravirine and lamivudine through 24 weeks in treatment-naïve adults with HIV-1 infection. Late-breaking Poster Presentation. Tuesday, July 23, 12:30-14:30 CDT. Abstract LBPED46. J-M Molina et al.
Cellular Modulation and HIV reactivation in response to serial treatment of latently HIV-infected CD4 T cells with Histone Deacetylase inhibitors (HDACi). Poster Presentation. Wednesday, July 24, 12:30-14:30 CDT. Abstract WEPEA044. J. Maxwell et al.
For more information, please visit the IAS 2019 website.
Doravirine is marketed as PIFELTRO® in the United States. PIFELTRO (doravirine, 100 mg) is a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral (ARV) medicines currently indicated for the treatment of HIV-1 infection in adult patients not previously treated with antiretroviral therapy. PIFELTRO was approved by the U.S. Food and Drug Administration (FDA) on August 30, 2018 to be administered in combination with other antiretrovirals for the treatment of HIV-1 infection in adult patients with no prior ARV treatment experience. A supplemental New Drug Application is under review by the FDA for use (in combination with other antiretrovirals) in people living with HIV-1 who are switching from a stable antiretroviral regimen and whose virus is suppressed (HIV-1 RNA <50 copies/mL). The Prescription Drug User Fee Act (PDUFA) date is Sept. 20, 2019.
Selected Safety Information about PIFELTRO (doravirine)
PIFELTRO is contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers (including the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and the herbal product St. John’s wort (Hypericum perforatum)), as significant decreases in PIFELTRO plasma concentrations may occur, which may decrease the effectiveness of PIFELTRO. Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment. Co-administration of PIFELTRO with efavirenz, etravirine or nevirapine is not recommended. If co-administered with rifabutin, increase PIFELTRO dosage to one tablet twice daily (approximately 12 hours apart).
Consult the full Prescribing Information prior to and during treatment for important potential drug-drug interactions. The safety of PIFELTRO is based on two studies, DRIVE-FORWARD and DRIVE-AHEAD. In DRIVE-FORWARD, the most common adverse reactions (incidence ≥5%, all intensities) were nausea (7%), headache (6%), fatigue (6%), diarrhea (5%) and abdominal pain (5%). In DRIVE-AHEAD, the most common adverse reactions (incidence ≥5%, all intensities) were dizziness (7%), abnormal dreams (5%) and nausea (5%).
There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PIFELTRO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry at 1-800-258-4263. Mothers infected with HIV-1 should be instructed not to breastfeed if they are receiving PIFELTRO (doravirine) due to the potential for HIV-1 transmission.
Original source can be found here.