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MK-8527 is an investigational substance with no marketing authorisation in the product records; it is supplied by Merck & Co. Inc. as the film-coated tablet formulation MK-8527 F1.[2] It is classified as a chemically synthesised substance and is being studied in the therapeutic area of virus diseases.[2]
MK-8527 is a chemically synthesised, investigational antiretroviral substance. It has no marketing authorisation in the product records, meaning it is not yet an approved medicine.[2] The product name used in the trials is MK-8527 F1, a film-coated tablet for oral use.[2] The authorisation holder is Merck & Co. Inc.[2] In the registered trials, MK-8527 appears as the test substance in one trial.[2]
MK-8527 is a novel inhibitor of HIV-1 reverse transcriptase translocation, a mechanism that blocks an essential step in the virus's replication cycle.[3] Reverse transcriptase is an enzyme HIV-1 uses to copy its genetic material; inhibiting its translocation prevents the virus from multiplying. This mechanism has potential for extended-duration dosing, which is why MK-8527 is being studied as a once-monthly oral option.[3]
MK-8527 is given as a film-coated tablet for oral use.[2] In the Phase 1 trial, oral doses of 1 mg and 10 mg were studied.[1] In the Phase 3 prevention trial, the MK-8527 F1 formulation is given at an 11 mg oral dose.[2] The comparison arm in the Phase 3 trial is emtricitabine/tenofovir disoproxil 445 mg taken orally once daily, with matching placebos for both arms.[2]
Two clinical trials of MK-8527 are registered in the EU Clinical Trials Information System. One is a completed Phase 1 study in people with HIV-1, and the other is an authorised Phase 3 study for HIV-1 prevention.
The Phase 1 trial MK-8527-004 enrolled 26 participants with HIV-1 and tested the antiretroviral activity, safety, and tolerability of MK-8527.[1] The Phase 3 trial MK-8527-011 is focused on HIV-1 prevention and plans to enrol 4,700 participants.[2]
The Phase 1 trial is completed.[1] The Phase 3 trial is authorised, meaning it has received regulatory approval to proceed.[2]
The Phase 3 prevention trial measures the number of participants with adjudicated HIV-1 infection, the number who experience at least one adverse event (AE), and the number who discontinue study intervention due to an AE.[2] The Phase 1 trial measured the change from baseline in plasma HIV-1 ribonucleic acid (RNA), the number of participants experiencing at least one AE, and the number discontinuing from the study due to an AE.[1]
The Phase 3 trial is for people at risk of HIV-1 infection who are being considered for prevention; the Phase 1 trial enrolled people already living with HIV-1.[2][1] The Phase 1 trial tested MK-8527 in 26 participants, while the Phase 3 trial plans to enrol 4,700 participants, making it the largest of the two.[2][1]
The registered trials list adverse events as a primary outcome, but no specific side effects of MK-8527 are reported in the provided sources. The Phase 1 and Phase 3 trials are measuring the number of participants who experience at least one adverse event and the number who discontinue due to an adverse event.[2][1]
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