In short
MK-8527 is an investigational chemical substance being studied for the prevention and treatment of HIV-1 infection. It is given as a film-coated tablet taken by mouth. Two clinical trials are registered for MK-8527: a completed Phase 1 study in 26 people with HIV-1, and an authorised Phase 3 prevention study planning to enrol 4,700 participants.
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. It is classified as a chemically synthesised substance and is being studied in the therapeutic area of virus diseases.
Key points
- MK-8527 is an investigational antiretroviral with no marketing authorisation in these records.
- It is being studied for HIV-1 prevention in a Phase 3 trial with 4,700 planned participants.
- A completed Phase 1 trial tested MK-8527 in 26 people with HIV-1.
- The Phase 3 trial compares MK-8527 taken once monthly with daily emtricitabine/tenofovir disoproxil.
- Trials measure HIV-1 infections, adverse events, and changes in plasma HIV-1 RNA.
- The Phase 3 trial is currently authorised; the Phase 1 trial is completed.
What is MK-8527?
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. The product name used in the trials is MK-8527 F1, a film-coated tablet for oral use. The authorisation holder is Merck & Co. Inc. In the registered trials, MK-8527 appears as the test substance in one trial.
How does MK-8527 work?
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. 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.
Which conditions is MK-8527 used or studied for?
- HIV-1 prevention — the Phase 3 trial MK-8527-011 is evaluating whether MK-8527 taken once monthly can prevent HIV-1 infection compared with daily emtricitabine/tenofovir disoproxil.
- HIV-1 (Human Immunodeficiency Virus Type 1) — the completed Phase 1 trial MK-8527-004 studied MK-8527 in people already living with HIV-1 to assess its antiretroviral activity.
How is MK-8527 given?
MK-8527 is given as a film-coated tablet for oral use. In the Phase 1 trial, oral doses of 1 mg and 10 mg were studied. In the Phase 3 prevention trial, the MK-8527 F1 formulation is given at an 11 mg oral dose. The comparison arm in the Phase 3 trial is emtricitabine/tenofovir disoproxil 445 mg taken orally once daily, with matching placebos for both arms.
What do the clinical trials show?
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.
Which conditions are being studied?
The Phase 1 trial MK-8527-004 enrolled 26 participants with HIV-1 and tested the antiretroviral activity, safety, and tolerability of MK-8527. The Phase 3 trial MK-8527-011 is focused on HIV-1 prevention and plans to enrol 4,700 participants.
What phases and status do the trials have?
The Phase 1 trial is completed. The Phase 3 trial is authorised, meaning it has received regulatory approval to proceed.
What are the trials measuring?
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. 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.
Who can take part in these trials?
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. 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.
What side effects are known?
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.