Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-8591A · 2 trials · 2 indications
Percentage of participants with serious adverse events (SAEs)
Percentage of participants who discontinued study treatment due to an AE.
AUC0-inf is a measure of plasma drug concentration from time 0 to infinity and is estimated as the area under the plot of plasma concentration against time 0 to infinity after drug administration. Blood samples collected at designated time points will be used to determine the AUC0-inf of DOR.
AUC0-last is defined as the area under the concentration-time curve from time 0 to time of last measurable concentration of DOR. Blood will be collected at designated time points to determine the AUC0-last of DOR.
Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected at designated time points will be used to determine Cmax of DOR.
C24 is the concentration at 24 hours postdose of the drug observed in plasma. Blood samples collected at 24 postdose will be used to determine C24 of DOR.
AUC0-inf is a measure of plasma drug concentration and time 0 to infinity and is estimated as the area under the plot of plasma concentration against time 0 to infinity after drug administration. Blood samples collected at designated time points will be used to determine the AUC0-inf of ISL.
AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of ISL. Blood will be collected at designated time points to determine the AUC0-last of ISL.
Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected at designated time points will be used to determine Cmax of ISL.
| Arm | Type | Description |
|---|---|---|
| MK-8591A | EXPERIMENTAL | Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks. |
| MK-8591A Sequence 1A | EXPERIMENTAL | Participants will receive Doravine/Islatravir (DOR/ISL) fixed-dose combination (FDC) tablet under fasting conditions followed by a DOR/ISL FDC tablet under fed conditions followed by a single dose Doravine tablet and a single dose Islatravir capsule under fasting conditions. |
| MK-8591A Sequence 2A | EXPERIMENTAL | Participants will receive DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions. |
| MK-8591A Sequence 1B | EXPERIMENTAL | Participants will receive DOR/ISL FDC tablet under fed conditions followed by a DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions. |
| MK-8591A Sequence 2B | EXPERIMENTAL | Participants will receive DOR/ISL FDC tablet under fed conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting condition followed by a DOR/ISL FDC tablet under fasting conditions. |
| MK-8591A Sequence 1C | EXPERIMENTAL | Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fasting conditions followed by followed by a DOR/ISL FDC tablet under fed conditions. |
| MK-8591A Sequence 2C | EXPERIMENTAL | Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions followed by followed by a DOR/ISL FDC tablet under fasting conditions. |
| Name | Type | Description |
|---|---|---|
| MK-8591A | DRUG | FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks |
| Islatravir | DRUG | Oral capsule |
| Doravine | DRUG | Oral tablet |
Inclusion Criteria: * Is currently receiving DOR 100 mg/ISL 0.75 mg adult FDC tablet in an MSD-sponsored clinical study and has completed the last treatment visit. * Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL...
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MK-8591A is an investigational small molecule being developed for the treatment of HIV-1 infection. It is a combination of doravirine and islatravir, studied as a once-daily oral regimen. The drug is currently in Phase 3 clinical development for this indication.
MK-8591A combines doravirine, a non-nucleoside reverse transcriptase inhibitor, and islatravir, a nucleoside reverse transcriptase inhibitor. Both components target the HIV-1 reverse transcriptase enzyme, interfering with viral replication. The combination is designed to provide a complete antiretroviral regimen.
MK-8591A is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the safety and efficacy of this investigational combination therapy.
MK-8591A is in Phase 3 clinical development for HIV-1 infection. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial is currently active but not recruiting participants, while a Phase 1 study in healthy volunteers has been completed.
MK-8591A is being evaluated in a Phase 3 open-label follow-up study (NCT04776252) enrolling 2,000 participants with HIV-1 infection across multiple countries. A Phase 1 study (NCT06719570) in healthy adults has been completed, examining the drug's effect with food.
Yes, MK-8591A is the combination of doravirine and islatravir, often referred to as DOR/ISL. The Phase 3 trial title describes it as doravirine/islatravir (DOR/ISL 100 mg/0.75 mg). This combination is being studied as a single-tablet regimen for HIV-1 treatment.