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Placebo to FDC DOR/ISL
A fixed-dose combination of doravirine and islatravir that inhibits HIV reverse transcriptase to suppress viral replication.
A fixed-dose combination of doravirine and islatravir that inhibits HIV reverse transcriptase to suppress viral replication. Used for HIV-1 infection in treatment-naive adults.
At a glance
| Generic name | Placebo to FDC DOR/ISL |
|---|---|
| Also known as | Placebo to MK-8591A |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Antiretroviral combination (NNRTI + NRTI) |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and islatravir is a nucleoside reverse transcriptase inhibitor (NRTI) that work synergistically to block HIV reverse transcriptase, preventing the virus from converting its RNA genome into DNA and integrating into host cells. This combination targets a critical step in the HIV replication cycle.
Approved indications
- HIV-1 infection in treatment-naive adults
Common side effects
- Nausea
- Diarrhea
- Headache
- Rash
- Elevated liver enzymes
Key clinical trials
- Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (PHASE3)
- Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020) (PHASE3)
- Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo to FDC DOR/ISL CI brief — competitive landscape report
- Placebo to FDC DOR/ISL updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI