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Doravirine, Tenofovir, Lamivudine
This combination inhibits HIV reverse transcriptase and integrase to block viral replication and reduce viral load in HIV-infected patients.
This combination inhibits HIV reverse transcriptase and integrase to block viral replication and reduce viral load in HIV-infected patients. Used for HIV-1 infection in treatment-naïve adults, HIV-1 infection in treatment-experienced patients (with specific resistance profiles).
At a glance
| Generic name | Doravirine, Tenofovir, Lamivudine |
|---|---|
| Also known as | Doravirine (PIFELTRO™), Doravirine/Lamivudine/Tenofovir disoproxil fumarate (DELSTRIGO™), MK-1439A |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Antiretroviral combination (NNRTI + NRTIs) |
| Target | HIV reverse transcriptase, HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV reverse transcriptase, while tenofovir and lamivudine are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) that are incorporated into viral DNA to terminate chain elongation. Together, these three agents target different steps of HIV replication to suppress viral replication and restore immune function.
Approved indications
- HIV-1 infection in treatment-naïve adults
- HIV-1 infection in treatment-experienced patients (with specific resistance profiles)
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Rash
- Renal impairment (tenofovir-related)
- Bone density loss (tenofovir-related)
Key clinical trials
- Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066) (PHASE2)
- Doravirine Dose Optimisation in Pregnancy (PHASE4)
- Efficacy and Safety of Doravirine in the Rapid Initiation (PHASE4)
- DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection (PHASE3)
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (PHASE3)
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2, PHASE3)
- Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study (PHASE4)
- DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or Obesity (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:
- Doravirine, Tenofovir, Lamivudine CI brief — competitive landscape report
- Doravirine, Tenofovir, Lamivudine updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI