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Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is a Antiretroviral combination (NNRTI + NRTIs) Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for HIV-1 infection in treatment-naïve adults, HIV-1 infection in treatment-experienced adults. Also known as: MK-1439A, DELSTRIGO™, Delstrigo.
This combination drug inhibits HIV reverse transcriptase and integrase to block viral replication and reduce HIV viral load.
This combination drug inhibits HIV reverse transcriptase and integrase to block viral replication and reduce HIV viral load. Used for HIV-1 infection in treatment-naïve adults, HIV-1 infection in treatment-experienced adults.
At a glance
| Generic name | Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate |
|---|---|
| Also known as | MK-1439A, DELSTRIGO™, Delstrigo |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Antiretroviral combination (NNRTI + NRTIs) |
| 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) that blocks HIV reverse transcriptase, while lamivudine and tenofovir disoproxil fumarate are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) that also target reverse transcriptase through chain termination. Together, these three agents work synergistically to suppress HIV replication by targeting the same enzyme through different mechanisms.
Approved indications
- HIV-1 infection in treatment-naïve adults
- HIV-1 infection in treatment-experienced adults
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Rash
- Renal impairment (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)
- 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)
- DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road) (PHASE2)
- Can INSTI-associated Weight Gain be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF? (PHASE4)
- A Randomised, Phase 3 Non-inferiority Study of DOR/3TC/TDF Compared to DTG/TAF/FTC in Participants Infected With HIV-1 Starting First-line Antiretroviral Therapy (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/Lamivudine/Tenofovir Disoproxil Fumarate CI brief — competitive landscape report
- Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
What is Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate?
How does Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate work?
What is Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate used for?
Who makes Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate?
Is Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate also known as anything else?
What drug class is Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in?
What development phase is Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in?
What are the side effects of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate?
What does Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate target?
Related
- Drug class: All Antiretroviral combination (NNRTI + NRTIs) drugs
- Target: All drugs targeting HIV reverse transcriptase
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection in treatment-naïve adults
- Indication: Drugs for HIV-1 infection in treatment-experienced adults
- Also known as: MK-1439A, DELSTRIGO™, Delstrigo
- Compare: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate vs similar drugs
- Pricing: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate cost, discount & access