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Doravirine, Tenofovir, Lamivudine - Open-Label
Doravirine, Tenofovir, Lamivudine - Open-Label is a HIV-1 reverse transcriptase inhibitor Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 2 development for Treatment of HIV-1 infection in adults with no antiretroviral treatment history or with viral suppression on a stable antiretroviral regimen for at least 6 months. Also known as: MK-1439A.
Doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), while Tenofovir and Lamivudine are HIV-1 nucleotide reverse transcriptase inhibitors (NtRTIs) and nucleoside reverse transcriptase inhibitors (NRTIs), respectively.
Doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), while Tenofovir and Lamivudine are HIV-1 nucleotide reverse transcriptase inhibitors (NtRTIs) and nucleoside reverse transcriptase inhibitors (NRTIs), respectively. Used for Treatment of HIV-1 infection in adults with no antiretroviral treatment history or with viral suppression on a stable antiretroviral regimen for at least 6 months.
At a glance
| Generic name | Doravirine, Tenofovir, Lamivudine - Open-Label |
|---|---|
| Also known as | MK-1439A |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | HIV-1 reverse transcriptase inhibitor |
| Target | HIV-1 reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 2 |
Mechanism of action
Doravirine works by binding to the HIV-1 reverse transcriptase enzyme, preventing the replication of the virus. Tenofovir and Lamivudine work by inhibiting the HIV-1 reverse transcriptase enzyme, thereby preventing the replication of the virus. This combination of drugs is used to treat HIV-1 infection.
Approved indications
- Treatment of HIV-1 infection in adults with no antiretroviral treatment history or with viral suppression on a stable antiretroviral regimen for at least 6 months
Common side effects
- Nausea
- Diarrhea
- Fatigue
- Headache
- Dizziness
- Insomnia
- Abdominal pain
- Vomiting
- Rash
- Pyrexia
Key clinical trials
- 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 Switch With M184V/I in People With Controlled HIV (Drive Off-Road) (PHASE2)
- Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028) (PHASE2)
- Study Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV Viruses (PHASE2)
- Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) (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 - Open-Label CI brief — competitive landscape report
- Doravirine, Tenofovir, Lamivudine - Open-Label updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Doravirine, Tenofovir, Lamivudine - Open-Label
What is Doravirine, Tenofovir, Lamivudine - Open-Label?
How does Doravirine, Tenofovir, Lamivudine - Open-Label work?
What is Doravirine, Tenofovir, Lamivudine - Open-Label used for?
Who makes Doravirine, Tenofovir, Lamivudine - Open-Label?
Is Doravirine, Tenofovir, Lamivudine - Open-Label also known as anything else?
What drug class is Doravirine, Tenofovir, Lamivudine - Open-Label in?
What development phase is Doravirine, Tenofovir, Lamivudine - Open-Label in?
What are the side effects of Doravirine, Tenofovir, Lamivudine - Open-Label?
What does Doravirine, Tenofovir, Lamivudine - Open-Label target?
Related
- Drug class: All HIV-1 reverse transcriptase inhibitor drugs
- Target: All drugs targeting HIV-1 reverse transcriptase
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Treatment of HIV-1 infection in adults with no antiretroviral treatment history or with viral suppression on a stable antiretroviral regimen for at least 6 months
- Also known as: MK-1439A