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Dolutegravir + Lamivudine FDC
Dolutegravir + Lamivudine FDC is a Antiretroviral combination (INSTI + NRTI) Small molecule drug developed by ViiV Healthcare. It is currently in Phase 3 development for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (age and weight-dependent formulations).
Dolutegravir inhibits HIV integrase to prevent viral DNA integration into the host genome, while lamivudine inhibits reverse transcriptase to block viral replication.
Dolutegravir inhibits HIV integrase to prevent viral DNA integration into the host genome, while lamivudine inhibits reverse transcriptase to block viral replication. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (age and weight-dependent formulations).
At a glance
| Generic name | Dolutegravir + Lamivudine FDC |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | Antiretroviral combination (INSTI + NRTI) |
| Target | HIV integrase and HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
This fixed-dose combination targets two critical steps in the HIV replication cycle. Dolutegravir is an integrase strand transfer inhibitor (INSTI) that prevents the viral enzyme integrase from inserting HIV DNA into human chromosomes. Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) that blocks the reverse transcriptase enzyme from converting viral RNA into DNA. Together, they provide complementary antiretroviral activity.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced adults
- HIV-1 infection in adolescents and children (age and weight-dependent formulations)
Common side effects
- Headache
- Nausea
- Diarrhea
- Fatigue
- Insomnia
- Hypersensitivity reaction (lamivudine-related)
Key clinical trials
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) (PHASE2)
- A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy (PHASE3)
- Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents (PHASE3)
- A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy (PHASE3)
- A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF (PHASE3)
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2, PHASE3)
- Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment (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:
- Dolutegravir + Lamivudine FDC CI brief — competitive landscape report
- Dolutegravir + Lamivudine FDC updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI
Frequently asked questions about Dolutegravir + Lamivudine FDC
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Who makes Dolutegravir + Lamivudine FDC?
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Related
- Drug class: All Antiretroviral combination (INSTI + NRTI) drugs
- Target: All drugs targeting HIV integrase and HIV reverse transcriptase
- Manufacturer: ViiV Healthcare — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection in treatment-naïve and treatment-experienced adults
- Indication: Drugs for HIV-1 infection in adolescents and children (age and weight-dependent formulations)
- Compare: Dolutegravir + Lamivudine FDC vs similar drugs
- Pricing: Dolutegravir + Lamivudine FDC cost, discount & access