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DTG + 3TC FDC
DTG + 3TC 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).
DTG (dolutegravir) inhibits HIV integrase to prevent viral replication, while 3TC (lamivudine) inhibits reverse transcriptase to block HIV from converting its RNA genome into DNA.
DTG (dolutegravir) inhibits HIV integrase to prevent viral replication, while 3TC (lamivudine) inhibits reverse transcriptase to block HIV from converting its RNA genome into DNA. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (age and weight-dependent formulations).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | DTG + 3TC FDC |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | Antiretroviral combination (INSTI + NRTI) |
| Target | HIV integrase (DTG); HIV reverse transcriptase (3TC) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
This fixed-dose combination (FDC) pairs two antiretroviral agents with complementary mechanisms. Dolutegravir is an integrase strand transfer inhibitor (INSTI) that prevents HIV from integrating into the host genome. Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) that terminates DNA chain elongation during reverse transcription. Together, they provide dual suppression of HIV replication at different stages of the viral lifecycle.
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
- Insomnia
- Headache
- Diarrhea
- Nausea
- Fatigue
- Rash
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:
- DTG + 3TC FDC CI brief — competitive landscape report
- DTG + 3TC FDC updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI
Frequently asked questions about DTG + 3TC FDC
What is DTG + 3TC FDC?
How does DTG + 3TC FDC work?
What is DTG + 3TC FDC used for?
Who makes DTG + 3TC FDC?
What drug class is DTG + 3TC FDC in?
What development phase is DTG + 3TC FDC in?
What are the side effects of DTG + 3TC FDC?
What does DTG + 3TC FDC target?
Related
- Drug class: All Antiretroviral combination (INSTI + NRTI) drugs
- Target: All drugs targeting HIV integrase (DTG); HIV reverse transcriptase (3TC)
- 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)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing