Last reviewed · How we verify
ABC/DTG/3TC FDC
ABC/DTG/3TC FDC is a Antiretroviral combination therapy (NRTI + INSTI) Small molecule drug developed by ViiV Healthcare. It is currently in Phase 3 development for HIV-1 infection in treatment-naive and treatment-experienced adults.
A fixed-dose combination of three antiretroviral agents that inhibits HIV reverse transcriptase and integrase to suppress viral replication.
The ABC/DTG/3TC FDC is a fixed-dose combination of small molecule antiretroviral medications used to treat HIV-1 infection. It is a tablet formulation that can be used as a switch from an ongoing cART regimen, as studied in clinical trials such as NCT02105987.
-
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 | ABC/DTG/3TC FDC |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | Antiretroviral combination therapy (NRTI + INSTI) |
| Target | HIV reverse transcriptase, HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
ABC (abacavir) is a nucleoside reverse transcriptase inhibitor (NRTI), DTG (dolutegravir) is an integrase strand transfer inhibitor (INSTI), and 3TC (lamivudine) is an NRTI. Together, they target two critical steps of HIV replication: reverse transcription of viral RNA and integration of viral DNA into the host genome, providing complementary mechanisms to suppress HIV-1 replication.
Approved indications
- HIV-1 infection in treatment-naive and treatment-experienced adults
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Hypersensitivity reaction (abacavir)
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)
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2, PHASE3)
- A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA) (PHASE3)
- A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants (PHASE1)
- Effects of Biktarvy on CFR in Stable HIV Patients (PHASE3)
- ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection (PHASE3)
- Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection (NA)
- Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants (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:
- ABC/DTG/3TC FDC CI brief — competitive landscape report
- ABC/DTG/3TC FDC updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI
Frequently asked questions about ABC/DTG/3TC FDC
What is ABC/DTG/3TC FDC?
How does ABC/DTG/3TC FDC work?
What is ABC/DTG/3TC FDC used for?
Who makes ABC/DTG/3TC FDC?
What drug class is ABC/DTG/3TC FDC in?
What development phase is ABC/DTG/3TC FDC in?
What are the side effects of ABC/DTG/3TC FDC?
What does ABC/DTG/3TC FDC target?
Related
- Drug class: All Antiretroviral combination therapy (NRTI + INSTI) drugs
- Target: All drugs targeting HIV reverse transcriptase, HIV integrase
- Manufacturer: ViiV Healthcare — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection in treatment-naive and treatment-experienced adults
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing