Last reviewed 2026-06-02 · How we verify

ABC/DTG/3TC STR - Tablet

ViiV Healthcare · Phase 3 active Small molecule Under review

ABC/DTG/3TC STR - Tablet is a Antiretroviral combination (NRTI + INSTI) 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).

A fixed-dose combination of three antiretroviral agents that inhibit HIV reverse transcriptase and integrase to suppress viral replication.

The ABC/DTG/3TC STR - Tablet is not mentioned in the provided facts, but the ABC/DTG/3TC STR is likely referring to a combination of antiretroviral medications. The combination of Cabotegravir (CAB) and Rilpivirine (RPV) is studied for the treatment of HIV Infections, with Cabotegravir available in both tablet and injectable suspension forms.

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 STR - Tablet
Sponsor	ViiV Healthcare
Drug class	Antiretroviral combination (NRTI + INSTI)
Target	HIV reverse transcriptase, HIV integrase
Modality	Small molecule
Therapeutic area	Infectious Disease / Virology
Phase	Phase 3

Mechanism of action

Abacavir (ABC) and lamivudine (3TC) are nucleoside reverse transcriptase inhibitors (NRTIs) that block HIV reverse transcriptase, while dolutegravir (DTG) is an integrase strand transfer inhibitor (INSTI) that prevents viral DNA integration into the host genome. Together, this triple-agent combination provides potent suppression of HIV replication through complementary mechanisms.

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

Diarrhea
Nausea
Headache
Insomnia
Hypersensitivity reaction (abacavir)
Elevated liver enzymes

Key clinical trials

Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive 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 STR - Tablet CI brief — competitive landscape report
ABC/DTG/3TC STR - Tablet updates RSS · CI watch RSS
ViiV Healthcare portfolio CI

Frequently asked questions about ABC/DTG/3TC STR - Tablet

What is ABC/DTG/3TC STR - Tablet?

ABC/DTG/3TC STR - Tablet is a Antiretroviral combination (NRTI + INSTI) drug developed by ViiV Healthcare, indicated for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (age and weight-dependent formulations).

How does ABC/DTG/3TC STR - Tablet work?

A fixed-dose combination of three antiretroviral agents that inhibit HIV reverse transcriptase and integrase to suppress viral replication.

What is ABC/DTG/3TC STR - Tablet used for?

ABC/DTG/3TC STR - Tablet is indicated for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (age and weight-dependent formulations).

Who makes ABC/DTG/3TC STR - Tablet?

ABC/DTG/3TC STR - Tablet is developed by ViiV Healthcare (see full ViiV Healthcare pipeline at /company/viiv-healthcare).

What drug class is ABC/DTG/3TC STR - Tablet in?

ABC/DTG/3TC STR - Tablet belongs to the Antiretroviral combination (NRTI + INSTI) class. See all Antiretroviral combination (NRTI + INSTI) drugs at /class/antiretroviral-combination-nrti-insti.

What development phase is ABC/DTG/3TC STR - Tablet in?

ABC/DTG/3TC STR - Tablet is in Phase 3.

What are the side effects of ABC/DTG/3TC STR - Tablet?

Common side effects of ABC/DTG/3TC STR - Tablet include Diarrhea, Nausea, Headache, Insomnia, Hypersensitivity reaction (abacavir), Elevated liver enzymes.

What does ABC/DTG/3TC STR - Tablet target?

ABC/DTG/3TC STR - Tablet targets HIV reverse transcriptase, HIV integrase and is a Antiretroviral combination (NRTI + INSTI).

Drug class: All Antiretroviral combination (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-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