Drugs / Dolutegravir/Lamivudine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | Dovato | HIV infectious disease | 2026-05-11 | “European Medicines Agency (EMA) has validated the company’s marketing application seeking approval to extend the use of Dovato (dolutegravir/lamivudine (DTG/3TC))” viivhealthcare.com ↗ “DTG/3TC as a complete, once-daily, single-tablet, two-drug regimen for HIV-1 therapy is currently under review by the European Medicines Agency (EMA)” viivhealthcare.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT04826562 | Sep 2021 → Oct 2023 | HIV infectious disease | Saint Michael's Medical Center | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-07-27 | ViiV Healthcare | Results ViiV HEALTHCARE’S 2-DRUG REGIMEN DOVATO IS AS EFFECTIVE AS 3-DRUG REGIMEN BIKTARVY IN FIRST-OF-ITS-KIND HEAD-TO-HEAD STUDY IN TREATMENT-NAÏVE ADULTS LIVING WITH HIV viivhealthcare.com ↗
Data show that Dovato (dolutegravir/lamivudine (DTG/3TC)) demonstrated non-inferior efficacy to Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)) in treatment-naïve adults living with HIV, including people with high viral loads or a low CD4+ cell count. |
| 2026-02-23 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES DATA SHOWING SWITCHING TO DOVATO WAS ASSOCIATED WITH A LOWER PROPORTION OF STEATOTIC LIVER DISEASE VERSUS BIKTARVY FOR HIV-1 TREATMENT viivhealthcare.com ↗
Steatotic liver disease, an increasingly recognised comorbidity in people living with HIV, was reported in 49% (n=26/53) of participants switching to BIC/FTC/TAF versus 29% (n=17/58) switching to DTG/3TC |
| 2025-07-14 | ViiV Healthcare | Results ViiV HEALTHCARE DATA SHOW 89% OF TREATMENT-NAÏVE PEOPLE WITH HIV CHOOSE TO SWITCH TO LONG-ACTING INJECTABLE VOCABRIA + REKAMBYS FROM DAILY PILLS AFTER ACHIEVING RAPID VIRAL SUPPRESSION viivhealthcare.com ↗
Multiple real-world studies show consistent high effectiveness of Vocabria + Rekambys (cabotegravir + rilpivirine LA (CAB+RPV LA)) across a broad range of populations |
| 2025-07-08 | ViiV Healthcare | Results ViiV HEALTHCARE PRESENTS NEW DATA DEMONSTRATING POSITIVE REAL-WORLD IMPACT OF ITS INNOVATIVE LONG-ACTING INJECTABLES FOR HIV AT IAS 2025 viivhealthcare.com ↗
Real-world and implementation data describe effectiveness of long-acting Vocabria + Rekambys (cabotegravir + rilpivirine LA (CAB + RPV LA)) for HIV treatment and assess experiences of using Apretude (cabotegravir long-acting (CAB LA) for PrEP) in range of populations |
| 2024-11-07 | ViiV Healthcare | Results ViiV HEALTHCARE EXPANDS ON REAL-WORLD DATA SUPPORTING USE OF LONG-ACTING THERAPIES IN DIVERSE PATIENT POPULATIONS AT HIV GLASGOW viivhealthcare.com ↗
RUMBA’s week 144 results confirm reassuring metabolic outcomes in both DTG/3TC and B/FTC/TAF |
| 2024-10-10 | ViiV Healthcare | Results GSK AND ViiV HEALTHCARE TO SHOWCASE ADVANCES ACROSS INDUSTRY-LEADING INFECTIOUS DISEASE PORTFOLIO AT IDWEEK 2024 viivhealthcare.com ↗
People with HIV in the US switching to cabotegravir + rilpivirine long-acting (CAB+RPV LA) from oral antiretroviral therapy (ART) have numerous real-world benefits, including high adherence and treatment satisfaction |
| 2024-07-23 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES POSITIVE DATA DEMONSTRATING 2-DRUG REGIMEN DOVATO IS AS EFFECTIVE AS 3-DRUG REGIMEN BIKTARVY FOR MAINTENANCE THERAPY OF HIV-1 viivhealthcare.com ↗
Findings showed that switching to DTG/3TC in virologically suppressed adults living with HIV demonstrated non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF. |
| 2022-07-25 | ViiV Healthcare | Results ViiV HEALTHCARE TO PRESENT NEW DATA FROM INNOVATIVE HIV TREATMENT AND PREVENTION PORTFOLIO AT AIDS 2022 viivhealthcare.com ↗
Findings to be presented feature the most common reason for initiating dolutegravir/lamivudine (DTG/3TC) and an analysis of real-world results among treatment-naïve people living with HIV initiating a DTG/3TC regimen and people living with HIV switching to a DTG/3TC regimen. |
| 2022-02-07 | ViiV Healthcare | Results ViiV HEALTHCARE TO PRESENT NEW LONG-TERM FINDINGS FROM ITS INNOVATIVE 2-DRUG AND LONG-ACTING HIV MEDICINES PORTFOLIO AT CROI 2022 viivhealthcare.com ↗
Long-acting cabotegravir + rilpivirine every 2 months: ATLAS-2M week 152 weeks |
| 2021-09-29 | ViiV Healthcare | Results ViiV Healthcare presents three-year switch data for Dovato (dolutegravir/lamivudine) confirming long-term, non-inferior efficacy with no virologic failure versus continuation of TAF-based regimens of at least three drugs viivhealthcare.com ↗
At three years, no participants on dolutegravir/lamivudine (0% [0/369]) met confirmed protocol-defined virologic failure, versus three participants (<1% [3/372]) on the TAF-based regimen. |
| 2020-10-08 | ViiV Healthcare | Results ViiV HEALTHCARE PRESENTS LONG-TERM SWITCH DATA FOR DOVATO DEMONSTRATING NON-INFERIOR EFFICACY IN ADULTS WITH HIV-1 AND ZERO CASES OF VIROLOGIC FAILURE VERSUS CONTINUATION OF A 3-DRUG TAF-BASED REGIMEN viivhealthcare.com ↗
Data from the study revealed that no participants on Dovato (0/369, 0%) and three participants (3/372, <1%) on the TAF-based regimen met protocol-defined virologic failure, and no participants developed resistance mutations upon failure. |
| 2020-10-05 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES DOLUTEGRAVIR PLUS LAMIVUDINE THREE-YEAR DATA CONFIRMING LONG-TERM VIRAL SUPPRESSION NON-INFERIOR TO A 3-DRUG REGIMEN FOR TREATMENT-NAÏVE ADULTS WITH HIV-1 viivhealthcare.com ↗
The percentage of individuals with protocol-defined confirmed virologic withdrawal (CVW) was 1.7% (12/716) in the dolutegravir plus lamivudine arm and 1.3% (9/717) in the dolutegravir plus TDF/FTC arm. |
| 2020-07-02 | ViiV Healthcare | Results ViiV Healthcare to present new data on long-acting regimens for HIV prevention and treatment, alongside extensive insights into the evolving needs of people living with HIV at 23rd International AIDS Conference (AIDS 2020: Virtual) viivhealthcare.com ↗
Improved metabolic parameters after switching from TAF-based 3- or 4-drug regimen to the 2-drug regimen of DTG/3TC (dolutegravir/lamivudine): the TANGO study |
| 2020-03-09 | ViiV Healthcare | Results ViiV Healthcare presents positive long-term data from phase III study demonstrating efficacy and safety of cabotegravir and rilpivirine, its investigational, long-acting injectable treatment regimen in adults living with HIV-1 viivhealthcare.com ↗
The study demonstrated that the 2DR of once-monthly cabotegravir and rilpivirine continued to provide non-inferior efficacy and comparable safety to the daily, oral, three-drug regimen of Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC) at Week 96. |
| 2020-01-15 | ViiV Healthcare | Regulatory Dovato (dolutegravir/lamivudine), the once-daily, single-pill, 2-drug regimen for the treatment of HIV-1 infection, granted marketing approval by Japan Ministry of Health, Labour and Welfare viivhealthcare.com ↗
The authorisation of Dovato in Japan marks a significant development for people living with HIV. |
| 2019-11-06 | ViiV Healthcare | Results EACS 2019: ViiV HEALTHCARE TO PRESENT 17 ABSTRACTS FROM ITS PORTFOLIO ADDRESSING THE DIVERSE NEEDS OF PEOPLE LIVING WITH HIV viivhealthcare.com ↗
Assessments of very low-level HIV replication for dolutegravir + lamivudine (DTG+3TC) vs dolutegravir + tenofovir disoproxil/emtricitabine (DTG+TDF/FTC) in the GEMINI 1 & 2 studies through week 96 |
| 2019-07-24 | ViiV Healthcare | Results ViiV HEALTHCARE PRESENTS GEMINI 1 & 2 STUDIES THROUGH WEEK 96 SHOWING 2-DRUG REGIMEN OF DOLUTEGRAVIR PLUS LAMIVUDINE CONTINUES TO DEMONSTRATE HIGH EFFICACY RATES AND NO CASES OF TREATMENT EMERGENT RESISTANCE viivhealthcare.com ↗
Both the GEMINI 1 & 2 studies showed that dolutegravir plus lamivudine continued to offer non-inferior efficacy to dolutegravir plus TDF/FTC at Week 96. |
All press releases naming this drug 24 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dolutegravir/Lamivudine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04826562 ↗ |