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 | congenital human immunodeficiency virus | 2026-05-11 | “the European Medicines Agency (EMA) has validated the company’s marketing application seeking approval to extend the use of Dovato” viivhealthcare.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT07616739 | Sep 2026 → Oct 2028 expected | HIV infectious disease | Fundación Huésped | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 38
| Date | Issuer | Release |
|---|---|---|
| 2026-07-27 | GlaxoSmithKline | 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 gsk.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 count1. |
| 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. |
| 2026-05-11 | ViiV Healthcare | Regulatory ViiV HEALTHCARE AIMS TO CLOSE TREATMENT GAPS FOR CHILDREN LIVING WITH HIV WITH PAEDIATRIC DOVATO MARKETING APPLICATIONS TO THE EMA AND FDA viivhealthcare.com ↗
A New Drug Application was also submitted to the U.S. Food and Drug Administration (FDA) as part of ViiV Healthcare’s commitment to help address longstanding gaps in HIV treatment options for children living with HIV. |
| 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 | GlaxoSmithKline | 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 gsk.com ↗ |
| 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 ↗ |
| 2024-11-11 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES DATA DEMONSTRATING DOVATO (DTG/3TC) IS HIGHLY EFFECTIVE IN TREATMENT-NAIVE PEOPLE WITH ADVANCED HIV viivhealthcare.com ↗
A post-hoc analysis of the study showed DTG/3TC was non-inferior to 3-drug therapy regardless of the participant’s baseline viral load. |
| 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 ↗
PAIRED - PAtIent Reported Experiences and perceiveD benefit of treatment with dolutegravir/lamivudine (DTG/3TC): a diverse sample of people with HIV-1 reporting high treatment satisfaction, good adherence, and high quality of life |
| 2024-07-23 | GlaxoSmithKline | 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 gsk.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. |
| 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. |
| 2023-10-10 | GlaxoSmithKline | Results GSK and ViiV Healthcare to present scientific advancements in their industry-leading infectious diseases portfolio at IDWeek 2023 gsk.com ↗
Virological suppression in people with HIV-1 (PWH) receiving dolutegravir/lamivudine was high and similar across age groups despite older PWH having increased rates of comorbidities and polypharmacy (TANDEM subgroup analysis) (encore) |
| 2021-09-29 | GlaxoSmithKline | 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 gsk.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. |
| 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. |
| 2021-07-17 | GlaxoSmithKline | Results ViiV Healthcare to present new data from diverse portfolio and pipeline of 2-drug and long-acting regimens for HIV treatment and prevention at IAS 2021 gsk.com ↗
After three years of therapy, dolutegravir/lamivudine maintained non-inferior virologic efficacy compared with a TBR, with no confirmed virologic withdrawals or resistance development noted in the dolutegravir/lamivudine treatment arm. |
| 2021-07-17 | GlaxoSmithKline | Results ViiV Healthcare presents data from second Dovato (dolutegravir/lamivudine) switch study confirming non-inferior efficacy and no virologic failure versus a broad range of regimens of at least 3 drugs gsk.com ↗
The 2-drug regimen (2DR) Dovato (dolutegravir/lamivudine) demonstrated non-inferior efficacy compared to continuation of a current antiretroviral regimen (CAR) of at least three drugs*, with zero cases of virologic failure and no development of resistance |
| 2021-07-17 | ViiV Healthcare | Results ViiV Healthcare to present new data from diverse portfolio and pipeline of 2-drug and long-acting regimens for HIV treatment and prevention at IAS 2021 viivhealthcare.com ↗
The occurrence of any elevated viral loads above 50 copies/mL was lower in the dolutegravir/lamivudine arm (6%) versus the TBR arm (10%). |
| 2021-07-17 | ViiV Healthcare | Results ViiV Healthcare presents data from second Dovato (dolutegravir/lamivudine) switch study confirming non-inferior efficacy and no virologic failure versus a broad range of regimens of at least 3 drugs viivhealthcare.com ↗
The 48-week data from the phase III SALSA study represent a diverse patient population, and demonstrate comparable safety for 2-drug regimen Dovato versus continuation of a current antiretroviral regimen of at least 3 drugs, reinforcing its use in a switch setting |
| 2020-10-08 | GlaxoSmithKline | 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 gsk.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. |
| 2020-10-08 | 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 | GlaxoSmithKline | 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 gsk.com ↗
Dolutegravir plus lamivudine continues to demonstrate long-term non-inferior efficacy compared to dolutegravir plus TDF/FTC with benefits beyond viral suppression. |
| 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 ↗
Dolutegravir plus lamivudine continues to demonstrate long-term non-inferior efficacy compared to dolutegravir plus TDF/FTC with benefits beyond viral suppression. |
| 2020-08-20 | ViiV Healthcare | Results ViiV Healthcare announces data demonstrating the feasibility of Dovato (dolutegravir/lamivudine) as a treatment option for rapid initiation after diagnosis in adults with HIV-1 viivhealthcare.com ↗
Dovato was found to be effective and well tolerated in this setting, indicating the feasibility of its use in Test and Treat strategies. |
| 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 |
| 2020-01-15 | GlaxoSmithKline | 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 gsk.com ↗
With the authorisation of Dovato, people living with HIV in Japan can - for the first time - start treatment on a once-daily, single-pill, 2-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen. |
| 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. |
| 2019-07-24 | GlaxoSmithKline | 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 gsk.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. |
| 2019-07-24 | GlaxoSmithKline | Results ViiV Healthcare announces positive Week 48 results in first study to evaluate treatment switch from TAF-containing regimen with three or more drugs to 2-drug regimen of dolutegravir/lamivudine for HIV-1 infection gsk.com ↗
Today ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced that data from the phase III TANGO study showed that the 2-drug regimen (2DR) of Dovato▼ (dolutegravir/lamivudine) has similar efficacy to a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs in virally supressed and stable adults with HIV-1. |
| 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. |
| 2019-07-24 | ViiV Healthcare | Results ViiV Healthcare announces positive Week 48 results in first study to evaluate treatment switch from TAF-containing regimen with three or more drugs to 2-drug regimen of dolutegravir/lamivudine for HIV-1 infection viivhealthcare.com ↗
Today ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced that data from the phase III TANGO study showed that the 2-drug regimen (2DR) of Dovato▼ (dolutegravir/lamivudine) has similar efficacy to a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs in virally suppressed adults with HIV-1. |
| 2019-07-10 | GlaxoSmithKline | Results ViiV Healthcare announces phase III study meets primary endpoint, demonstrating the ability to control HIV-1 with a 2-drug regimen of dolutegravir plus lamivudine in virally suppressed patients switching from a TAF-containing, 3-drug regimen gsk.com ↗
The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48. |
| 2019-07-10 | ViiV Healthcare | Results ViiV Healthcare announces phase III study meets primary endpoint, demonstrating the ability to control HIV-1 with a 2-drug regimen of dolutegravir plus lamivudine in virally suppressed patients switching from a TAF-containing, 3-drug regimen viivhealthcare.com ↗
The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48. |
| 2019-07-03 | GlaxoSmithKline | Regulatory ViiV Healthcare receives EU Marketing Authorisation for Dovato (dolutegravir/lamivudine), a new once-daily, single-pill, two-drug regimen for the treatment of HIV-1 infection gsk.com ↗ |
| 2019-07-03 | ViiV Healthcare | Regulatory ViiV HEALTHCARE RECEIVES EU MARKETING AUTHORISATION FOR DOVATO (DOLUTEGRAVIR/LAMIVUDINE), A NEW ONCE-DAILY, SINGLE-PILL, TWO-DRUG REGIMEN FOR THE TREATMENT OF HIV-1 INFECTION viivhealthcare.com ↗
London, UK, 3 July 2019 – ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Commission has granted Marketing Authorisation for Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine. |
| 2019-04-27 | ViiV Healthcare | Regulatory ViiV HEALTHCARE ANNOUNCES CHMP POSITIVE OPINION FOR DOVATO® (DOLUTEGRAVIR/LAMIVUDINE) AS A ONCE-DAILY, SINGLE-PILL, TWO-DRUG REGIMEN FOR THE TREATMENT OF HIV INFECTION viivhealthcare.com ↗ |
| 2019-04-26 | GlaxoSmithKline | Regulatory ViiV Healthcare announces CHMP Positive Opinion for Dovato® (dolutegravir/lamivudine) as a once-daily, single-pill, two-drug regimen for the treatment of HIV infection gsk.com ↗
Today’s CHMP Positive Opinion for Dovato is an important step towards providing treatment-naïve people living with HIV in Europe the first once-daily, single-pill, complete 2-drug regimen for the treatment of HIV. |
| 2019-04-09 | ViiV Healthcare | Regulatory US FDA APPROVES ViiV HEALTHCARE’S DOVATO (DOLUTEGRAVIR/LAMIVUDINE), THE FIRST, ONCE-DAILY, SINGLE-TABLET, TWO-DRUG REGIMEN FOR TREATMENT-NAÏVE HIV-1 ADULTS viivhealthcare.com ↗ |
| 2019-04-08 | GlaxoSmithKline | Regulatory US FDA approves ViiV Healthcare’s Dovato (dolutegravir/lamivudine), the first, once-daily, single-tablet, two-drug regimen for treatment-naïve HIV-1 adults gsk.com ↗
ViiV Healthcare today announced that the US Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC. |
All press releases naming this drug 44 releases
Evidence & citations 3 cited values
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 NCT07616739 ↗ |
| Known as | DOVATO | “Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]” NCT07616739 ↗ |
| Route | Oral | “Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]” NCT07616739 ↗ |