Drugs / Dolutegravir/Lamivudine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | Dovato | HIV infectious disease | 2026-05-11 | “EMA has validated the company’s marketing application seeking approval to extend the use of Dovato (dolutegravir/lamivudine (DTG/3TC)) to younger age groups.” viivhealthcare.com ↗ |
| Filed | US (FDA) | Dovato | HIV infectious disease | 2026-05-11 | “Dovato (dolutegravir/lamivudine (DTG/3TC)) to younger age groups. A New Drug Application was also submitted to the U.S.” viivhealthcare.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT06497465 | Sep 2025 → Jan 2028 expected | HIV infectious disease, tuberculosis | Johns Hopkins University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| 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. |
| 2026-05-11 | 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. |
| 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 ↗ |
| 2025-03-09 | ViiV Healthcare | Results ViiV HEALTHCARE CONTINUES TO DELIVER LONG-ACTING INJECTABLE HIV INNOVATION WITH LATE-BREAKING DATA AND REAL-WORLD INSIGHTS ACROSS PIPELINE AND PORTFOLIO AT CROI 2025 viivhealthcare.com ↗
Dolutegravir Does Not Reduce Levonorgestrel or Medroxyprogesterone Acetate Concentrations in WLWH |
| 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. |
| 2024-10-10 | ViiV Healthcare | Results GSK AND ViiV HEALTHCARE TO SHOWCASE ADVANCES ACROSS INDUSTRY-LEADING INFECTIOUS DISEASE PORTFOLIO AT IDWEEK 2024 viivhealthcare.com ↗
Characterization of Herpes Zoster Cases and Sustained High Vaccine Efficacy Against Herpes Zoster Complications in Individuals Vaccinated with Recombinant Zoster Vaccine During A Long-Term Follow-Up Study |
| 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) |
| 2022-10-12 | GlaxoSmithKline | Results GSK to present updates on its industry-leading infectious disease portfolio at IDWeek 2022 gsk.com ↗
Long-term Protection Against Herpes Zoster (HZ) by the Adjuvanted Recombinant Zoster Vaccine (RZV): Interim Efficacy, Immuno and Safety Results at Approximately 10 Years after Initial Vaccination |
| 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 ↗
Findings showed that the 2-drug regimen (2DR) Dovato (dolutegravir/lamivudine) continued to demonstrate non-inferior efficacy and a high barrier to resistance compared to continuation of tenofovir alafenamide fumarate (TAF)-based regimens of at least three drugs in virologically suppressed adults living with HIV-1 who had not experienced prior virologic failure. |
| 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 ↗
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 | 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. |
| 2020-10-05 | 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. |
| 2019-11-06 | GlaxoSmithKline | Results EACS 2019: ViiV Healthcare to present 17 abstracts from its portfolio addressing the diverse needs of people living with HIV gsk.com ↗
Week 48 data showing that switching to dolutegravir/lamivudine from a 3-drug TAF-based regimen was not associated with a higher frequency of intermittent viremia |
| 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. |
| 2019-07-10 | 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. |
All press releases naming this drug 42 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 NCT06497465 ↗ |
| Known as | DOVATO | “Participants will receive Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]” NCT06497465 ↗ |
| Route | Oral | “Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]” NCT06497465 ↗ |