Lamivudine
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 3 milestones | |||||
| Filed | US (FDA) | — | HIV infectious disease | 2018-10-18 | “submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of dolutegravir (DTG) and lamivudine (3TC)” gsk.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2018-09-14 | “today announced submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for a single-tablet, two-drug regimen of dolutegravir (DTG) and...” gsk.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2013-10-23 | “ViiV Healthcare announces US regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine” gsk.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (2) | US (FDA) | EPIVIR-HBV | — | 2001-08-16 – 2018-11-15 | fda.gov ↗ |
| Label expansions (6) | US (FDA) | EPIVIR | — | 1997-04-11 – 2016-07-20 | fda.gov ↗ |
| Approved | EU (EMA) | Epivir | — | 1996-08-08 | europa.eu ↗ |
| Approved | US (FDA) | EPIVIR | — | 1995-11-17 | fda.gov ↗ |
Trials 332 · started per year
News releases announcing trial results or a regulatory action · 75
| Date | Issuer | Release |
|---|---|---|
| 2026-07-29 | GlaxoSmithKline | Results Cabenuva demonstrates superiority to daily oral therapy in adolescents living with HIV, as ViiV Healthcare highlights new long-acting injectable data at AIDS 2026 gsk.com ↗
Confirmed viral rebound occurred in 0.9% (n=2/235) of adolescents receiving CAB+RPV LA versus 6.4% (n=15/241) receiving daily oral therapy. |
| 2026-07-29 | ViiV Healthcare | Results CABENUVA DEMONSTRATES SUPERIORITY TO DAILY ORAL THERAPY IN ADOLESCENTS LIVING WITH HIV, AS ViiV HEALTHCARE HIGHLIGHTS NEW LONG-ACTING INJECTABLE DATA AT AIDS 2026 viivhealthcare.com ↗
Week 96 results from the LATA trial, led by University College London, showed CAB+RPV LA dosed every two months was superior to daily oral dolutegravir/tenofovir disoproxil fumarate/lamivudine (DTG/TDF/3TC) in 476 virologically suppressed adolescents aged 12 to 19 years living with HIV in Kenya, South Africa, Uganda and Zimbabwe. |
| 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. |
| 2026-02-23 | 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 ↗
Multiple real-world studies show consistent high effectiveness of Vocabria + Rekambys (cabotegravir + rilpivirine LA (CAB+RPV LA)) across a broad range of populations |
| 2025-07-14 | 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 ↗ |
| 2025-03-12 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Data from Phase 3 Trials that Show the Investigational, Once-Daily, Oral, Two-Drug Regimen of Doravirine/Islatravir (DOR/ISL) Maintained HIV-1 Viral Suppression at Week 48 merck.com ↗
In the double-blind trial MK-8591A-052 (Abstract #204A), results for the primary endpoint (HIV-1 RNA ≥50 copies/mL) showed that 1.5% of participants who switched to DOR/ISL had a viral load of ≥50 copies/mL at Week 48, compared to 0.6% on BIC/FTC/TAF (treatment difference 0.9%, 95% CI -1.9, 2.9). |
| 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 | 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. |
| 2024-02-28 | GlaxoSmithKline | Results ViiV Healthcare to present data for its next generation of ultra long-acting treatments for HIV gsk.com ↗
A single once-daily ABC/DTG/3TC tablet predicts safe and effective exposures in children 3 to <6kg |
| 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) |
| 2023-09-05 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Regulatory Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC), a Once-daily Treatment for Children Living with HIV viatris.com ↗
The FDA's tentative approval through the President's Emergency Plan for AIDS Relief (PEPFAR) program means the formulation meets all the agency's quality, safety, and efficacy standards. |
| 2022-06-14 | Drugs for Neglected Diseases | Regulatory Cipla and DNDi launch child-friendly 4-in-1 antiretroviral treatment for young children living with HIV in South Africa dndi.org ↗
The South African Health Products Regulatory Authority (SAHPRA) has approved a sweet-tasting, heat-stable, ‘4-in-1’ fixed-dose combination of four antiretroviral (ARV) treatments composed of abacavir, lamivudine, lopinavir, and ritonavir that is specifically designed for infants and young children with HIV. |
| 2022-03-30 | GlaxoSmithKline | Regulatory ViiV Healthcare announces US FDA approval of Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV gsk.com ↗ |
| 2022-03-30 | ViiV Healthcare | Regulatory ViiV HEALTHCARE ANNOUNCES US FDA APPROVAL OF TRIUMEQ PD, THE FIRST DISPERSIBLE SINGLE TABLET REGIMEN CONTAINING DOLUTEGRAVIR, A ONCE-DAILY TREATMENT FOR CHILDREN LIVING WITH HIV viivhealthcare.com ↗ |
| 2021-10-27 | Merck Sharp & Dohme LLC | Results Merck Presents New Data from Ongoing Phase 2b Clinical Trial Evaluating Efficacy and Safety of Investigational Islatravir in Combination With Doravirine Through 144 Weeks for HIV-1 Treatment at EACS 2021 merck.com ↗
Phase 2b data through 144 weeks demonstrated that islatravir combined with doravirine continued to maintain viral suppression, as measured by the number of study participants achieving HIV-1 RNA levels <50 copies/mL, similar to DOR/3TC/TDF. |
| 2021-10-25 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Top-Line Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily Oral Fixed Dose Combination of Doravirine/Islatravir for the Treatment of People with HIV-1 Infection merck.com ↗
At 48 weeks, both trials met their primary efficacy endpoint of percentage of participants with HIV-1 RNA levels ≥50 copies/mL, demonstrating that antiviral efficacy was comparable between DOR/ISL and ART (ILLUMINATE SWITCH A) and between DOR/ISL and BIC/FTC/TAF (ILLUMINATE SWITCH B). |
| 2021-10-04 | GlaxoSmithKline | Regulatory ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV gsk.com ↗ |
| 2021-10-04 | ViiV Healthcare | Regulatory ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV viivhealthcare.com ↗ |
| 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 | 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 ↗
Injection site reactions were the most common drug-related adverse event; most were Grade 1 or 2 (99.5%). |
| 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. |
| 2020-07-02 | GlaxoSmithKline | 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) gsk.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 |
| 2020-03-11 | Janssen Research & Development, LLC | Results Janssen Announces Results of Phase 3 Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment Regimen of Rilpivirine And Cabotegravir through 96 Weeks jnj.com ↗
The study – First Long-Acting Injectable Regimen (FLAIR) trial – demonstrated positive 96-week results in long-term safety and efficacy of rilpivirine and cabotegravir. |
| 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. |
| 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 |
| 2019-11-06 | Gilead Sciences | Results Gilead’s Biktarvy Maintained High Efficacy With No Cases of Treatment-Emergent Resistance Through Three Years in Phase 3 HIV Clinical Trials gilead.com ↗
Across all treatment groups no participants developed treatment failure with treatment-emergent resistance. |
| 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 ↗
Switching to DTG/3TC fixed dose combination (FDC) is non-inferior to continuing a TAF-based regimen (TBR) through 48 weeks: subgroup analyses from the TANGO study |
| 2019-09-20 | Merck Sharp & Dohme LLC | Regulatory Merck’s PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive US FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed merck.com ↗ |
| 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 | 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. |
| 2019-03-07 | GlaxoSmithKline | Results ViiV Healthcare presents positive, 48-week data from two pivotal phase III studies showing long-acting, injectable two-drug regimen of cabotegravir and rilpivirine has similar efficacy to daily, three-drug oral treatment in adults living with HIV-1 infection gsk.com ↗
The study found virologic suppression rates (HIV-1 RNA <50 c/mL) at Week 48 were similar between treatment arms (cabotegravir + rilpivirine: 265/283 [93.6%], Triumeq: 264/283 [93.3%], adjusted difference: 0.4%. 95% CI: -3.7, 4.5). |
| 2018-11-28 | Merck Sharp & Dohme LLC | Regulatory European Commission Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in… merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved DELSTRIGO™ and PIFELTRO™ for the treatment of HIV-1 infection. |
| 2018-10-30 | GlaxoSmithKline | Results ViiV Healthcare reports positive 48-week results for second phase III study for novel, long-acting, injectable HIV-treatment regimen gsk.com ↗
The study showed long-acting cabotegravir and rilpivirine, injected once a month, had similar efficacy to Triumeq at Week 48 based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre [c/mL] using the FDA Snapshot algorithm. |
| 2018-10-18 | GlaxoSmithKline | Regulatory ViiV Healthcare submits New Drug Application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV gsk.com ↗
ViiV Healthcare today announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of dolutegravir (DTG) and lamivudine (3TC) for the treatment of HIV-1 infection. |
| 2018-10-04 | Merck Sharp & Dohme LLC | Results Merck’s HIV Therapy DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate) Meets Primary Efficacy Endpoint in Phase 3 DRIVE-SHIFT Study Evaluating Switch to DELSTRIGO from Other Antiretroviral Treatment Regimens merck.com ↗ |
| 2018-10-04 | Merck Sharp & Dohme LLC | Results Merck Announces Week 96 Data from Pivotal Phase 3 DRIVE-AHEAD Study Evaluating DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate) for the Treatment of HIV-1 in Treatment-Naïve Patients merck.com ↗
The efficacy findings at Week 96 in DRIVE-AHEAD were consistent with the findings at Week 48 in which DELSTRIGO demonstrated non-inferior efficacy in comparison to a fixed-dose combination of efavirenz (EFV, 600 mg), emtricitabine (FTC, 200 mg) and TDF (300 mg). |
| 2018-10-03 | Gilead Sciences | Results Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy gilead.com ↗
In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine (600/50/300mg, ABC /DTG/3TC) through 96 weeks of therapy. |
| 2018-09-20 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive CHMP Opinion for DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) and PIFELTRO™ (doravirine) in the European Union for the Treatment of HIV-1 Infection merck.com ↗ |
| 2018-09-14 | GlaxoSmithKline | Regulatory ViiV Healthcare submits regulatory application to European Medicines Agency for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV gsk.com ↗
London, UK ViiV Healthcare today announced submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for a single-tablet, two-drug regimen of dolutegravir (DTG) and lamivudine (3TC) for the treatment of HIV-1 infection. |
| 2018-08-30 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in Appropriate Patients merck.com ↗
Today’s approvals of DELSTRIGO and PIFELTRO provide two new options for the treatment of HIV-1 in appropriate treatment-naïve adult patients. |
| 2018-07-24 | GlaxoSmithKline | Results ViiV Healthcare presents phase III data at AIDS 2018 from landmark GEMINI studies showing two-drug regimen of dolutegravir and lamivudine has similar efficacy to a three-drug regimen in treatment naïve HIV patients, with no emergence of resistance gsk.com ↗
The studies met their primary endpoint for non-inferiority based on plasma HIV-1 RNA <50c/mL, a standard measure of HIV control, at Week 48. |
| 2018-06-14 | GlaxoSmithKline | Results ViiV Healthcare reports landmark phase III studies for dolutegravir and lamivudine, demonstrating the ability to control HIV with a two-drug regimen in treatment naïve patients gsk.com ↗
The studies met their primary endpoint for non-inferiority based on plasma HIV-1 RNA <50 copies per millilitre (c/mL), a standard measure of HIV control, at Week 48. |
| 2018-03-05 | Gilead Sciences | Results Gilead Presents Results from Phase 3 Study Evaluating Patients Who Switched to Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) from Regimen Containing Abacavir, Dolutegravir and Lamivudine gilead.com ↗
Through Week 48, Biktarvy was found to be statistically non-inferior to ABC /DTG/3TC with a numerically lower incidence of mild or moderate study drug-related adverse events and no treatment-emergent resistance. |
| 2018-01-08 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection merck.com ↗
The FDA has set a target action date of Oct. 23, 2018, for both applications under the Prescription Drug User Fee Act (PDUFA). |
| 2017-10-04 | Gilead Sciences | Results Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens gilead.com ↗
In the ongoing study, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing bPIs and demonstrated no treatment-emergent resistance at 48 weeks. |
| 2017-07-25 | Merck Sharp & Dohme LLC | Results Merck’s Investigational NNRTI, Doravirine, Meets Primary Efficacy Endpoint of Non-Inferiority to Efavirenz, Both in Combination with Other Antiretroviral Agents, in Pivotal Phase 3 Trial for Treatment of HIV-1 Infection merck.com ↗
In addition, through 48 weeks, statistically significantly fewer patients taking DOR/3TC/TDF reported pre-specified categories of neuropsychiatric events (dizziness, sleep disorders and disturbances, and inability to think clearly or concentrate) than patients receiving the EFV/FTC/TDF regimen. |
| 2017-07-24 | Gilead Sciences | Results Gilead Announces Phase 3 Results for Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗
At Week 48, 92.4 percent (n=290/314) of patients taking BIC/FTC/TAF and 93.0 percent (n=293/315) of patients taking ABC /DTG/3TC achieved the primary endpoint |
| 2016-07-18 | GlaxoSmithKline | Results ARIA study shows superior efficacy of Triumeq® for treatment-naïve women living with HIV gsk.com ↗
Results show statistically superior viral suppression (HIV-1 RNA <50 c/mL) rates at week 48: 82% versus 71% (adjusted difference 10.5%, 95% CI: 3.1%-17.8%, p=0.005) respectively.1 |
| 2014-09-03 | GlaxoSmithKline | Regulatory ViiV Healthcare receives EU marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine), a new once-daily single-pill regimen for the treatment of HIV gsk.com ↗
We are delighted with today’s approval that offers people living with HIV in Europe the first single-pill regimen containing dolutegravir. |
| 2014-08-22 | GlaxoSmithKline | Regulatory ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the treatment of HIV-1 infection gsk.com ↗
ViiV Healthcare announced today that the US Food and Drug Administration (FDA) has approved Triumeq® (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection. |
| 2014-06-27 | GlaxoSmithKline | Regulatory Triumeq® (dolutegravir/abacavir/lamivudine) single-tablet regimen receives positive CHMP opinion in Europe for the treatment of HIV gsk.com ↗
the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine) |
| 2014-06-24 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts Merck’s NDA for Fixed-Dose Combination of Raltegravir with Lamivudine merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for a fixed-dose combination (FDC) of raltegravir with lamivudine for the treatment of HIV-1 infection (MK-0518B) has been accepted for standard review by the U.S. Food and Drug Administration (FDA). |
| 2013-10-25 | GlaxoSmithKline | Regulatory ViiV Healthcare announces European regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV gsk.com ↗
ViiV Healthcare today announced the submission of a regulatory application in Europe for its investigational single-tablet regimen (STR) combining dolutegravir (DTG), abacavir (ABC) and lamivudine (3TC) for the treatment of people living with HIV. |
| 2013-10-22 | GlaxoSmithKline | Regulatory ViiV Healthcare announces US regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV gsk.com ↗
ViiV Healthcare today announced the submission of a regulatory application in the United States for its investigational single-tablet regimen (STR) combining dolutegravir, abacavir and lamivudine for the treatment of people living with HIV-1. |
| 2012-07-11 | GlaxoSmithKline | Results Shionogi-ViiV Healthcare announces positive initial data from phase III study of dolutegravir-based regimen vs Atripla in HIV gsk.com ↗
The study demonstrated superiority of the dolutegravir-based regimen compared to the single tablet regimen Atripla®. |
| 2011-05-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Generic Combivir Tablets: Launch Expected in Fourth Quarter 2011 tevapharm.com ↗ |
| 2008-10-29 | Bristol-Myers Squibb | Results Use of Investigational Agent Entecavir Demonstrated Statistically Significant Improvement in Liver Histology and Viral Suppression Compared to Lamivudine in Chronically Infected Hepatitis B E-Antigen (HBeAg) Positive Patients bms.com ↗
At Week 48, histologic improvement was observed in 72 percent of patients taking entecavir compared to 62 percent of patients receiving lamivudine using the Knodell necroinflammatory score analysis. |
| 2008-04-24 | Gilead Sciences | Results Gilead Announces 72-Week Data From Two Pivotal Phase III Studies Evaluating Viread(R) for the Treatment of Chronic Hepatitis B gilead.com ↗
The studies' primary efficacy endpoints were reached at 48 weeks, at which time Viread demonstrated superior efficacy over Hepsera. |
| 2007-10-29 | Gilead Sciences | Results Gilead Announces 48-Week Data Evaluating Switching from Combivir(R) To Truvada(R) Among Virologically-Suppressed HIV Patients gilead.com ↗
Patients in both study arms maintained virological suppression at 48 weeks. |
| 2006-08-17 | Vertex Pharmaceuticals Incorporated | Results Head-to-Head Study Comparing LEXIVA(R) (fosamprenavir calcium) to Kaletra Presented at IAC 2006 and Published in The Lancet vrtx.com ↗
This month, The Lancet published results of a study showing that HIV regimens using LEXIVA (Telzir) Tablets+ritonavir and Kaletra (lopinavir/ritonavir) Capsules both given twice-daily had comparable (non-inferior) efficacy and tolerability in adults who had no previous exposure to HIV medicines. |
| 2006-08-14 | Gilead Sciences | Results 96-Week Data from Gilead's Study 934 Comparing Viread(R) and Emtriva(R) to Combivir(R) Both in Combination with Sustiva(R) Presented at XVI International AIDS Conference gilead.com ↗ |
| 2006-01-18 | Gilead Sciences | Results Data Comparing Viread(R) and Emtriva(R) to Combivir(R) as Part of Combination HIV Therapy Published in New England Journal of Medicine gilead.com ↗
Publication Describes Superior Viral Suppression with Fewer Adverse Events Leading to Discontinuation for Patients Taking Viread and Emtriva at 48 Weeks |
| 2005-02-03 | Gilead Sciences | Results Gilead Announces Preliminary 48-Week Data From Study 934 Comparing Viread and Emtriva to Combivir Both in Combination With Sustiva in Patients With HIV gilead.com ↗
Gilead Sciences (Nasdaq:GILD) today announced preliminary 48-week data from the company's Study 934. |
| 2004-10-31 | Gilead Sciences | Results Interim 24-Week Data from Study 934 Comparing a Regimen of Viread and Emtriva Versus Combivir, Both in Combination with Efavirenz, in Patients with HIV Presented at 44th ICAAC gilead.com ↗
Although both triple-drug regimens are relatively convenient, we observed a difference in the two arms, with more patients discontinuing in the Combivir group due to adverse events. |
| 2004-08-26 | Gilead Sciences | Results Gilead Announces Preliminary 24-Week Data from Study 934 Comparing Viread and Emtriva to Combivir Both in Combination With Efavirenz In Patients With HIV gilead.com ↗
Preliminary results show a statistically significant difference favoring Viread/Emtriva in the percentage of patients who achieved and maintained HIV RNA less than 400 copies/mL at 24 weeks, based on the FDA Time to Loss of Virologic Response algorithm (TLOVR). |
| 2003-02-11 | Gilead Sciences | Results 96-Week Data From Phase III Study Show Long-Term Efficacy With Reduced Risk of Lipid and Metabolic Changes for Viread Versus Stavudine in Treatment-Naive HIV Patients gilead.com ↗
The 96-week results presented today show that the Viread and stavudine arms reduced HIV RNA to less than 400 copies/mL in 82 and 78 percent of patients respectively, using the most conservative "missing equals failure" analysis. |
| 2002-11-04 | Gilead Sciences | Results New Data Demonstrate Antiviral Activity of Gilead's Hepsera in Patients with Lamivudine-Resistant Chronic Hepatitis B gilead.com ↗
Patients treated with lamivudine alone did not show significant virological, biochemical or serological benefit compared with their baseline values. |
| 2001-06-05 | Gilead Sciences | Results Gilead Sciences Presents Data Characterizing Resistance Profile of Tenofovir DF, Investigational Agent for the Treatment of HIV gilead.com ↗
The results demonstrate that chain-terminator removal occurs more readily with nucleosides than nucleotides and may contribute to the higher-level of resistance associated with nucleosides. |
| 1998-09-23 | Gilead Sciences | Results Gilead Sciences Provides Update on PREVEON® Clinical Program for the Treatment of HIV gilead.com ↗
These data demonstrate that PREVEON has durable anti-HIV activity in treatment-experienced patients, including those infected with strains of HIV resistant to most currently approved therapies. |
All press releases naming this drug 103 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 103 releases opens the full record — a long page | ||
Evidence & citations 35 cited values
Every value below carries the sentence it was read from. 634 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | lamivudine | “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗560“Participants on any stable second-generation integrase strand transfer inhibitor-based 3DR regimen with HIV-1 RNA < 50 copies/mL plasma for at least 3 months were randomized to...” PMID 39226296 ↗ Feb 2025 “This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed...” NCT00085943 ↗ “Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose...” NCT00955968 ↗ “Both HIV and HBV can be treated with tenofovir disoproxil fumarate (TDF) and lamivudine (3TC), so we evaluated the safety and efficacy of combination antiretroviral therapy...” PMID 26831232 ↗ Feb 2016 “Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with...” NCT07075146 ↗ “A Randomised, Multi-Centre, Open-Label Study in Well-Controlled Treatment-Experienced HIV-Infected Patients to Assess Compliance With a Once-Daily Regimen of Lamivudine,...” NCT00214435 ↗ “Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC,...” NCT01363011 ↗ “Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir...” NCT05729568 ↗ “Second generation integrase inhibitor 1) Bictegravir 50 mg/ alafenamide tenofovir 25 mg/ emtricitabine 200 mg (BIC/TAF/FTC); 2) Dolutegravir 50 mg/ abacavir 600 mg/ lamivudine...” NCT06602622 ↗ “NRTIs included abacavir, emtricitabine, Combivir (lamivudine/zidovudine, coformulated), Epzicom (abacavir/lamivudine, coformulated), lamivudine, stavudine, tenofovir DF,...” NCT01252940 ↗ |
| Known as | 3-thiacytidine | “Lamivudine (also known as 3-thiacytidine: 3TC) is an antiviral medication given as a pill once a day for twelve months.” NCT00001457 ↗ |
| Known as | 3TC | “First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV...” NCT03076359 ↗227“The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations,...” NCT00116298 ↗ “Multi-center Study to Evaluate Virological Efficacy, Safety Tolerability, Drug Exposure and Patients' Reported Outcomes Over 48 Weeks Following Randomization to 2-drug Therapy...” NCT05735535 ↗ “Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose...” NCT00955968 ↗ “Daily Antiretroviral Therapy (DART-II): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial To Evaluate the Efficacy and Safety fo Stavudine Extended Release...” NCT00116116 ↗ “BACKGROUND: New regimens may provide better tolerability, convenience, and safety for nonoccupational human immunodeficiency virus (HIV) postexposure prophylaxis (PEP). For...” PMID 37539061 ↗ Jul 2023 “An International, Double Blind, Randomized, Phase III Study to Evaluate the Tolerance, Safety, and Effectiveness of Viramune (Nevirapine) in Preventing Clinical AIDS...” NCT00002368 ↗ “Both HIV and HBV can be treated with tenofovir disoproxil fumarate (TDF) and lamivudine (3TC), so we evaluated the safety and efficacy of combination antiretroviral therapy...” PMID 26831232 ↗ Feb 2016 “Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with...” NCT07075146 ↗ “Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC,...” NCT01363011 ↗ “The investigators propose to evaluate the safety of combination therapy comprising the three nucleoside analog reverse-transcriptase inhibitors (NRTIs) zidovudine (AZT),...” NCT02363452 ↗ |
| Known as | 3TC: lamivudine: Epivir | “3TC: lamivudine: Epivir” NCT02028676 ↗ |
| Known as | BCH 189, (-)- | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Epivir | “A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy With ABT-378/Ritonavir (Kaletra), Lamivudine (Epivir), Efavirenz (Sustiva)and Tenofovir DF to...” NCT00038220 ↗10“100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) +...” NCT00002369 ↗ “combination with lamivudine (Epivir®) 300 mg once a day + dolutegravir (Tivicay®) 50 mg once a day.” NCT02527096 ↗ “Lamivudine (Epivir, GSK), Atazanavir (Reyataz, BMS), Ritonavir (Norvir, Abbott)” NCT01599364 ↗ “150 mg lamivudine (Epivir tablets, GlaxoSmithKline)” NCT00966160 ↗ “Epivir (Lamivudine; 3TC)” NCT00002234 ↗ “Lamivudine (Epivir® )” NCT03491553 ↗ “Lamiduvine (Epivir)” NCT00885482 ↗ “Epivir (Lamivudine)” NCT00002168 ↗ |
| Known as | Epivir-hbv | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | GR109714X | “3TC (Lamivudine; GR109714X) Open-Label Program” NCT00002108 ↗1“Lamivudine (3TC; GR109714X) Monotherapy” NCT00002320 ↗ |
| Known as | LAM | “BACKGROUND: The efficacy of switching to tenofovir disoproxil fumarate (TDF) monotherapy from lamivudine (LAM) plus adefovir dipivoxil (ADV) combination therapy (stable...” PMID 29329305 ↗ Jan 20185“The objective of this prospective randomized clinical trial was to compare the strategy of HBV monotherapy with lamivudine (LAM) or tenofovir disoproxil fumarate (TDF) versus...” PMID 18697216 ↗ Oct 2008 “Suboptimal responses to lamivudine or telbivudine plus adefovir (LAM/LdT+ADV) rescue therapy are common in patients with LAM-resistant hepatitis B virus (HBV) infections.” PMID 32460460 ↗ May 2020 “Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated)” NCT00708162 ↗ “Lamivudine (LAM)” NCT01095835 ↗ “Lamivudine (LAM)” NCT00316719 ↗ |
| Known as | Lamivudina | “Resistance Profile to Antiretroviral Medications in Individuals Living With HIV Who Failed a First-Line Regimen With Tenofovir / Lamivudina and Dolutegravir in Brasil” NCT07618507 ↗ |
| Known as | Lamivudine (3TC) | “Lamivudine (3TC)” NCT01338025 ↗ |
| Known as | lamivudine (zeffix) | “lamivudine (zeffix)” NCT01804387 ↗ |
| Known as | lamivudine 100 mg tablets (GlaxoSmithKline); | “lamivudine 100 mg tablets (GlaxoSmithKline);” NCT01894269 ↗ |
| Known as | Lamivudine component of /zidovudine teva | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudine component of cimduo | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudine component of combivir | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudine component of delstrigo | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudine component of dovato | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudine component of dutrebis | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudine component of epzicom | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudine component of kivexa | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudine component of symfi | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudine component of temixys | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudine component of triumeq | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudine component of trizivir | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudine teva | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudine teva pharma b.v. | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Lamivudinum | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | LVD | “we conducted a randomized controlled trial in which CHB patients with spontaneous SAE were randomized to receive lamivudine (LVD) or entecavir (ETV)” PMID 28671553 ↗ 2018 |
| Known as | NSC-760061 | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Virolam | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Known as | Zeffix | ChEMBL registry synonym — accepted as the source's own label CHEMBL141 ↗ |
| Action | Inhibit | “nucleoside reverse transcriptase inhibitors” NCT00000882 ↗ |
| Modality | Other / unclassified | “HIV nucleoside reverse transcriptase inhibitors (NRTI)” PMID 16103764 ↗ Sep 2005 |
| Route | Oral | “Oral 3TC.” NCT00000878 ↗ |