Drugs / Abacavir/lamivudine
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT00549198 | Jun 2007 → Dec 2009 | HIV infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
Real world data of using Triumeq (dolutegravir/abacavir/lamivudine (DTG/ABC/3TC): final outcomes of the 3-year German TRIUMPH cohort show good virologic effectiveness and safety in clinical routine |
| 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) |
| 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. |
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Abacavir/lamivudine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00549198 ↗ |
| Known as | KIVEXA | “Recently, the fixed-dose combinations (FDC) KIVEXA™ (abacavir/lamivudine) and TRUVADA (tenofovir disoproxil fumarate/emtricitabine) have facilitated the usage of once-daily regimens.” NCT00549198 ↗ |