Drugs / ABC/DTG/3TC
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03016533 | Jun 2017 → Dec 2024 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 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). |
| 2019-03-07 | ViiV Healthcare | 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 viivhealthcare.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). |
| 2018-10-30 | 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. |
| 2015-09-23 | GlaxoSmithKline | Results New Phase IIIb/IV data show switching to once-daily Triumeq® maintains HIV viral suppression gsk.com ↗
Furthermore, statistically, the treatment satisfaction score improved significantly more for those patients switching to once-daily abacavir/dolutegravir/lamivudine from their established regimen, as assessed by the HIV Treatment Satisfaction Questionnaire (adjusted difference 2.4, 95% CI: 1.3, 3.5; p<0.001). |
All press releases naming this drug 5 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 | ABC/DTG/3TC | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03016533 ↗ |
| Known as | Abacavir/Dolutegravir/Lamivudine | “Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC)” NCT03016533 ↗ |