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Glasgow 2018 – Evidence supporting the 2-drug regimen era continues to build


2-drug regimen of dolutegravir plus lamivudine (DTG + 3TC) is non–inferior to dolutegravir plus tenofovir/emtricitabine (DTG + TDF/FTC) at 48 weeks in antiretroviral treatment-naïve adults with HIV-1 infection: subgroup analyses in the GEMINI studies1

GEMINI-1 and GEMINI-2 results assessed by age, gender, race or baseline characteristics

Results in GEMINI-1 and GEMINI-2 showed efficacy results generally consistent with the overall study results across demographic and baseline disease characteristics. Overall, rates of adverse events (AEs) were similar between arms, with low rates of withdrawals due to AEs in both arms.1

GEMINI-1 and GEMINI-2 are 2 identical, global, double-blind, multicentre Phase III studies evaluating efficacy and safety of DTG + 3TC once-daily in treatment-naïve, HIV-1–infected, HBV-negative adults, with screening HIV-1 RNA ≤500,000 copies/mL. Participants were randomised 1:1 to treatment with DTG + 3TC or DTG + TDF/FTC, stratified by screening plasma HIV-1 RNA and CD4+ T-cell count, and the primary endpoint was the proportion of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 (by Snapshot algorithm).

Tivicay + lamivudine is only suitable for the treatment of HIV-1 infection where there is no known or suspected resistance to the integrase inhibitor class, or to lamivudine.

Learn more about Tivicay + lamivudine and the GEMINI Studies here.

Comparison of viral replication for 2-drug (DTG + RPV) vs 3-drug current antiretroviral regimen (CAR) in the SWORD-1 and SWORD-2 studies2

Week 100 analysis of elevated viral loads (VLs), including transient “blips,” during 2 years of the studies conducted with the 2-drug regimen dolutegravir (DTG) plus rilpivirine (RPV) within SWORD-1 and SWORD–22

A week 100 analysis of elevated viral loads, including transient “blips,” during 2 years of study conduct with DTG + RPV within the SWORD-1 and SWORD-2 trials, revealed the incidence of blips was low in both the virologically suppressed early-switch and late-switch DTG + RPV groups, and was comparable to the 3-drug regimen (3DR) control group, and remained low in the second year. “Blips” were defined as any viral load (VL) between 50 and 200 copies/mL preceded and followed by VL <50 copies/mL. All other categories of VL >50 copies/mL occurred infrequently in all groups.2

Comparison of viral replication below 50 copies/mL for 2-drug (DTG + RPV) vs 3-drug current antiretroviral regimen (CAR) therapy in the SWORD-1 and SWORD-2 studies3

A Week 48 Snapshot analysis of low-level viremia in virologically suppressed patients.

A week 48 Snapshot analysis of qualitative “target detected” (TD) or “target not detected” (TND) for viral loads <40 copies/mL in virologically suppressed patients within the SWORD-1 and SWORD-2 studies found that incident viremia (>40 copies/mL and ≥50 copies/mL) was similar between arms by baseline TD vs TND. While it was more common with TD, this had limited clinical consequence as efficacy rates were high (95%) and equal between arms, and confirmed virological withdrawal numbers were low and equal between arms.3

SWORD-1 and SWORD-2 are 2 identical open-label, multicentre, global, Phase III non-inferiority studies evaluating the efficacy and safety of switching from a current antiretroviral regimen to DTG + RPV once-daily in HIV-1–infected adults, with HIV-1 RNA viral load of <50 copies/mL and no history of virological failure.

Learn more about Juluca and the SWORD Studies here.

References:

  1. Orkin C, Porteiro N, Berhe M, et al. 2-drug regimen of dolutegravir plus lamivudine (DTG + 3TC) is non-inferior to dolutegravir plus tenofovir/emtricitabine (DTG + TDF/FTC) at 48 weeks in antiretroviral treatment-naïve adults with HIV-1 infection: subgroup analyses in the GEMINI studies. Presented at: HIV Drug Therapy Glasgow 2018; October 28-31, 2018; Glasgow, UK.
  2. Wang R, Underwood M, Koteff J, et al. Comparison of viral replication for 2-drug (DTG + RPV) vs 3-drug current antiretroviral regimen in the SWORD-1 and SWORD-2 studies. Presented at: HIV Drug Therapy Glasgow 2018; October 28-31, 2018; Glasgow, UK.
  3. Underwood M, Angelis K, Wang R, et al. Comparison of viral replication below 50 copies/mL for 2-drug (DTG + RPV) vs 3-drug current antiretroviral regimen (CAR) therapy in the SWORD-1 and SWORD-2 studies. Presented at: HIV Drug Therapy Glasgow 2018; October 28-31, 2018; Glasgow, UK.

▼ These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Tivicay & Triumeq is registered trademark of the GlaxoSmithKline Group of Companies.