Mounir Ait-Khaled1, Juan Sierra Madero2, Vicente Estrada3, Roberto Gulminetti4, Debbie Hagins5, Hung-Chin Tsai6,7, Choy Man8, Jörg Sievers1, Richard Grove9, Andrew Zolopa8,10, Brian Wynne8, Jean van Wyk1. 1. (MA-K, Clinical Science; JS, Clinical Development; JvW, Global Medical), ViiV Healthcare, Brentford, UK. 2. Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. 3. Departamento de Medicina, Hospital Clinico San Carlos, Madrid, Spain. 4. Institute of Infectious Diseases, University of Pavia, Pavia, Italy. 5. Georgia Department of Public Health, Coastal Health District, Chatham CARE Center, Savannah, GA, USA. 6. Department of Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. 7. Department of Medicine, National Yang Ming Chiao Tung University, Tainan City, Taiwan. 8. (CM, Clinical Science; BW, Medicines Development; AZ, Medical Affairs), ViiV Healthcare, Research Triangle Park, NC, USA. 9. Statistics, GlaxoSmithKline, Brentford, UK. 10. Department of Medicine, Infectious Diseases, Stanford University, Palo Alto, CA, USA.
Abstract
Background: GEMINI-1 and GEMINI-2 (ClinicalTrials.gov, NCT02831673 and NCT02831764, respectively) are double-blind, multicenter, phase III studies that demonstrated the non-inferiority of once-daily dolutegravir + lamivudine to dolutegravir + tenofovir disoproxil fumarate/emtricitabine in achieving HIV-1 RNA <50 copies/mL at 48, 96, and 144 weeks in treatment-naive adults with HIV-1 infection.Objective: We present a post hoc analysis of the impact of treatment adherence on Week 48 virologic response. Methods: Adherence was estimated using pill counts and categorized as ≥90% vs <90%. Unadjusted treatment differences with exact 95% CIs were derived for the proportion of participants with HIV-1 RNA <50 copies/mL within each adherence category, using Snapshot algorithm and last available on-treatment viral load through Week 48. Results: In each treatment group, 5% of participants had <90% adherence (dolutegravir + lamivudine group, 35/716; dolutegravir + tenofovir disoproxil fumarate/emtricitabine group, 34/717). The proportion of participants with HIV-1 RNA <50 copies/mL (Snapshot) at Week 48 in the <90% adherence group was 69% in the dolutegravir + lamivudine group and 65% in the dolutegravir + tenofovir disoproxil fumarate/emtricitabine group (analysis by last on-treatment viral load: 91% and 85%, respectively). Corresponding proportions in the ≥90% adherence group were 93% and 96% (analysis by last on-treatment viral load: 97% and 99%, respectively).Conclusions: Decreased adherence resulted in lower Week 48 virologic efficacy outcomes that were comparable between treatment groups. These results indicate that the robust antiviral activity and regimen forgiveness of dolutegravir + lamivudine is similar to dolutegravir-containing 3-drug regimens (see graphical abstract).
Background: GEMINI-1 and GEMINI-2 (ClinicalTrials.gov, NCT02831673 and NCT02831764, respectively) are double-blind, multicenter, phase III studies that demonstrated the non-inferiority of once-daily dolutegravir + lamivudine to dolutegravir + tenofovir disoproxil fumarate/emtricitabine in achieving HIV-1 RNA <50 copies/mL at 48, 96, and 144 weeks in treatment-naive adults with HIV-1 infection.Objective: We present a post hoc analysis of the impact of treatment adherence on Week 48 virologic response. Methods: Adherence was estimated using pill counts and categorized as ≥90% vs <90%. Unadjusted treatment differences with exact 95% CIs were derived for the proportion of participants with HIV-1 RNA <50 copies/mL within each adherence category, using Snapshot algorithm and last available on-treatment viral load through Week 48. Results: In each treatment group, 5% of participants had <90% adherence (dolutegravir + lamivudine group, 35/716; dolutegravir + tenofovir disoproxil fumarate/emtricitabine group, 34/717). The proportion of participants with HIV-1 RNA <50 copies/mL (Snapshot) at Week 48 in the <90% adherence group was 69% in the dolutegravir + lamivudine group and 65% in the dolutegravir + tenofovir disoproxil fumarate/emtricitabine group (analysis by last on-treatment viral load: 91% and 85%, respectively). Corresponding proportions in the ≥90% adherence group were 93% and 96% (analysis by last on-treatment viral load: 97% and 99%, respectively).Conclusions: Decreased adherence resulted in lower Week 48 virologic efficacy outcomes that were comparable between treatment groups. These results indicate that the robust antiviral activity and regimen forgiveness of dolutegravir + lamivudine is similar to dolutegravir-containing 3-drug regimens (see graphical abstract).
Authors: Franco Maggiolo; Daniela Valenti; Rodolfo Teocchi; Laura Comi; Elisa Di Filippo; Marco Rizzi Journal: J Int Assoc Provid AIDS Care Date: 2022 Jan-Dec