Summary

This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

• Tivicay (dolutegravir) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but INSTI-naïve) aged at least 4 weeks and weighing at least 3 kg; Tivicay is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.
• This summary is based on the review of 21 systematic reviews/meta-analyses. ^[1-21]
• Virologic Suppression: Dolutegravir (DTG) showed higher virologic suppression rates compared to efavirenz, ritonavir-boosted darunavir, and other integrase strand transfer inhibitors across various studies, including randomized controlled trials and meta-analyses. In pediatric populations, DTG achieved >70% viral suppression at 12 months.
• Durability and Long-Term Efficacy: DTG regimens demonstrated durable efficacy with low virologic failure rates. DTG combined with lamivudine or rilpivirine was non-inferior to traditional triple regimens.
• Subgroup Analyses: DTG exhibited superior or comparable efficacy in patients with baseline viral load >100,000 copies/mL or CD4+ counts ≤200 cells/μL. Among pregnant women, DTG did not increase adverse perinatal outcomes risk.
• Comparison to Other Drugs: DTG-based regimens were more effective than efavirenz and ritonavir-boosted protease inhibitors, with comparable or superior outcomes to other integrase inhibitors, and DTG dual therapy was non-inferior to triple therapy in virologically suppressed individuals.
• DTG-containing regimens generally had lower or comparable adverse event rates compared to other ART regimens, with neuropsychiatric symptoms (depression, anxiety, insomnia) being common but similar in incidence to other regimens.
• DTG was notably associated with significant weight gain compared to other INSTIs, with a greater impact on weight than BIC and RAL.
• DTG was considered safe in pediatric and adolescent populations, and showed no increased risk of adverse perinatal outcomes in pregnant women.
• Population types and subgroup considerations include pregnant women, pediatric and adolescent populations, treatment-naive and experienced patients, those with high baseline viral load and low CD4 counts, and virologically suppressed patients. DTG-based regimens show high efficacy and safety across these subgroups, with specific recommendations for pregnant women and high effectiveness in children and adolescents. DTG is also effective for treatment-naive patients with high viral loads and safe for virologically suppressed patients switching regimens.