Dolutegravir

(Tivicay®)

Tivicay®

Drug updated on 9/4/2024

Dosage FormTablet (oral; 10 mg, 25 mg, 50 mg); PD Tablet for suspension (oral; 5 mg)
Drug ClassHIV-1 integrase strand transfer inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Tivicay and Tivicay PD are 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.

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Summary
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  • 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.

Product Monograph / Prescribing Information

Document TitleYearSource
Tivicay (dolutegravir) Prescribing Information.2022ViiV Healthcare, Research Triangle Park, NC

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative risk of adverse perinatal outcomes associated with classes of antiretroviral therapy in pregnant women living with HIV: systematic review and meta-analysis.2024Frontiers in Medicine
Comparison of the design and methodology of Phase 3 clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir-based dual therapy (DTG) in HIV: a systematic review of the literature.2023Expert Review of Anti-infective Therapy
Virologic response to dolutegravir plus lamivudine in people with suppressed human immunodeficiency virus type 1 and historical m184v/i: a systematic literature review and meta-analysis.2023Open Forum Infectious Diseases
Pharmacokinetics of antiretroviral drugs in older people living with HIV: a systematic review.2023Clinical Pharmacokinetics
New onset type 2 diabetes mellitus risks with integrase strand transfer inhibitors-based regimens: A systematic review and meta-analysis.2023Metabolism Open
Effects of different integrase strand transfer inhibitors on body weight in patients with HIV/AIDS: a network meta-analysis.2022BMC Infectious Diseases
Effectiveness and safety of dolutegravir and raltegravir for treating children and adolescents living with HIV: a systematic review.2022Journal of International AIDS Society
HIV-1 integrase resistance associated mutations and the use of dolutegravir in Sub-Saharan Africa: A systematic review and meta-analysis.2022PLoS Glob Public Health
Pre-treatment HIV-1 drug resistance in antiretroviral therapy-naive adults in Eastern Africa: a systematic review and meta-analysis.2022Journal of Antimicrobial Chemotherapy
Changes in inflammatory and atherogenesis biomarkers with the 2-drug regimen dolutegravir plus lamivudine in antiretroviral therapy-experienced, virologically suppressed people with HIV-1: a systematic literature review.2022Open Forum Infectious Diseases
Effectiveness and safety of dolutegravir two-drug regimens in virologically suppressed people living with HIV: a systematic literature review and meta-analysis of real-world evidence.2021HIV Medicine
Three-drug regimens containing integrase inhibitor show good efficacy and safety in treatment-naive patients with HIV-1: a Bayesian analysis.2021Frontiers in Pharmacology
HIV treatment with the two-drug regimen dolutegravir plus lamivudine in real-world clinical practice: a systematic literature review.2021Infectious Diseases and Therapy
Neurotoxicities in the treatment of HIV between dolutegravir, rilpivirine and dolutegravir/rilpivirine: a meta-analysis.2021Sexually Transmitted Infections
Comparative efficacy, safety and durability of dolutegravir relative to common core agents in treatment-naïve patients infected with HIV-1: an update on a systematic review and network meta-analysis.2021BMC Infectious Diseases
Efficacy and safety of triple versus dolutegravir-based dual therapy in patients with HIV-1 infection: a meta-analysis of randomized controlled trials.2021AIDS Reviews
Comparative efficacy, tolerability and safety of dolutegravir and efavirenz 400mg among antiretroviral therapies for first-line HIV treatment: a systematic literature review and network meta-analysis.2020EClinicalMedicine
Pharmacokinetics of antiretroviral and tuberculosis drugs in children with HIV/TB co-infection: a systematic review.2020Journal of Antimicrobial Chemotherapy
Dolutegravir based antiretroviral therapy compared to other combined antiretroviral regimens for the treatment of HIV-infected naive patients: a systematic review and meta-analysis.2019PLoS One
Comparative efficacy and safety of dolutegravir relative to common core agents in treatment-naïve patients infected with HIV-1: a systematic review and network meta-analysis.2019BMC infectious Diseases
A systematic review of the genetic mechanisms of dolutegravir resistance.2019The Journal of Antimicrobial Chemotherapy

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