Dolutegravir

(Tivicay®)

Dolutegravir

Drug updated on 3/28/2024

Dosage FormTablet (oral; 10 mg, 25 mg, 50 mg); PD Tablet for suspension (oral; 5 mg)
Drug ClassHIV-1 integrase strand transfer inhibitor (INSTI)
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.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
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
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
Effectiveness and safety of dolutegravir two-drug regimensin 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
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
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 resistance2019The Journal of Antimicrobial Chemotherapy
Safety and pharmacokinetics of dolutegravir in HIV-positive pregnant women: a systematic review.2018Journal of Virus Eradication
Virologic failure and HIV drug resistance on simplified, dolutegravir-based maintenance therapy: Systematic review and meta-analysis.2018F1000Research
Risks of cardiovascular or central nervous system adverse events and immune reconstitution inflammatory syndrome, for dolutegravir versus other antiretrovirals: meta-analysis of randomized trials.2018Current Opinion in HIV and AIDS

Clinical Practice Guidelines