Dolutegravir

(Tivicay®)

Dolutegravir

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Drug updated on 6/11/2024

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.

Summary
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  • Dolutegravir (Tivicay) is used in combination with other antiretroviral agents for treating HIV-1 infection in adults and pediatric patients, as well as a complete regimen for virologically suppressed adults.
  • The information was derived from 21 systematic reviews/meta-analyses on Tivicay's safety and effectiveness compared to other antiretroviral agents.
  • For pregnant women living with HIV, dolutegravir-based therapy does not present an increased risk of adverse perinatal outcomes compared to other ART classes, offering a safer alternative than Protease Inhibitor-based ART, which is associated with a risk of small gestational age outcomes.
  • Dolutegravir-containing regimens have superior efficacy over non-dolutegravir containing regimens in achieving viral suppression at 48 to 96 weeks, especially beneficial for patients with high baseline viral loads (>100,000 copies/mL).
  • Data shows reassuring safety and efficacy profiles for dolutegravir and Raltegravir use in children and adolescents, with minimal concerns regarding grade 3/4 adverse events or treatment discontinuations due to drug-related issues, making it the preferred regimen choice for this population group.
  • Aging can affect the pharmacokinetics of ARVs; however, exposure to dolutegravir appears modestly increased or unaffected by age, suggesting that it could be a favorable option considering the higher likelihood of co-medications and comorbidities among older individuals living with HIV.
  • Analysis of different Integrase Strand Transfer Inhibitors (INSTIs) indicates that dolutegravir may lead to more significant weight gain compared to others like Elvitegravir, suggesting a need for monitoring and management strategies for weight among recipients.
  • In cases of virological failure on dolutegravir-based regimens, the most common resistance mutations were R263K and G118R, predominantly seen in INSTI-naive individuals, highlighting dolutegravir's high barrier to resistance as an essential factor for selection, especially for those experienced or with prior issues.

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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