Dolutegravir

(Tivicay®)

Dolutegravir

Drug updated on 11/1/2024

Dosage FormTablet (oral; 10 mg, 25 mg, 50 mg); PD Tablet for suspension (oral; 5 mg)
Drug ClassHIV integrase strand transfer inhibitors (HIV-1 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-nave or -experienced) and in pediatric patients (treatment-nave or -experienced but INSTI- nave) 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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  • This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
  • Relapse Rates and Disease Activity: Dimethyl fumarate demonstrated a moderate relapse rate reduction over 24 months (RR (relative risk) 0.62, 95% CI (confidence interval) 0.55 to 0.70), with greater efficacy when DMTs were continued into early pregnancy rather than discontinued. Cladribine tablets outperformed dimethyl fumarate in achieving NEDA-3 (OR (odds ratio) =1.76, 95% CrI: 1.02-3.03).
  • Disability Progression: Ozanimod showed improved outcomes over dimethyl fumarate for confirmed disability progression (CDP) at 3 months (HR (hazard ratio) 0.67, 95% CI 0.53-0.86); however, no significant difference was observed at 6 months. Natalizumab was more effective for high-risk patients, while dimethyl fumarate showed effectiveness in low-risk patients.
  • Treatment Adherence: Dimethyl fumarate demonstrated a high adherence rate, with approximately 78.5% of patients maintaining adherence at one year (MPR ≥80%).
  • Comparative Efficacy with Other Oral DMDs: Dimethyl fumarate showed a slightly lower relapse risk than teriflunomide (RR = 0.92) and demonstrated moderate effectiveness compared to fingolimod, which exhibited superior MRI and ARR outcomes.
  • Dimethyl fumarate displayed a non-inferior risk of serious adverse events (SAEs) compared to placebo (RR 0.79, 95% CI 0.67 to 0.93).
  • Dimethyl fumarate was associated with a higher risk of treatment discontinuation due to adverse events relative to teriflunomide (RR 1.07, p = 0.007), with commonly reported adverse events including gastrointestinal disturbances and flushing.
  • Dimethyl fumarate and glatiramer acetate had a favorable safety profile, showing lower withdrawal rates due to adverse events compared to interferon beta-1a and fingolimod.
  • Evidence indicates dimethyl fumarate shows protective effects against relapses when used preconception and during early pregnancy, is effective for low-risk patients compared to high-risk patients who benefit more from natalizumab, demonstrates varying relapse risk reductions in younger and treatment-naive patients, does not increase risk of SARS-CoV-2 infection or severe COVID-19, and is associated with PML cases where younger age and lower JCV viral load present favorable prognostic factors.

Product Monograph / Prescribing Information

Document TitleYearSource
Tivicay (dolutegravir) Prescribing Information.2024ViiV Healthcare, Durham, NC

Systematic Reviews / Meta-Analyses

Document TitleYearSource
An indirect comparison of 144-week efficacy, safety, and tolerability of dolutegravir plus lamivudine and second-generation integrase inhibitor-based, 3-drug, single-tablet regimens in therapy-naive people with HIV-12023Aids Research And Therapy
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 Review2022Open Forum Infectious Diseases
HIV-1 integrase resistance associated mutations and the use of dolutegravir in Sub-Saharan Africa: A systematic review and meta-analysis2022Plos Global Public Health
Pre-treatment HIV-1 drug resistance in antiretroviral therapy-naive adults in Eastern Africa: a systematic review and meta-analysis2022The Journal Of Antimicrobial Chemotherapy
Acquired HIV drug resistance mutations on first-line antiretroviral therapy in Southern Africa: Systematic review and Bayesian evidence synthesis2022Journal Of Clinical Epidemiology
Effects of different integrase strand transfer inhibitors on body weight in patients with HIV/AIDS: a network meta-analysis2022Bmc Infectious Diseases
Efficacy and Safety of Triple versus Dolutegravir-based Dual Therapy in Patients with HIV-1 Infection: A Meta-analysis of Randomized Controlled Trials2021Aids Reviews
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 evidence2021Hiv Medicine
HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review2021Infectious Diseases And Therapy
Comparative efficacy, safety and durability of dolutegravir relative to common core agents in treatment-naive patients infected with HIV-1: an update on a systematic review and network meta-analysis2021Bmc Infectious Diseases
Genital Human Immunodeficiency Virus-1 RNA and DNA Shedding in Virologically Suppressed Individuals Switching From Triple- to Dual- or Monotherapy: Pooled Results From 2 Randomized, Controlled Trials2020Clinical Infectious Diseases : An Official Publication Of The Infectious Diseases
A systematic review of the genetic mechanisms of dolutegravir resistance2019The Journal Of Antimicrobial Chemotherapy

Clinical Practice Guidelines