Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 10 mg, 25 mg, 50 mg); PD Tablet for suspension (oral; 5 mg) |
Drug Class | HIV 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.
Latest News
Summary
- 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 (relative risk (RR) 0.62, 95% confidence interval (CI) 0.55 to 0.70), with greater efficacy when disease-modifying therapies (DMTs) were continued into early pregnancy rather than discontinued. Cladribine tablets outperformed dimethyl fumarate in achieving the no evidence of disease activity-3 (NEDA-3) (odds ratio (OR) =1.76, 95% CrI (credible interval): 1.02-3.03).
- Disability Progression: Ozanimod showed improved outcomes over dimethyl fumarate for confirmed disability progression (CDP) at 3 months (hazard ratio (HR) 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 (medication possession ratio (MPR) ≥80%).
- Comparative Efficacy with Other Oral Disease-modifying Drugs (DMDs): Dimethyl fumarate showed a slightly lower relapse risk than teriflunomide (RR = 0.92) and demonstrated moderate effectiveness compared to fingolimod, which exhibited superior magnetic resonance imaging (MRI) and annualized relapse rate (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 John Cunningham virus (JCV) viral load present favorable prognostic factors.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tivicay (dolutegravir) Prescribing Information. | 2024 | ViiV Healthcare, Durham, NC |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
EACS Guidelines version 12.0. | 2023 | European AIDS Clinical Society |
Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. | 2023 | NIH |
Major revision version 12.0 of the European AIDS Clinical Society guidelines 2023. | 2023 | HIV Medicine |
European AIDS clinical society guidelines v10.1 October 2020. | 2020 | European AIDS Clinical Society |