Background: In British Columbia, antiretrovirals (ARVs) for HIV treatment (HIV-Tx) and pre-exposure prophylaxis (PrEP) are free-of-charge through publicly-funded Drug Treatment Programs (DTPs). When available, less costly generics are substituted for brand-name ARVs. We describe the incidence and type of product substitution issue (PSI) adverse drug reactions (ADRs) attributed to generic ARVs.
Methods: Cohorts included DTP clients ≥19 years who received generic ARVs for HIV-Tx (abacavir-lamivudine, emtricitabine-tenofovir DF, efavirenz-emtricitabine-tenofovir DF, atazanavir or darunavir between 01 Jun 2017 and 30 Jun 2022) or PrEP (emtricitabine-tenofovir DF, 01 Apr 2018 to 30 Jun 2022). Demographic, ARV and ADR data were extracted from DTP databases and summarized by descriptive statistics. PSI incidence was calculated for each product during the year following brand-to-generic and generic-to-generic transitions (first-year-post-rollout), and compared between generic versions using generalized estimating equations. For context, incidence of any ARV product-related ADR was calculated in the same 1-year periods.
Results: During first-year-post-rollout periods, 5339 HIV-Tx (83% male, median age 52 years) and 8095 PrEP (99% male, median 33 years) clients received generic ARVs, and reported 78 and 23 generic PSIs, respectively. PSI incidence was <1% for most generic ARVs, with mild-moderate symptoms including gastrointestinal upset, headache, dizziness, fatigue/malaise and skin rash. In HIV-Tx clients, the efavirenz-containing product had higher PSI incidence than other ARVs (2.2%, = .004), due to more neuropsychiatric adverse reactions. Any ADR incidence was stable across measurement periods, and generic PSIs represented less than one third of all product-related ADRs.
Conclusions: Generic substitution of antiretrovirals for HIV-Tx and PrEP was well tolerated, with ≤2% incidence of mild-moderate PSI ADRs.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1177/13596535241233128 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Optimising Pirfenidone Dosage Regimens in Idiopathic Pulmonary Fibrosis: Toward a Guide for Personalised Treatment.
Xenobiotica
January 2025
Department of Pharmacy, School of Health Sciences, National and Kapodistrian University of Athens, Athens, Greece.
Idiopathic Pulmonary Fibrosis (IPF) is a chronic respiratory disorder for which pirfenidone is the recommended first-line anti-fibrotic treatment. While pirfenidone has demonstrated efficacy in slowing the progression of IPF, its use is associated with several challenges and unresolved issues that impact patient outcomes. Pirfenidone administration can result in gastrointestinal side effects, photosensitivity reactions, and significant drug interactions, particularly in patients with hepatic impairment.
View Article and Find Full Text PDFPharmacovigilance insights into medication-induced risk of dural arteriovenous fistula.
Int J Surg
January 2025
Department of Orthopedics, Civil Aviation General Hospital, Beijing, China.
Background: Dural arteriovenous fistulas (DAVFs) pose a significant health threat owing to their high misdiagnosis rate. Case reports suggest that DAVFs or related acute events may follow medication use; however, drug-related risk factors remain unclear. In clinical practice, the concomitant use of multiple drugs for therapy is known as "polypharmacy situations," further increasing the risk of drug-induced DAVF.
View Article and Find Full Text PDFL-arginine in patients with spinocerebellar ataxia type 6: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.
EClinicalMedicine
December 2024
Department of Neurology, Brain Research Institute, Niigata University, Niigata, Japan.
Background: Therapeutic advancements for the polyglutamine diseases, particularly spinocerebellar degeneration, are eagerly awaited. We evaluated the safety, tolerability, and therapeutic effects of L-arginine, which inhibits the conformational change and aggregation of polyglutamine proteins, in patients with spinocerebellar ataxia type 6 (SCA6).
Methods: A multicenter, randomized, double-blind, placebo-controlled phase 2 trial (clinical trial ID: AJA030-002, registration number: jRCT2031200135) was performed on 40 genetically confirmed SCA6 patients enrolled between September 1, 2020, and September 30, 2021.
Safety assessment of deutetrabenazine: real-world adverse event analysis from the FAERS database.
Front Pharmacol
December 2024
Department of Clinical Psychology, The Third Affiliated Hospital of Soochow University, Changzhou, China.
Background: Deutetrabenazine is a widely used drug for the treatment of tardive dyskinesia (TD), and post-marketing testing is important. There is a lack of real-world, large-sample safety studies of deutetrabenazine. In this study, a pharmacovigilance analysis of deutetrabenazine was performed based on the FDA Adverse Event Reporting System (FAERS) database to evaluate its relevant safety signals for clinical reference.
View Article and Find Full Text PDFSafety evaluation of medroxyprogesterone acetate: a pharmacovigilance analysis using FDA adverse event reporting system data.
Front Pharmacol
December 2024
Department of Obstetrics and Gynecology, Second Hospital of Hebei Medical University, Shijiazhuang, China.
Background: Medroxyprogesterone acetate (MPA), a synthetic progestogen, is extensively used for the treatment of various conditions, including contraception, irregular menstruation, functional uterine bleeding, and endometriosis. However, like all pharmaceutical agents, MPA is associated with adverse drug reactions. This study aimed to evaluate the adverse events (AEs) associated with MPA in by analyzing real-world data from the U.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!