RESUMEN
Sustainable access to high-quality antimalarial medicines is pivotal to achieving universal and effective malaria control. Poor-quality antimalarial medicines are prevalent in sub-Saharan Africa, impeding malaria control initiatives and claiming the lives of many children. Regular monitoring of the quality of antimalarial medicines is crucial to ensure the quality of service to the community. A cross-sectional study using a postmarket surveillance (PMS) approach was conducted from 2019 to 2023. Samples were collected from the port of entry, local manufacturers, and various distribution outlets in 15 regions of mainland Tanzania. The samples were subjected to tier 1 evaluation, comprising a product information review (PIR) and identification using the Global Pharma Health Fund-Minilab® techniques. Samples that failed the identification tests and 10% of the samples from distribution outlets that passed the tests were subjected to confirmatory testing (tier 2), which included assays, related substances, dissolution, and sterility per the pharmacopeial monographs. During five annual PMSs, 2,032 antimalarial samples were collected and subjected to quality tests. All samples complied with the standard specifications for identity, dissolution, related substances, sterility, physical evaluation, disintegration, and assay. A total of 292 (55.5%) tested samples failed the PIR evaluation, with incomplete package information in leaflets contributing to 64.7% of all deviations. Antimalarial medicines circulating in the mainland Tanzanian market meet expected quality standards. Continuous monitoring of the quality of antimalarial medicines is recommended.
RESUMEN
Tanzania adopted a Dolutegravir (DTG)-based regimen as first-line treatment in 2019 following the World Health Organization recommendation. Data on the DTG safety profile from sub-Saharan Africa including Tanzania are limited. We investigated the incidence of DTG-related adverse events (AEs) and associated factors among people living with HIV (PLHIV) initiated on a DTG regimen. A prospective cohort study was conducted from 25 Care and Treatment Clinics in mainland Tanzania. PLHIV aged 12 years and above who were initiated on a DTG-based regimen were actively followed up for three months. The Cox regression model was used to determine the predictors of occurrence of AEs over time. A p-value of 0.05 was considered statistically significant. From January 2020 to June 2022, a cohort of 935 participants who were both newly diagnosed and ART-experienced who transitioned to a DTG-based regimen was enrolled. Out of 935 participants, 59 (6.3%) reported a total of 62 AEs. The most frequently experienced AE was skin itching and rashes (15/62; 24.2%). DTG-associated neuropsychiatric AEs were less common and included headache (6 [9.6%]) and sleep disturbances (3 [4.8%]). The overall incidence of occurrence of the first AEs was 96.7 per 1000 person-months [95% C.I: 74.4-125.7] with the highest incidence observed among the elderly (≥ 60 years). Individuals on WHO HIV Clinical Stage 2 had a 2.7 significantly higher risk of developing AEs (adjusted hazard ratio = 2.73, 95% CI = 1.46-5.12, p = 0.017). We report a low incidence of grade I (mild) and grade II (moderate) DTG-associated AEs suggesting that the regimen is generally safe in the population. Continued monitoring of DTG safety in the population is recommended.