Rafaella’s Literature Update
The following message is courtesy of Dr Raffaella Ravinetto, Public Health Department, Institute of Tropical Medicine Antwerp, Belgium.
Ref: Do NT, Boupha P, Newton PN, et al. The quality of antiretroviral medicines: an uncertain problem. BMJ Global Health 2023;8:e011423.
Dear Friends,
We are not very much used to discussing quality problems for antiretroviral medicines (ARVs), as major purchasers are guided by the lists of ARVs pre-qualified by the WHO. Nonetheless, the global ARV market value exceeded US$ 24.7 billion in 2018, and projections suggest that it will be US$ 22.5 billion by 2024; therefore, even a low prevalence of substandard and falsified (SF) ARVs would have a significant impact on public health.
Do and colleagues conducted this systematic review, including scientific and grey literature, to summarize the available evidence on ARV medicines quality globally, and to discuss their potential impact on patients and society. In total, 216 publications were included, of which 205 were on ARV medicines and eleven on HIV medical devices. More than half were original research articles, including prevalence studies, analytical technique development/ validation, routine quality control analysis, equivalence studies, one bioavailability study, and the data from the United States Pharmacopoeia’s Medicines Quality Database. Others were recall/warning/alerts, reports of seizures and case reports published in newspapers or medicines regulatory authorities websites.
1.4% of the 3713 ARV samples collected in 19 prevalence surveys in 21 countries failed at least 1 quality test. The Authors found no publicly available evidence for almost 90% of national states; for 17 of the 30 countries that bear 89% of the new HIV infection; and for the quality of dolutegravir. They found limited information on tenofovir-based oral combinations for PrEP, and no studies on the quality of rapid diagnostic tests (RDT) including for self-testing. This indicates the importance of strengthening post-marketing surveillance of diagnostic kits; and the surveillance of online purchases of ARV, which is likely to increase, particularly for oral PrEP.
Despite limitations, this work shows clear gaps in the understanding of the epidemiology of substandard and falsified (SF) ARV and related diagnostic tests, particularly in sectors that do not necessarily follow the guidance of the WHO Prequalification, or that are affected by shortages. As noted, “even a small proportion of SF ARV is unacceptable, as it may result in a myriad of HIV positive people not receiving the correct treatment, risking poor outcomes and resistance, and those using ARV as prophylaxis unknowingly being unprotected against infection”.
Have a nice reading – and I take this opportunity to share also the most recent update of our Informal Quality Fact Sheet. Best,
Raffaella