New study highlights the evidence gap on the quality of antiretrovirals globally
A new study suggests that, although there is sparse evidence, substandard and falsified (SF*) antiretrovirals occur and enhanced surveillance is needed.
The paper, The quality of antiretroviral medicines: an uncertain problem, was published in BMJ Global Health.
From the very limited available data, the Medicine Quality Research Group of the MORU Tropical Health Network, NDM-CGHR and IDDO found that 1.4 per cent of antiretrovirals reported as sampled in the scientific literature were substandard or falsified.
The researchers found published data on 3,713 samples and of these 1.4 per cent were falsified or substandard, but the sample size is small in relation to the vast global trade in medical products for HIV prevention and treatment. Due to the inadequacy of the underlying data they do not imply that 1.4 per cent of antiretrovirals are substandard and falsified globally. However, considering the millions of people that are using them, even a small proportion is unacceptable as it may result in many people with HIV not receiving the correct treatment; risking poor outcomes and resistance; and those using antiretrovirals as prophylaxis unknowingly being unprotected against infection.
Recalls and seizures of substandard and falsified antiretrovirals, and of diagnostic tests were described in the study; including the substitution of 140,000 HIV rapid diagnostic test (RDT) kits by pregnancy tests, and the recall of one million HIV-testing kits in Kenya out of concern they were giving false negative results.
According to the World Health Organization (WHO), in 2021 there were an estimated 38.43 million of people with HIV and by, July 2022, HIV/AIDS had caused 40.1 million deaths globally. At the end of 2021, around 75 per cent of HIV-infected people were receiving antiretroviral therapy globally.
Due to their vital role in saving lives and reducing the percentage of new HIV infections, poor quality antiretrovirals will inevitably have adverse health impacts for patients, both short and long-term, including on the emergence and spread of resistance to antiretrovirals.
Although most studies investigating this issue come from financially poor countries, the issue of poor-quality medicines is a global problem. Crucially, the quality of antiretrovirals used in pre-exposure prophylaxis and the quality of rapid diagnostic tests have been neglected research areas.
This systematic review suggests that more and better-quality data and data sharing are needed to better understand the global burden of this problem and inform interventions.
The researchers concluded that to better inform policy, more effort is needed to pinpoint issues with the quality of antiretrovirals and to seek appropriate solutions to prevent, detect and respond to them as it is vital to ensure that their benefits for the millions of people who need them are realised.
* About SF medical products
Substandard medical products result from errors and negligence during manufacture, transportation or storage. In contrast, falsified products result from criminal fraud. Although they have been traded for many centuries, in the last few decades the problem seems to have grown, partly because of the increased complexity of the global pharmaceutical economy and internet sales.