Increased availability of HIV pre-exposure prophylaxis (PrEP) drugs has helped England sharply reduce its rate of new HIV diagnoses, and now a recent study has looked at the quality of generic versions of PrEP medications purchased online in the United Kingdom.
A 2019 study reported that the annual incidence of HIV in men who have sex with men (MSM) in England decreased 60.5% from 2012 to 2016. Through its PrEP IMPACT trial, the National Health Service (NHS) in England has enrolled more than 11,500 people who will receive tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) to reduce their risk of acquiring HIV, with a goal of enrolling 26,000 trial participants.
According to a study published in the International Journal of STD & AIDS, high-risk individuals unable to access PrEP through the trial are more frequently purchasing generic formulations online, prompting concerns over the authenticity of the generics. “Internet improves access to generic drugs, but it circumvents established safeguards against aspects of quality control, from manufacturing to distribution,” write the study’s authors. “As for all generic drugs, without specialized analytical equipment, it is impossible to inform individuals who purchase generic PrEP online of the quality or authenticity of the drugs.”
The study team, led by Imperial College London investigators, purchased different brands of generic PrEP tablets in sealed bottles from the 6 most commonly used internet-based generic PrEP suppliers featured on UK-based PrEP education websites. The purchases were made by volunteers and none of the PrEP suppliers were notified of the test purchases. Investigators obtained Truvada from Gilead as well as PrEP tablets from the IMPACT trial for comparison, and the brand and supplier of the generic PrEP samples were blinded from the researcher conducting the analysis.
Investigators conducted testing on all of the PrEP tablets that were purchased. The drugs tested had 94.3% to 104.9% of the 300 mg of TDF claimed on the label and 97.3% to 104.4% of the 200 mg FTC claimed on the label. “Confirming drug content in generic PrEP drugs, as one of contained the claimed amount of TDF and FTC the ways to assess quality of the drugs, is valuable as governments, charities and activist groups advocate for PrEP use in high-risk groups,” note the authors. “To our knowledge, the present report represents the first study measuring drug content in generic PrEP obtained via the internet.”
The authors emphasize that they only tested a relatively small number of PrEP samples, and that their findings should not lead to any generalized conclusion about the quality of generic PrEP purchased online. “Moreover, it is important to note that this is not a bioavailability study, so we could not draw any conclusion on the efficacy or safety of the generic PrEP drugs,” the authors add. “However, this study provides reassurance to the community purchasing generic PrEP online via safe sources and is a good example of a close collaboration between academics, clinicians, HIV charities and PrEP advocates.”
By Einav Keet