Up until 1 March 2016, access to direct acting antiviral (DAA) therapies for hepatitis C in Australia remained limited to first- and second-generation protease inhibitors (telaprevir, bocepravir and simeprevir), used in combination with pegylated interferon and ribavirin. On 1 March 2016, the Pharmaceutical Benefit Scheme listed three new DAA, namely daclatasvir, sofosbuvir and ledipasvir (in fixed-dose combination with sofosbuvir). Prior to this, there was considerable uncertainty around the timing of approval of these drugs in Australia, yet they were available in some countries outside Australia at greatly reduced cost through compassionate drug agreements between pharmaceutical companies and local governments. With the advent of medical tourism to countries that have access to these drugs, there was a concern that counterfeit medicines would be sold to unsuspecting patients. Anecdotally, there were increasing reports of patients or their relatives and friends returning from overseas having acquired a course of DAA therapy. Although this was performed with the best intentions, it presents a clinical and ethical conundrum for treating physicians in Australia. On the one hand, patients with cirrhosis may benefit from early access to antiviral therapy by preventing fibrosis progression and risk of hepatic decompensation; on the other hand, it is not always clear how these drugs were acquired and whether the drugs were authentic. Denying patients access to therapy or supervision during a course of treatment may not be in their best interest, but alternatively, the use of potentially counterfeit medication risks, at the very least, falsely raising hopes of cure and, at worst, subjecting our patients to the risk of contaminants or other constituents that may be contained within the counterfeit medication.
Lubel, J., Chivers, S., Taylor, D., & Capuano, B. (2016). Testing of direct acting antiviral agents purchased overseas: a necessary precaution to protect patients? Internal Medicine Journal, 46(9), 1111-1113. https://doi.org/10.1111/imj.13182