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Jennifer A. Kieran, Susanne Schmitz, Aisling O'Leary, Cathal Walsh, Colm Bergin, Suzanne Norris, Michael G. Barry, Reply to Calcagno et al, Clinical Infectious Diseases, Volume 56, Issue 11, 1 June 2013, Pages 1678–1679, https://doi.org/10.1093/cid/cit092
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To the Editor—In their comment regarding our meta-analysis, Calcagno et al make a very salient point with regard to the longer half-life of telaprevir and the impact this may have on its therapeutic robustness in the setting of less-than-optimal adherence [1]. However, in the clinical trials examined by our meta-analysis, although adherence was not explicitly measured or reported, the discontinuation rates were very similar between the 2 agents and the rates of failure with resistance mutations were also low [2]. The subgroup of relapsers, in whom the difference between the 2 agents was detected, looked at a patient population with proven sensitivity to pegylated interferon and ribavirin and presumably with adherence that was adequate to result in an end-of-treatment response with standard of care. Therefore, it is unlikely that differences in patient adherence to treatment would account for the difference in efficacy detected by our analysis. That being said, the point regarding adherence is well made, especially as these treatment regimens are being rolled out into standard clinical practice and away from the idealized setting of a randomized clinical trial. The pharmacokinetic properties of telaprevir may allow some “forgiveness” in practice where adherence is likely to be lower than that found in a clinical trial setting. If there is indeed a benefit from a pharmacokinetic perspective in patients with poorer adherence, it would be expected that this would become more evident with increasing availability of real-world effectiveness data.
