Abstract
Licensed for chronic hepatitis C treatment in 2011, the protease inhibitors (PIs) telaprevir (TVR) and boceprevir (BOC), which have high sustained viral responses (SVR), ushered a new era characterized by the development of direct-action drugs against the hepatitis C virus (HCV). The aim of this study was to analyze the effectiveness and safety of BOC and TVR administered with pegylated interferon and ribavirin and to share the experience of a Brazilian reference center. A retrospective descriptive study was conducted in patients with HCV genotype 1 infection who started treatment between July 2013 and December 2015. Data were collected using a computerized system. A total of 115 subjects were included, of which 58 (50.4 %) had liver cirrhosis and 103 (89.6 %) used TVR. The overall SVR rate was 61.7 % (62.1 % for TVR and 58.3 % for BOC). The presence of cirrhosis was associated with a lower SVR rate, whereas patients who relapsed after prior therapy had a greater chance of showing SVR than did non-responders. The incidence of adverse drug reactions (ADRs) was high. Almost all patients (~100 %) presented with hematologic events. Furthermore, treatment had to be discontinued in 15 subjects (13 %) due to severe ADRs. In conclusion, the SVR rates in our study were lower than those reported in pre-marketing studies but were comparable to real-life data. ADRs, particularly hematological ADRs, were more common compared to those in previous studies and resulted in a high rate of treatment discontinuity.
Highlights
Licensed for chronic hepatitis C treatment in 2011, the protease inhibitors (PIs) telaprevir (TVR) and boceprevir (BOC), which have high sustained viral responses (SVR), ushered a new era characterized by the development of direct-action drugs against the hepatitis C virus (HCV)
Initial studies showed a promising increase in the sustained viral response (SVR) among patients infected with HCV genotype 1, despite high costs and increased adverse drug reactions (ADRs), which often resulted in early treatment discontinuation[1,2,3,4,5]
According to the health policies established by the MH6, triple therapies were made available to individuals infected with HCV genotype 1 who presented with the following conditions related to the degree of hepatic fibrosis according to the METAVIR10 classification: cirrhosis, F4; advanced fibrosis without cirrhosis, F3; or moderate fibrosis, F2 demonstrated by an examination performed more than three years ago
Summary
Licensed for chronic hepatitis C treatment in 2011, the protease inhibitors (PIs) telaprevir (TVR) and boceprevir (BOC), which have high sustained viral responses (SVR), ushered a new era characterized by the development of direct-action drugs against the hepatitis C virus (HCV). Treatment had to be discontinued in 15 subjects (13 %) due to severe ADRs. Conclusions: In conclusion, the SVR rates in our study were lower than those reported in pre-marketing studies but were comparable to real-life data. Initial studies showed a promising increase in the sustained viral response (SVR) among patients infected with HCV genotype 1, despite high costs and increased adverse drug reactions (ADRs), which often resulted in early treatment discontinuation[1,2,3,4,5]. This study was aimed at analyzing the safety and effectiveness of the above-mentioned triple regimens, in addition to sharing the experience of a referral center established at a tertiary/quaternary university hospital in Southeastern Brazil.
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