Real World Experience in the Era of First Generation Protease Inhibitors in the Treatment of Hepatitis C
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HEPATITIS C: THERAPEUTICS (MP MANNS AND T VON HAHN, SECTION EDITORS)
Real World Experience in the Era of First Generation Protease Inhibitors in the Treatment of Hepatitis C Hope Hubbard & Eric Lawitz
Published online: 6 October 2013 # Springer Science+Business Media New York 2013
Abstract The treatment for hepatitis C has been revolutionized with the new era of protease inhibitors. Boceprevir (BOC) and telaprevir (TVR) are potent first generation direct acting antivirals which have demonstrated significantly improved response rates compared to interferon and ribavirin in phase III trials. However there are multiple real-life data sets showing increased adverse events and treatment discontinuations compared to clinical trials, especially in the cirrhotic patient. The advent of all oral, non-interferon regimens offers a promising treatment paradigm for hepatitis C infected patients. Keywords Real . World . Acting . Antivirals . Boceprevir . Direct . Experience . Hepatitis c . Inhibitors . Protease . Telaprevir . Treatment
Introduction Hepatitis C is a chronic virus that affects about 170 million people worldwide and puts patients at increased risk of developing cirrhosis, portal hypertension, and hepatocellular carcinoma [1, 2]. Cirrhosis can develop in 30–40 % of patients unless hepatitis C is treated and the complications from advanced liver disease secondary to hepatitis C is a leading
H. Hubbard Division of Gastroenterology, University of Texas Health Science Center San Antonio, 7703 Floyd Curl Drive, Mail code 7878, San Antonio, TX 78229, USA e-mail: [email protected] E. Lawitz (*) The Texas Liver Institute, University of Texas Health Science Center San Antonio, 607 Camden, San Antonio, TX 78215, USA e-mail: [email protected]
indication for liver transplantation worldwide [3]. The previous standard of care with pegylated interferon (PEG-IFN) and ribavirin (RBV) for genotype 1 hepatitis C led to sustained virologic response (SVR) in 40–50 % and even lower response rates in those with advanced fibrosis, diabetes, or African American background [2–4]. In 2011 the new standard of care for those with genotype 1 infection became a combination of a protease inhibitor (PI), boceprevir (BOC) or telaprevir (TVR), with pegylated interferon and ribavirin. BOC and TVR are first generation directacting antiviral (DAA) agents which have led to improved SVR rates in both treatment naïve and experienced patients [3]. While the addition of BOC and TVR have enhanced rates of sustained viral response they have added additional adverse events, an increased pill burden and drug-drug interactions that did not negatively influence phase 3 results but make community use of these agents more challenging. Several real life reports with the protease inhibitors in combination with PEG-IFN/RBV have demonstrated the challenges that can occur in some subgroups of patients as they are used in increasingly diverse populations in the community. The use in broad populations has resulted in varied reported results on response rates, safety
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