In Reply

We thank your correspondents for their letter and welcome the IQWiG’s willingness to enter into an objective dialogue with experts. We wish to point out that the discussions about the benefits assessments of boceprevir and telaprevir that were held by the medical specialty societies (DGVS [Deutsche Gesellschaft für Verdauungs- und Stoffwechselkrankheiten e.V., German Society for Digestive and Metabolic Diseases], DGIM [Deutsche Gesellschaft für Innere Medizin, German Society of Internal Medicine] and others) were extremely objective and constructive (1, 2).

While the IQWiG regards “sustained virologic response” (SVR) in the treatment of patients with chronic hepatitis C as merely a sufficiently valid surrogate for the subsequent complication “hepatocellular carcinoma” (HCC), the international consensus is that virus eradication leads to a reduction in inflammatory activity in the liver and regression of fibrosis and even cirrhosis. Furthermore, there is no doubt that the regression of fibrosis in turn reduces the risks of other complications of cirrhosis (among others, portal hypertension, ascites). In line with with the medical speciality societies, the authors also regard the benefit of SVR in patients with chronic hepatitis as fundamentally (semi-)quantifiable (3).

Indeed there are small groups of patients whose SVR rate cannot be raised by adding an HCV protease inhibitor to treatment with peginterferon-alfa/ribavirin. the IQWiG does not take into account in its analysis, however, that by giving triple, rather than dual, therapy to these patients, the overall duration of treatment can be shortened, in some cases substantially, and that this is clinically of major importance on the background of the side effects of peginterferon-alfa/ribavirin.

With regard to information for doctors and patients, the authors think it’s more important to document the dynamics of the clinical development of other, directly antivirally effective, medications for the treatment of chronic hepatitis C. On the basis of current studies, effective interferon-free therapeutic options with fewer side effects may be available in just a few years’ time.

DOI: 10.3238/arztebl.2012.0755b

PD Dr. med. Wolf-Peter Hofmann

POLIKUM Berlin MVZ GmbH

Prof. Dr. med. Christoph Sarrazin

Prof. Dr. med. Stefan Zeuzem

Medizinische Klinik 1, Klinikum der Goethe-Universität, Frankfurt am Main

zeuzem@em.uni-frankfurt.de

Conflict of interest statement

Dr Hofmann has received participation fees for continuing medical educational events from Bristol-Myers Squibb, Gilead Sciences, MSD, and Roche. Furthermore he has received honoraria for preparing scientific continuing educational events from Bristol-Myers Squibb, Gilead Sciences, MSD, Janssen-Cilag, and Roche. For conducting clinical studies and a study project he initiated he has received funding from Roche.
Professor Sarrazin co-holds a patent regarding the resistances of HCV-NS3-protease inhibitors. He is on the advisory boards of the following companies: Abbott, Bristol-Myers Squibb, Boehringer Ingelheim, Gilead Sciences, Janssen-Cilag, MSD, Novartis, Pharmasset, and Roche. He has received honoraria for preparing scientific continuing educational events from Abbott, Bristol-Myers Squibb, Boehringer Ingelheim, Falk Pharma, Gilead Sciences, MSD, Novartis, and Roche. He has received funding for conducting clinical studies from Abbott, Gilead Sciences, Merck, MSD, Roche, and Vertex Pharmaceuticals.
Professor Zeuzem consults on the following advisory boards: Abbott, Achillion, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Gilead Sciences, Janssen-Cilag, Merck, Novartis, Roche, Santaris, and Vertex Pharmaceuticals. He has received travel and hotel expenses and honoraria for preparing scientific continuing educational events from Bristol-Myers Squibb, Gilead Sciences, Merck, Novartis, and Roche.