Long-term outcome of interferon/ribavirin treatment in the German real-life setting: Durable SVR associated with low rates of liver-related events

• Published in: Zeitschrift für Gastroenterologie
• Main Authors: Mauss, S, Petersen, J, Witthöft, T, Busch, W, Christensen, S, Zehnter, E, John, C, Gölz, J, Nowok, K, Bilzer, M, Hüppe, D
• Format: Conference Proceeding
• Language: English
• Published: 09.08.2011
• ISSN: 0044-2771; 1439-7803
• DOI: 10.1055/s-0031-1285599

Background: Limited data exist regarding long-term durability of SVR and incidence of liver-related morbidity after treatment with peginterferon-based therapies in the real-life setting. We therefore conducted a non-interventional follow-up survey in German gastroenterological practices to determine long-term clinical outcome after interferon-based treatments in the real-life setting. Methods: Patients with chronic hepatitis C who achieved SVR/Non-SVR after IFN-based treatment ≥3 years ago and who are still under routine medical observation were enrolled by 45 gastroenterological centers in Germany. Significant clinical events related to progression of liver disease (liver transplant, signs of decompensated liver disease [ascites, variceal bleeding, encephalopathy], and hepatic malignancy) were recorded. Patients with documented SVR after at least 6 months following termination of IFN-based therapy were assessed for durability of undetectable serum HCV RNA. Results: From May 2009 until October 2010 N=1355 patients (male 58.0%, mean age 49.2±11.48yrs) infected with G1 (62.4%), G2 (8.1%), G3 (26.3%) and G4/other (3.2%) have been enrolled. Median follow up was 4yrs (range 3 to 8yrs). 42 and 1313 pts were treated with conventional/pegylated IFN and ribavirin. In total 759/1355 (56%) achieved SVR after first therapy. Only 3 SVR patients (0.4%) developed a liver-related clinical event in contrast to 31 (6.2%) Non-SVR pts. Of the 34 pts patients who had significant hepatic-related clinical events, 24 (including the 3 pts with SVR) had baseline cirrhosis. Most SVR patients (98.6%; 704/714) continued to have undetectable HCV RNA after a mean 2.4±1.5yrs follow-up. Similar results were obtained in the subgroup of intravenous drug user who achieved SVR under opiod maintenance: Of these 98.0% (246/251) remained HCV RNA serum-negative after a mean follow-up of 2.5yrs. Only 5 patients became HCV RNA detectable after a mean of 1.8yrs (range 1 to 3yrs). Conclusions: SVR following treatment with conventional/pegylated IFN±ribavirin is durable in the real-life setting, in particular also for the majority of patients under opioid maintenance. In addition, SVR almost completely eliminates morbidity by liver-related clinical events suggesting cure of chronic hepatitis C.