The LOTOS study (Longterm Outcome of cHC) is an ongoing noninterventional study in 115 private practices aimed to determine long-term clinical outcome of pts. who were followed from 2003 on. Pts. with cHC who were screened, diagnosed and treated and not treated in one of 4 preceding noninterventional studies >3 yrs ago, and who are still under routine medical observation were included. Hematol., biochem. and virolog. as well as clinical data (develop. of varices, decomp. liver disease, cirrhosis, HCC, liver transplantation, death) were recorded. Until April 2010, for 682 pts. complete documentation was available with FU of at least 3 yrs and mean FU of 4±1 yrs. 58% of pts. was male, 50±13 years, BMI 25±4kg/m². HCV GT 1, 2, 3 and 4 were found in 55, 3.8, 30.4 and 1.8% of patients. 350 pts were treated with pegIFN and RBV (SVR=202, nonresponders/relapsers/breakthrough (NRB)=148), and 331 individuals were never treated (NT) because of age (n=34), comorbidities (n=51), too advanced disease (n=8), ongoing drug abuse (n=119), mild disease (n=24) or patient’s wish (n=108). SVR pts as compared to NRB or NT pts had significantly higher platelets (92% during FU vs. normal vs. 78% and 74%, rsp.), lower ALT, AST and GGT levels. In NT pts HBA1c were elevated in 17% comp. to 10% SVR – and NRB-pts. Only 1 SVR patient (0.5%) developed a liver-related clin. endpoint while this was the case in 4 (2.7%) NRB and 6 (1.8%) NT pts. HCCs developed in 4 NRB and 4 NT pts. Considering all pts, 0.3%, 2.8% and 6.1% of SVR, NRB and NT pts died, the latter with an overall 45% liver-related mortality (ITT).This long-term FU-study (i) confirms excellent outcome of SVR pts showing that HCV clearance almost eliminates liver related morbidity and mortality, (ii) shows a poorer outcome of pts with treatment failure, (iii) demonstrates a surprisingly high frequency of clin. endpoints in pts who could not be treated for various reasons and thus highlights the severity of HCV-induced liver disease.
Chronische Hepatitis C - Langzeitbeobachtung - Peginterferon-alpha 2a
