Introduction Many factors affect treatment outcomes in Hepatitis C genotype 1 patients, some of which may differentiate between those achieving sustained viral response (SVR) and those who don't. Several variables were studied in unselected patients to look at predictive factors for achieving SVR.
Methods Medical records of 438 patients treated with PEG-IFN α-2b and Ribavirin from 20 UK centres were studied to better understand factors predicting successful treatment outcome in the “real world” outside clinical trials. Data included patient demographics, SVR rates, early viral response (EVR), rapid viral response (RVR), methadone and other medication use and lab assay data. This study was supported by Schering-Plough.
Results HCV was contracted from injection drug use (61%), blood/blood products (13%) or other source (26%). 55% (243/438) of patients achieved SVR. As expected, male sex, high viral load and cirrhosis were all associated with failure to achieve SVR. 78% (341/438) had a liver biopsy prior to treatment, 12% were cirrhotic. The use of methadone / buprenorphine (65/438) or antidepressants (102/438) did not affect SVR negatively. EPO and GCSF were used in a small number of cases (2%). Higher doses and longer duration use was associated with greater chance of achieving SVR. Younger age (40 vs 46 years, p<0.001) and starting treatment sooner (28 vs 40 months, SVR vs non-SVR, P<0.05) were important factors in achieving SVR. ALT level at baseline was significantly higher in patients achieving SVR (p<0.05). Early normalisation of ALT (week 4) was significantly associated with achieving SVR (p<0.001). GGT levels were significantly higher in patients not achieving SVR (p<0.05). 130 patients had an early viral response. These were divided into two groups – EVR with HCV RNA undetectable (EVR-U, n=73), and those that had >2 log drop in HCV RNA but RNA still detectable at 12 weeks (EVR-D, n=57). EVR-U patients were more likely to achieve SVR when compared to EVR-D patients (p<0.001). 18 patients had a rapid viral response (treatment week 4) with 89% achieving SVR.
Conclusion Treatment outcomes in UK real world patients mirror results of registration trials, despite treatment of significant numbers on opiate substitutes and antidepressants. Early normalisation of ALT on treatment strongly predicted achieving SVR and may be useful in encouraging adherence. Interestingly, a high GGT appears to be associated with a poorer outcome.
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