Background: Treatment with PEG-IFN plus RBV of HCV carriers with persistently normal ALT levels (PNALT) has been discouraged outsideclinical trials. Only one trial (Zeuzem 2004) evaluated the efficacy of this therapy in PNALT; however, HCV-1 subjects were treated with low RBV dose (800 mg/day). Thus, the efficacy of the approved dosage of RBV (1000–1200 mg/day) has never been studied in clinical practice in patients with HCV-1 and PNALT. Simulations based on generalised additive model (GAM) analysis suggest that SVR in HCV-1 patients with PNALT significantly increases when the standard weight-adjusted dose of ribavirin is administered (Snoeck et al, 2007). Aims of this study were (i) to evaluate the overall virological responses (EoTR, SVR) to combined antiviral treatment in HCV patients with PNALT, and (ii) to evaluate whether HCV-1 patients with PNALT treated with optimal RBV dosage (1000–1200 mg/day) might achieve higher EVR than those obtained in previous RCT with lower RBV doses. Patients. 88 PNALT (53 females, range 22−60 yrs) were studied. 32 patients did harbour HCV type 1, 46 HCV-2, and 10 had HCV-3. Liver biopsy was performed in 72 patients, showing minimal fibrosis in all but 3 patients (F0−F1 Metavir). All patients received PEG interferon alfa2a 180 mg/wk plus RBV 800 mg/day for 24 wks (HCV 2 and 3 patients) or 1000–1200 mg/day for 48 wks (HCV-1 patients, according to bw). Persistent ALT normality was defined by at least 3 normal values two months apart over a 6 mo. observation period. Results: EoTR was seen in 81/88 pts (82%; 84% of HCV-1, 100% of HCV-2, 90% of HCV-3). To date, SVR has been evaluated in 63 pts (24 HCV-1 and 39 HCV-2); virological response was maintained in 37/39 HCV-2 patients (SVR 95%) and in 20/24 HCV-1 patients (83%). Side effects were not different from those observed among patients with elevated ALT levels treated in the same period. Conclusions. Antiviral treatment with PEG IFN plus RBV is safe and effective in patients with PNALT. Using standard RBV doses in patients with HCV-1, rates of SVR higher than those seen in patients with abnormal ALT can be achieved.
ANTIVIRAL TREATMENT OF HCV CARRIERS WITH NORMAL ALT
Picardi A;
2008-01-01
Abstract
Background: Treatment with PEG-IFN plus RBV of HCV carriers with persistently normal ALT levels (PNALT) has been discouraged outsideclinical trials. Only one trial (Zeuzem 2004) evaluated the efficacy of this therapy in PNALT; however, HCV-1 subjects were treated with low RBV dose (800 mg/day). Thus, the efficacy of the approved dosage of RBV (1000–1200 mg/day) has never been studied in clinical practice in patients with HCV-1 and PNALT. Simulations based on generalised additive model (GAM) analysis suggest that SVR in HCV-1 patients with PNALT significantly increases when the standard weight-adjusted dose of ribavirin is administered (Snoeck et al, 2007). Aims of this study were (i) to evaluate the overall virological responses (EoTR, SVR) to combined antiviral treatment in HCV patients with PNALT, and (ii) to evaluate whether HCV-1 patients with PNALT treated with optimal RBV dosage (1000–1200 mg/day) might achieve higher EVR than those obtained in previous RCT with lower RBV doses. Patients. 88 PNALT (53 females, range 22−60 yrs) were studied. 32 patients did harbour HCV type 1, 46 HCV-2, and 10 had HCV-3. Liver biopsy was performed in 72 patients, showing minimal fibrosis in all but 3 patients (F0−F1 Metavir). All patients received PEG interferon alfa2a 180 mg/wk plus RBV 800 mg/day for 24 wks (HCV 2 and 3 patients) or 1000–1200 mg/day for 48 wks (HCV-1 patients, according to bw). Persistent ALT normality was defined by at least 3 normal values two months apart over a 6 mo. observation period. Results: EoTR was seen in 81/88 pts (82%; 84% of HCV-1, 100% of HCV-2, 90% of HCV-3). To date, SVR has been evaluated in 63 pts (24 HCV-1 and 39 HCV-2); virological response was maintained in 37/39 HCV-2 patients (SVR 95%) and in 20/24 HCV-1 patients (83%). Side effects were not different from those observed among patients with elevated ALT levels treated in the same period. Conclusions. Antiviral treatment with PEG IFN plus RBV is safe and effective in patients with PNALT. Using standard RBV doses in patients with HCV-1, rates of SVR higher than those seen in patients with abnormal ALT can be achieved.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
