P. Ciccorossi

OC-19 Modelling HCV kinetics by IL28B genotype is a new accurate tool for individual treatment management

s of the A.I.S.F. Annual Meeting 2010 /Digestive and Liver Disease 43S (2011), S65–S108 S71

OC.09.3: MODELLING HCV DYNAMICS ACCORDING TO IL28B POLYMORPHISM SHOWS DIFFERENT ANTIVIRAL EFFECTS OF PEGIFNS/RIBAVIRIN AND PROVIDES A NEW ACCURATE TOOL FOR TREATMENT MANAGEMENT

Material and methods: 418 consecutive NUC-naive patients with chronic hepatitis B were recruited in 18 Liver Units in Italy and treated with ETV 0.5 mg for 30 months (2-38). Liver function tests and HBV DNA, assessed by a sensitive assays, were performed every 3 months. Virological breakthrough was defined as >1 log U increase of viremia, a “blip” was the reoccurrence of detectable viremia ( 9.0) and ALT were elevated in 85% of the patients. During ETV treatment, 90% of the patients achieved undetectable HBV DNA: virological response rates were 67%, 86%, 92%, 95% and 96% at month 6, 12, 18, 24, and 30. The corresponding features for ALT normalization were 69%, 81%, 85%, 87% and 93%. After achieving undetectable HBV DNA, few patients had blips of viremia which were not confirmed in the following visits in the vast majority of cases. Primary non response at week 12, partial virological response at week 48 and virological breakthroughs occurred in < 1%, 14% and < 1% of the patients. TDF was added to ETV in 17 patients with partial virological response. Of the 39 partial virologial responders at week 48 not rescued with TDF and followed for additional 6-9 months, only 20 (50%) cleared viremia spontaneously. No major safety issues were reported. Median serum creatinine remained unchanged during treatment: from 0.90 (0.50-9.0) at baseline to 0.90 (0.91 (0.50-8.0) mg/dl at the last visit. A greater than 0.3 or 0.5 mg/dl increase of serum creatinine in the last visit versus baseline occurred in 3% and 0.6% of the patients, respectively. Blood phosphorus levels dropped below 2.3 mg/dl in 1% of the patients. Conclusions: The vast majority of NUC-naive patients treated with ETV monotherapy in field practice achieved and maintained a virological response through 30 months.