Cost-effectiveness analysis of early treatment of chronic HCV with sofosbuvir/velpatasvir in Italy

Background Chronic Hepatitis C virus (cHCV) is a major health issue worldwide. New efective direct-acting anti-viral (DAA) drugs such as the combination sofosbuvir/velpatasvir, represent an important turning point, given the high sustained virologic response (SVR) rates associated with their use. Objectives To estimate the cost and efects of two diferent treatment strategies based on sofosbuvir/velpatasvir. Strategy 1: treating all patients, including those in the early stages of fbrosis; Strategy 2: reserving treatments for patients at more advanced stages of disease (≥F3). The analysis compares the incremental cost-efectiveness ratio (ICER) of Strategy 1 versus Strategy 2 in a cohort of HCV-infected patients and a cohort of hepatitis C virus (HCV)-human immunodefciency virus (HIV) patients. Methods A Markov model simulating the natural history of the disease was built considering a 60-year time horizon and two cohorts of 1000 patients aged≥35 years. Disease morbidity was classifed according to the METAVIR classifcation. The robustness of the model was tested using deterministic and probabilistic sensitivity analyses (PSA). Results In both cohorts, Strategy 1 results in higher resource consumption and a greater number of quality-adjusted lifeyears (QALYs) compared with Strategy 2. The ICERs for the cohort of HCV patients and the cohort of co-infected HCV/ HIV patients ranged between €15,555–74,804/QALY and €10,708–55,138/QALY, respectively, depending on the assumed cost of the treatment. In the PSA, the ICER distribution remained below the threshold of €30,000/QALY in 96 and 97% of the scenarios in the cohorts of HCV and HCV/HIV patients, respectively. Conclusions Extending the treatment of HCV to patients at an early stage of HCV infection is estimated to be cost efective from the perspective of the Italian Healthcare System.