Perspectives of fixed daily dose of sofosbuvir and ledipasvir for the treatment of chronic hepatitis C.

The fixed dose combination of sofosbuvir and ledipasvir (SOF/LDV) has marked a new era for patients with chronic HCV because it is the first drug to be approved by the FDA that does not include peginterferon or ribavirin. The results of three clinical studies show that SOF/LDV has sustained virologic response of approximately 96% when given as once a day pill for 3 months to both treatment naive and treatment-experienced HCV-1 patients with the exception of prior null responder patients with cirrhosis. Moreover, emerging data in special populations (patients with decompensated cirrhosis, with post-transplant recurrence, with prior SOF-based therapy failure, and with HIV co-infection) show a good tolerance and high sustained virological profile. Many other emerging therapies are now available. Actually, the recommendations of the international guidelines are applicable only for selected patients followed-up by dedicated specialists, including hepatologists and infectologists, and are specifically individualized for patients with advanced fibrosis. We will expect that the landscape for management of HCV will include direct-acting antivirals for treatment of patients with different genotypes and low-grade fibrosis in order to interrupt the progression to late stage of disease and the complications of the infection, including renal disease, thyroid dysfunction, and some cancers.