Efficacy of the "first wave" Direct Acting antivirals against HCV infection: results from the Italian LINA (Liver Network Activity) cohort.

Approximately 71 million people are chronically infected with HCV worldwide. Recently, interferonfree therapies effective against HCV became available and nowadays, therapeutic strategies include a combination of two or three drugs with different mechanisms of action. In the present study, we reported real-life SVR rates in a large cohort of four prescribing centers in a high-endemic area of Southern Italy. We conducted a prospective multicenter study among all the patients with chronic HCV infection, who received therapy with the first available interferon-free therapies between March 2015 and December 2017 and who referred to one of the 4 DAA-prescribing centers in Campania, Southern Italy. Patients with Child C cirrhosis, a diagnosis of active HCC at the baseline or who refused the consent form, were excluded. Nine-hundred fifty-three patients were enrolled. Most of the enrolled patients had HCV genotype 1b infection (66.4%), were older than 65 years (64.1%) and had advanced liver fibrosis (Metavir > F4) (73.5%). The overall SVR12 rate was 98.5%. Patients with clinical cirrhosis had a similar SVR12 rate compared with those without cirrhosis (97.8% vs 99.2%, p=0.09), while patients with decompensated cirrhosis had a significantly lower rate of SVR12 compared with those without decompensated disease (95.3% vs 99.0%, p<0.05). Patients aged more than 65 years had a similar rate of SVR12 compared with patients aged ≤ 65 years (98.6% vs 98.0%, p=0.57). Among patients >65 years, those with clinical cirrhosis, as well as those with advanced liver fibrosis, had a similar SVR12 rate compared with the patients with a Metavir score < F4 (98.3% vs 99.0%, p=0.70 and 98.6% vs 98.6%, p=1.00, respectively). In the present, real-life study, DAA regimens are effective and safe in patients with chronic HCV infection, regardless of age and stage of liver disease, providing very high rates of SVR12 (98.5%).

[1]  Santosh Kumar,et al.  Sofosbuvir + velpatasvir + voxilaprevir for the treatment of hepatitis C infection , 2018, Expert opinion on pharmacotherapy.

[2]  S. Hirono,et al.  Efficacy and safety of sofosbuvir and ledipasvir in Japanese patients aged 75 years or over with hepatitis C genotype 1 , 2017, World journal of hepatology.

[3]  I. Sporea,et al.  Efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for the treatment of HCV genotype 1b compensated cirrhosis in patients aged 70 years or older , 2017, Medicine.

[4]  Yan Wang,et al.  Efficacy and safety of direct‐acting antivirals‐based antiviral therapies for hepatitis C virus patients with stage 4‐5 chronic kidney disease: a meta‐analysis , 2017, Liver international : official journal of the International Association for the Study of the Liver.

[5]  P. Maisonneuve,et al.  Survival of patients with HCV cirrhosis and sustained virologic response is similar to the general population. , 2016, Journal of hepatology.

[6]  G. Borgia,et al.  Investigational direct-acting antivirals in hepatitis C treatment: the latest drugs in clinical development , 2016, Expert opinion on investigational drugs.

[7]  E. Schiff,et al.  Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease. , 2015, Gastroenterology.

[8]  G. Borgia,et al.  Discontinued drugs in 2012 – 2013: hepatitis C virus infection , 2015, Expert opinion on investigational drugs.

[9]  H. Razavi,et al.  Global epidemiology and genotype distribution of the hepatitis C virus infection. , 2014, Journal of hepatology.

[10]  G. Borgia,et al.  Interferon-free therapies for chronic hepatitis C: toward a hepatitis C virus-free world? , 2014, Expert review of anti-infective therapy.

[11]  Stefan Zeuzem,et al.  Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. , 2014, The New England journal of medicine.

[12]  Eoin Coakley,et al.  Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. , 2014, The New England journal of medicine.

[13]  G. Castaldo,et al.  MK-5172: a second-generation protease inhibitor for the treatment of hepatitis C virus infection , 2014, Expert opinion on investigational drugs.

[14]  John McNally,et al.  Sofosbuvir for previously untreated chronic hepatitis C infection. , 2013, The New England journal of medicine.

[15]  E. Sagnelli,et al.  A Simple Noninvasive Score Based on Routine Parameters can Predict Liver Cirrhosis in Patients With Chronic Hepatitis C , 2013, Hepatitis monthly.

[16]  M. Volk,et al.  A sustained viral response is associated with reduced liver-related morbidity and mortality in patients with hepatitis C virus. , 2010, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association.

[17]  M. Manns,et al.  Thrombocytopenia associated with chronic liver disease. , 2008, Journal of hepatology.

[18]  D. Thabut,et al.  Hepatitis C in 6,865 Patients 65 yr or Older: A Severe and Neglected Curable Disease? , 2006, The American Journal of Gastroenterology.

[19]  P. Couzigou,et al.  A randomized trial of ribavirin and interferon-alpha vs. interferon-alpha alone in patients with chronic hepatitis C who were non-responders to a previous treatment. Multicenter Study Group under the coordination of the Necker Hospital, Paris, France. , 1999, Journal of hepatology.

[20]  C. Trepo [From non-A non-B hepatitis to hepatitis C virus]. , 1990, Gastroentérologie Clinique et Biologique.