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Real‐world safety and effectiveness of retreatment of Egyptian chronic hepatitis C patients not responding to NS5A inhibitor‐based therapies
Author(s) -
Yousif Monkez M.,
Ahmed Hussien,
Elsadek Hany M.,
shendi Ali M.,
Gouda Tamer M.,
Elsayed Islam A.,
Gendia Mohamed A.,
Magdy Mahmoud M.,
lbrahim Nevin F.,
Sadek Ayman M. E. M.,
Zaki Ayman M.,
Shafeik Hamdy,
Zahran Mahmoud H.
Publication year - 2020
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.13349
Subject(s) - sofosbuvir , daclatasvir , medicine , simeprevir , ombitasvir , paritaprevir , ribavirin , gastroenterology , ledipasvir , hepatitis c , ritonavir , chronic hepatitis , virology , viral load , human immunodeficiency virus (hiv) , virus , antiretroviral therapy
The aim of this study was to assess the efficacy and safety of two protocols for retreatment of a cohort of Egyptian patients with chronic hepatitis C (CHC) who relapsed after NS5A inhibitor‐based therapy. We conducted a prospective cohort study to assess the safety and efficacy of 12 weeks’ retreatment with either combination of sofosbuvir/daclatasvir/simeprevir plus ribavirin (SOF/DCV/SMV/RBV, n = 45) or sofosbuvir/ombitasvir/paritaprevir/ritonavir plus ribavirin (SOF/OBV/PTV/r/RBV, n = 163) in patients who had previously failed NS5A inhibitors‐based regimens. The primary end point was SVR 12 weeks after the end of treatment (SVR12). Safety follow‐up data were recorded for 60 weeks after the end of treatment. Two hundred‐eight patients were included in the study. Of them, 53.4% of patients were females and 40.4% had liver cirrhosis. The most common prior drug combinations were sofosbuvir/daclatasvir (n = 94) and sofosbuvir/daclatasvir plus ribavirin (n = 109). The overall SVR12 rates were 98.1%. In SOF/DCV/SMV/RBV group, 95.6% achieved SVR12, while in SOF/OBV/PTV/r/RBV group, the SVR12 rates were 98.8%. SVR12 was higher in cirrhotic patients (84/84) than noncirrhotic (120/124), P value = .0149. Regarding the safety outcomes, anaemia and fatigue were significantly higher in SOF/OBV/PTV/r/RBV group. Hepatocellular carcinoma (HCC) was reported in eight (3.8%) patients (four in each group). Of them, death was confirmed in four patients. Retreatment of Egyptian CHC relapsed patients with either sofosbuvir/daclatasvir/simeprevir plus ribavirin or sofosbuvir/ombitasvir/paritaprevir/ritonavir plus ribavirin is highly effective and well‐tolerated for both noncirrhotic and compensated cirrhotic patients. Incidental de novo HCC and hepatic decompensation are comparable in the two groups.