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Safety, efficacy and cost of two direct‐acting antiviral regimens: A comparative study in chronic hepatitis C Egyptian patients
Author(s) -
Ibrahim Mohammed Ebid AbdelHameed,
Ashraf Ahmed Osama,
Hassan Agwa Sara,
Mohamed AbdelMotaleb Sara,
Mohamed Elsawy Amira,
Hagag Radwa Samir
Publication year - 2020
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/jcpt.13104
Subject(s) - medicine , daclatasvir , sofosbuvir , ribavirin , ombitasvir , regimen , ritonavir , gastroenterology , paritaprevir , alanine transaminase , hepatitis c virus , viral load , immunology , virus , antiretroviral therapy
What is known and objective Direct‐acting antivirals ( DAAs) have become the most widely used treatment of chronic hepatitis C infection. Comparative studies on DAAs regimens approved by the Egyptian Ministry of Health for easy‐to‐treat genotype 4 ( G4 ) Egyptian patients are still deficient. In this prospective study, we compared the efficacy and cost of two DAA regimens that are used in the treatment of Egyptian chronic hepatitis C virus (HCV) G4. The cost‐saving regimen is determined. Methods Eligible patients were randomized into 2 groups. Group 1 (Gp 1) received sofosbuvir plus daclatasvir, and group 2 (Gp 2) received ombitasvir, paritaprevir and ritonavir plus ribavirin (RBV) for 12 weeks. Data were collected and evaluated at baseline and at weeks 4, 8 and 12. Sustained virologic response 12 weeks after the end of treatment (SVR 12 ) was evaluated. Cost‐minimization analysis (CMA) was performed. Results and discussion Eligibility was achieved in 107 patients, Gp1 included 57 patients, and Gp 2 included 50 patients. Two patients dropped out from Gp 2 due to non‐compliance. All patients in the two groups showed negative HCV blood levels at the end of treatment. At the 24th week, 3 relapsers (5.2%) were detected in Gp1 and 2 relapsers (4.1%) were detected in Gp 2. SVR 12 was 54/57 (94.7%) and 46/48 (95.8%) for Gp 1 and Gp 2, respectively. After the 12th week of treatment, a significant decrease in aspartate aminotransferase (AST), alanine aminotransferase (ALT) and haemoglobin levels were observed in both groups. Albumin levels declined in Gp 2 only. CMA showed higher cost in Gp 2 than Gp 1, although similar efficacy and safety. What is new and conclusion The two DAA regimens showed high SVR 12 and safety in Egyptian HCV G4 patients. Sofosbuvir plus daclatasvir is the cost‐saving regimen.