Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real‐world results from 18 378 patients in Egypt

Omar, Heba; El-Akel, Wafaa; Elbaz, Tamer; Kassas, Mohamed El; Elsaeed, Kadry; Shazly, H. El; Said, Mohamed; Yousif, Monkez M; Gomaa, Ahmed; Nasr, Ahmed; AbdAllah, Mohamed; Korany, Mohamed A.; Ismail, Sahar A.; Mohammed, Shaker; Doss, Wahid; Esmat, Gamal; Waked, Imam; Shazly, Yehia El

doi:10.1111/apt.14428

Cited by 104 publications

(85 citation statements)

References 39 publications

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“…A patient was considered eligible for the study when he or she met the following criteria according to the protocol of Egyptian Ministry of Health: HCV‐ribonucleic acid (RNA) positive. Age ≥18 years, while patients ≥65 years performed a cardiology assessment prior to therapy by ECG and echocardiography before recruitment to the study. Only easy‐to‐treat HCV patients were included in the study, and they had all of the following criteria: (according to The National Committee for Control of Viral Hepatitis (NCCVH) Treatment naïve patients Total bilirubin ≤1.2 mg/dL Serum albumin ≥3.5 g/dL International normalized ratio (INR) ≤1.2 Platelet count ≥150,000/mm 3 …”

Section: Methodsmentioning

confidence: 99%

Safety, efficacy and cost of two direct‐acting antiviral regimens: A comparative study in chronic hepatitis C Egyptian patients

et al. 2019

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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. K E Y W O R D Scost-minimization analysis, DAAs, daclatasvir, hepatitis C genotype 4, ombitasvir, paritaprevir, ritonavir, sofosbuvir, SVR 12

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Section: Methodsmentioning

confidence: 99%

Safety, efficacy and cost of two direct‐acting antiviral regimens: A comparative study in chronic hepatitis C Egyptian patients

et al. 2019

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“…[22][23][24][25][26] Several studies carried out in Egyptian adults with HCV infection showed similar results. [27][28][29][30][31][32] The aim of this study was to investigate the safety and efficacy of combined therapy with SOF and DCV in HCV GT-4 chronic infection in children aged 8 to 18 years or weighing 17 kg or more.…”

Section: Introductionmentioning

confidence: 99%

“…Currently, a study in younger children 3-11 years of age with genotypes 2 and 3 treated with SOF + Ribavirin is ongoing until April 2018 and is yet to release its results (NCT02175758).Several previous studies revealed high efficacy of SOF/DCV based treatments in adults across different genotypes and subpopulation groups, including treatment-naïve, treatment experienced, cirrhotic, non-cirrhotic, HIV-coinfected and post-transplant patients, with at least 12-week long regimens resulting in SVR12 rates ranging from 84.54 to 98% [22][23][24][25][26][27][28][29][30][31][32]. There have thus far only been two published studies of SOF/DCV use in adolescents.…”

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confidence: 99%

Safety and efficacy of combined sofosbuvir/daclatasvir treatment of children and adolescents with chronic hepatitis C Genotype 4

Ghaffar

Naghi

Gawad

et al. 2018

Journal of Viral Hepatitis

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Summary Direct‐acting antivirals have become available for treating chronic HCV (hepatitis C virus) infection in adults and, recently, in children at least 12 years old. Our aim was to investigate the safety and efficacy of combined sofosbuvir (SOF)/daclatasvir (DCV) for HCV Genotype 4 in children aged 8 to 18 years or weighing 17 kg or more. A total of 40 chronic HCV‐infected, treatment‐naïve children with well compensated livers were recruited from two sites. Patients received combined therapy of SOF (400 mg/d for patients weighing greater than 45 kg; 200 mg/d for patients weighing 17 to 45 kg) and DCV (60 mg/d for patients weighing greater than 45 kg; 30 mg/d for patients weighing 17 to 45 kg) for 12 weeks. They were followed up regularly by clinical examination and laboratory tests during treatment (weekly in the first month then monthly to the end of treatment), every 3 months for 6 months post‐treatment, and at 48 weeks post‐treatment. In our cohort, which included 45% of children below the age of 12 years (72.5% genotype 4 and 27.5% mixed genotype 4 and 1), end of treatment response (ETR) was 97.5%. Sustained virologic response for weeks 12 and 24 post‐treatment (SVR12 and SVR24) were 97.5% and 95%, respectively, on an intention to treat basis, and 100% and 100% for those who completed the study protocol. Observed side effects were mild and none required drug cessation. Combined SOF/DCV was found to be effective and safe for treating HCV Genotype 4‐infected children, 8 years of age and above.

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“…The increasing prestige of the journal is reflected in the most recent increase in our impact factor (IF); during 2019, our 2‐year IF increased from 7.357 to 7.731 ranking AP&T in 11th place among 84 journals in gastroenterology and hepatology. The 10 papers published during 2018 that were the most highly cited during 2019 included such diverse topics as the epidemiology of Helicobacter pylori infection, the intestinal mirobiome and dysbiosis, biologic agents for IBD and evolving treatments for chronic viral hepatitis.…”

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confidence: 99%

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2019

Aliment Pharmacol Ther

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Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real‐world results from 18 378 patients in Egypt

Abstract: Real-world experience of generic SOF-DCV in patients with chronic HCV-G4 proved to be safe and associated with a high SVR12 rate, in patients with different stages of fibrosis.

Cited by 104 publications

References 39 publications

Safety, efficacy and cost of two direct‐acting antiviral regimens: A comparative study in chronic hepatitis C Egyptian patients

Safety, efficacy and cost of two direct‐acting antiviral regimens: A comparative study in chronic hepatitis C Egyptian patients

Safety and efficacy of combined sofosbuvir/daclatasvir treatment of children and adolescents with chronic hepatitis C Genotype 4

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