Effect of Sofosbuvir Plus Daclatasvir in Hepatitis C Virus Genotype-4 Patients: Promising Effect on Liver Fibrosis

Abdel-Aziz, Asmaa Mohamed; Ibrahim, Mohamed; El-Sheikh, Azza A. K.; Kamel, Maha Yehia; Zenhom, Nagwa M.; Abdel-Raheim, Salam; Abdelhaleem, Hisham

doi:10.1016/j.jceh.2017.06.006

Cited by 19 publications

(12 citation statements)

References 29 publications

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“…Interestingly, the present study showed a significant effect of SOF/DAV based regimen on liver fibrosis, that was significantly decreased at end of the treatment than at baseline ( P = 0.001). Similar results were reported in Egypt with the same regimen and also in Japan with DAV‐based regimen in HCV‐G1 patients that suggest that this regimen may decrease the incidence of HCC. Further studies are needed to show whether DAA combinations, including SOF/DAV based regimen, can prevent HCC, and to detect whether the improvement of the fibrosis is caused by the effect of drugs or due to eradication of virus.…”

Section: Discussionsupporting

confidence: 81%

Association of IL‐1β, IL‐1RN, and ESR1 genes polymorphism with risk of infection and response to sofosbuvir plus daclatasvir combination therapy in hepatitis C virus genotype‐4 patients

et al. 2018

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Sofosbuvir (SOF) and daclatasvir combination with or without ribavirin proved to be effective and safe in the treatment of hepatitis C virus infection. The study aimed to assess the efficacy of (SOF plus daclatasvir) combination + ribavirin in the treatment of treatment-experienced HCV genotype 4 Egyptian patients and to investigate the impact of IL-1β _31, IL-1β _511, and IL-1RN and T29C of ESR1 genes polymorphisms on treatment outcome. The study also aimed to assess the effect of the treatment on liver fibrosis. The sustained virologic response was assessed at 0, 4, 12, and 24 weeks from the beginning of treatment by RT-PCR. IL-1β _31, IL-1β _511, IL-1RN, and T29C genes polymorphisms were examined by PCR-based techniques in two groups of patients (responders and non-responders) and a control group of healthy subjects. A significant association between IL-1β_511 gene polymorphism and SOF/DAV-induced response was observed, where the "CC" genotype was the most frequent in responders while the "CT" genotype was the most frequent among non-responders (P = 0.0001, OR = 39; 95% CI = 4.7-316). IL-1RN gene polymorphism also showed significant associations with response to treatment, genotypes that include allele "1" were the most frequent in responders, particularly the homozygous genotype "1/1" (P = 0.0001, OR = 2.3; 95% CI = 1.57-3.2). However, the genotypes "4/4" and "2/4" were the most frequent in nonresponders; (P = 0.0001). At least 71% of the responders carry allele "1" while 54% of non-responders were allele "4" carriers (P value = 0.0001. OR = 2.8; 95% CI = 6.4-134.2). Liver fibrosis is significantly improved regardless of the response.

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Section: Discussionsupporting

confidence: 81%

Association of IL‐1β, IL‐1RN, and ESR1 genes polymorphism with risk of infection and response to sofosbuvir plus daclatasvir combination therapy in hepatitis C virus genotype‐4 patients

et al. 2018

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“…[ 34 ] Furthermore, liver fibrosis after DAA treatment improved in patients harbouring HCV GT 4 and in CHC patients with or without an HIV coinfection. [ 35 , 36 ] Concurrently, the present results indicate that non-invasive measurements of liver fibrosis, APRI index, and FIB-4 score were gradually reduced when patients achieved SVR12 after DAA therapy, suggesting that eradication of HCV may be responsible for decreased APRI and FIB-4 score. These scores were improved significantly upon laboratory investigation owing to normalization of liver enzymes after treatment.…”

Section: Discussionsupporting

confidence: 68%

Efficacy and safety of sofosbuvir-based pangenotypic direct-acting antiviral agents for chronic hepatitis C patients without genotype determination

Li¹,

Jiang

et al. 2020

Medicine

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Several new, pangenotypic direct-acting antiviral agents (DAAs) have been approved, may reduce the need for genotyping to guide therapy decisions for patients with chronic hepatitis C (CHC). This study aimed to investigate the efficacy and safety of Sofosbuvir (SOF)-based pangenotypic DAAs therapy for CHC patients without genotype (GT determination in the real-world practice. This retrospective cohort study included treatment-naïve CHC patients without GT determination, who received SOF-based DAAs therapy, including 400 mg SOF plus 60 mg daclatasvir (DCV) daily or 400 mg SOF plus 100 mg velpatasvir (VEL) daily for 12 or 24 weeks. Clinical and laboratory data, including sustained virologic response (SVR), were obtained at baseline, end of treatment (EOT), 12 weeks after EOT, and 48 weeks after EOT. A total of 95 CHC patients, including 30 (31.58%) had liver cirrhosis were enrolled. SVR rates after 12 weeks of treatment (SVR12) was 96.84% (92/95), including 96.20% (76/79) of patients receiving SOF plus DCV and 100% (16/16) of patients receiving SOF plus VEL. For 92 patients achieving an SVR12, no virological relapse was observed at 48 weeks after EOT. Furthermore, serum evaluation of liver fibrosis aspartate aminotransferase-to-platelet ratio index and Fibrosis-4 score were decreased significantly at EOT and 12 weeks after EOT, compared to pre-treatment values (both P < .05). Treatment was well-tolerated by our patients. SOF-based pangenotypic DAAs including SOF plus DCV and SOF plus VEL, were effective and safe for CHC patients without GT determination in this study. This may provide a potential simple strategy for CHC treatment without GT determination.

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“…IFN‐free regimens have shown to give better results . Sofosbuvir and daclatasvir in combination had shown safety and efficacy in HCV G4 patients with attenuation of liver fibrosis despite the combination's higher direct cost when compared with PEG IFN‐RBV regimen …”

Section: What Is Known and Objectivementioning

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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Effect of Sofosbuvir Plus Daclatasvir in Hepatitis C Virus Genotype-4 Patients: Promising Effect on Liver Fibrosis

Cited by 19 publications

References 29 publications

Association of IL‐1β, IL‐1RN, and ESR1 genes polymorphism with risk of infection and response to sofosbuvir plus daclatasvir combination therapy in hepatitis C virus genotype‐4 patients

Association of IL‐1β, IL‐1RN, and ESR1 genes polymorphism with risk of infection and response to sofosbuvir plus daclatasvir combination therapy in hepatitis C virus genotype‐4 patients

Efficacy and safety of sofosbuvir-based pangenotypic direct-acting antiviral agents for chronic hepatitis C patients without genotype determination

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

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