Real life Egyptian experience of efficacy and safety of Simeprevir/Sofosbuvir therapy in 6211 chronic <scp>HCV</scp> genotype <scp>IV</scp> infected patients

Eletreby, Rasha; Elakel, Wafaa; Said, Mohamed; Kassas, Mohamed El; Seif, Sameh; Elbaz, Tamer; Raziky, Maissa El; Rehim, Siham Abdel; Zaky, Samy; Fouad, Rabab; Eldeen, Hadeel Gamal; Abdo, Mahmoud; Korany, Mohamed A.; Yosry, Ayman; Serafy, Magdy El; El-Sayed, Manal Hamdy; Elshazly, Yehia; Waked, Imam; Doss, Wahid; Esmat, Gamal

doi:10.1111/liv.13266

Cited by 52 publications

(34 citation statements)

References 20 publications

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“…These results obtained from our study are broadly consistent with the major trends of proven efficacy of such combination therapy in managing HCV as shown in several previous publications [12][13][14][15][16][17][18][19][20]. Our findings were matching with the published results of a Phase III (PLUTO) clinical trial which investigated Simeprevir in combination with sofosbuvir in treatment of naïve and experienced patients with and without compensated cirrhosis in hepatitis C virus genotype 4 infection where this combination achieved SVR rate of 100% among study subjects [12].…”

Section: Discussionsupporting

confidence: 93%

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Safety and efficacy of combination therapy (Simeprevir/Sofosbuvir) in the treatment of chronic HCV genotype IV patients

Wahsh¹,

Hussein²,

Gomaa³

et al. 2018

Med-Science

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Chronic infection with HCV is a worldwide health problem that may lead to cirrhosis, portal hypertension, hepatocellular failure and hepatocellular carcinoma in most of cases. A new era in HCV treatment has been started using direct acting antiviral activity. In this study we assess the safety and efficacy of a combination therapy Sofosbuvir/Simprevir in the treatment of chronic HCV patients genotype IV either cirrhotic or non-cirrhotic. In the outpatient clinic, one hundred and seventy five chronic HCV patients were recruited from Tropical Medicine Department at Fayoum public hospital. A combination of Sofosbuvir (400 mg) and Simeprevir (150 mg) was administered for those patients once daily over a period of 12 weeks. All patients have been followed up for clinical and laboratory parameters and HCV PCR to evaluate the efficacy and safety of this therapy. Sustained Virologic Response rate (SVR12) were 97.7% (169/173) (primary end point), and same results obtained at the second end point (SVR 24). In this study, cirrhotic patients showed lower SVR (92.7%) compared to non-cirrhotic patients (98.5%) (p-value 0.085). Majority of patients (57.14%) reported adverse events (AEs) during treatment and most common AEs were headache, fatigue, pruritus, dizziness and photosensitivity. On the basis of the evidence currently available, it seems fair to suggest that the combination therapy of (SMV/SOF) in the treatment of chronic HCV genotype IV naïve and experienced patient whether cirrhotic or non-cirrhotic is safe and effective. This was evidenced by monitoring patients' clinically and using hepatic parameters after drug administration. The adverse events affected patients were mild and tolerable among patients.

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Section: Discussionsupporting

confidence: 93%

“…Their study reported a SVR in easy and difficult-totreat groups were 96% and 93% respectively after 12 weeks [14]. [17], while in Phase III OPTIMIST-2 study in patients with cirrhosis achieved 83% SVR12 [18].…”

Section: Discussionmentioning

confidence: 96%

Safety and efficacy of combination therapy (Simeprevir/Sofosbuvir) in the treatment of chronic HCV genotype IV patients

Wahsh¹,

Hussein²,

Gomaa³

et al. 2018

Med-Science

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“…Study characteristics were summarised in Tables and . Fifty‐six studies were included, with a total of 5522 patients with HCC, while 27 studies enrolled non‐HCC patients as control groups. Fifty‐three (95%) studies were observational cohorts (45 retrospective and eight prospective) and three studies were clinical trials.…”

Section: Resultsmentioning

confidence: 99%

Systematic review with meta‐analysis: effectiveness of direct‐acting antiviral treatment for hepatitis C in patients with hepatocellular carcinoma

Lockart

Alavi

et al. 2019

Aliment Pharmacol Ther

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Summary Background Direct‐acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection is highly curative and tolerable. Among patients with hepatocellular carcinoma (HCC), optimal timing of DAA therapy remains unclear. Data on efficacy of DAA therapy in patients with HCC would inform this decision‐making. Aim To evaluate response to DAA therapy among patients diagnosed with HCV infection and HCC. Methods Bibliographic databases and conference abstracts were searched. Meta‐analysis was conducted to pool sustained virologic response (SVR) estimates. Results Fifty‐six studies with 5522 patients with HCV and HCC were included. Overall SVR was 88.3% (95% CI 86.1‐90.4). Twenty‐seven studies included patients with prior or present HCC (n = 3126) and patients without HCC (n = 49 138), in which SVR was 88.2% (95% CI 85.0‐91.4) and 92.4% (95% CI 91.1‐93.7) among patients with and without HCC, respectively (odds ratio: 0.54, 95% CI 0.43‐0.68, P < .001). In the subgroup analyses, higher SVR was seen in patients who received curative HCC management (SVR 90.4%, 95% CI 88.3‐92.4), or treated with sofosbuvir + NS5A inhibitor DAAs (SVR 96.9%, 95% CI 94.3‐99.4), or in patients with HCV genotype 1 infection (SVR 92.0%, 95% CI 88.1‐95.6). Conclusion Response to DAA therapy was lower in patients with HCC compared to those without HCC, regardless of cirrhosis status. Among HCC patients, there was an impact of proportion with curative HCC management on DAA therapy response.

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“…Since then, several studies of real-life have been published. [12][13][14][15][16] One of the largest was the US-TARGET cohort, 12 which included 491 cirrhotic patients (45% with prior hepatic decompensation). Most of these patients (79.8%) received SOF/SMV without RBV.…”

Section: Introductionmentioning

confidence: 99%

High efficacy of Sofosbuvir plus Simeprevir in a large cohort of Spanish cirrhotic patients infected with genotypes 1 and 4

Mariñó

Pascasio-Acevedo

Gallego

et al. 2017

Liver International

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Real life Egyptian experience of efficacy and safety of Simeprevir/Sofosbuvir therapy in 6211 chronic HCV genotype IV infected patients

Abstract: Sofosbuvir/Simeprevir combination is an effective and well tolerated regimen for patients with chronic HCV genotype IV.

Cited by 52 publications

References 20 publications

Safety and efficacy of combination therapy (Simeprevir/Sofosbuvir) in the treatment of chronic HCV genotype IV patients

Safety and efficacy of combination therapy (Simeprevir/Sofosbuvir) in the treatment of chronic HCV genotype IV patients

Systematic review with meta‐analysis: effectiveness of direct‐acting antiviral treatment for hepatitis C in patients with hepatocellular carcinoma

High efficacy of Sofosbuvir plus Simeprevir in a large cohort of Spanish cirrhotic patients infected with genotypes 1 and 4

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