Efficacy and safety of sofosbuvir plus simeprevir therapy in Egyptian patients with chronic hepatitis C: a real-world experience

El-Khayat, Hisham R; Fouad, Yasser; Maher, Mohamed; –Amin, Hussain El; Muhammed, Hala

doi:10.1136/gutjnl-2016-312012

Cited by 35 publications

(32 citation statements)

References 15 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: 92%

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: 92%

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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“…Our findings are consistent with those of two recent real‐world studies of patients infected with HCV GT4. In treatment‐naïve and treatment‐experienced patients in Egypt, overall SVR12 rates of 96% (558/583) in all patients and 81% (42/52) in METAVIR F4 patients were achieved following 12 weeks of treatment with simeprevir plus sofosbuvir without ribavirin . No patients in this study received ribavirin.…”

Section: Discussionmentioning

confidence: 72%

Simeprevir plus sofosbuvir for eight or 12 weeks in treatment‐naïve and treatment‐experienced hepatitis C virus genotype 4 patients with or without cirrhosis

Raziky

Gamil

Ashour

et al. 2016

Journal of Viral Hepatitis

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The OSIRIS study investigated efficacy and safety of simeprevir plus sofosbuvir for eight or 12 weeks in hepatitis C virus (HCV) genotype 4-infected patients with METAVIR F0-F4 fibrosis. Sixty-three patients (33 treatment-naïve and 30 peg-interferon/ribavirin (Peg-IFN/RBV)-experienced) enrolled in a partly randomized, open-label, multicentre, phase IIa study. Patients with F0-F3 fibrosis were randomized (1:1) into two groups (A1 and A2), stratified according to treatment experience and METAVIR score, to receive either eight weeks (Group A1, n=20) or 12 weeks (Group A2, n=20) of treatment. Patients with compensated cirrhosis (METAVIR F4) received 12 weeks of treatment (Group B, n=23). Treatment comprised simeprevir 150 mg and sofosbuvir 400 mg daily. The primary efficacy endpoint was sustained virologic response 12 weeks after planned end of treatment (SVR12). Safety and tolerability were assessed throughout. Overall, 92% (95% CI: 82-97) of patients achieved SVR12; 75% (15/20) in Group A1 and 100% in groups A2 and B. Patients who did not achieve SVR12 (n=5) experienced viral relapse during the first 32 days following treatment and were all prior Peg-IFN/RBV null responders. The most commonly reported treatment-emergent adverse events (TEAEs) were asymptomatic lipase increase (14%), pruritus (14%), headache (13%) and hyperbilirubinaemia (11%). No patients discontinued due to TEAEs. In conclusion, simeprevir plus sofosbuvir for 12 weeks achieved a 100% SVR rate in HCV genotype 4-infected patients with or without compensated cirrhosis (ClinicalTrials.gov: NCT02278419). The AE and laboratory profile were favourable and consistent with previous data for simeprevir plus sofosbuvir in eight- and 12-week regimens.

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“…International guidelines have been published to guide treatment decisions and management in order to optimize the results of anti‐HCV therapy . In addition, real‐world studies have confirmed the safety and efficacy of HCV‐DAA combination regimens . Virological failures (VFs), most often posttreatment relapses, are rare.…”

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confidence: 99%

Frequent Antiviral Treatment Failures in Patients Infected With Hepatitis C Virus Genotype 4, Subtype 4r

et al. 2019

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Efficacy and safety of sofosbuvir plus simeprevir therapy in Egyptian patients with chronic hepatitis C: a real-world experience

Abstract: A 12-week regimen of simeprevir/sofosbuvir was efficacious and well tolerated by treatment-naïve and treatment-experienced patients with chronic HCV genotype 4.

Cited by 35 publications

References 15 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

Simeprevir plus sofosbuvir for eight or 12 weeks in treatment‐naïve and treatment‐experienced hepatitis C virus genotype 4 patients with or without cirrhosis

Frequent Antiviral Treatment Failures in Patients Infected With Hepatitis C Virus Genotype 4, Subtype 4r

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