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Gut. 2017 Nov;66(11):2008-2012. doi: 10.1136/gutjnl-2016-312012. Epub 2016 Aug 10.

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

Author information

1
Gastroenterology and Endemic Medicine Department, Theodore Research Institute, Cairo, Egypt.
2
Gastroenterology and Endemic Medicine Department, Minia University, Minia, Egypt.
3
Gastroenterology and Endemic Medicine Department, Ain Shams University, Cairo, Egypt.
4
Internal Medicine Department, Assuit University, Assuit, Egypt.
5
Gastroenterology and Endemic Medicine, Endemic Medicine Department, Minia University, Faculty of Medicine, Minia, Egypt.

Abstract

BACKGROUND:

Simeprevir plus sofosbuvir (SIM/SOF) regimen was recommended by professional guidelines for certain patients with HCV genotype 1 infection and there is lack of data about this regimen in patients with genotype 4 infection.

AIM:

To evaluate the efficacy and safety of this regimen in Egyptian patients with chronic HCV genotype 4 infection in the real world.

METHODS:

Multicentre observational study included 583 patients with HCV genotype 4 infection who began 12 weeks of treatment with SIM plus SOF. Demographic, clinical and virological data as well as adverse outcomes were collected. Treatment naïve patients were 342 (59%) of all included patients, 45% of patients had severe fibrosis (F3 and F4) while 55% had mild fibrosis (F1 and F2) and the primary outcome was sustained virological response (SVR).

RESULTS:

The overall SVR rate was 95.7% (558 out of 583 patients). In total, SVR12 in naïve patients with mild fibrosis score (F1 and F2) was achieved in 98.9% (94/95) for F1 and 98.1% (105/107) for F2, while naïve patients with severe fibrosis (F3 and F4) achieved SVR of 97.7% (86/88) for F3 and (42/52) 80.8% for F4. SVR in patients with previous interferon treatment achieved in 100% (45/45) for patients with F1 and 98.7% (74/75) for F2. While 94.7% (72/76) in experienced patients with F3; and 88.9% (40/45) for F4 achieved SVR12. Notable side effects included rash in 21 patients, photosensitivity in 18 patients, pruritus in 44 patients and hyperbilirubinemia in 42 patients.

CONCLUSIONS:

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

KEYWORDS:

CHRONIC HEPATITIS; CIRRHOSIS; HCV

PMID:
27511197
DOI:
10.1136/gutjnl-2016-312012
[Indexed for MEDLINE]

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