Efficacy and safety of sofosbuvir-ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection

被引：31

作者：

Ahmed, Ossama A. ^{[1
]}

Kaisar, Hany H. ^{[1
]}

Badawi, Rehab ^{[2
]}

Hawash, Nehad ^{[2
]}

Samir, Hossam ^{[1
]}

Shabana, Sherif S. T. ^{[1
]}

Fouad, Mohamed Hassan A. ^{[1
]}

Rizk, Fatma H. ^{[3
]}

Khodeir, Samy A. ^{[4
]}

Abd-Elsalam, Sherief ^{[2
]}

机构：

[1] Ain Shams Univ, Dept Internal Med, Fac Med, Cairo, Egypt

[2] Tanta Univ, Dept Trop Med & Infect Dis, Fac Med, Tanta, Egypt

[3] Tanta Univ, Physiol Dept, Fac Med, Tanta, Egypt

[4] Tanta Univ, Dept Internal Med, Tanta, Egypt

来源：

INFECTION AND DRUG RESISTANCE | 2018年 / 11卷

关键词：

HCV; treatment; Egypt; sofosbuvir; ledipasvir; Harvoni; VIRUS-INFECTION; TREATMENT-NAIVE; CHRONIC HCV; OPEN-LABEL; RIBAVIRIN; REGIMENS; THERAPY;

D O I：

10.2147/IDR.S153060

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Background and aims: Treatment of hepatitis C virus (HCV) infection has significantly changed during the last few years. The combination of ledipasvir and sofosbuvir has been shown to treat high proportions of patients with HCV genotype 1 with remarkable tolerability. The aim of the work was to assess the efficacy and safety of sofosbuvir plus ledipasvir in treating treatment-naive Egyptian patients with genotype 4 HCV infection. Patients and methods: In this open-label randomized study, 200 treatment-naive patients who were HCV antibody positive and HCV RNA positive by polymerase chain reaction, aged >18 years, were enrolled. The patients were classified into two groups: group I included 100 patients who received single therapy with sofosbuvir plus ledipasvir for 12 weeks and group II included 100 patients who received sofosbuvir plus oral weight-based ribavirin for 24 weeks. The primary end point was a sustained virological response at 12 weeks (SVR12) after the end of treatment, determined by quantitative polymerase chain reaction for HCV RNA. Results: Group I patients showed statistically significant (p<0.05) higher SVR12 compared with group II patients (99% vs. 80%). There was no statistical difference (p>0.05%) between the studied groups regarding the frequencies of the side effects (26% vs. 29%). The most common adverse effects were headache, fatigue, myalgia, and cough. Conclusion: Sofosbuvir and ledipasvir treatment for 12 weeks was well tolerated by patients with HCV genotype 4 and resulted in 99% SVR for all patients who received 12 weeks of the study drugs.

引用

页码：295 / 298

页数：4