Effectiveness of 8-week sofosbuvir/ledipasvir in the adolescent chronic hepatitis C-infected patients. Issue 8 (August 2019)

• Record Type: Journal Article
• Authors: El-Khayat, Hesham; Kamal, Enas M.; Yakoot, Mostafa; Gawad, Manal A.; Kamal, Naglaa; El Shabrawi, Mortada; Sameh, Yehia; Haseeb, Alaa; Fouad, Yasser; Attia, Dina
• Is Part Of: European journal of gastroenterology & hepatology. Volume 31:Issue 8(2019)
• Publication Date: 2019-08
• Subjects: direct-acting antivirals -- GT-4 -- hepatitis C virus -- SVR12 -- 12–17 years old; Digestive organs -- Diseases -- Periodicals; Liver -- Diseases -- Periodicals; Digestive organs -- Diseases; Liver -- Diseases; Periodicals; 616.33
• DOI: 10.1097/MEG.0000000000001360
• Languages: English
• ISSNs: 0954-691X

Abstract

Abstract : Background: The sustained virological response (SVR) rate for the 12-week sofosbuvir (SOF)/ledipasvir (LVD) treatment of adolescent genotype-4 patients is high. The aim of this study is to evaluate 8 versus 12-week treatment efficacy and safety in adolescent genotype-4 patients. Patients and methods: In total, 157 chronic hepatitis C-infected adolescent patients (mean age 14±2 years, 62% males) were included in this study. All patients received a morning dose of SOF (400 mg)/LVD (90 mg) as a single tablet for 8 and 12 weeks. Laboratory and biochemical monitoring were performed at weeks 4 and 8, end of treatment (8/12) and 12 weeks after the end of treatment (SVR12). Results: In total, SVR12 was 98% [95% confidence interval (CI): 96–100] for all treated patients. For patients treated for 12 weeks, SVR12 was 97.6% (95% CI: 96–101) (82/84 patients), and 98.6% (95% CI: 93–101) (72/73) patients for those treated for 8 weeks. For both regimens, no serious adverse effects, treatment discontinuation or cases of death were detected. The main adverse effects for the 8-week patient group were fatigue (2.8%), headache (1.4%), nausea (1.4%) and epigastric tenderness (1.4%). For the 12-week-treated group, adverse events were epigastric tenderness (1.2%), nausea (1.2%), diarrhoea (2.4%) and rash (2.4%). Three patients were lost to follow-up: two were in the 12-week treatment group and one was in the 8-week group. All of them reached end of treatment but were lost before SVR12. No relapsers were observed in either group. Conclusion: Eight weeks of treatment of SOF/LVD combination is equally effective and safe as 12 weeks in adolescent genotype-4 patients.