Effectiveness of 8-week sofosbuvir/ledipasvir in the adolescent chronic hepatitis C-infected patients

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.

High SVR12 With 8-Week Course of Direct-Acting Antivirals in Adolescents and Children With Chronic Hepatitis C: A Comprehensive Analysis

“…We did not detect any significant differences between the various treatment durations in terms of efficacy in adolescents or children (P b = 0.398, P d = 0.716). Hesham et al also found that 8 weeks of treatment with the SOF/LDV combination was as effective and safe as the 12-week regimen in adolescent GT4 patients (15). Similar results were reported by Mortada et al (38).…”

“…Common AEs included fatigue, nausea, and so on. The SAEs were defined as any event causing disability, congenital malformation, or death (8,(15)(16)(17). The worsening of laboratory test values from baseline was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (18).…”

Systematic review with meta‐analysis: the efficacy and safety of direct‐acting antivirals in children and adolescents with chronic hepatitis C virus infection

“…In total, 39 references met the inclusion criteria. Twenty‐eight papers were published as full‐text articles 3‐8,11‐32 and 11 as abstracts 33‐43 . Two studies were randomised clinical trials, 27,33 whereas all the other studies were nonrandomised studies.…”

Treating paediatric hepatitis C in the era of direct‐acting antiviral agents

“…98.6% for the 12-and 8-week regimen, respectively). 68 The same authors also reported an SVR12 rate of 99% after 12 weeks of SOF/ LED in 144 adolescent chronic HCV patients with genotype 4. 69 In a final observational study, 40 Egyptian children and adolescents with HCV genotype 4 (age ranging from 11.5 to 17.5 years) were treated with 12 weeks of SOF/LED, resulting in an SVR12 rate of 100%.…”