Open Label Study of 8 vs. 12 Weeks of Ledipasvir/Sofosbuvir in Genotype 6 Treatment Naïve or Experienced Patients. (December 2017)

• Record Type: Journal Article
• Authors: Nguyen, Mindie H; Trinh, Huy; Do, Son; Nguyen, Thuan; Nguyen, Pauline; Henry, Linda
• Is Part Of: American journal of gastroenterology. Volume 112:Number 12(2017)
• Publication Date: 2017-12
• Subjects: Stomach -- Diseases -- Periodicals; Intestines -- Diseases -- Periodicals; Gastroenterology -- Periodicals; Gastrointestinal Diseases -- Periodicals; Electronic journals; Periodicals; 616.33
• DOI: 10.1038/ajg.2017.399
• Languages: English
• ISSNs: 0002-9270

Abstract

Abstract : Objectives: Hepatitis C genotype 6 (HCV‐GT6) is one of the most prevalent genotypes in Southeast Asia. Ledipasvir and sofosbuvir fixed‐dose combination (LDV/SOF FDC) for 12 weeks has been shown to be effective for multiple HCV genotypes including treatment‐naïve HCV‐6. Our goal was to examine treatment outcomes in a diverse HCV‐6 population. Methods: We prospectively enrolled 60 HCV‐GT6 patients at four US centers. Treatment ‐naïve without cirrhosis patients received open‐labeled LDV/SOF FDC orally once a day for 8 weeks; All cirrhotic and/or treatment‐experienced patients received LDV/SOF FDC for 12 weeks. The primary outcome was sustained virological response 12 weeks after therapy (SVR12). Secondary outcomes were adverse events (AEs) and/or serious adverse events (SAEs). All patients gave written consent. Results: Overall mean age was 58±10 and 58% were male. All patients were Asian and foreign born. The 8‐week group included 20 patients (33.3%) and the 12‐week included 40 patients (66.7%). There were 2 (5%) patients with decompensation, 3 with liver cancer (7.5%), and 14 with prior treatment (35%) in the 12‐week group. SVR12 was 95.0% for the 8‐week group (19/20) and 95.0% for the 12‐week group (38/40). AEs included fatigue (5%), insomnia (3.3%), headache (1.7%), and nausea (1.7%); however, all patients completed the intended treatment duration. There were two treatment‐unrelated SAEs. Conclusions: LDV/SOF FDC for 8 or 12 weeks was safe and effective for patients without cirrhosis or prior treatment failure as well as for patients with cirrhosis and/or prior treatment failure, respectively.