Sofosbuvir-ledipasvir with or without ribavirin for chronic hepatitis C genotype-1 and 6: real-world experience in Vietnam.

Abstract

BACKGROUND:

Therapy with sofosbuvir-ledipasvir (SOF-LDV) has been very effective in chronic HCV genotype-1 in clinical trials and several real-world cohorts. However, the safety and efficacy data of SOF-LDV for HCV genotype-6 is quite limited.

METHODS:

This open-label, clinical experience evaluated the safety and efficacy of SOF-LDV with or without ribavirin (RBV) for 12-24 weeks in patients with HCV genotype-1 (n=356) and genotype-6 (n=175) in Vietnam between September 2015 and May 2017.

RESULTS:

Among 539 patients evaluated for therapy, 531 patients completed treatment with either SOF-LDV for 12 weeks (n=284); SOF-LDV + RBV for 12 weeks (n=109); SOF-LDV for 24 weeks (n=36); or SOF-LDV + RBV for 24 weeks (n=102). 45% were male with a mean age of 56.3 (range 20-87) years. The mean HCV RNA was 4,370,000 IU/ml and 72.7% had high viral load of >800,000 IU/ml. 17.3% failed prior interferon-based therapy and 52.5% had advanced fibrosis (F3-4) as noted by transient elastography. The overall sustained virological response (SVR12) rate was 99.6% (529/531). Virological relapses occurred in two patients with genotype-1 in the SOF-LDV for 12 weeks and SOF-LDV + RBV for 24 weeks treatment groups. There was no significant difference in demographic data and treatment outcomes between patients with genotype-1 versus 6. Adverse events were mild with all SOF-LDV regimens, but appeared to be more common with 24-week treatment groups.

CONCLUSIONS:

SOF-LDV with or without RBV was highly effective and safe in Vietnamese patients with HCV genotype-1 and 6.

• Authors: Pham Thi Thu Thuy, Chalermrat Bunchorntavakul, Ho Tan Dat, Julia Palecki, K Rajender Reddy
• Journal: Antiviral therapy (Antivir Ther) Vol. 23 Issue 5 Pg. 415-423 ( 2018) ISSN: 2040-2058 [Electronic] England
• PMID: 29303482 (Publication Type: Clinical Study, Journal Article)

Chemical References

• Antiviral Agents
• Benzimidazoles
• Fluorenes
• RNA, Viral
• ledipasvir, sofosbuvir drug combination
• Ribavirin
• Uridine Monophosphate
• Sofosbuvir

Topics

• Adult
• Aged
• Aged, 80 and over
• Antiviral Agents (therapeutic use)
• Benzimidazoles (therapeutic use)
• Drug Therapy, Combination
• Female
• Fluorenes (therapeutic use)
• Genotype
• Hepacivirus (classification, drug effects, genetics, metabolism)
• Hepatitis C, Chronic (complications, drug therapy, pathology, virology)
• Humans
• Liver (drug effects, pathology, virology)
• Liver Cirrhosis (etiology, pathology, prevention & control, virology)
• Male
• Middle Aged
• Patient Safety
• RNA, Viral (antagonists & inhibitors, genetics, metabolism)
• Recurrence
• Ribavirin (therapeutic use)
• Sofosbuvir
• Sustained Virologic Response
• Uridine Monophosphate (analogs & derivatives, therapeutic use)
• Vietnam
• Viral Load (drug effects)