Community-based real-world treatment outcomes of sofosbuvir/ledipasvir in Asians with chronic hepatitis C virus genotype 6 in the United States.
Sofosbuvir/ledipasvir (SOF/LDV) is the first all-oral ribavirin-free treatment approved for chronic hepatitis C virus (HCV) genotype 6, offering a safe and highly efficacious treatment option. Large studies evaluating real-world outcomes of this regimen are lacking. We aim to evaluate real-world treatment outcomes for HCV genotype 6. A retrospective cohort study evaluated 65 adults (age ≥18) with chronic HCV genotype 6 treated with SOF/LDV without ribavirin at a community gastroenterology clinic in the United States from November 2014 to May 2016. Rates of undetectable virus at week 4 on treatment, at end of treatment (EOT) and SVR12 were stratified by the presence of cirrhosis and prior treatment (treatment naïve vs treatment experienced). Among 65 patients with chronic HCV genotype 6 treated with SOF/LDV (52.3% male, mean age 66.3 years [SD 9.7], 41.5% cirrhosis and 15.4% treatment experienced), 97.3% had undetectable virus at week 4 on treatment, 96.9% had undetectable virus at EOT and 95.3% achieved SVR12. SVR12 was 100% in females vs 91.2% in males, P=.096, and 92.3% in patients with cirrhosis vs 97.4% in those without cirrhosis, P=.347. Resistance testing of treatment failures was attempted but unsuccessful due to lack of conforming primers to define the possible resistance mutations. Among the largest U.S. community-based real-world cohort of Asian chronic HCV genotype 6 patients treated with all-oral SOF/LDV without ribavirin, SVR12 was similar to SVR12 reported in clinical trials, confirming the safety and effectiveness of this regimen and validating current HCV genotype 6 treatment guideline recommendations.
Division of Gastroenterology and Hepatology, Alameda Health System - Highland Hospital, Oakland, CA, USA.
R J
RJ
Wong
Silicon Valley Research Institute, San Jose, CA, USA.
M T
MT
Nguyen
San Jose Gastroenterology, San Jose, CA, USA.
H N
HN
Trinh
Silicon Valley Research Institute, San Jose, CA, USA.
A
A
Huynh
Silicon Valley Research Institute, San Jose, CA, USA.
M T
MT
Ly
San Jose Gastroenterology, San Jose, CA, USA.
H A
HA
Nguyen
San Jose Gastroenterology, San Jose, CA, USA.
K K
KK
Nguyen
San Jose Gastroenterology, San Jose, CA, USA.
J
J
Yang
San Jose Gastroenterology, San Jose, CA, USA.
R T
RT
Garcia
San Jose Gastroenterology, San Jose, CA, USA.
B
B
Levitt
San Jose Gastroenterology, San Jose, CA, USA.
E
E
da Silveira
Division of Gastroenterology and Hepatology, Stanford Health Care, Stanford, CA, USA.|National Viral Hepatitis Roundtable, San Francisco, CA, USA.
R G
RG
Gish
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000627:therapeutic use*; D001213:Asian; D001562:Benzimidazoles / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000627:therapeutic use*; D005838:Genotype; D016174:Hepacivirus / Q000145:classification* / Q000235:genetics* / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000069474:Sofosbuvir / Q000627:therapeutic use*; D000072230:Sustained Virologic Response; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C586541:ledipasvir; D000069474:Sofosbuvir
direct-acting antivirals; hepatitis C virus; sustained virologic response