Theme: Clinical Research Year: 2019
Background: Is still unclear how to treat patients, failures to previously anti-HCV treatment
with interferon-free DAA’s.
Aim: To assess the efficacy and safety of Sofosbuvir/Velpatasvir/Ribavirin, in treatmentexperienced to direct acting antivirals(DAA’s), HCV genotype 3 infected cirrhotics receiving
opioid substitution therapy(OST).
Materials/Methods: 138 HCV patients under OST, cirrhotics (compensated) or with severe
fibrosis, were treated with DAA’s. 41(29,71%) were infected with the HCV genotype 3 and
were treated with the sofosbuvir/daclatasvir/ribavirin combination for 12w.
5(3,62% of total, 12,19% of the genotype 3 infected, males, age 47-58y) failed to respond to
treatment reported above. All were cirrhotics (Fibroscan 32-75 Kp(a)). For this population,
was decided to receive Sofosbuvir/Velpatasvir (400/100mg, 1×1) plus Ribavirin(1200mg) for
24w and to be followed for 12w post-treatment. The pre-treatment viral load was between
0,54-0,92×106
IU/ml and the aminotransferase levels were: ALT 248-99U/l, AST 179-98U/l, γGT
54-203U/l. HCV-RNA was measured at 4,12,24 and 36w, general blood count and liver
biochemistry were monitored monthly, and measurements of AFP and upper abdominal
ultrasound were performed every 12w.
Results: Although, viral load was undetectable at the end of w4 in all patients,
aminotransferase and γGT levels were abnormal during the first 12w (but with a trend of
normalization). At w16 normalization of liver biochemistry was observed in all patients. At the
end of treatment all patients presented normal liver biochemistry and undetectable HCV-RNA.
Variceal bleeding was noted in 2 patients at w3 and 5 of treatment. No other serious side
effects or events were observed. 12w after the end of treatment four patients(80%) achieved
undetectable HCV-RNA. 8w later the patient who not achieved SVR developed multinodular
HCC.
Conclusion: Sofosbuvir/Velpatasvir/Ribavirin for 24w is an effective treatment option for
cirrhotic HCV, genotype 3, patients receiving OST, failures to sofosbuvir/daclatasvir/ribavirin,
which achieves rapid HCV-RNA undetectability but no rapid normalization of liver
biochemistry.
Disclosure of interest statement for all authors: None