ABSTRACT FINAL ID: 2004
TITLE: 100% virological response and adherence in HCV genotype 1 liver cirrhosis treated with 3D regimen in a Romanian real-life cohort
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Background: In Romania, hepatitis C virus (HCV)-infection has an overall prevalence of 3.23% and genotype 1b is responsible for >99% of the infections in people who do not inject drugs. Compensated and decompensated cirrhosis is projected to increase by 25-30% by 2030, while liver related mortality was projected to increase by 30% until 2030 in Romania. However, in Romania, the single approved interferon free regimen is ombitasvir/paritaprevir/ritonavir/dasabuvir and only in F4 fibrosis.
Aim: The aim of this study was to assess the efficacy and tolerability of 3D regimen in Romanian patients with liver cirrhosis.
Methods: 393 consecutive patients with HCV genotype 1b liver cirrhosis and without hepatocellular carcinoma were treated with ombitasvir/paritaprevir/ritonavir/dasabuvir and ribavirin for 12 weeks in 6 tertiary Gastroenterology/Infectious Diseases Centers from Romania between December 2015 and May 2016. Student T test was used to compare different continuous variables at beginning and at the end of antiviral therapy.
Results: There were included 44.5% men and 55.5% women with a mean age of 59±9 years with compensated Child Pugh A liver cirrhosis. 18.8% of the patients had associated diabetes mellitus and 3.3% autoimmune thyroiditis. 58.3% of patients were previously treated with pegylated interferon and 43.2% had esophageal varices. Median baseline viral load was 687000 UI/mL. End of treatment virological response was 100% (only 3 patients had HCV RNA<15UI/L but still detectable, all the rest had HCV RNA undetectable). Adherence was 100%, none of the patients stopped 3D medications. Ribavirin was stopped after one month due to renal dysfunction in one patient. There was a statistically significant increase of MELD score at EOT, although the mean value is low <10 (6.7±3 vs 7.1±3.5, p=0.02). There was no difference between baseline and EOT for total bilirubin and INR, but creatinine significantly increased (0.80±0.15 vs 0.86±0.21 mg/dL, p<0.0001). There was a significant decrease of hemoglobin (14.1±1.6 vs 12.3±1.5mg/dL, p<0.0001) and white blood count (5947.7±3626.4 vs 4816±2773.2/mm3, p<0.0001) levels at EOT, but a significant increase of platelets (138599.5±71017.4 vs 151881.8±80745/mm3, p<0.0001).
Conclusion: An interferon-free regimen of ombitasvir, paritaprevir, ritonavir, dasabuvir achieved 100% virological response at EOT in patients with HCV GT1b infection with cirrhosis. This regimen was well tolerated and was associated with no treatment discontinuation. Results of SVR12 are pending and will be presented during the meeting.