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Efficacy of generic oral directly acting agents in patients with hepatitis C virus infection

Journal of Viral Hepatitis Feb 01, 2018

Gupta S, et al. - Novel direct-acting antivirals (DAAs) are now the standard of care for the management of hepatitis C virus (HCV) infection. In a real life clinical scenario, the efficacy of generic oral DAAs was evaluated. Findings demonstrated that in such a setting, generic oral DAAs were associated with high sustained virological response (SVR) rates in patients with HCV infection.

Methods
  • Researchers performed this study in consecutive patients with known HCV infection who were treated with generic-oral DAA regimens (May 2015 to January 2017).
  • They gathered information regarding demographic details, prior therapy and SVR12.

Results
  • During the study time period, a total of 490 patients (mean age: 38.9±12.7years) were treated with generic DAAs.
  • Chronic hepatitis (CHC), compensated cirrhosis, and decompensated cirrhosis were documented as their clinical presentations in 339 (69.2%) of cases, in 120 (24.48%) cases, and in 31 (6.32%) cases, respectively.
  • Findings demonstrated that genotype 3 was most common (n=372, 75.9%) followed by genotype 1 (n=97, 19.8%), and 432 (88.2%) were treatment naïve and treatment-experienced (defined as having previous treatment with peginterferon and ribavirin) were 58 (11.8%).
  • The following generic DAA treatment regimens were included: sofosbuvir in combination with ribavirin (n=175), daclatasvir alone (n=149), ribavirin and peginterferon (n=80), ledipasvir alone (n=43), daclatasvir and ribavirin (n=37), and ledipasvir and ribavirin (n=6).
  • For all treatment regimens, overall SVR12 was 95.9% (470/490).
  • Data reported that SVR12 for treatment-naïve and experienced patients was 97.0% (419/432) and 87.9% (51/58) respectively, P=0.005.
  • Irrespective of genotype and underlying liver disease status, researchers observed high SVR12 with various regimens.
  • They noted that there were no differences in SVR12 with 12 weeks or 24 weeks therapy.
  • In addition, no major adverse event occurred requiring treatment stoppage.
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