J Viral Hepat. 2018 Jan 28. doi: 10.1111/jvh.12870. [Epub ahead of print]
Efficacy of Generic Oral Directly Acting Agents in Patients with Hepatitis C Virus Infection.
Gupta S1, Rout G1, Patel AH2, Mahanta M1, Kalra N1, Sahu P1, Sethia R1, Agarwal A1, Ranjan G1, Kedia S1, Acharya SK1, Nayak B1, Shalimar1.
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Abstract
Novel direct-acting antivirals (DAAs) are now the standard of care for the management of Hepatitis C virus (HCV) infection. Branded DAAs are associated with high sustained virological response at 12 weeks post-completion of therapy (SVR12), but are costly. We aimed to assess the efficacy of generic oral DAAs in a real life clinical scenario. Consecutive patients with known HCV infection who were treated with generic-oral DAA regimens (May 2015 to January 2017) were included. Demographic details, prior therapy and SVR12 were documented. 490 patients (mean age: 38.9±12.7years) were treated with generic DAAs in the study time period. Their clinical presentations included chronic hepatitis (CHC) in 339 (69.2%) of cases, compensated cirrhosis in 120 (24.48%) cases, and decompensated cirrhosis in 31 (6.32%) cases. Genotype 3 was most common (n=372, 75.9%) followed by genotype 1 (n=97, 19.8%). Treatment naïve and treatment-experienced (defined as having previous treatment with peginterferon and ribavirin) were 432 (88.2%) and 58 (11.8%) respectively. Generic DAA treatment regimens 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). Overall SVR12 was 95.9% (470/490) for all treatment regimens. SVR12 for treatment-naïve and experienced patients was 97.0% (419/432) and 87.9% (51/58) respectively, P=0.005. High SVR12 was observed with various regimens, irrespective of genotype and underlying liver disease status. There were no differences in SVR12 with 12 weeks or 24 weeks therapy. No major adverse event occurred requiring treatment stoppage. Generic oral DAAs are associated with high SVR rates in patients with HCV infection in a real life clinical scenario.
Abstract
Novel direct-acting antivirals (DAAs) are now the standard of care for the management of Hepatitis C virus (HCV) infection. Branded DAAs are associated with high sustained virological response at 12 weeks post-completion of therapy (SVR12), but are costly. We aimed to assess the efficacy of generic oral DAAs in a real life clinical scenario. Consecutive patients with known HCV infection who were treated with generic-oral DAA regimens (May 2015 to January 2017) were included. Demographic details, prior therapy and SVR12 were documented. 490 patients (mean age: 38.9±12.7years) were treated with generic DAAs in the study time period. Their clinical presentations included chronic hepatitis (CHC) in 339 (69.2%) of cases, compensated cirrhosis in 120 (24.48%) cases, and decompensated cirrhosis in 31 (6.32%) cases. Genotype 3 was most common (n=372, 75.9%) followed by genotype 1 (n=97, 19.8%). Treatment naïve and treatment-experienced (defined as having previous treatment with peginterferon and ribavirin) were 432 (88.2%) and 58 (11.8%) respectively. Generic DAA treatment regimens 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). Overall SVR12 was 95.9% (470/490) for all treatment regimens. SVR12 for treatment-naïve and experienced patients was 97.0% (419/432) and 87.9% (51/58) respectively, P=0.005. High SVR12 was observed with various regimens, irrespective of genotype and underlying liver disease status. There were no differences in SVR12 with 12 weeks or 24 weeks therapy. No major adverse event occurred requiring treatment stoppage. Generic oral DAAs are associated with high SVR rates in patients with HCV infection in a real life clinical scenario.
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Effectiveness & safety of original & generic SOF for the treatment of chronic #hepatitis C: a real-world study→https://t.co/ZtCkZkX3Zm @AAEEH5 #HCV #HepC #HepatitisC 🇦🇷— Henry E. Chang (@HenryEChang) January 29, 2018
First prospective study assessing effectiveness & safety of generic SOF in Latin America @richmond_lab 🌎 pic.twitter.com/3UOqZl4meY
4 months post treatment with generics, genotype 3a. Took treatment for 4 months due to genotype. Undetected!
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