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CP-151 Efficacy of 4, 12 and 24 weeks of treatment with ledipasvir/sofosbuvir, simeprevir, sofosbuvir, sofosbuvir/simeprevir and sofosbuvir/daclatasvir in patients with chronic hepatitis C virus
  1. A Sánchez Ruiz1,
  2. M Barrales Iglesias2,
  3. T Moreno Diaz1,
  4. MJ Barbero Hernandez1,
  5. M Merino Almazan1,
  6. R Saldaña Soria1,
  7. C Del Moral Alcazar1,
  8. T Vilchez Medina1,
  9. R Millan Garcia1,
  10. F Horno Ureña1
  1. 1Complejo Hospitalario Jaen, Pharmacy, Jaén, Spain
  2. 2Complejo Hospitalario Jaen, Nefrology, Jaén, Spain

Abstract

Background Several new drugs for the treatment of hepatitis C virus (HCV) have been released in the past years. Clinical trials have demonstrated good efficacy. These clinical trials of regimens to treat chronic infection with HCV used as their primary efficacy endpoint HCV RNA levels 24 weeks after the end of treatment (SVR24). More recently, regulatory authorities have begun to accept SVR at 12 weeks post-treatment (SVR12) as a valid efficacy endpoint.

Purpose To evaluate the efficacy of 5 of the newest treatments for HCV, analysing HCV RNA levels after 4 (HCVRNA4), 12 (HCVRNA12) and 24 (HCVRNA24) weeks.

Material and methods Retrospective observational study conducted from September 2014 to September 2015. We searched for recommendations in HCV guidelines and drug data sheets. We obtained patient information from the electronic prescription software (PRISMA-APD) and clinical data from the medical history database (DIRAYA).

Results 63 patients were included (47 males and 16 females), with an average age of 53 years. The genotype of the virus was 1A in 14 patients, 1B in 33, 3A in 8 and genotype 4 in 7. 30 (47.62%) were previously treated with another drug and 10 (15.87%) were coinfected with HIV. 13 were treated with ledipasvir/sofosbuvir, 15 with simeprevir, 3 with sofosbuvir, 17 with sofosbuvir/simeprevir and 15 with sofosbuvir/daclatasvir. 48 (81%) presented HCVRNA4 undetectable levels. After 12 weeks of treatment, only 2 patients presented with detectable levels of HCVRNA (1 with genotype 4 with level 4 liver fibrosis, treated with sofosbuvir plus simeprevir, who suffered a relapse). Another patient, genotype 3A with level 4 liver fibrosis, treated with sofosbuvir plus daclatasvir, also suffered a relapse after 24 weeks. The rest of the patients remain with undetectable levels waiting for the next analysis.

Conclusion The results confirm the expectations proved in clinical trials, with an early response. Coinfection with HIV does not seem to modify treatment response. The 2 relapsers in this study were previously treated patients. Future studies including more patients are needed in order to ensure the effectiveness of the new treatments in the long term.

No conflict of interest.

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