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Digestive Diseases and Sciences

, Volume 63, Issue 12, pp 3480–3486 | Cite as

Eight-Week Hepatitis C Treatment with New Direct Acting Antivirals Has a Better Safety Profile While Being Effective in the Treatment-Naïve Geriatric Population Without Liver Cirrhosis and Hepatitis C Virus-RNA < 6 Million IU/mL

  • Beshoy YannyEmail author
  • Sammy Saab
  • Francisco Durazo
  • Nyan Latt
  • Amanda Mitry
  • Mira Moris Mikhail
  • Ramy M. Hanna
  • Antony Aziz
  • Amandeep Sahota
Original Article
  • 174 Downloads

Abstract

Aim

Results of recent studies have confirmed the efficacy of an 8-week course of ledipasvir/sofosbuvir (LDV/SOF) in patients who are non-cirrhotics, native to treatment, are infected with hepatitis C (HCV) genotype 1, and have HCV viral load < 6 million IU/mL. However, there are limited data on a shortened treatment course in patients who are over the age of 65.

Methods

A retrospective study was performed to examine the safety, tolerability, and sustained viral response rates (SVR) of the 8-week LDV/SOF therapy compared to the 12-week LDV/SOF therapy among non-cirrhotic, treatment-naïve, genotype 1 HCV patients with viral load < 6 million IU/mL who are 65 years of age or older.

Results

A total of 454 patients were identified of which 182 non-cirrhotic, genotype 1 HCV-RNA < 6 million IU/mL patients received the 8-week LDV/SOF treatment and 272 received the 12-week LDV/SOF treatment. Mean [± standard deviation (SD)] aspartate aminotransferase to platelet ratio index score for the entire cohort was 0.45 ± 0.03. The mean (± SD) age for the 8-week treatment was 69.7 (± 7) years, 54.7% male and 45.3% female. The mean (± SD) age of the 12-week treatment was 71.7 (± 3) years, 56.4% male and 43.6% female. Overall, SVR-12 for the 8-week regimen was 93% and SVR-12 for the 12-week regimen was 95%. For the 182 treated with the 8-week LDV/SOF treatment, there were no serious adverse events requiring hospitalization or signs of liver failure requiring transplantation. Overall, the 8-week treatment patient cohort experienced less fatigue, headache, dry mouth, and diarrhea. This finding was statistically significant with a P value < 0.001.

Conclusion

Eight-week LDV/SOF therapy in treatment-naive, non-cirrhotic, genotype 1 HCV patients with RNA < 6 million IU/mL was found safe, better tolerated, effective, and required less upfront cost when compared with the 12-week LDV/SOF treatment regimen in properly selected geriatric population.

Keywords

Hepatitis C Sustained viral response Ledipasvir/sofosbuvir 

Abbreviations

HCV

Hepatitis C virus

DAA

Direct acting antiviral

LED/SOF

Ledipasvir/sofosbuvir

SVR-12

Sustained viral response at 12 weeks post-treatment with direct acting antiviral agents for hepatitis C

APRI

Aspartate aminotransferase to platelet ratio index

AST

Aspartate aminotransferase

ALT

Alanine aminotransferase

HIV

Human immunodeficiency virus

EMR

Electronic medical record

Notes

Author’s contribution

BY, SA, and SS conceived and designed the study; BY and NL helped in acquisition of data; BY, NL, and SS analyzed and interpreted the data; BY, AM, MM, RH, and AA drafted the manuscript; BY, AS, FD, and SS critically revised the manuscript for important intellectual content; NL and BY performed the statistical analysis; BY, AS, SS, and FD contributed to administrative, technical, or material support and study supervision.

Compliance with ethical standards

Conflict of interest

The authors have no conflict of interest or disclosures to declare.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Beshoy Yanny
    • 4
    • 5
    Email author
  • Sammy Saab
    • 4
    • 5
  • Francisco Durazo
    • 4
    • 5
  • Nyan Latt
    • 9
  • Amanda Mitry
    • 8
  • Mira Moris Mikhail
    • 6
    • 7
  • Ramy M. Hanna
    • 4
    • 6
    • 7
  • Antony Aziz
    • 4
    • 5
  • Amandeep Sahota
    • 1
    • 2
    • 3
  1. 1.Department of MedicineKaiser Permanente Los Angeles Medical CenterLos AngelesUSA
  2. 2.Department of GastroenterologyKaiser Permanente Los Angeles Medical CenterLos AngelesUSA
  3. 3.Department of Transplant HepatologyKaiser Permanente Los Angeles Medical CenterLos AngelesUSA
  4. 4.Department of MedicineUniversity of California Los AngelesLos AngelesUSA
  5. 5.Department of SurgeryUniversity of California Los AngelesLos AngelesUSA
  6. 6.Department of NephrologyUniversity of California Los AngelesLos AngelesUSA
  7. 7.Biological ScienceBiola UniversityLa MiradaUSA
  8. 8.Claremont Graduate UniversityClaremontUSA
  9. 9.Ochsner Clinic FoundationJeffersonUSA

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