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Sustained virological response 12 versus sustained virological response 24 as evaluation endpoints in chronic hepatitis C virus Egyptian patients treated with sofosbuvir-based regimens

The Egyptian Journal of Internal Medicine volume 31, pages 495–501 (2019)Cite this article

Abstract

Background

The recommended reliance on 12 weeks posttreatment sustained virological response (SVR12) instead of SVR24 was validated for treatment evaluation.

Aim

Judging claimed concordance between SVR12 and SVR24.

Patients and methods

In a prospective study, 91 patients received sofosbuvir (SOF)+interferon+ribavirin (RV) for 12 weeks; 52 patients received SOF+RV for 24 weeks; and 56 patients received SOF+simeprevir for 12 weeks. Demographic and laboratory data, transient elastography, treatment regimens, hepatitis C virus RNA at week 4, week 12, and SVR12 and were reported. Patients who failed to achieve undetectable hepatitis C virus RNA at the end of therapy were excluded.

Results

Concordance between SVR12 and SVR24 was 96.5%, with a positive predictive value of 96.4%. Regarding treatment groups it was found to be 95.6% for SVR24 in SOF+interferon+RV-treated patients, 94.2% in SOF+RV-treated patients, and 100% concordance in SOF+simeprevir-treated patients with insignificant values (P=0.2). In spite of nonsignificance, the reported seven (3.5%) relapsers were mainly male gender (five cases, P=0.9), naïvely treated (five cases, P=0.6), achieved rapid virological response (five cases, P>0.005), with advanced fibrosis (F4) by fibroscan (five cases, P=0.7). Regression analysis failed to detect any predictors of relapse.

Conclusion

In spite of the high grade of concordance between SVR12 and SVR24, the reported rate of relapsers necessitates the backward commitment to SVR24 as a reliable primary endpoint of treatment response evaluation.

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Authors and Affiliations

  1. Department of Hepatology, National Liver Institute, Menoufia University, Shebin Elkom, Egypt

    Maha M. Elsabaawy PHD, Khalid Gameel, Heba Eldemerdash, Talaat Zakareia, Mahmoud Eltahawy, Helmy Elshazly & Ashraf Eljaky

  2. Department of Clinical Pathology Medicine, National Liver Institute, Menoufia University, Shebin Elkom, 32511, Egypt

    Marry Albert

  3. Department of Community Medicine, National Liver Institute, Menoufia University, Shebin Elkom, Egypt

    Marwa Fekry

  4. Department of Clinical Pharmacology, Faculty of Medicine Girls, Azhar University, Cairo, Egypt

    Enas Ouda

Authors
  1. Maha M. Elsabaawy PHD
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  2. Khalid Gameel
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  3. Heba Eldemerdash
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  4. Talaat Zakareia
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  5. Mahmoud Eltahawy
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  7. Marwa Fekry
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  9. Helmy Elshazly
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Corresponding author

Correspondence to Maha M. Elsabaawy PHD.

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Elsabaawy, M.M., Gameel, K., Eldemerdash, H. et al. Sustained virological response 12 versus sustained virological response 24 as evaluation endpoints in chronic hepatitis C virus Egyptian patients treated with sofosbuvir-based regimens. Egypt J Intern Med 31, 495–501 (2019). https://doi.org/10.4103/ejim.ejim_80_19

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