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Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin for Treatment of Hepatitis C Virus Genotype 1: A Systematic Review and Meta-analysis

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Abstract

Background and objective

Interferon-free regimens are rapidly evolving for patients with chronic hepatitis C virus (HCV) infection. We performed this meta-analysis to investigate the safety and efficacy of a combination regimen (ombitasvir [OBV]/paritaprevir [PTV]/ritonavir [r] ± dasabuvir [DSV]) for the treatment of patients with HCV genotype 1 infection.

Methods

A computerized literature search for relevant clinical trials was conducted during May 2017. Data on sustained virological response (SVR), virological relapse, and safety outcomes were extracted and calculated as pooled proportion (PP) or risk ratio (RR) with their 95% confidence interval (CI), using StatsDirect and RevMan software.

Results

The final analysis included 13 studies for HCV genotype 1 (3115 patients). The pooled effect estimate showed that 12-week treatment of genotype 1 patients with the OBV/PTV/r regimen achieved a high SVR rate (PP = 94%, 95% CI 92–96) that increased to (PP = 97%, 95% CI 96–98) upon the addition of DSV. These results were consistent when independent subgroup analyses were conducted based on viral subgenotypes, the presence of cirrhosis, or former treatment failure. Adding ribavirin (RBV) to this regimen was not associated with increased SVR rates (risk ratio = 1, 95% CI 0.98–1.02), while it increased the risk of serious adverse events (p = 0.02), insomnia (p = 0.001), and pruritus (p < 0.001).

Conclusion

The current meta-analysis showed a high efficacy for the OBV/PTV/r regimen in the treatment of HCV genotype 1 (with DSV) infection, regardless of the presence of cirrhosis or former treatment failure. Adding RBV to this regimen slightly decreased the relapse rate. Future studies with larger sample sizes are required to investigate the efficacy of this regimen in other HCV genotypes and to establish the evidence about the effect of adding RBV to OBV/PTV/r + DSV.

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Acknowledgements

The authors would like to thank the members of Medical Research Group of Egypt (MRGE), and in particular Dr. Attia Attia for his help and support.

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Authors and Affiliations

  1. Faculty of Medicine, Zagazig University, Zagazig, El-Sharkia, Egypt

    Hussien Ahmed, Arwa Mohamed & Ahmed Negida

  2. Medical Research Group of Egypt, Cairo, Egypt

    Hussien Ahmed, Abdelrahman Ibrahim Abushouk, Amr Menshawy, Arwa Mohamed & Ahmed Negida

  3. Student Research Unit, Zagazig University, Zagazig, El-Sharkia, Egypt

    Hussien Ahmed & Ahmed Negida

  4. Faculty of Medicine, Ain Shams University, Cairo, Egypt

    Abdelrahman Ibrahim Abushouk

  5. Faculty of Medicine, Al-Azhar University, Cairo, Egypt

    Amr Menshawy

  6. National Cancer Institute, Cairo University, Cairo, Egypt

    Samah A. Loutfy

  7. Pharmacology Department, Faculty of Veterinary Medicine, Suez Canal University, Ismailia, 41522, Egypt

    Mohamed M. Abdel-Daim

  8. Department of Ophthalmology and Micro-Technology, Yokohama City University, Yokohama, Japan

    Mohamed M. Abdel-Daim

Authors
  1. Hussien Ahmed
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Contributions

Hussien Ahmed and Abdelrahman Ibrahim Abushouk contributed to the study concept and design;Hussien Ahmed, Arwa Mohamed, Amr Menshawy, and Ahmed Negida contributed to data extraction, analysis, and interpretation of data; Samah A. Loutfy and Mohamed M. Abdel-Daim were responsible for drafting the manuscript.

Corresponding authors

Correspondence to Hussien Ahmed or Mohamed M. Abdel-Daim.

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This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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The authors declare no conflicts of interest.

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Ahmed, H., Abushouk, A.I., Menshawy, A. et al. Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin for Treatment of Hepatitis C Virus Genotype 1: A Systematic Review and Meta-analysis. Clin Drug Investig 37, 1009–1023 (2017). https://doi.org/10.1007/s40261-017-0565-5

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  • DOI: https://doi.org/10.1007/s40261-017-0565-5

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