Clinical Research
BibTex RIS Cite

Real Life Data for Glecaprevir/Pibrentasvir: A Single-Center Study

Year 2021, Volume: 2 Issue: 1, 14 - 18, 29.01.2021
https://doi.org/10.47482/acmr.2021.9

Abstract

Background: Licensing of next-generation direct-acting antiviral agents (DAA) has revolutionized the treatment of Hepatitis C Virus (HCV) infection. These agents are important due to their high virological efficacy, high resistance barrier, short duration of treatment, and rare serious side effects. The purpose of our study was to present real-life data of chronic hepatitis C (CHC) infected patients with genotypes 2 and 3 who were treated with glecaprevir/pibrentasvir regimen.

Methods: Glecaprevir/pibrentasvir treatment was initiated in 127 patients infected with CHC genotype 2 and 3. Patients received glecaprevir/pibrentasvir (100 mg/40 mg) orally in the form of three tablets once a day as per recommendations of the Republic of Turkey, Ministry of Health. In the assessments of patients at the time of diagnosis and following DAA use, virological response criteria HCV-RNA value was <25 IU/ml.

Results: 127 patients were included in the study. The mean age of the patients was 27 ± 6, and 125 patients (98.4%) were male. 118 patients (92.9%) had a history of intravenous drug use, and 78 patients (61.4%) were convicts. 83.6% (n:106) of the patients were genotype 3, 15% (n:19) genotype 2, 0.7% (n:1) genotype 1+3, and 0.7% (n:1) genotype 3+4. The mean liver fibrosis stage was 1.7±0.8 and histological activity index was 7.9±2.7. 99.2% (n:126) of the patients achieved virological response and sustained virological response (SVR)-12, and only 1 patient did not achieve end-of-treatment response and SVR-12.

Conclusion: An effective, well-tolerated, oral and short-term treatment for patients infected with CHC genotypes 2 and 3 is currently possible with glecaprevir/pibrentasvir.

References

  • 1.Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modeling study. Lancet Gastroenterol Hepatol. 2017;2:161–176.
  • 2. European Union HCV Collaborators. Hepatitis C virus prevalence and level of intervention required to achieve the WHO targets for elimination in the European Union by 2030: a modeling study. Lancet Gastroenterol Hepatol. 2017;2:325–336.
  • 3. Tozun N, Ozdogan O, Cakaloglu Y, Idilman R, Karasu Z, Akarca U et al. Seroprevalence of hepatitis B and C virus infections and risk factors in Turkey: a fieldwork TURHEP study. Clin Microbiol Infect. 2015;21(11):1020-6.
  • 4. Pawlotsky JM, Negro F, Aghemo A, Berenguer M, Dalgard O, Dusheiko G et al. EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol. 2018;69(2):461-511.
  • 5. Van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F et al. Association between sustained virological response and allcause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. Jama. 2012;308(24):2584-2593.
  • 6. Linas BP, Wong AY, Schackman BR, Kim AY, Freedberg KA. Cost effective screening for acute hepatitis C virus infection in hiv-infected men who have sex with men. Clin Infect Dis. 2012;55(2):279–90.
  • 7. Hadziyannis SJ, Sette H, Jr, Morgan TR, et al. Peginterferon alfa-2a and ribavirin combination therapy in chronic hepatitis C: A randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004;140:346-55.
  • 8. Carrion AF, Martin P. Glecaprevir + pibrentasvir for treatment of hepatitis C. Expert Opin Pharmacother. 2018;19(4):413-419.
  • 9. Poordad F, Felizarta F, Asatryan A, Sulkowski MS, Reindollar RW, Landis CS et al. Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment. Hepatology. 2017;66(2):389-397.
  • 10. Tamori A,Inoue K, Kagawa T, Takaguchi K, Nouso K, Iwasaki Y et al. Intention to treat assessment of glecaprevir + pibrentasvir combination therapy for patients with chronic hepatitis C in the real world. Hepatology Res. 2017;49(12), 1365-1373.
  • 11. Foster GR,Gane E, Asatryan A, Asselah T, Ruane PJ, Pol S et al. ENDURANCE-3: safety and efficacy of glecaprevir/pibrentasvir compared to sofosbuvir plus daclatasvir in treatment-naïve HCV genotype 3-infected patients without cirrhosis. J Hepatol. 2017; 66(1), S33.
  • 12. Wyles D, Poordad F, Wang S, Alric L, Felizarta F, Kwo PY et al.Glecaprevir/Pibrentasvir for HCV Genotype 3 Patients with Cirrhosis and/or Prior Treatment Experience: A Partially Randomized Phase III Clinical Trial. Hepatology. 2018;67(2):514-523.
  • 13. D’Ambrosio R,Pasulo L, Puoti M, Vinci M, Schiavini M, Lazzaroni S et al. Real-world effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C. J Hepatol. 2019, 70(3), 379-387.
  • 14. Gane E, Lawitz E, Pugatch D, Papatheodoridis G, Bräu N, Brown A et al. Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment. N Engl J Med. 2017;377:1448–1455.
  • 15. Asselah T, Lee SS, Yao BB, Nguyen T, Wong F, Mahomed A et al. Efficacy and safety of glecaprevir/ pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial. Lancet Gastroenterol Hepatol. 2019;4:45–51.
  • 16. Rockstroh JK,Lacombe K, Viani RM, Orkin C, Wyles D, Luetkemeyer AF et al. Efficacy and safety of glecaprevir/pibrentasvir in patients coinfected with hepatitis C virus and human immune deficiency virus type 1: the EXPEDITION-2 study. Clin Infect Dis. 2018;67(7), 1010- 1017.
  • 17. Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH et al; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011;364:2405-16.
  • 18. Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S et al; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011;364:2417-28.
  • 19. Osawa M, Imamura M, Teraoka Y, Uchida T, Morio K, Fujino H et al. Real-world efficacy of glecaprevir plus pibrentasvir for chronic hepatitis C patient with previous direct-acting antiviral therapy failures. J Gastroenterol. 2019; 54: 291–6.
  • 20. Dufour JF, Zuckerman E, Zadeikis N, Hezode C, Paik SW, Andreone P et al. Safety of glecaprevir/ pibrentasvir in adults with chronic genotype 1–6 hepatitis C virus infection: an integrated analysis [abstractno. FRI-238]. J Hepatol. 2017;66(1 Suppl):S515.
Year 2021, Volume: 2 Issue: 1, 14 - 18, 29.01.2021
https://doi.org/10.47482/acmr.2021.9

Abstract

References

  • 1.Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modeling study. Lancet Gastroenterol Hepatol. 2017;2:161–176.
  • 2. European Union HCV Collaborators. Hepatitis C virus prevalence and level of intervention required to achieve the WHO targets for elimination in the European Union by 2030: a modeling study. Lancet Gastroenterol Hepatol. 2017;2:325–336.
  • 3. Tozun N, Ozdogan O, Cakaloglu Y, Idilman R, Karasu Z, Akarca U et al. Seroprevalence of hepatitis B and C virus infections and risk factors in Turkey: a fieldwork TURHEP study. Clin Microbiol Infect. 2015;21(11):1020-6.
  • 4. Pawlotsky JM, Negro F, Aghemo A, Berenguer M, Dalgard O, Dusheiko G et al. EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol. 2018;69(2):461-511.
  • 5. Van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F et al. Association between sustained virological response and allcause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. Jama. 2012;308(24):2584-2593.
  • 6. Linas BP, Wong AY, Schackman BR, Kim AY, Freedberg KA. Cost effective screening for acute hepatitis C virus infection in hiv-infected men who have sex with men. Clin Infect Dis. 2012;55(2):279–90.
  • 7. Hadziyannis SJ, Sette H, Jr, Morgan TR, et al. Peginterferon alfa-2a and ribavirin combination therapy in chronic hepatitis C: A randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004;140:346-55.
  • 8. Carrion AF, Martin P. Glecaprevir + pibrentasvir for treatment of hepatitis C. Expert Opin Pharmacother. 2018;19(4):413-419.
  • 9. Poordad F, Felizarta F, Asatryan A, Sulkowski MS, Reindollar RW, Landis CS et al. Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment. Hepatology. 2017;66(2):389-397.
  • 10. Tamori A,Inoue K, Kagawa T, Takaguchi K, Nouso K, Iwasaki Y et al. Intention to treat assessment of glecaprevir + pibrentasvir combination therapy for patients with chronic hepatitis C in the real world. Hepatology Res. 2017;49(12), 1365-1373.
  • 11. Foster GR,Gane E, Asatryan A, Asselah T, Ruane PJ, Pol S et al. ENDURANCE-3: safety and efficacy of glecaprevir/pibrentasvir compared to sofosbuvir plus daclatasvir in treatment-naïve HCV genotype 3-infected patients without cirrhosis. J Hepatol. 2017; 66(1), S33.
  • 12. Wyles D, Poordad F, Wang S, Alric L, Felizarta F, Kwo PY et al.Glecaprevir/Pibrentasvir for HCV Genotype 3 Patients with Cirrhosis and/or Prior Treatment Experience: A Partially Randomized Phase III Clinical Trial. Hepatology. 2018;67(2):514-523.
  • 13. D’Ambrosio R,Pasulo L, Puoti M, Vinci M, Schiavini M, Lazzaroni S et al. Real-world effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C. J Hepatol. 2019, 70(3), 379-387.
  • 14. Gane E, Lawitz E, Pugatch D, Papatheodoridis G, Bräu N, Brown A et al. Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment. N Engl J Med. 2017;377:1448–1455.
  • 15. Asselah T, Lee SS, Yao BB, Nguyen T, Wong F, Mahomed A et al. Efficacy and safety of glecaprevir/ pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial. Lancet Gastroenterol Hepatol. 2019;4:45–51.
  • 16. Rockstroh JK,Lacombe K, Viani RM, Orkin C, Wyles D, Luetkemeyer AF et al. Efficacy and safety of glecaprevir/pibrentasvir in patients coinfected with hepatitis C virus and human immune deficiency virus type 1: the EXPEDITION-2 study. Clin Infect Dis. 2018;67(7), 1010- 1017.
  • 17. Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH et al; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011;364:2405-16.
  • 18. Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S et al; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011;364:2417-28.
  • 19. Osawa M, Imamura M, Teraoka Y, Uchida T, Morio K, Fujino H et al. Real-world efficacy of glecaprevir plus pibrentasvir for chronic hepatitis C patient with previous direct-acting antiviral therapy failures. J Gastroenterol. 2019; 54: 291–6.
  • 20. Dufour JF, Zuckerman E, Zadeikis N, Hezode C, Paik SW, Andreone P et al. Safety of glecaprevir/ pibrentasvir in adults with chronic genotype 1–6 hepatitis C virus infection: an integrated analysis [abstractno. FRI-238]. J Hepatol. 2017;66(1 Suppl):S515.
There are 20 citations in total.

Details

Primary Language English
Subjects Clinical Sciences
Journal Section ORIGINAL ARTICLE
Authors

Fatma Çölkesen This is me 0000-0001-9545-5179

Arzu Tarakçı 0000-0002-1245-3221

Fatma Kacar 0000-0001-7013-6403

Esma Eroğlu 0000-0002-0181-6023

Şule Özdemir Armağan 0000-0001-9137-7150

Publication Date January 29, 2021
Submission Date December 17, 2020
Published in Issue Year 2021 Volume: 2 Issue: 1

Cite

APA Çölkesen, F., Tarakçı, A., Kacar, F., Eroğlu, E., et al. (2021). Real Life Data for Glecaprevir/Pibrentasvir: A Single-Center Study. Archives of Current Medical Research, 2(1), 14-18. https://doi.org/10.47482/acmr.2021.9

Archives of Current Medical Research (ACMR) provides instant open access to all content, bearing in mind the fact that presenting research

free to the public supports a greater global exchange of knowledge.

http://www.acmronline.org/