Uojima H, Kobayashi S, Hidaka H, Kinbara T, Fujikawa T, Nakayama T, Yamanoue H, Kanemaru T, Hashimoto T, Sung JH, Kako M, Koizumi W

Language: English
References: 20
Page: 109-115
PDF size: 164.58 Kb.

ABSTRACT

Introduction and aim. We assessed the characteristics of virological response to a combination treatment of ombitasvir, paritaprevir, and ritonavir in hepatitis C virus genotype 1-infected elderly Japanese patients. Material and Methods. This multicenter prospective study was conducted at six locations in Japan. Seventy patients with chronic hepatitis C virus genotype 1b infection were orally administered ombitasvir/paritaprevir/ritonavir once daily for 12 weeks. The primary endpoint was the proportion of elderly patients with sustained virological response (SVR) 12 weeks after the completion of treatment. Adverse events were also recorded to evaluate drug safety and tolerability during the trial period. SVR in elderly patients (age › 65; 94% [47 / 50]) was lower than that in younger patients (100% [20 / 20]). Results. No significant differences in SVR 12 weeks after the completion of treatment were observed between the age groups (P = 0.153). Adverse events were observed in 16 patients (23.3%). Multivariate analysis confirmed that the change or discontinuation of concomitant drugs owing to drug interactions was independent of risk factors for adverse events associated with this drug combination (P = 0.015; odds ratio, 15.9; 95% confidence interval, 1.79 - 148). Ombitasvir/paritaprevir/ ritonavir combination treatment was highly effective in elderly patients. Conclusion. Tolerability should be monitored in older patients for whom concomitant medications are discontinued or changed because of drug interactions.

REFERENCES

1. 1 Pinzone MR, Zanghì AM, Rapisarda L, D’Agata V, Benanti F, Spartà D, Nunnari G, et al. Cirrhotic patients are still at risk of developing hepatocellular carcinoma despite Interferon-induced sustained virological response. Eur Rev Med Pharmacol Sci 2014; 18: 11-5.

2. 2 Moon C, Jung KS, Kim DY, Baatarkhuu O, Park JY, Kim BK, Kim SU, et al. Lower incidence of hepatocellular carcinoma and cirrhosis in hepatitis C patients with sustained virological response by pegylated interferon and ribavirin. Dig Dis Sci 2015; 60: 573-81.

3. 3 von Köckritz L, Dufour JF. Management of chronic hepatitis C in 2017. Hamostaseologie 2017; 37: 186-95.

4. 4 Latt N, Alachkar N, Gurakar A. Hepatitis C virus and its renal manifestations: a review and update. Gastroenterol Hepatol 2012; 8: 434-45.

5. 5 Holmes JA, Thompson AJ. Interferon-free combination therapies for the treatment of hepatitis C: current insights. Hepat Med 2015; 7: 51-70.

6. 6 Flisiak R, Flisiak-Jackiewicz M. Ombitasvir and paritaprevir boosted with ritonavir and combined with dasabuvir for chronic hepatitis C. Expert Rev Gastroenterol Hepatol 2017; 11: 559-67.

7. 7 Johnson SJ, Parisé H, Virabhak S, Filipovic I, Samp JC, Misurski D. Economic evaluation of ombitasvir/paritaprevir/ ritonavir and dasabuvir for the treatment of chronic genotype 1 hepatitis C virus infection. J Med Econ 2016; 19: 983-94.

8. 8 Fabrizi F. Hepatitis C virus infection and dialysis: 2012 update. ISRN Nephrol 2012; 2013: 159760.

9. 9 Alseiari M, Meyer KB, Wong JB. Evidence underlying KDIGO (Kidney Disease: Improving Global Outcomes) guideline recommendations: a systematic review. Am J Kidney Dis 2016; 67: 417-22.

10. 10 Kumada H, Chayama K, Rodrigues L Jr., Suzuki F, Ikeda K, Toyoda H, Sato K, et al. Randomized phase 3 trial of ombitasvir/ paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis. Hepatology 2015; 62: 1037-46.

11. 11 Dreisbach AW, Lertora JJ. The effect of chronic renal failure on drug metabolism and transport. Expert Opin Drug Metab Toxicol 2008; 4: 1065-74.

12. 12 Alshogran OY, Nolin TD. Implications of Kidney Disease on Metabolic Reduction. Curr Drug Metab 2016; 17: 663-72.

13. 13 Alshogran OY, Naud J, Ocque AJ, Leblond FA, Pichette V, Nolin TD. Effect of experimental kidney disease on the functional expression of hepatic reductases. Drug Metab Dispos 2015; 43: 100-6.

14. 14 Tani S, Asayama K, Oiwa K, Harasawa S, Okubo K, Takahashi A, Tanabe A, et al. The effects of increasing calcium channel blocker dose vs. adding a diuretic to treatment regimens for patients with uncontrolled hypertension. Hypertens Res 2017; 40: 892-8.

15. 15 Sueta D, Tabata N, Hokimoto S. Clinical roles of calcium channel blockers in ischemic heart diseases. Hypertens Res 2017; 40: 423-8.

16. 16 Michaud J, Nolin TD, Naud J, Dani M, Lafrance JP, Leblond FA, Himmelfarb J, et al. Effect of hemodialysis on hepatic cytochrome P450 functional expression. J Pharmacol Sci 2008; 108: 157-63.

17. 17 Pockros PJ, Reddy KR, Mantry PS, Cohen E, Bennett M, Sulkowski MS, Bernstein DE, et al. Efficacy of direct-acting antiviral combination for patients with hepatitis C virus genotype 1 infection and severe renal impairment or end-stage renal disease. Gastroenterology 2016; 150: 1590-8.

18. 18 Muñoz-Gómez R, Rincón D, Ahumada A, Hernández E, Devesa MJ, Izquierdo S, Ortiz M, et al. Therapy with ombitasvir/ paritaprevir/ritonavir plus dasabuvir is effective and safe for the treatment of genotypes 1 and 4 hepatitis C virus (HCV) infection in patients with severe renal impairment: A multicentre experience. J Viral Hepat 2017; 24: 464-71.

19. 19 Morisawa N, Koshima Y, Kuriyama S, Matsuyama M, Hayashi N, Satoh JI, Amemiya M, et al. Effectiveness of a fixed combination formula of ombitasvir/paritaprevir/ritonavir for hepatitis C virus infection in patients on maintenance haemodialysis. Nephrology (Carlton) 2017; 22: 562-5.

20. 20 Larrey D, Ripault MP, Pageaux GP. Patient adherence issues in the treatment of hepatitis C. Patient Prefer Adherence 2014; 8: 763-73.