Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt

Alimentary Pharmacology and Therapeutics

Volumn 47, Issue 3, 2018, Pages 421-431

  Omar, H ^a   El Akel, W ^a   Elbaz, T ^a   El Kassas, M ^b   Elsaeed, K ^c   El Shazly, H ^d   Said, M ^a   Yousif, M ^e   Gomaa, A A ^f   Nasr, A ^g   AbdAllah, M ^h   Korany, M ⁱ   Ismail, S A ^j   Shaker, M K ^c   Doss, W ^a   Esmat, G ^a   Waked, I ^d   El Shazly, Y ^c  

^a CAIRO UNIVERSITY   (Egypt)

^b Helwan University   (Egypt)

^c AIN SHAMS UNIVERSITY   (Egypt)

^d MENOUFIA UNIVERSITY   (Egypt)

^e ZAGAZIG UNIVERSITY   (Egypt)

^f Fayoum University   (Egypt)

^g Assiut University Faculty of Medicine   (Egypt)

^h NATIONAL RESEARCH CENTRE   (Egypt)

ⁱ National Committee for Control of Viral Hepatitis   (Egypt)

^j NATIONAL HEPATOLOGY AND TROPICAL MEDICINE RESEARCH INSTITUTE   (Egypt)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DACLATASVIR; GENERIC DRUG; RIBAVIRIN; SOFOSBUVIR; ANTIVIRUS AGENT; BMS-790052; IMIDAZOLE DERIVATIVE;

ADULT; ADVERSE OUTCOME; ARTICLE; ASCITES; CHRONIC HEPATITIS C; COHORT ANALYSIS; DEATH; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EGYPT; FEMALE; HUMAN; LIVER CIRRHOSIS; LIVER FAILURE; LIVER FIBROSIS; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SINGLE DRUG DOSE; SUSTAINED VIROLOGIC RESPONSE; TREATMENT OUTCOME; COMBINATION DRUG THERAPY; RETROSPECTIVE STUDY; VIROLOGY;

ADULT; ANTIVIRAL AGENTS; DRUG THERAPY, COMBINATION; DRUGS, GENERIC; EGYPT; FEMALE; HEPATITIS C, CHRONIC; HUMANS; IMIDAZOLES; LIVER CIRRHOSIS; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; RIBAVIRIN; SOFOSBUVIR; SUSTAINED VIROLOGIC RESPONSE; TREATMENT OUTCOME;

EID: 85040165711     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.14428     Document Type: Article

References (45)

1. The Polaris Observatory. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017;2:161-176.
2. Messina JP, Humphreys I, Flaxman A, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology. 2015;61:77-87.
3. Asselah T, De Muynck S, Broet P, et al. IL28B polymorphism is associated with treatment response in patients with genotype 4 chronic hepatitis C. J Hepatol. 2011;56:527-532.
4. Doss W, Shiha G, Hassany M, et al. Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4. J Hepatol. 2015;63:581-585.
5. Asselah T. Daclatasvir plus sofosbuvir for HCV infection: an oral combination therapy with high antiviral efficacy. J Hepatol. 2014;61:435-438.
6. Wantuck JM, Ahmed A, Nguyen MH. Review article: the epidemiology and therapy of chronic hepatitis C genotypes 4, 5 and 6. Aliment Pharmacol Ther. 2014;39:137-147.
7. Gao M, Nettles RE, Belema M, et al. Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature. 2010;465:96-100.
8. Bunchorntavakul C, Reddy KR. The efficacy and safety of daclatasvir in the treatment of chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2015;42:258-272.
9. Gane EJ, Stedman CA, Hyland RH, et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med. 2013;368:34-44.
10. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014;370:211-221.
11. Boglione L, Pinna SM, Cardellino CS, et al. Treatment with daclatasvir and sofosbuvir for 24 weeks without ribavirin in cirrhotic patients who failed first-generation protease inhibitors. Infection. 2017;45:103-106.
12. Pol S, Bourliere M, Lucier S, et al. Safety and efficacy of daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients. J Hepatol. 2017;66:39-47.
13. Moshyk A, Martel MJ, TahamiMonfared AA, Goeree R. Cost-effectiveness of daclatasvir plus sofosbuvir-based regimen for treatment of hepatitis C virus genotype 3 infection in Canada. J Med Econ. 2016;19:181-192.
14. Wyles DL, Ruane PJ, Sulkowski MS, et al. Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med. 2015;373:714-725.
15. Luetkemeyer AF, McDonald C, Ramgopal M, Noviello S, Bhore R, Ackerman P. 12 weeks of daclatasvir in combination with sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): efficacy and safety by HIV combination antiretroviral regimens. Clin Infect Dis. 2016;62:1489-1496.
16. Mandorfer M, Schwabl P, Steiner S, et al. Interferon-free treatment with sofosbuvir/daclatasvir achieves sustained virologic response in 100% of HIV/hepatitis C virus-coinfected patients with advanced liver disease. AIDS. 2016;30:1039-1047.
17. Leroy V, Angus P, Bronowicki JP, et al. Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: a randomized phase III study (ALLY-3+). Hepatology. 2016;63:1430-1441.
18. Poordad F, Schiff ER, Vierling JM, et al. Daclatasvir with sofosbuvir and ribavirin for hepatitis C virus infection with advanced cirrhosis or post-liver transplantation recurrence. Hepatology. 2016;63:1493-1505.
19. Welzel TM, Petersen J, Herzer K, et al. Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort. Gut. 2016;65:1861-1870.
20. Coilly A, Fougerou-Leurent C, de Ledinghen V, et al. Multicentre experience using daclatasvir and sofosbuvir to treat hepatitis C recurrence – the ANRS CUPILT study. J Hepatol. 2016;65:711-718.
21. Gevers TJ, Burger D, Schipper-Reintjes E, Kooistra MP, Richter C. Full-dose sofosbuvir and daclatasvir for chronic hepatitis C infection in haemodialysis patients. Neth J Med. 2016;74:225-227.
22. Centre for Disease Control and Prevention. Morbidity and Mortality Weekly Report (MMWR). 2012, MMWR/Vol. 61/No. 29.
23. Elsharkawy A, Fouad R, El Akel W, et al. Sofosbuvir-based treatment regimens: real life results of 14 409 chronic HCV genotype 4 patients in Egypt. Aliment Pharmacol Ther. 2017;45:681-687.
24. Buti M, Calleja JL, Lens S, et al. Simeprevir in combination with sofosbuvir in treatment-naïve and -experienced patients with hepatitis C virus genotype 4 infection: a phase III, open-label, single-arm study (PLUTO). Aliment Pharmacol Ther. 2017;45:468-475.
25. Eletreby R, Elakel W, Said M, et al. Real life Egyptian experience of efficacy and safety of simeprevir/sofosbuvir therapy in 6211 chronic HCV genotype IV infected patients. Liver Int. 2017;37:534-541.
26. Sterling RK, Lissen E, Clumeck N, et al. Development of a simple noninvasive index to predict significant fibrosis patients with HIV/HCV coinfection. Hepatology. 2006;43:1317-1325.
27. U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) table for grading the severity of adult and pediatric adverse events, version 2.0. (November 2014). http://rsc.tech-res.com/docs/default-source/safety/daids_ae_grading_table_v2_nov2014.pdf (accessed 26 October 2017)
28. Nelson DR, Cooper JN, Lalezari JP, et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015;61:1127-1135.
29. Majumdar A, Kitson MT, Roberts SK. Systematic review: current concepts and challenges for the direct-acting antiviral era in hepatitis C cirrhosis. Aliment Pharmacol Ther. 2016;43:1276-1292.
30. Deterding K, Höner Z, Siederdissen C, et al. Improvement of liver function parameters in advanced HCV-associated liver cirrhosis by IFN-free antiviral therapies. Aliment Pharmacol Ther. 2015;42:889-901.
31. Guarino M, Morisco F, Valvano MR, et al. Systematic review: interferon-free regimens for patients with HCV-related Child C cirrhosis. Aliment Pharmacol Ther. 2017;45:1193-1200.
32. Hézode C, Hirschfield GM, Ghesquiere W, et al. Randomized study of daclatasvir plus peginterferon alfa-2a and ribavirin for previously untreated chronic hepatitis C. Gut. 2015;64:948-956.
33. Hézode C, Abergel A, Chas J, et al. Sustained virologic response to daclatasvir and sofosbuvir, with or without ribavirin, among patients in the French daclatasvir ATU programme infected with HCV genotypes 4, 5 and 6. J Hepatol. 2015;62:S755.
34. Young J, Weis N, Hofer H, et al. The effectiveness of daclatasvir based therapy in European patients with chronic hepatitis C and advanced liver disease. BMC Infect Dis. 2017;17:45.
35. Vermehren J, Peiffer KH, Welsch C, et al. The efficacy and safety of direct acting antiviral treatment and clinical significance of drug-drug interactions in elderly patients with chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2016;44:856-865.
36. Poordad F, Fontana R, Schiff E, et al. Factors impacting SVR12 for patients with advanced cirrhosis receiving daclatasvir and sofosbuvir with ribavirin in the ally-1 study. J Hepatol. 2016;64:S768-S769.
37. Hill A, Simmons B, Gotham D, Fortunak J. Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C. J Virus Erad. 2016;2:28-31.
38. HCV treatment in Egypt: why cost remains a challenge? http://www.eipr.org/sites/default/files/pressreleases/pdf/hcv_treatment_in_egypt.pdf (accessed 26 October 2017)
39. WHO: Global report on access to hepatitis C treatment - Focus on overcoming barriers. Published October 2016. http://www.who.int/hepatitis/publications/hep-c-access-report/en/ (accessed 26 October 2017).
40. Gilead: access partnerships. http://www.gilead.com/responsibility/developing-world-access/ access%20partnerships (accessed 26 October 2017).
41. The Medicines Patent Pool signs first sub-licenses for hepatitis C medicine daclatasvir. Medicines Patent Pool [website]. Geneva: Medicines Patent Pool; 2015. https://medicinespatentpool.org/mpp-media-post/the-medicines-patent-pool-signs-licence-with-bristol-myers-squibb-to-increase-access-to-hepatitis-c-medicine-daclatasvir/ (accessed 26 October 2017).
42. Salama H, Zekri A, Medhat E, Al Ansary M, Zakaria Z. Effect of sofosbuvir, brand drug (Sovaldi) versus generic (MPI Viropack) in treating chronic HCV genotype 4 infection among Egyptian patients. EC Gastroenterology and Digestive System 2016;1:56-61.
43. Fouad R, Hashem MB, Elsharkawy A, et al. High SVR4 in the treatment of chronic HCV genotype 4 patients with sofosbuvir and daclatasvir (both generic). EASL-AASLD special conference: new perspectives in hepatitis C virus infection – the roadmap for cure. Paris, September 2016, Abstract 2014.
44. Esmat G, Elbaz T, El Raziky M, et al. Effectiveness of ravidasvir plus sofosbuvir in interferon-naïve and experienced patients with chronic hepatitis c genotype-4. J Hepatol. 2017; https://doi.org/10.1016/j.jhep.2017.09.006 [Epub ahead of print].
45. He T, Lopez-Olivo MA, Hur C, Chhatwal J. Systematic review: cost-effectiveness of direct-acting antivirals for treatment of hepatitis C genotypes 2-6. Aliment Pharmacol Ther. 2017;46:711-721.