EFFICIENCY OF THERAPY OF PATIENTS WITH CHRONIC HEPATITIS C WITH BELARUSIAN-MADE DIRECT ANTI-VIRAL DRUGDS
Abstract
Background. Starting from 2016-2017 years Belarusian-made generics of sofosbuvir, daclatasvir and ledipasvir have been used in the Republic of Belarus for antiviral therapy of chronic hepatitis C. Objective of the study is to evaluate the effectiveness of treatment of chronic hepatitis C with Belarusian-made direct antiviral drugs (DADs) in patients of the Grodno region in terms of the frequency of achieving direct virologic response (DVR).
Materials and methods. Of the 294 examined patients with chronic hepatitis C, 67 received a combination of sofosbuvir (Hepasoft, Reb Pharma, RB) and daclatasvir (Daclasof, Reb Pharma, RB); 159 patients were treated with sofosbuvir and ledipasvir (Sofosled, OOO “EKZON”, RB), 58 received sofosbuvir (Sovaldi, Gilead Sciences Inc., USA) and daclatasvir (Daclahep, Hetero Healthcare Limited, India), 10 patients were treated with sofosbuvir (Sovaldi, Gilead Sciences Inc., USA) and ribavirin.
Results. DVR in patients treated with Sovaldi and Daklasoft was 98.3%, Sovaldi in combination with ribavirin – 80%, Hepasoft + Daclasoft – 94%, Sofosled – 89.3%. Conclusion. The effectiveness of the Belarusian generics in the treatment of chronic hepatitis C is not inferior to the original DADs.
References
1. Foster GR, Irving WL, Cheung MC, Walker AJ, Hudson BE, Verma S, McLauchlan J, Mutimer DJ, Brown A, Gelson WT, MacDonald DC, Agarwal K. Impact of direct acting antiviral therapy in patients with chronic hepatitis C and decompensated cirrhosis. Journal of Hepatology. 2016;64(6):1224-1231. doi: 10.1016/j.jhep.2016.01.029.
2. Pol S, Bourliere M, Lucier S, Hezode C, Dorival C, Larrey D, Bronowicki JP, Ledinghen VD, Zoulim F, Tran A, Metivier S, Zarski JP, Samuel D, Guyader D, Marcellin P, Minello A, Alric L, Thabut D, Chazouilleres O, Riachi G, Bourcier V, Mathurin P, Loustaud-Ratti V, D’Alteroche L, Fouchard-Hubert I, et al. Safety and efficacy of daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients. Journal of Hepatology. 2017;66(1):39-47. doi: 10.1016/j.jhep.2016.08.021.
3. Andreychyn MA, Vasylieva NA, Ivakhiv OL, Vyshnevska NYu, Iosyk II. Protivovirusnoe lechenie pacientov s hronicheskim gepatitom S: jeradikacija virusa dostignuta, risk vozniknovenija oslozhnenij ostaetsja [Anti-virus treatment of patients with chronic hepatitis C: eradication of the virus has been reached, the risc of complications remains]. Gepatologija i gastrojenterologija [Hepatology and gastroenterology]. 2018;2(1):26-29. (Russian).
4. Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Bräu N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. New England Journal of Medicine. 2014;370(20):1889-1898. doi: 10.1056/NEJMoa1402454.
5. Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, Ghalib R, Gitlin N, Herring R, Lalezari J, Younes ZH, Pockros PJ, Di Bisceglie AM, Arora S, Subramanian GM, Zhu Y, Dvory-Sobol H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Sulkowski M, Kwo P. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. New England Journal of Medicine. 2014;370(16):1483-1493. doi: 10.1056/NEJMoa1316366.
6. Sarrazin C, Dvory-Sobol H, Svarovskaia ES, Doehle BP, Pang PS, Chuang SM, Ma J, Ding X, Afdhal NH, Kowdley KV, Gane EJ, Lawitz E, Brainard DM, McHutchison JG, Miller MD, Mo H. Prevalence of Resistance-Associated Substitutions in HCV NS5A, NS5B, or NS3 and Outcomes of Treatment With Ledipasvir and Sofosbuvir. Gastroenterology. 2016;151(3):501-512. doi: 10.1053/j.gastro.2016.06.002.
7. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestrosa F, Thuluvath PJ, Schwartz H, Nelson DR, Everson GT, Eley T, Wind-Rotolo M, Huang SP, Gao M, Hernandez D, McPhee F, Sherman D, Hindes R, Symonds W, Pasquinelli C, Grasela DM. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. New England Journal of Medicine. 2014;370(3):211-221. doi: 10.1056/NEJMoa1306218.
8. Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, Freilich BF, Younes ZH, Harlan W, Ghalib R, Oguchi G, Thuluvath PJ, Ortiz-Lasanta G, Rabinovitz M, Bernstein D, Bennett M, Hawkins T, Ravendhran N, Sheikh AM, Varunok P, Kowdley KV, Hennicken D, McPhee F, Rana K, Hughes EA. 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(4):1127-1135. doi: 10.1002/hep.27726.
9. Leroy V, Angus P, Bronowicki JP, Dore GJ, Hezode C, Pianko S, Pol S, Stuart K, Tse E, McPhee F, Bhore R, Jimenez-Exposito MJ, Thompson AJ. Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY-3+). Hepatology. 2016;63(5):1430-1441. doi: 10.1002/hep.28473.
10. Litvinchuk DV, Danilau DE, Karpov IA. Jetiotropnaja terapija lekarstvennymi sredstvami prjamogo protivovirusnogo dejstvija u pacientov s cirrozom pecheni v ishode hronicheskogo gepatita S [Direct-acting antivirals in the treatment of chronic HCV infection in patients with cirrhosis]. Gepatologija i gastrojenterologija [Hepatology and gastroenterology]. 2017;1(2):128-134. (Russian).
1.png)
