International network for natural sciences – research journal
  • mendeley icon
  • linkedin icon
  • google plus icon
  • twitter icon
  • google scholar icon
  • facebook icon

A STEP FORWARD TOWARDS COMBINATION THERAPY FOR THE PREVENTION OF HCV

By: Jabir Ali, Syed Saad Ul Hassan Bukhari, Kinza Tanvir, Ujalla Tanveer, Maheen Shafiq, Juon Abbass, Iqra Mumtaz, Zoha Naeem, Sajid Ali, Mubbara Tariq

Key Words: Combination Therapy, NS5A inhibitor, Cirrhosis, Anemia, Bias Risk.

Int. J. Biosci. 16(1), 68-82, January 2020.

DOI: http://dx.doi.org/10.12692/ijb/16.1.68-82

Certification: ijb 2020 0304 [Generate Certificate]

Abstract

Chronic hepatitis C is very common condition prevailing worldwide. In Pakistan, its prevalence is about 5.9%. Now, there is no vaccine available for HCV prophylaxis, so focus must be toward the treatment of HCV through combination therapy. Combination of peg-interferon alpha and ribavirin exhibits strong potential for treating Hepatitis C and at present, reported as standard treatment. Patients infected with genotype 1 and do not have any previous HCV treatment are subjected to 8 week course of treatment with ledipasvir and sofobuvir so; the treatment is limited according to fibrosis stage and baseline viral load. Ribavirin free regimens-oral interferon and elbasvir-grazoprevir are presenting as a new therapeutic treatment for HCV. End point of this therapy is sustained virological response which is aviremia condition developed after 24 weeks of therapy however, end treatment response is a condition after completion of therapy. The main goal of anti-HCV combination therapy is to eliminate HCV infection and complications associated with extrahepatic tissues and liver diseases including cirrhosis, fibrosis, hepatocellular cancer and death.

| Views 40 |

| Views 40 |

A STEP FORWARD TOWARDS COMBINATION THERAPY FOR THE PREVENTION OF HCV

Abergel A, Asselah T, Metivier S, Kersey K, Jiang D, Mo H, Pang PS, Samuel D, Loustaud-Ratti V. 2016. Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection: an open-label, multicentre, single-arm, phase 2 study. The Lancet infectious diseases 16(4), 459-64.

Abergel A, Metivier S, Samuel D, Jiang D, Kersey K, Pang PS, Svarovskaia E, Knox SJ, LoustaudRatti V, Asselah T. 2016. Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection. Hepatology 64 (4), 1049-56.

Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR. 2014. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. New England Journal of Medicine 370(20), 1889-98.

Asselah T, Thompson AJ, Flisiak R, Romero-Gomez M, Messinger D, Bakalos G, Shiffman ML. 2016. A predictive model for selecting patients with HCV genotype 3 chronic Infection with a high probability of sustained virological response to peginterferon alfa-2a/ribavirin. PloS one 11(3), e0150569.

Brochot E, Castelain S, Duverlie G, Capron D, Nguyen-Khac E, François C. 2010. Ribavirin monitoring in chronic hepatitis C therapy: anaemia versus efficacy. AntivirTher. Jan 15(5), 687-95.

Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown Jr RS, Fried MW, Terrault NA, O’Leary JG, Vargas HE, Kuo A. 2015. Ledipasvir and sofosbuvir plus ribavirin for treatment of HCV infection in patients with advanced liver disease. Gastroenterology 149(3), 649-59.

Deeks ED. 2015. Ombitasvir/paritaprevir/ritonavir plus dasabuvir: a review in chronic HCV genotype 1 infection. Drugs 75(9), 1027-38.

Deutsch M, Hadziyannis SJ. 2008. Old and emerging therapies in chronic hepatitis C: an update. Journal of Viral Hepatitis 15(1), 2-11.

El Raziky M, Gamil M, Ashour MK, Sameea EA, Doss W, Hamada Y, Van Dooren G, DeMasi R, Keim S, LonjonDomanec I, HammadR. 2017. Simeprevir plus sofosbuvir for eight or 12 weeks in treatment‐naïve and treatment‐experienced hepatitis C virus genotype 4 patients with or without cirrhosis. Journal of viral hepatitis 24(2), 102-10.

Feld JJ, Jacobson IM, Hézode C, Asselah T, Ruane PJ, Gruener N, Abergel A, Mangia A, Lai CL, Chan HL, Mazzotta F. 2015. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection. New England Journal of Medicine 373(27), 2599-607.

Feld JJ, Kowdley KV, Coakley E, Sigal S, Nelson DR, Crawford D, Weiland O, Aguilar H, Xiong J, Pilot-Matias T, DaSilva-Tillmann B. 2014. Treatment of HCV with ABT-450/r–ombitasvir and dasabuvir with ribavirin. New England Journal of Medicine 370(17), 1594-603.

Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, Tam E, Marinho RT, Tsai N, Nyberg A, Box TD. 2014. ABT-450/r–ombitasvir and dasabuvir with or without ribavirin for HCV. New England Journal of Medicine 370(21), 1983-92.

Flisiak R, Janczewska E, WawrzynowiczSyczewska M, Jaroszewicz J, ZarębskaMichaluk D, Nazzal K, Bolewska B, Bialkowska J, Berak H, FleischerStępniewska K, Tomasiewicz K. 2016. Real‐world effectiveness and safety of ombitasvir/paritaprevir/ritonavir±dasabuvir±ribaviri n in hepatitis C: AMBER study. Alimentary pharmacology & therapeutics 44(9), 946-56.

Forns X, Gordon SC, Zuckerman E, Lawitz E, Calleja JL, Hofer H, Gilbert C, Palcza J, Howe AY, DiNubile MJ, Robertson MN. 2015. Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent. Journal of Hepatology63 (3), 564-72.

De Franceschi L, Fattovich G, Turrini F, Ayi K, Brugnara C, Manzato F, Noventa F, Stanzial AM, Solero P, Corrocher R. 2000. Hemolytic anemia induced by ribavirin therapy in patients with chronic hepatitis C virus infection: role of membrane oxidative damage. Hepatology31 (4), 997-1004.

Gane EJ, Hyland RH, An D, Svarovskaia E, Pang PS, Brainard D, Stedman CA. 2015. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology 149(6), 1454-61.

Gower E, Estes C, Blach S, Razavi-Shearer K, Razavi H. 2014. Global epidemiology and genotype distribution of the hepatitis C virus infection. Journal of hepatology61 (1), S45-57.

Grebely J, Dore GJ, Morin S, Rockstroh JK, Klein MB. 2017. Elimination of HCV as a public health concern among people who inject drugs by 2030–What will it take to get there?. Journal of the International AIDS Society 20(1), 22146.

Hajarizadeh B, Grebely J, Dore GJ. 2013. Epidemiology and natural history of HCV infection. Nature reviews Gastroenterology &hepatology10 (9), 553.

Hochberg Y. 1988. A sharper Bonferroni procedure for multiple tests of significance. Biometrika75 (4), 800-2.

Horner SM, Naggie S. 2015 Successes and challenges on the road to cure hepatitis C. PLoS pathogens 11(6), e1004854.

Howe AY, Black S, Curry S, Ludmerer SW, Liu R, Barnard RJ, Newhard W, Hwang PM, Nickle D, Gilbert C, Caro L. 2014. Virologic resistance analysis from a phase 2 study of MK-5172 combined with pegylated interferon/ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection. Clinical Infectious Diseases 59(12), 1657-65.

Huang Z, Murray MG, Secrist III JA. 2006. Recent development of therapeutics for chronic HCV infection. Antiviral research 71(2-3), 351-62.

Kohli A, Kapoor R, Sims Z, Nelson A, Sidharthan S, Lam B, Silk R, Kotb C, Gross C, Teferi G, Sugarman K. 2015. Ledipasvir and sofosbuvir for hepatitis C genotype 4: a proof-of-concept, single-centre, open-label phase 2a cohort study. The Lancet Infectious Diseases 15(9), 1049-54.

Kohli A, Shaffer A, Sherman A, Kottilil S. 2014. Treatment of hepatitis C: a systematic review. Jama312 (6), 631-40.

Kowdley KV, Lawitz E, Poordad F, Cohen DE, Nelson DR, Zeuzem S, Everson GT, Kwo P, Foster GR, Sulkowski MS, Xie W. 2014. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. New England Journal of Medicine 370(3), 222-32.

Kwo PY, Mantry PS, Coakley E, Te HS, Vargas HE, Brown Jr R, Gordon F, Levitsky J, Terrault NA, Burton Jr JR, Xie W. 2014. An interferon-free antiviral regimen for HCV after liver transplantation. New England Journal of Medicine 371(25), 2375-82.

Kwo P, Gane EJ, Peng CY, Pearlman B, Vierling JM, Serfaty L, Buti M, Shafran S, Stryszak P, Lin L, Gress J. 2017. Effectiveness of elbasvir and grazoprevir combination, with or without ribavirin, for treatment-experienced patients with chronic hepatitis C infection. Gastroenterology 152(1), 164-75.

Kwo P, Gitlin N, Nahass R, Bernstein D, Etzkorn K, Rojter S, Schiff E, Davis M, Ruane P, Younes Z, Kalmeijer R. 2016. Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1‐infected patients without cirrhosis: OPTIMIST‐1, a phase 3, randomized study. Hepatology64 (2), 370-80.

Labesque SF, Ratti VL, Babany G, Gagnieu CM and Marquet P. 2009. Ribavirin therapeutic drug.

Landau A., Batisse D, Piketty C, Jian R, Kazatchkine MD. 2000. Lack of interference between ribavirin and nucleosidic analogues in HIV/HCV co-infected individuals undergoing concomitant antiretroviral and anti-HCV combination therapy. Aids14(12), 1857-1858.

Lahser F, Liu R, Bystol K, Xia E, Raubertas R, Asante-Appiah E, Howe AY. 2012. A combination containing MK-5172 (HCV NS3 protease inhibitor) and MK-8742 (HCV NS5A inhibitor) demonstrates high barrier to resistance in vitro in HCV replicons. Hepatology 56(suppl S1), 236A.

Lavanchy D. 2011. Evolving epidemiology of hepatitis C virus. Clinical Microbiology and Infection 17(2), 107-15.

Lawitz E, Sulkowski MS, Ghalib R, Rodriguez-Torres M, Younossi ZM, Corregidor A, DeJesus E, Pearlman B, Rabinovitz M, Gitlin N, Lim JK. 2014. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. The Lancet 384(9956), 1756-65.

Lawitz E, Gane E, Pearlman B, Tam E, Ghesquiere W, Guyader D, Alric L, Bronowicki JP, Lester L, Sievert W, Ghalib R. 2015. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial. The Lancet 385(9973), 1075-86.

Lawitz E, Gane E, Pearlman B, Tam E, Ghesquiere W, Guyader D, Alric L, Bronowicki JP, Lester L, Sievert W, Ghalib R. 2015. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial. The Lancet 385(9973), 1075-86.

Lawitz E, Matusow G, DeJesus E, Yoshida EM, Felizarta F, Ghalib R, Godofsky E, Herring RW, Poleynard G, Sheikh A, Tobias H. 2016. Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: a phase 3 study (OPTIMIST‐2). Hepatology 64(2), 360-9.

Lawitz E, Poordad FF, Pang PS, Hyland RH, Ding X, Mo H, Symonds WT, McHutchison JG, Membreno FE. 2014. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. The Lancet 383(9916), 515-23.

Leroy V, Angus P, Bronowicki JP, Dore GJ, Hezode C, Pianko S, Pol S, Stuart K, Tse E, McPhee F, Bhore R. 2016. Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: a randomized phase III study (ALLY‐3+). Hepatology 63(5), 1430-41.

Manns MP, Vierling JM, Bacon BR, Bruno S, Shibolet O, Baruch Y, Marcellin P, Caro L, Howe AY, Fandozzi C, Gress J. 2014. The combination of MK-5172, peginterferon, and ribavirin is effective in treatment-naive patients with hepatitis C virus genotype 1 infection without cirrhosis. Gastroenterology 147(2), 366-76.

Manns M, Samuel D, Gane EJ, Mutimer D, McCaughan G, Buti M, Prieto M, Calleja JL, Peck-Radosavljevic M, Müllhaupt B, Agarwal K. 2016. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. The Lancet Infectious Diseases 16(6), 685-97.

McConachie SM, Wilhelm SM, Kale-Pradhan PB. 2016. New direct-acting antivirals in hepatitis C therapy: a review of sofosbuvir, ledipasvir, daclatasvir, simeprevir, paritaprevir, ombitasvir and dasabuvir. Expert review of clinical pharmacology 9(2), 287-302.

Mutimer D, Aghemo A, Diepolder H, Negro F, Robaeys G, Ryder S and Zoulim F. 2014. EASL clinical practice guidelines: Management of hepatitis C Virus infection. Journal of Hepatology 60, 392-420.

Naggie S, Cooper C, Saag M, Workowski K, Ruane P, Towner WJ, Marks K, Luetkemeyer A, Baden RP, Sax PE, Gane E. 2015. Ledipasvir and sofosbuvir for HCV in patients coinfected with HIV-1. New England Journal of Medicine 373(8), 705-13.

Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, Freilich BF, Younes ZH, Harlan W, Ghalib R, Oguchi G. 2015. All‐oral 12‐week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY‐3 phase III study. Hepatology 61(4), 1127-35.s

Oberg CL, Hiensch RJ, Poor HD. 2017. Ombitasvir-Paritaprevir-Ritonavir-Dasabuvir(Viekira Pak)–Induced Lactic Acidosis. Critical care medicine 45(3), e321-5.

Ogawa E, Furusyo N, Nakamuta M, Kajiwara E, Nomura H, Dohmen K, Takahashi K, Satoh T, Azuma K, Kawano A, Tanabe Y. 2013. Clinical milestones for the prediction of severe anemia by chronic hepatitis C patients receiving telaprevir-based triple therapy. Journal of hepatology 59(4), 667-74.

Pak V. 2015. Prescribing information. North Chicago, IL: Abbvie.

Pearlman BL, Traub N. 2011. Sustained virologic response to antiviral therapy for chronic hepatitis C virus infection: a cure and so much more. Clinical Infectious Diseases 52(7), 889-900.

Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG, CONSORT Group FT. 2012. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. Jama 308(24), 2594-604.

Pockros PJ, Reddy KR, Mantry PS, Cohen E, Bennett M, Sulkowski MS, Bernstein DE, Cohen DE, Shulman NS, Wang D, Khatri A. 2016. 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 150(7), 1590-8.

Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, Shiffman ML, Wedemeyer H, Berg T, Yoshida EM, Forns X. 2014. ABT-450/r–ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. New England Journal of Medicine 370(21), 1973-82.

Poordad F, Schiff ER, Vierling JM, Landis C, Fontana RJ, Yang R, McPhee F, Hughes EA, Noviello S, Swenson ES. 2016. Daclatasvir with sofosbuvir and ribavirin for hepatitis C virus infection with advanced cirrhosis or post‐liver transplantation recurrence. Hepatology 63(5), 1493-505.

Raedler LA. 2015. Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; Dasabuvir tablets): all-oral fixed combination approved for genotype 1 chronic hepatitis C infection. American health & drug benefits 8(Spec Feature), 142.

Reau N, Hadziyannis SJ, Messinger D, Fried MW, Jensen DM. 2008. Early predictors of anemia in patients with hepatitis C genotype 1 treated with peginterferon alfa-2a (40KD) plus ribavirin. The American journal of gastroenterology 103(8), 1981.

Reddy KR, Nelson DR, Zeuzem S. 2009. Ribavirin: current role in the optimal clinical management of chronic hepatitis C. Journal of hepatology 50(2), 402-11.

Rockstroh JK, Nelson M, Katlama C, Lalezari J, Mallolas J, Bloch M, Matthews GV, Saag MS, Zamor PJ, Orkin C, Gress J. 2015. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. The lancet HIV 2(8), e319-27.

Roth D, Nelson DR, Bruchfeld A, Liapakis A, Silva M, MonsourJr H, Martin P, Pol S, Londoño MC, Hassanein T, Zamor PJ. 2015. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4–5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. The Lancet 386(10003), 1537-45.

Shepard CW, Finelli L, Alter MJ. 2005. Global epidemiology of hepatitis C virus infection. The Lancet infectious diseases 5(9), 558-67.

Sulkowski MS, Eron JJ, Wyles D, Trinh R, Lalezari J, Wang C, Slim J, Bhatti L, Gathe J, Ruane PJ, Elion R. 2015. Ombitasvir, paritaprevir co-dosed with ritonavir, dasabuvir, and ribavirin for hepatitis C in patients co-infected with HIV-1: a randomized trial. Jama 313(12), 1223-31.

Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestrosa F, Thuluvath PJ, Schwartz H. 2014. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. New England Journal of Medicine 370(3), 211-21.

Sulkowski M, Hezode C, Gerstoft J, Vierling JM, Mallolas J, Pol S, Kugelmas M, Murillo A, Weis N, Nahass R, Shibolet O. 2015. Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a randomised, open-label phase 2 trial. The Lancet 385(9973), p 1087-1097.

Summa V, Ludmerer SW, McCauley JA, Fandozzi C, Burlein C, Claudio G, Coleman PJ, DiMuzio JM, Ferrara M, Di Filippo M, Gates AT. 2012. MK-5172, a selective inhibitor of hepatitis C virus NS3/4a protease with broad activity across genotypes and resistant variants. Antimicrobial agents and chemotherapy 56(8), 4161-7.

Townsend K, Petersen T, Gordon LA, Kohli A, Nelson A, Seamon C, Gross C, Tang L, Osinusi A, Polis MA, Masur H. 2016. Effect of HIV co-infection on adherence to a 12-week regimen of hepatitis C virus therapy with ledipasvir and sofosbuvir. Aids 30(2), 261-6.

Wyles DL, Ruane PJ, Sulkowski MS, Dieterich D, Luetkemeyer A, Morgan TR, Sherman KE, Dretler R, Fishbein D, GatheJr JC, Henn S. 2015. Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1. New England Journal of Medicine 373(8), 714-25.

Yeh W, Lipardi C, Jumes P, De Lepeleire I, Van Den Bulk N, Caro L, Huang X, Mangin E, Nachbar R, Gane E, Popa S. 2013. MK-8742, a HCV NS5A inhibitor with a broad spectrum of HCV genotypic activity, demonstrates potent antiviral activity in genotype-1 and-3 HCV-infected patients. Hepatology 58.

Zeuzem S, Ghalib R, Reddy KR, Pockros PJ, Ari ZB, Zhao Y, Brown DD, Wan S, DiNubile MJ, Nguyen BY, Robertson MN. 2015. Grazoprevir–elbasvir combination therapy for treatment-naive cirrhotic and noncirrhotic patients with chronic hepatitis C virus genotype 1, 4, or 6 infection: a randomized trial. Annals of internal medicine 163(1), 1-3.

Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourlière M, Sulkowski MS,

Wedemeyer H, Tam E, Desmond P, Jensen DM. 2014. Retreatment of HCV with ABT-450/r–ombitasvir and dasabuvir with ribavirin. New England Journal of Medicine 370(17), 1604-14.

Jabir Ali, Syed Saad Ul Hassan Bukhari, Kinza Tanvir, Ujalla Tanveer, Maheen Shafiq, Juon Abbass, Iqra Mumtaz, Zoha Naeem, Sajid Ali, Mubbara Tariq.
A STEP FORWARD TOWARDS COMBINATION THERAPY FOR THE PREVENTION OF HCV.
Int. J. Biosci. 16(1), 68-82, January 2020.
https://innspub.net/ijb/step-forward-towards-combination-therapy-prevention-hcv/
Copyright © 2020
By Authors and International Network for
Natural Sciences (INNSPUB)
https://innspub.net
brand
innspub logo
english language editing
  • CALL FOR PAPERS
    CALL FOR PAPERS
    Publish Your Article
  • CALL FOR PAPERS
    CALL FOR PAPERS
    Submit Your Article
INNSPUB on FB
Email Update