ISSUES PERTAINING TO DAAS
AbstractWith the discovery of DAAs, the treatment of hepatitis C has improved a lot. But in this new era of DAAs several issues are also emerging. In this brief communication, we have tried to address the salient issues regarding DAAs.Keywords: Direct acting antivirals; Resistance; Drug Interactions; Side Effects
Ogata N, Alter HJ, Miller RH, Purcell RH. Nucleotide sequence and mutation rate of the H strain of hepatitis C virus. Proc Natl Acad Sci U S A 1991;88(8):3392–6.
Bartenschlager R, Lohmann V. Replication of hepatitis C virus. J Gen Virol 2000;81(Pt 7):1631–48.
Mandell GL, Bennett JE, Dolin R, editors. Mandell, Douglas, and Bennett’s principles and practice of infectious diseases. 7th ed. Philadelphia, PA: Churchill Livingstone/Elsevier; 2010.
Pawlotsky JM. Hepatitis C Virus Resistance to Direct-Acting Antiviral Drugs in Interferon-Free Regimens. Gastroenterology 2016;151(1):70–86.
Ahmed A, Felmlee DJ. Mechanisms of Hepatitis C Viral Resistance to Direct Acting Antivirals. Viruses 2015;7(12):6716–29.
Recommendations for Testing, Managing, and Treating Hepatitis C [Internet]. [cited 2016 Aug 30]. Available from: http://www.hcvguidelines.org/
Vermehren J, Susser S, Dietz J, Von Hahn T, Petersen J, Hinrichsen H, et al. Retreatment of Patients who failed DAA-Combination Therapies: Real-World Experience from a Large Hepatitis C Resistance Database. J Hepatol 2016;64(2):S188.
Foster GR, Afdhal N, Roberts SK, Bräu N, Gane EJ, Pianko S, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med 2015;373(27):2608–17.
Curry MP, O’Leary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, et al. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. N Engl J Med 2015;373(27):2618–28.
Hill A, Khoo S, Simmons B, Ford N. What is the minimum cost per person to cure HCV. In Poster presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). 2013.
WHO. Notes on the design of a bioequivalence study: sofosbuvir. Guidance Document 25 March 2015. [Internet]. [cited 2016 Oct 6]. Available from: http://apps.who.int/prequal/info_applicants/BE/2015/Sofosbuvir_BE25March2015.pdf
Freeman J, Sallie R, Kennedy A, Hieu P, Jeffreys G, Hill A. High sustained virological response rates using generic direct acting antiviral treatment for hepatitis C, imported into Australia. J Hepatol 2016;2(64):S209.
Akhter TS, Umer M, Bushra HT, Shehzad A, Nisar G, Bilal M, et al. Response to Sofosbuvir treatment for Chronic Hepatitis C infection in Genotype 3 patients—an experience from Center for Liver and Digestive Diseases Pakistan. Gastro. Forthcoming 2016.
EASL clinical practice guidelines: management of hepatitis C virus infection. J Hepatol 2015;63:199–236.
Afdhal N, Bacon B, Curry M, Dieterich D, Flamm S, Guest L, et al. No Effect of Proton Pump Inhibitor (PPI) Use on SVR with Ledipasvir/Sofosbuvir (LDV/SOF): Real World Data from 2034 Genotype 1 Patients in the Trio Network. J Hepatol 2016;64(2):S222.
Drug Interactions With New/Investigational Hepatitis C NS5A Inhibitors. [Internet]. [cited 2016 Oct 10]. Available from: http://www.hcvdruginfo.ca/downloads/Hepatitis%20C-int_new%20NS5A%20inhibitors.pdf
AETC. Ledipasvir/Sofosbuvir (Harvoni®) Drug Interactions A Quick Guide for Clinicians – January 2015. [Internet]. [cited 2016 Oct 10]. Available from: http://www.nynjaetc.org/documents/LEDSOFHIV_and_HCV_Drug_Interaction_Quick_GuideJanuary2015FINAL.pdf
AETC. Sofosbuvir/Velpatasvir (Epclusa®) Drug Interactions A Quick Guide for Clinicians – June 2016. [Internet]. [cited 2016 Oct 10]. Available from: http://www.nynjaetc.org/documents/VELSOFHIV_and_HCV_Drug_Interaction_Quick_Guide-Epclusa.pdf
Drug Interactions with Sofosbuvir. [Internet]. [cited 2016 Oct 10]. Available from: http://www.hcvdruginfo.ca/downloads/Hepatitis%20C-sofosbuvir%20int.pdf
Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013;368(20):1867–77.
Managing Side Effects of Sofosbuvir and Ribavirin. [Internet]. [cited 2016 Oct 10]. Available from: http://www.hepatitis.va.gov/pdf/side-effects-sofosbuvir-ribavirin-da-508.pdf
Managing Side Effects of Daclatasvir + Sofosbuvir + Ribavirin [Internet]. [cited 2016 Oct 10]. Available from: http://www.hepatitis.va.gov/pdf/side-effects-daclatasvir-sofosbuvir-ribavirin.pdf
Spera AM, Eldin TK, Tosone G, Orlando R. Antiviral therapy for hepatitis C: Has anything changed for pregnant/lactating women? World J Hepatol 2016;8(12):557–65.
El-Guindi MA. Hepatitis C Viral Infection in Children: Updated Review. Pediatr Gastroenterol Hepatol Nutr 2016;19(2):83–95.
Welzel T, Schott E, Petersen J, Mauss S, Zimmermann T, Simon KG, et al. Effectiveness and safety of DAA combination therapies for treatment of HCV In elderly patients (>70 Yrs.): Results from the German hepatitis C-registry. J Hepatol 2016;64(Suppl 2):S824–5.
Safety Alerts for Human Medical Products > Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating [Internet]. [cited 2016 Oct 10]. Available from: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm523690.htm
Dyson JK, Hutchinson J, Harrison L, Rotimi O, Tiniakos D, Foster GR, et al. Liver toxicity associated with sofosbuvir, an NS5A inhibitor and ribavirin use. J Hepatol 2016;64(1):234–8.
Kalafateli M, Dusheiko G, Manousou P. Clinical decompensation after achieving SVR with sofosbuvir, daclatasvir and ribavirin in a patient with recurrent HCV post-liver transplant. J Gastrointestin Liver Dis 2015;24(2):257–8.
Reig M, Mariño Z, Perelló C, Iñarrairaegui M, Ribeiro A, Lens S, et al. Unexpected high rate of early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy. J Hepatol 2016;65(4):719–26.
Kattakuzhy S, Gross C, Teferi G, Jenkins V, Silk R, Akoth E, et al. A Novel Task Shifting Model to Expand the HCV Care Continuum: The Ascend Investigation. J Hepatol 2016;64(2):S224–5.
Esmat G, El Raziky M, Gomaa A, Elbaz T, Abouelkhair MM, Sabry A, et al. High virologic response rate in Egyptian HCV-genotype 4 patients treated with ravidasvir (PPI-668) and sofosbuvir: results of a large multicenter phase 3 registrational trial. In WILEY-BLACKWELL 111 RIVER ST, HOBOKEN 07030-5774, NJ USA; 2015;62(6):1381A.
Drugs for neglected diseases initiative. An alternative research and development strategy to deliver affordable treatments for hepatitis C patients. [Internet]. [cited 2016 Oct 6]. Available from: http:// http://www.dndi.org/wp-content/uploads/2016/04/AlternativeRDStrategyHepC.pdf
Rockstroh JK. Summary from EASL 2016 for Hepatitis C Highly efficacious pan-genotypic DAA combinations on their way: the last gaps in difficult-to-treat patient populations are going to be closed soon. [Internet]. [cited 2016 Oct 8]. Available from: http://www.natap.org/2016/EASL/EASL_157.htm
Journal of Ayub Medical College, Abbottabad is an OPEN ACCESS JOURNAL which means that all content is FREELY available without charge to all users whether registered with the journal or not. The work published by J Ayub Med Coll Abbottabad is licensed and distributed under the creative commons License CC BY ND Attribution-NoDerivs. Material printed in this journal is OPEN to access, and are FREE for use in academic and research work with proper citation. J Ayub Med Coll Abbottabad accepts only original material for publication with the understanding that except for abstracts, no part of the data has been published or will be submitted for publication elsewhere before appearing in J Ayub Med Coll Abbottabad. The Editorial Board of J Ayub Med Coll Abbottabad makes every effort to ensure the accuracy and authenticity of material printed in J Ayub Med Coll Abbottabad. However, conclusions and statements expressed are views of the authors and do not reflect the opinion/policy of J Ayub Med Coll Abbottabad or the Editorial Board.
USERS are allowed to read, download, copy, distribute, print, search, or link to the full texts of the articles, or use them for any other lawful purpose, without asking prior permission from the publisher or the author. This is in accordance with the BOAI definition of open access.
AUTHORS retain the rights of free downloading/unlimited e-print of full text and sharing/disseminating the article without any restriction, by any means including twitter, scholarly collaboration networks such as ResearchGate, Academia.eu, and social media sites such as Twitter, LinkedIn, Google Scholar and any other professional or academic networking site.