Literature DB >> 28970713

Chronic Hepatitis C: Do Generics Work as Well as Branded Drugs?

Madhumita Premkumar1, Gagandeep S Grover2, Radha K Dhiman1.   

Abstract

India has a large share of the hepatitis C virus (HCV) burden of the world. Unsafe medical practices and blood transfusions are the leading modes of transmission of HCV in India. The commonest HCV genotype in India is genotype 3 followed by genotype 1. While directly acting antivirals (DAAs) agents have become available at reasonable rates in India, cost of therapy remains a major barrier for control of HCV in India. Generic DAAs have been proven to be cost-saving in prior studies. We examined data from various studies in India and elsewhere using generic DAAs, and evaluated whether they are equally efficacious as the branded drugs. Since the availability of generic DAAs in the Indian market, there is a lot of real life data as well as prospective studies in special patient populations such as hematological disorders (thalassemia and hemophilia), chronic kidney disease, hemodialysis patients, post liver and renal transplant patients on immunosuppression, intravenous drug users, confections and other high risk groups. Control of HCV infection in India requires multi pronged approach. There is a need to formulate a health educational curriculum targeting not only the high-risk population but also the general population regarding the transmission of HCV. Adopting the dual approach of treating the old cases (decreasing the reservoir pool of HCV) and decreasing the incidence of new ones would help curtail the disease and decrease liver related mortality. In this scenario, the role of efficacious low cost generic medications is essential.

Entities:  

Keywords:  ALT, alanine aminotransferase; CHC, chronic hepatitis C; CI, confidence interval; DAAs; DAAs, direct-acting antiviral agents; DCV, daclatasvir; EASL, The European Association for the Study of the Liver; GT, Genotype; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; IL, interleukin; INASL, Indian National Association for study of the Liver; LDV, ledipasvir; Peg-IFN, pegylated interferon; RBV, ribavirin; SOF, sofosbuvir; SVR, sustained virologic response; VEL, velpatasvir; chronic hepatitis C; generic direct antivirals; real life efficacy study

Year:  2017        PMID: 28970713      PMCID: PMC5620363          DOI: 10.1016/j.jceh.2017.08.003

Source DB:  PubMed          Journal:  J Clin Exp Hepatol        ISSN: 0973-6883


  33 in total

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Review 2.  Journey of Generic Imatinib: A Case Study in Oncology Drug Pricing.

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Journal:  J Oncol Pract       Date:  2017-04-26       Impact factor: 3.840

3.  Experience with direct acting anti-viral agents for treating hepatitis C virus infection in renal transplant recipients.

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Journal:  Indian J Gastroenterol       Date:  2017-03-27

4.  Early Acute Severe HCV Recurrence After Transplantation: From Universal Mortality to Cure.

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Journal:  J Clin Exp Hepatol       Date:  2016-10-29

5.  Treatment of chronic hepatitis C genotype 3 with Sofosbuvir-based therpy: a real-life study.

Authors:  Sandeep Singh Sidhu; Nirmaljeet Singh Malhi; Omesh Goyal; Rupinder Singh; Usha Dutta; Rajiv Grover; J S Sidhu; Vijay Nanda; Harmeet Saluja; Ajesh Bansal; Gursewak Singh; Alok Sehgal; Harsh Kishore; Simran Sidhu
Journal:  Hepatol Int       Date:  2017-03-31       Impact factor: 6.047

6.  Sofosbuvir-based treatment is safe and effective in Indian hepatitis C patients on maintenance haemodialysis: A retrospective study.

Authors:  Mohammed Shujauddin Akhil; Balaji Kirushnan; Melvin Martin; Kanakaraj Arumugam; N K Ganesh Prasad; Rajan Ravichandran
Journal:  Nephrology (Carlton)       Date:  2018-05       Impact factor: 2.506

7.  Results of sofosbuvir-based combination therapy for chronic hepatitis C cohort of Indian patients in real-life clinical practice.

Authors:  Ajit Sood; Vandana Midha; Ramit Mahajan; Vikram Narang; Varun Mehta; Praneet Wander; Suresh Sharma; Kirandeep Kaur; Dharmatma Singh
Journal:  J Gastroenterol Hepatol       Date:  2017-04       Impact factor: 4.029

8.  Efficacy and safety of sofosbuvir-based therapy for chronic hepatitis C infection in "real-life" cohort.

Authors:  Rajiv Mehta; Mayank Kabrawala; Subhash Nandwani; Rini Tekriwal; Payal Nandaniya; Mrunal Shah; Vishwa Bhayani
Journal:  Indian J Gastroenterol       Date:  2016-11-08

9.  The global burden of viral hepatitis from 1990 to 2013: findings from the Global Burden of Disease Study 2013.

Authors:  Jeffrey D Stanaway; Abraham D Flaxman; Mohsen Naghavi; Christina Fitzmaurice; Theo Vos; Ibrahim Abubakar; Laith J Abu-Raddad; Reza Assadi; Neeraj Bhala; Benjamin Cowie; Mohammad H Forouzanfour; Justina Groeger; Khayriyyah Mohd Hanafiah; Kathryn H Jacobsen; Spencer L James; Jennifer MacLachlan; Reza Malekzadeh; Natasha K Martin; Ali A Mokdad; Ali H Mokdad; Christopher J L Murray; Dietrich Plass; Saleem Rana; David B Rein; Jan Hendrik Richardus; Juan Sanabria; Mete Saylan; Saeid Shahraz; Samuel So; Vasiliy V Vlassov; Elisabete Weiderpass; Steven T Wiersma; Mustafa Younis; Chuanhua Yu; Maysaa El Sayed Zaki; Graham S Cooke
Journal:  Lancet       Date:  2016-07-07       Impact factor: 79.321

10.  Very rapid virologic response and early HCV response kinetics, as quick measures to compare efficacy and guide a personalized response-guided therapy.

Authors:  Mostafa Yakoot; Alaa M Abdo; Ahmed Yousry; Sherine Helmy
Journal:  Drug Des Devel Ther       Date:  2016-08-25       Impact factor: 4.162

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  4 in total

Review 1.  Hepatitis C Virus Elimination by 2030: Conquering Mount Improbable.

Authors:  Radha K Dhiman; Madhumita Premkumar
Journal:  Clin Liver Dis (Hoboken)       Date:  2021-01-13

2.  Direct-Acting Antiviral Agents for HCV Infection.

Authors:  Madhumita Premkumar; Radha K Dhiman
Journal:  J Clin Exp Hepatol       Date:  2018-03-26

3.  Real-world cost-effectiveness of pan-genotypic Sofosbuvir-Velpatasvir combination versus genotype dependent directly acting anti-viral drugs for treatment of hepatitis C patients in the universal coverage scheme of Punjab state in India.

Authors:  Yashika Chugh; Radha Krishan Dhiman; Madhumita Premkumar; Shankar Prinja; Gagandeep Singh Grover; Pankaj Bahuguna
Journal:  PLoS One       Date:  2019-08-29       Impact factor: 3.240

4.  Access to unauthorized hepatitis C generics: Perception and knowledge of physicians, pharmacists, patients and non-healthcare professionals.

Authors:  Amandine Garcia; Sascha Moore Boffi; Angèle Gayet-Ageron; Nathalie Vernaz
Journal:  PLoS One       Date:  2019-10-10       Impact factor: 3.240

  4 in total

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