LO3 : Safety and efficacy of the combination daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients from the french observational cohort ANRS CO22 hepather*

Pol, S.; Bourlière, Marc; Lucier, Sandy; Lédinghen, Victor de; Zoulim, Fabien; Dorival-Mouly, C.; Métivier, Sophie; Larrey, Dominique; Tran, Albert; Hézode, Christophe; Bronowicki, Jean–Pierre; Samuel, Didier; Marcellin, Patrick; Zarski, J.P.; Minello, Anne; Alric, Laurent; Trinchet, Jean Claude; Nahon, Pierre; Guyader, Dominique; Chazouillères, O.; Riachi, Ghassan; Loustaud‐Ratti, Véronique; Causse, Xavier; Mathurin, Philippe; Hubert-Fouchard, I.; Rosa, Isabelle; Benhamou, Yves; Gournay, Jérôme; Raabe, Jean–Jacques; Raffi, François; Petrov-Sanchez, V.; Diallo, Alpha; Fontaine, Hélène; Carrat, Fabrice

doi:10.1016/s0168-8278(15)30149-5

Cited by 31 publications

(30 citation statements)

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“…Extending treatment to 24 weeks and use of RBV were both significantly associated with SVR, whereas cirrhosis emerged as the main predictor for treatment failure. 68 These data reinforce the need for addition of RBV in the DCV and SOF regimen. For cirrhotic patients, treatment should be extended to 24 weeks and/or RBV should be added to the 12-week treatment regimen.…”

Section: Decompensated Cirrhosismentioning

confidence: 59%

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Puri

Saraswat

Dhiman

et al. 2016

Journal of Clinical and Experimental Hepatology

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India contributes significantly to the global burden of HCV. While the nucleoside NS5B inhibitor sofosbuvir became available in the Indian market in March 2015, the other directly acting agents (DAAs), Ledipasvir and Daclatasvir, have only recently become available in the India. The introduction of these DAA in India at a relatively affordable price has led to great optimism about prospects of cure for these patients as not only will they provide higher efficacy, but combination DAAs as all-oral regimen will result in lower side effects than were seen with pegylated interferon alfa and ribavirin therapy. Availability of these newer DAAs has necessitated revision of INASL guidelines for the treatment of HCV published in 2015. Current considerations for the treatment of HCV in India include the poorer response of genotype 3, nonavailability of many of the DAAs recommended by other guidelines and the cost of therapy. The availability of combination DAA therapy has simplified therapy of HCV with decreased reliance of evaluation for monitoring viral kinetics or drug related side effects. ( J CLIN EXP HEPATOL 2016;6:119-145) T here have been revolutionary changes in the management of chronic hepatitis C (CH-C) over the last few years. Pegylated interferon alfa (Peg-IFNa) plus ribavirin (RBV) therapy, which till the recent past was the standard of care, has been eclipsed by the arrival of newer directly acting antiviral agents (DAAs). Not only do the DAAs have better efficacy, they are also associated with lower side effects, have better tolerability, a shorter duration of therapy, and have simpler administration.In the recent guidelines issued by the American Association for the study of Liver Diseases (AASLD), in collaboration with the Infectious Diseases Society of America 1 and the European Association for Study of the Liver z (EASL), 2 the role of Peg-IFNa/RBV therapy in the management of HCV has been relegated to second-line, backup status. These newer guidelines, however, cannot be implemented in India as many of the recommended drugs are yet to be marketed in India. Other considerations for the treatment of HCV in India are a predominance of

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Section: Decompensated Cirrhosismentioning

confidence: 59%

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Puri

Saraswat

Dhiman

et al. 2016

Journal of Clinical and Experimental Hepatology

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“…Similar results were obtained in the "real world" TARGET study with low SVR rates in cirrhotic patients with a MELD score ≥ 10 ( 29 ). The best results were achieved with 24 weeks of SOF+DCV+RBV in the French observational cohort ( 30 19 ). LDV/SOF plus RBV was associated with a greater incidence of AEs as well as concomitant medication use than LDV/SOF alone.…”

Section: Genotypementioning

confidence: 96%

HCV targeting of patients with cirrhosis

Ferenci

Kozbial

Mandorfer

et al. 2015

Journal of Hepatology

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Interferon (IFN)-free treatments are now the treatment of choice for patients with chronic hepatitis C. Previously difficult to treat patients by IFN-containing treatments can now be treated safely by IFN-free therapies. More than 90% of hepatitis C genotype 1 and 4 patients with compensated cirrhosis or after orthotopic liver transplantation (OLT) can be cured by sofosbuvir combined with simeprevir, daclatasvir or ledipasvir, or by the paritaprevir/ritona-vir/ombitasvir/±dasabuvir (3D) combination. Addition of ribavirin confers to a minimal, if any, benefit to increase SVR. The need for ribavirin is controversial and remains to be studied. The optimal length of treatment is still unknown, and an individual approach may be needed. Most patients require only 12weeks of therapy. The safety of these drugs is not fully explored in patients with decompensated cirrhosis (Child-Pugh C), who should not be treated with protease inhibitors. In cirrhosis hepatitis C virus eradication does not necessarily mean a cure of the disease and patients regularly require follow-up. Drug-drug interactions with immunosuppressant in patients after OLT are easier to manage but still require attention. Better drugs are needed for genotype 3 patients.

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“…Most recently, preliminary reports given by Buggisch JP et al from the SOFGER Trial showed that with the sofosbuvir + daclatasvir combination without ribavirin for 12 weeks, 84% of the 161 patients who reached followup week 4, mostly difficult-to-treat patients (prior nonresponders and cirrhotics) achieved an SVR4 [38].…”

Section: Discussionmentioning

confidence: 99%

Pan Genotypic Response to Combination Treatment With Sofosbuvir and Daclatasvir in Chronic Hepatitis C Patients

Nair

Ramachandran

2017

Journal of Clinical and Experimental Hepatology

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Background and aims: Hepatitis C is a major cause of liver related morbidity and mortality. Prevalence of HCV infection in India has been variously estimated as 0.9 to 1.9%. With the advent of DAAs, the treatment has been revolutionized with more than 95% cure rate as observed in Caucasian population, while only scarce data on the same are available in the Indian population. Our study is aimed to assess the pan genotypic treatment response (SVR 12) to Sofosbuvir and Daclatasvir combination. Methods: Chronic hepatitis C patients who attended the department of gastroenterology in Calicut Medical College, Kerala, India were included in the study. All those patients with chronic hepatitis or compensated cirrhosis of liver received Sofosbuvir 400 mg and Daclatasvir 60 mg for 12 weeks and those with decompensated cirrhosis of liver received the both the drugs for 24 weeks. HCV RNA levels were measured at the beginning of the treatment, end of treatment and 12 weeks after completion of treatment. Results: 30 patients (22M: 8F) with a mean age of 47±8 years were included, of which 13 (43.3%) had cirrhosis of liver. Of the 13 Cirrhotic patients 9, 3, and 1 were in CTP A, B and C stage respectively. Among the total patients 23(76.7%), 5(16.7%), 2(6.7%) were genotype 3, 1 and 4 respectively .Three patients were treatment failure (previously treated with IFN and RBV combination), two were post renal transplant and one was a hemophilia patient. Median Viral load was: 499801 IU/ml (range: 2.4x10 3 -7.1x10 8 ), Median viral load in chronic hepatitis C patients and cirrhosis of liver patients were 2.8x10 6 and 1.3x10 6 IU/ml respectively. Overall ETR and SVR were 100% in patients across the genotype. No significant adverse reactions were observed. Conclusion: Combination treatment with Sofosbuvir and daclatasvir is very effective in chronic hepatitis patients with or without cirrhosis of liver, across the genotypes (Genotypes 1, 3 and 4)

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LO3 : Safety and efficacy of the combination daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients from the french observational cohort ANRS CO22 hepather*

Cited by 31 publications

References 0 publications

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

HCV targeting of patients with cirrhosis

Pan Genotypic Response to Combination Treatment With Sofosbuvir and Daclatasvir in Chronic Hepatitis C Patients

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