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

Manns, Michael P.; Samuel, Didier; Gane, Edward; Mutimer, David; McCaughan, Geoffrey W.; Buti, María; Prieto, M.; Calleja, José Luís; Peck‐Radosavljevic, Markus; Müllhaupt, Beat; Agarwal, Kosh; Angus, Peter W; Yoshida, Eric M.; Colombo, Massimo; Rizzetto, M.; Dvory‐Sobol, Hadas; Denning, Jill; Arterburn, Sarah; Pang, Phillip S.; Brainard, Diana M.; McHutchison, John G.; Dufour, Jean–François; Vlierberghe, Hans Van; Hoek, Bart van; Forns, Xavier

doi:10.1016/s1473-3099(16)00052-9

Cited by 417 publications

(466 citation statements)

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“…64 In the SOLAR-2 study, which included 107 patients with decompensated cirrhosis treated before liver transplant, SVR12 was achieved in 87% in the 12-week treatment group and 89% in the 24-week treatment group. 65 These studies have shown that SVR12 rates were comparable for 12 or 24 weeks of therapy with SOF/LDV/RBV. Similar data were recently published by Foster et al (NHS England Expanded Access Program).…”

Section: Decompensated Cirrhosismentioning

confidence: 96%

“…[64][65][66] In the SOLAR-1 and 2 trials, the most common grade 3/4 adverse effects seen in the decompensated patients were an increase in serum bilirubin and a decrease in lymphocyte count. In the SOLAR-1 trial, anemia was noted in 39% who dropped their hemoglobin values to less than 10 gm/dl; in 13%, it dropped to below 8.5 gm/dl.…”

Section: Decompensated Cirrhosismentioning

confidence: 99%

“…In the European SOLAR-2 trial, SVR12 was achieved in 95% patients with F0-3 fibrosis and 98% with CPT-A cirrhosis. 65 An uncommon complication of post-LT HCV recurrence is a condition called fibrosing cholestatic hepatitis (FCH). Till DAAs became available, this condition was associated with a very high mortality.…”

Section: Management Of Hcv Infection After Liver Transplant (Lt)mentioning

confidence: 99%

“…There was no drug-to-drug interaction with any of the immunosuppressive agents in these trial. 64,65 In the recent open-label ALLY-1 study, SOF/DCV RBV for 12 weeks was examined in LT recipients with recurrent HCV infection (n = 53, 41 GT-1 and 11 GT-3 patients). SVR12 was achieved in 50 out of 53 patients (94%).…”

Section: Management Of Hcv Infection After Liver Transplant (Lt)mentioning

confidence: 99%

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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: 96%

Section: Decompensated Cirrhosismentioning

confidence: 99%

Section: Management Of Hcv Infection After Liver Transplant (Lt)mentioning

confidence: 99%

Section: Management Of Hcv Infection After Liver Transplant (Lt)mentioning

confidence: 99%

See 2 more Smart Citations

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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“…The advent of highly effective direct acting antiviral (DAA) therapy in the management of these difficult-totreat chronic hepatitis C subpopulation has significantly improved sustained virologic response (SVR, absence of HCV RNA in plasma 12 weeks after cessation of therapy), while maintaining an excellent safety profile (3)(4)(5). Achieving SVR has resulted in reversal of the degree of fibrosis, reduction in the risk of hepatocellular carcinoma, lowers the rate of hepatic decompensation, and perhaps curtails the need for liver transplantation (2,6,7).…”

mentioning

confidence: 99%

Sofosbuvir and velpatasvir: a stellar option for patients with decompensated hepatitis C virus (HCV) cirrhosis

Chua¹,

Kottilil²

2016

Ann. Transl. Med.

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Treatment of Hepatitis C

Mecci

Cheung

2017

Encyclopedia of Life Sciences

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Hepatitis C virus (HCV) infection is a prime example of the speed at which modern medical science has evolved. Within 30 years of its discovery, this virus now has highly effective treatments with response rates up to 100%. HCV infection affects 3% of the world's population and can lead to severe sequelae. Chronic infection may progress to cirrhosis, hepatocellular carcinoma and death. Successful clearance of HCV prevents and may reverse such complications. The discovery of specific drug targets for HCV has revolutionised treatment using direct‐acting antivirals (DAAs). DAAs are potent and safe, allowing individuals who were unable to tolerate interferon treatment, to be cured. The WHO has targeted elimination of HCV by 2030. HCV treatment is triumphant with remarkable new drug developments, but at the same time, still a work in progress. Key Concepts Hepatitis C treatment has evolved in many areas from imaging to treatment. DAAs have improved treatment for patients by increasing SVR and tolerability. Eradication of HCV is now feasible, though barriers remain. HCV is a blood borne virus. Breakthroughs in basic science have been translated into real advances in patient care.

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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

Abstract: Gilead Sciences.

Cited by 417 publications

References 14 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

Sofosbuvir and velpatasvir: a stellar option for patients with decompensated hepatitis C virus (HCV) cirrhosis

Treatment of Hepatitis C

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