Daclatasvir plus Sofosbuvir with or without Ribavirin for the Treatment of Chronic HCV Infection in Patients with Decompensated Cirrhosis: Results of a European Multicentre Compassionate Use Program

Petersen, J.; Welzel, Tania M.; Herzer, Kerstin; Ferenci, Péter; Gschwantler, Michael; Cornberg, M.; Ingiliz, Patrick; Berg, Thomas; Spengler, Ulrich; Weiland, Ola; Valk, Marc van der; Klinker, H.; Rockstroh, JK; Peck‐Radosavljevic, Markus; Zhao, Youfei; Jiménez-Expósito, María Jesús; Zeuzem, Stefan

doi:10.1016/s0168-8278(16)01524-5

Cited by 4 publications

(5 citation statements)

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“…Additional information for one selected trial was retrieved from a follow‐up study of the same cohort of patients . Of the nine selected studies, three were clinical trials, and five were real‐life studies with a prospective or a retrospective design; the design of the ninth investigation was not explained . Data from an ongoing large, prospective Italian program evaluating treatment with the new antivirals in patients with chronic HCV infection were also interrogated, and information for patients with Child C cirrhosis was extracted and pooled in the final analysis.…”

Section: Resultsmentioning

confidence: 99%

“…The regimen of sofosbuvir plus simeprevir given for 12 weeks was evaluated in four studies: in the 31 patients with Child C cirrhosis treated with this schedule, the weighted mean SVR12 rate was 65.4% (95% CI: 46.8–80.2). In four studies, 55 patients received sofosbuvir plus daclatasvir, the majority of them for 24 weeks: the corresponding weighted mean SVR12 rate was 76.0% (95% CI: 54.4–89.3%). In three studies, sofosbuvir was administered in combination with ledipasvir to 101 patients: a weighted mean SVR12 rate of 83.0% (95% CI: 73.4–89.6) was observed.…”

Section: Resultsmentioning

confidence: 99%

“…Unfortunately, the MELD score was only available for 103 of the 228 treated Child C patients, but the percentage of patients with an improved MELD score was remarkable. The difference seen between our data and previous studies on post‐treatment benefit in patients with decompensated cirrhosis may be partially be due to the characteristics of the investigated patients: our survey was restricted to Child C patients, while in previous studies the majority of cases had Child B cirrhosis. About 50% of our patients with cirrhosis presented with a MELD score >15 at baseline, and the higher the MELD scores at baseline the more likely an improvement is seen at the post‐treatment evaluation.…”

Section: Discussionmentioning

confidence: 99%

“…Figure 1 shows the PRISMA flow diagram of the literature selection process. Seven full-text records [14][15][16][17][18][19][20] and two conference abstracts 21,22 were retained for analysis. Additional information for one selected trial 19 was retrieved from a follow-up study of the same cohort of patients.…”

Section: Statistical Analysesmentioning

confidence: 99%

“…23 Of the nine selected studies, three were clinical trials, 14,15,18 and five were real-life studies with a prospective 19,20 or a retrospective design; 16,17,21 the design of the ninth investigation was not explained. 22 Data from an ongoing large, prospective Italian program evaluating treatment with the new antivirals in patients with chronic HCV infection were also interrogated, 24 and information for patients with Child C cirrhosis was extracted and pooled in the final analysis. The main characteristics of patients with cirrhosis evaluated in the 10 selected studies are shown in Table 1.…”

Section: Statistical Analysesmentioning

confidence: 99%

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Systematic review: interferon‐free regimens for patients with HCV‐related Child C cirrhosis

Guarino

Morisco

Valvano

et al. 2017

Aliment Pharmacol Ther

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Statistical Analysesmentioning

confidence: 99%

Section: Statistical Analysesmentioning

confidence: 99%

See 3 more Smart Citations

Systematic review: interferon‐free regimens for patients with HCV‐related Child C cirrhosis

Guarino

Morisco

Valvano

et al. 2017

Aliment Pharmacol Ther

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Daclatasvir: A Review in Chronic Hepatitis C

Keating

2016

Drugs

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The hepatitis C virus (HCV) NS5A replication complex inhibitor daclatasvir (Daklinza(®)) is indicated for use in combination with sofosbuvir, with or without ribavirin, in a pangenotypic all-oral regimen. In patients with chronic HCV genotype 1 or 3 infection without cirrhosis, a 12-week regimen of daclatasvir plus sofosbuvir achieved high sustained virological response rates 12 weeks' post-treatment (SVR12), regardless of prior treatment experience, according to the results of the AI444040 and ALLY-3 trials. In the ALLY-3+ trial, high SVR12 rates were achieved with a 12- or 16-week regimen of daclatasvir plus sofosbuvir and ribavirin in patients with chronic HCV genotype 3 infection and advanced fibrosis or compensated cirrhosis. A daclatasvir plus sofosbuvir-based regimen demonstrated efficacy in patients with chronic HCV genotype 1, 3 or 4 infection and advanced cirrhosis or post-transplant recurrence in the ALLY-1 trial, and in patients co-infected with HCV genotype 1, 3 or 4 and HIV-1 in the ALLY-2 trial. Results of clinical trials were supported by real-world data from early-access programmes that included high numbers of patients who would have been excluded from phase 3 trials because of advanced disease and/or concomitant medical conditions. Daclatasvir plus sofosbuvir with or without ribavirin was generally well tolerated. In conclusion, an all-oral regimen comprising daclatasvir plus sofosbuvir with or without ribavirin is an important option for use in treatment-naive or treatment-experienced patients with chronic HCV genotype 1, 3 or 4 infection, including in patients with advanced liver disease, post-transplant recurrence and HIV-1 co-infection.

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Pharmacodynamic and pharmacokinetic evaluation of the combination of daclatasvir/sofosbuvir/ribavirin in the treatment of chronic hepatitis C

Rivero‐Juárez

Brieva

Frías

2018

Expert Opinion on Drug Metabolism & Toxicology

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The combination of daclatasvir (DCV), sofosbuvir (SOF), and ribavirin (RBV) is a direct-acting antiviral (DAA) regimen for the treatment of hepatitis C virus (HCV) infection. The inclusion of newer effective DAAs such as SOF and DCV with high efficacy and excellent tolerance introduced a new scenario in HCV infection therapy: high rates of sustained virological response (SVR), shorter therapies, less toxicity, and interferon-free treatments. This combination was approved for the treatment of HCV in treatment-naive or treatment-experienced patients with chronic HCV genotype 1 or 3 infection. Areas covered: This review summarizes the pharmacokinetics, pharmacodynamics, efficacy, and safety of DCV plus SOF and RBV therapy in the treatment of HCV infection. The topics include data regarding drug absorption, distribution, metabolism, excretion, and antiviral activity strategies, such as clinical dose selection and treatment duration. Expert opinion: This combination, taken orally with or without food, has an excellent pharmacokinetic and pharmacodynamic profile. DAC/SOF/RBV achieves very high rates of SVR in treatment-naive and treatment-experienced patients with chronic HCV infection, including difficult-to-treat patients such as those with compensated cirrhosis, post-transplant recurrence, or HIV-1 co-infection.

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Daclatasvir plus Sofosbuvir with or without Ribavirin for the Treatment of Chronic HCV Infection in Patients with Decompensated Cirrhosis: Results of a European Multicentre Compassionate Use Program

Cited by 4 publications

References 0 publications

Systematic review: interferon‐free regimens for patients with HCV‐related Child C cirrhosis

Systematic review: interferon‐free regimens for patients with HCV‐related Child C cirrhosis

Daclatasvir: A Review in Chronic Hepatitis C

Pharmacodynamic and pharmacokinetic evaluation of the combination of daclatasvir/sofosbuvir/ribavirin in the treatment of chronic hepatitis C

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