Current drugs in early development for treating hepatitis C virus-related hepatic fibrosis

Jaroszewicz, Jerzy; Flisiak-Jackiewicz, Marta; Lebensztejn, Dariusz Marek; Flisiak, Robert

doi:10.1517/13543784.2015.1057568

Cited by 25 publications

(23 citation statements)

References 91 publications

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“…The use of drugs which are not listed in Table 1 is also acceptable, provided that they are approved according to their SPC [9]. …”

Section: General Recommendationsmentioning

confidence: 99%

Recommendations for the treatment of hepatitis C in 2017

Halota¹,

Flisiak²,

Juszczyk³

et al. 2017

ceh

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The goals of treatment is to eliminate HCV infection, stop or reverse histological changes, reduce the risk of hepatocellular carcinoma development and transmission of the infection to other individuals. According to the recommendation of the Polish Group of Experts for HCV in 2017 all patients with chronic HCV infection should receive treatment, but it is not recommended in patients at high risk of short overall survival. If access to therapy is restricted, priority should be given to patients whose HCV infection can lead to an unfavourable outcome of the disease within a short time frame, particular to individuals with liver cirrhosis, rapidly progressing liver fibrosis, extrahepatic manifestations of HCV infection, chronic kidney diseases, patients before and after organ transplantation. Current recommendations of Polish Group of Experts for HCV provide guidelines to select optimal medication, assessment of liver fibrosis, treatment efficacy, dealing with resistance to direct acting antivirals, monitoring for hepatocellular carcinoma, management of HBV/HCV coinfection and drug interactions. It constains also advice on treatment of special patients populations such as renal failure, liver transplant and hepatic decompensation, as well as retreatment of patients which failed interferon free therapy. Moreover specific recommendations of management patients infected with different genotypes with currently reimbursed regimens or those expected to become available shortly in Poland are also included.

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“…The use of drugs which are not listed in Table 1 is also acceptable, provided that they are approved according to their SPC [9]. …”

Section: General Recommendationsmentioning

confidence: 99%

Recommendations for the treatment of hepatitis C in 2017

Halota¹,

Flisiak²,

Juszczyk³

et al. 2017

ceh

Self Cite

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“…Introduction of first‐generation protease inhibitors improved therapeutic outcomes in noncirrhotic, treatment‐naïve patients infected with HCV genotype 1, but schedules were still based on PEG‐IFN and RBV . Significant improvement of both efficacy and safety was achieved with the second‐generation direct‐acting antivirals (DAA) . Combination of 2‐3 DAA provided a high genetic barrier to prevent resistance‐associated substitutions in the HCV genome.…”

Section: Introductionmentioning

confidence: 99%

Durability of virologic response, risk of de novo hepatocellular carcinoma, liver function and stiffness 2 years after treatment with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin in the AMBER, real‐world experience study

Flisiak

Janczewska

Łucejko

et al. 2018

Journal of Viral Hepatitis

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We followed for 2 years patients treated with direct-acting agents (DAA) to assess long-term durability of virologic response, improvement of liver function, reduction in liver stiffness (LS) and risk of hepatocellular carcinoma (HCC). The study included patients from 16 hepatologic centres involved in the AMBER, investigator-initiated study on treatment of chronic hepatitis C patients within a programme preceding EU registration of ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin. A total of 204 patients among 209 from the primary study were enrolled, 200 with available testing at 2-year follow-up (2yFU) with undetectable HCV RNA (198 responders and 2 nonresponders retreated). During 2yFU, 4 patients died, 17 had hepatic decompensation and 3 needed liver transplantation. De novo hepatocellular carcinoma was diagnosed in 4 and its recurrence in 3 patients. Significant decreases in bilirubin, MELD, Child-Pugh scores and liver stiffness, and increases in albumin level were observed during 2yFU. Strengths of the study were a fixed period of post-treatment follow-up, prospective character of the study and high proportion of available patients from the primary study. The major weaknesses were lack of a comparative arm and relatively insufficient number of patients for subsets analysis. In conclusion, 2-year follow-up confirmed durability of virologic response after treatment of HCV infection with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin. It was accompanied by significant improvement of major measures of hepatic function and reduction of hepatic stiffness. Successful therapy did not prevent hepatic decompensation, HCC or death in cirrhotics that support the need for longer than 2-year monitoring for possible disease progression.

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“…Moreover, safety, especially in patients with advanced liver fibrosis, was not improved . The development of pangenotypic, highly effective and safe interferon‐free (IFN‐free) medications based on combinations of 2‐3 DAA quickly changed the landscape of HCV treatment . The new DAA are protease (NS3/4A), polymerase (NS5B) and NS5A inhibitors.…”

Section: Introductionmentioning

confidence: 99%

Hepatitis C: efficacy and safety in real life

Flisiak

Pogorzelska

Flisiak-Jackiewicz

2017

Liver International

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Interferon-free combinations were registered in 2014 and 2015 for the treatment of chronic HCV infection. As a result, real-world experience has been gathered in the last year and this paper presents data available in September 2016. Real-world studies on the efficacy of the ledipasvir/sofosbuvir (LDV/SOF)±ribavirin (RBV) regimen showed a sustained virologic response (SVR) rate of between 91% and 98%. The SVR rate in the 13858 patients included in this paper was 94%, and 92% in the 3506 patients with cirrhosis. In a number of recently published real-world studies evaluating ombitasvir/paritaprevir/ritonavir (OBV/PTV/r)±dasabuvir (DSV)±RBV, the SVR rate was between 92% and 100%. The SVR rate of the 4260 patients included in the studies in this paper was 97% and the rate was the same in the 1647 patients with cirrhosis. Recently, data evaluating SOF/simeprevir±RBV showed an SVR rate >90%, while in combination with daclatasvir this rate reached approximately 95%. The safety data available for LDV/SOF±RBV and OBV/PTV/r±DSV±RBV show that discontinuation due to adverse events was necessary in no more than 3% of patients and the frequency of serious adverse events was between 0 and 11%, in particular in real-world studies. Because of the similar efficacy and safety, real-world data support the use of either the LDV/SOF±RBV or OBV/PTV/r±DSV±RBV regimen in patients with genotypes 1 or 4. There is still not enough real-world data in patients with genotype 3 and other genotypes.

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Current drugs in early development for treating hepatitis C virus-related hepatic fibrosis

Cited by 25 publications

References 91 publications

Recommendations for the treatment of hepatitis C in 2017

Recommendations for the treatment of hepatitis C in 2017

Durability of virologic response, risk of de novo hepatocellular carcinoma, liver function and stiffness 2 years after treatment with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin in the AMBER, real‐world experience study

Hepatitis C: efficacy and safety in real life

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