Ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin for treatment of chronic hepatitis C 1 genotype in the Republic of Belarus

Danilau, Dzmitry; Malich, Nadzeya; Литвинчук, Д. В.; Karpov, Igor

doi:10.5114/ceh.2017.70281

Cited by 4 publications

(4 citation statements)

References 11 publications

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“…AMBER was the first RWE study in the world with this therapeutic regimen to demonstrate a high SVR rate and an excellent safety profile, even in patients with cirrhosis, a history of interferon-based therapy failure, and after liver transplantation [8]. Further studies published by other authors confirmed our findings from the 12-week post-treatment assessment [9][10][11][12][13][14]. A further two-year follow-up of patients participating in the AMBER program confirmed the persistence of the virological response, which was accompanied by a significant improvement in the main functional indicators including, in particular, a reduction in liver stiffness (LS).…”

Section: Introductionsupporting

confidence: 82%

Five-Year Follow-Up of Cured HCV Patients under Real-World Interferon-Free Therapy

Flisiak

Zarębska-Michaluk

Janczewska

et al. 2021

Cancers

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(1) Background: Treatment of hepatitis C virus (HCV) infections with direct-acting antivirals (DAA) has demonstrated high efficacy and an excellent safety profile. The cured patients showed a sustained virological response and improved liver function, but also a continued risk of hepatocellular carcinoma (HCC) during the 2–3 years of follow-up after treatment; (2) Methods: A total of 192 patients out of 209 of the primary AMBER study were analyzed five years after treatment with ombitasvir/paritaprevir/ritonavir with or without dasabuvir and with or without ribavirin. Results: We confirmed that HCV clearance after DAA treatment is stable regardless of baseline liver fibrosis. We found that sustained virologic response is associated with a gradual but significant reduction in liver stiffness over 5 years. Liver function improved during the first 2 years of follow-up and remained stable thereafter. The risk of death due to HCC as well as death due to HCV persists through 5 years of follow-up after successful DAA treatment. However, in non-cirrhotic patients, it appears to clear up 3 years after treatment; (3) Conclusions: Monitoring for more than 5 years after curing HCV infection is necessary to assess the long-term risk of possible development of HCC, especially in patients with cirrhosis of the liver.

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Section: Introductionsupporting

confidence: 82%

Five-Year Follow-Up of Cured HCV Patients under Real-World Interferon-Free Therapy

Flisiak

Zarębska-Michaluk

Janczewska

et al. 2021

Cancers

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“…Safety evaluation demonstrated mostly mild adverse events, which rarely led to treatment discontinuation . Efficacy and safety results from this study were shortly confirmed with other RWE studies …”

Section: Introductionsupporting

confidence: 80%

“…12 Efficacy and safety results from this study were shortly confirmed with other RWE studies. [13][14][15][16] The sustained virologic response in the AMBER study was assessed 12 weeks after the end of treatment (EOT), which is the current standard efficacy assessment endpoint. 17,18 However, longterm outcomes of successful treatment with DAA need further studies, because available up-to-now data were usually not collected in a fixed period on post-treatment follow-up.…”

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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“…Thus, a significant improvement of evolution of functional liver tests (ALT, AST) was observed during the 12 weeks of treatment compared with the baseline. This is confirmed by both Phase III clinical studies and real world studies [17,18,19]. The total bilirubin level increased significantly during the 12 weeks of treatment, with a peak in week 4, but returned to normal after 12 weeks following treatment completion.…”

Section: Discussionsupporting

confidence: 60%

Extended panel of biomarkers for long term monitoring of effectiveness of 3 direct antiviral regimen in HCV genotype 1b infection: results from a Romanian infectious disease hospital

Harja-Alexa

Mihaela

Manciuc

et al. 2021

Revista Romana De Medicina De Laborator

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Background: Hepatitis C virus can be eradicated with antiviral therapy, thus reducing the risk of disease progression and death associated with the final stage of liver disease. Methods: 241 patients received PrOD+RBV for 12 weeks. Clinical and laboratory data were assessed at baseline, week 4, 8, 12 (end of treatment, EOT), and 12 weeks after therapy (sustained virological response, SVR). Subsequently, biological and virological measurements were performed at least 48 weeks after obtaining SVR12 in responder patients. Results: Per protocol SVR12 rate was 97,6%. Severe adverse events were reported in 3 patients (1.24%) and led to treatment discontinuation (liver decompensation). One 58-year-old patient who completed the treatment died before SVR evaluation due to acute mesenteric ischemia (not related to antiviral therapy). Baseline total bilirubin above 2 mg/dl can be considered a predictive factor for non-response to PrOD+RBV treatment (p = 0.004). Of the 30 patients evaluated at least 48 weeks after SVR no one presented relapses, with no statistically significant differences in biological parameters changes and no adverse events were noted during the 48-week follow up period. Conclusion: Our study revealed the high effectiveness and good safety profile of PrOD +RBV in patients with genotype-1b HCV compensated cirrhosis (Child Pugh A) which were maintained during a 48-week period after treatment finalization.

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Ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin for treatment of chronic hepatitis C 1 genotype in the Republic of Belarus

Cited by 4 publications

References 11 publications

Five-Year Follow-Up of Cured HCV Patients under Real-World Interferon-Free Therapy

Five-Year Follow-Up of Cured HCV Patients under Real-World Interferon-Free Therapy

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

Extended panel of biomarkers for long term monitoring of effectiveness of 3 direct antiviral regimen in HCV genotype 1b infection: results from a Romanian infectious disease hospital

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