Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin (3D + RBV) Treatment of Hepatitis C (HCV) Genotype 1 (GT1) Infected Patients (pts) after Failure to Previous First Generation Protease-Inhibitor (PI) Therapy Interim Analysis

Hunyady, Béla; Abonyi, Margit; Gervain, Judit; Horváth, Gábor; Gerlei, Zsuzsanna; Lengyel, Gabriella; Makkai, Erzsébet; Péter, Zoltán; Pusztay, M.; Ribiczey, P.; Rókusz, László; Sarrazin, C.; Schneider, Fabrice; Schneider, M; Szalay, Ferenç; Tornai, István; Tusnádi, Anna; Újhelyi, Eszter; Makara, Mihály

doi:10.1016/s0168-8278(16)01460-4

Cited by 6 publications

(5 citation statements)

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“…This study also showed that the most significant predictive factor of on‐treatment decompensation was a history of decompensation . An SVR rate of 97% was also reported in 142 patients who had not responded to a previous interferon‐based triple regimen containing first generation protease inhibitors (boceprevir or telaprevir), who were enrolled in four studies including the largest one from Hungary …”

Section: Obv/ptv/r±dsv±rbv: Sustained Virologic Response In 92%‐100% mentioning

confidence: 58%

“…30 An SVR rate of 97% was also reported in 142 patients who had not responded to a previous interferon-based triple regimen containing first generation protease inhibitors (boceprevir or telaprevir), who were enrolled in four studies including the largest one from Hungary. 31 Unfortunately, safety data were only provided in a few studies. Table 3 the frequency of discontinuation due to adverse events, which can be considered to be a universal indicator of clinically significant adverse events, did not exceed 2.4%.…”

Section: Obv/ptv/r±dsv±rbv: Sustained Virologic Response In 92%-100mentioning

confidence: 99%

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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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Section: Obv/ptv/r±dsv±rbv: Sustained Virologic Response In 92%‐100% mentioning

confidence: 58%

Section: Obv/ptv/r±dsv±rbv: Sustained Virologic Response In 92%-100mentioning

confidence: 99%

Hepatitis C: efficacy and safety in real life

Flisiak

Pogorzelska

Flisiak-Jackiewicz

2017

Liver International

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“…Finally, while data regarding virologic outcomes in individuals who failed PEG‐IFN + RBV + PI ‘triple’ therapy is limited, we observed 100% effectiveness (16/16 patients) in this group. A similar SVR rate of 96.8% was recently demonstrated in a population of 62 patients who failed previous boceprevir‐ or telaprevir‐based regimen …”

Section: Discussionmentioning

confidence: 94%

Real‐world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study

Flisiak¹,

Janczewska²,

Wawrzynowicz‐Syczewska³

et al. 2016

Aliment Pharmacol Ther

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Summary Background Virologic and safety outcomes of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PTV/r ± DSV ± RBV) therapy have shown high sustained virologic response (SVR) rates and good tolerability in most patient populations in pre‐registration studies. Aim To confirm these clinical trial findings in the treatment of genotype 1 and 4 hepatitis C under real‐world conditions. Methods Patients enrolled for treatment with OBV/PTV/r ± DSV ± RBV based on therapeutic guidelines were included, and the regimen was administered according to product characteristics. Clinical and laboratory data, including virologic response, were collected at baseline, end of treatment (EOT) and 12 weeks after EOT. Results A total of 209 patients with chronic hepatitis C were enrolled, most were genotype 1b‐infected (84.2%) and 119 (56.9%) had liver cirrhosis. Among these, 150 (71.7%) had failed previous anti‐viral therapies and 84 (40.2%) were null‐responders. At 12 weeks after EOT, SVR was achieved by 207 (99.0%) patients, ranging from 96.4% to 100.0% across subgroups. All Child–Pugh B and post‐orthotopic liver transplantation patients achieved SVR. Adverse events occurred in 151 (72.2%) patients and were mostly mild and associated with the use of RBV. Serious adverse events, including hepatic decompensation, renal insufficiency, anaemia, hepatotoxicity and diarrhoea, were reported in eight (3.8%) patients. In five (2.4%) patients, adverse events led to treatment discontinuation. On‐treatment decompensation was experienced by seven (3.3%) patients. Conclusions The results of our study confirm previous findings. They demonstrate excellent effectiveness and a good safety profile of OBV/PTV/r± DSV±RBV in HCV genotype 1‐infected patients treated in the real‐world setting.

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“…In a relatively small but important study Hunyady et al . [ 13 ] demonstrated that failure of the interferon-based triple regimen containing the first generation protease inhibitor boceprevir or telaprevir did not affect the high efficacy of OBV/PTV/r ± DSV ± RBV (SVR rate 98%).…”

Section: Real-world Experiencementioning

confidence: 99%

Real-world experience with ombitasvir/paritaprevir boosted with ritonavir and possibly combined with dasabuvir and ribavirin in HCV infection

Pogorzelska

Flisiak

2016

ceh

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Ombitasvir/paritaprevir boosted with ritonavir and possibly combined with dasabuvir and ribavirin (OBV/PTV/r ± DSV ± RBV) is a new direct-acting antiviral (DAA) regimen which has improved efficacy of chronic hepatitis C virus (HCV) treatment significantly. OBV/PTV/r ± DSV ± RBV in clinical trials demonstrated sustained viral response (SVR) rates close to 100%. In this article we collected currently available data of 5726 patients for evaluation of OBV/PTV/r ± DSV ± RBV efficacy and safety in real-world experience. The sustained viral response rate in this large population was 97%, and it was exactly the same even in patients with liver cirrhotics. According to this meta-analysis, less than 3% of patients discontinued treatment due to adverse events.

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Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin (3D + RBV) Treatment of Hepatitis C (HCV) Genotype 1 (GT1) Infected Patients (pts) after Failure to Previous First Generation Protease-Inhibitor (PI) Therapy Interim Analysis

Cited by 6 publications

References 0 publications

Hepatitis C: efficacy and safety in real life

Hepatitis C: efficacy and safety in real life

Real‐world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study

Real-world experience with ombitasvir/paritaprevir boosted with ritonavir and possibly combined with dasabuvir and ribavirin in HCV infection

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