Identification of naïve HCV-1 patients with chronic hepatitis who may benefit from dual therapy with peg-interferon and ribavirin

Andriulli, Angelo; Marco, Vito Di; Margaglione, Maurizio; Ippolito, A.; Fattovich, Giovanna; Smedile, Antonina; Valvano, Maria Rosa; Calvaruso, Vincenza; Gioffreda, Domenica; Milella, Michele Stanislaw; Morisco, Filomena; Felder, Martina; Brancaccio, Giuseppina; Fasano, M.; Gatti, Pietro; Tundo, Paolo; Barone, M.; Cozzolongo, Raffaele; Angélico, M.; D’Andrea, Giovanna; Andriulli, Nicola; Abate, Maria Lorena; Mazzella, Giuseppe; Gaeta, Giovanni Battista; Santantonio, T.

doi:10.1016/j.jhep.2013.07.040

Cited by 24 publications

(30 citation statements)

References 22 publications

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“…High baseline viraemia is a known risk factor for virological-failure [30,31], and thus its correlation with lower responsiveness is not surprising. The slope of second phase decline, on the other hand, directly depends on treatment efficacy, as previously demonstrated [3].…”

Section: Discussionmentioning

confidence: 99%

Hepatitis C virus RNA levels at week-2 of telaprevir/boceprevir administration are predictive of virological outcome

Cento

Paolo

Carlo

et al. 2015

Digestive and Liver Disease

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a b s t r a c tBackground: Triple therapy with telaprevir/boceprevir + pegylated-interferon + ribavirin can achieve excellent antiviral efficacy, but it can be burdened with resistance development at failure. Aims: To evaluate kinetics of hepatitis C virus (HCV) RNA decay and early resistance development, in order to promptly identify patients at highest risk of failure to first generation protease inhibitors. Methods: HCV-RNA was prospectively quantified in 158 patients receiving pegylatedinterferon + ribavirin + telaprevir (N = 114) or + boceprevir (N = 44), at early time-points and during per protocol follow-up. Drug resistance was contextually evaluated by population sequencing. Results: HCV-RNA at week-2 was significantly higher in patients experiencing virological failure to triple-therapy than in patients with sustained viral response (2.3 [1.9-2.8] versus 1.2 [0.3-1.7] log IU/mL, p < 0.001). A 100 IU/mL cut-off value for week-2 HCV-RNA had the highest sensitivity (86%) in predicting virological success. Indeed, 23/23 (100%) patients with undetectable HCV-RNA reached success, versus 26/34 (76.5%) patients with HCV-RNA < 100 IU/mL, and only 11/31 (35.5%) with HCV-RNA > 100 IU/mL (p < 0.001). Furthermore, differently from failing patients, none of the patient with undetectable HCV-RNA at week-2 had baseline/early resistance. Cento et al. / Digestive and Liver Disease xxx (2014) xxx-xxx Conclusions: With triple therapy based on first generation protease inhibitors, suboptimal HCV-RNA decay at week-2 combined with early detection of resistance can help identifying patients with higher risk of virological failure, thus requiring a closer monitoring during therapy.

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Section: Discussionmentioning

confidence: 99%

Hepatitis C virus RNA levels at week-2 of telaprevir/boceprevir administration are predictive of virological outcome

Cento

Paolo

Carlo

et al. 2015

Digestive and Liver Disease

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“…Virological analyses and IL28B genotyping were conducted as previously reported [7]. Commercial assays were used to measure HCV RNA levels at local investigational sites, but real-time PCR based methods were used in all centres: levels below the lower limit of quantification at treatment week 4 or at week 24 of follow up off therapy were taken as indicative of RVR or SVR, respectively.…”

Section: Methodsmentioning

confidence: 99%

“…These patients were used as a model derivation cohort. Main characteristics of patients, as well as relevant inclusion and exclusion criteria, have been presented elsewhere [7]. Baseline features recorded included age, gender, serum levels of alanine-aminotransferase (ALT), and gamma-glutamyl transferase (␥GT), blood platelet counts, HCV viraemia levels, genotypes of the IL28B locus, diabetes and the stage of liver fibrosis.…”

Section: Patientsmentioning

confidence: 99%

“…These patients were recruited between 2003 and 2012 at 7 Italian centres who did not participate in the previous study [7].…”

Section: Patientsmentioning

confidence: 99%

“…For patients with hepatitis C virus genotype 1 (HCV-1) infection, triple therapy with peg-interferon and ribavirin (PEG/RBV) plus Patients who clear the virus after the initial 4 weeks of PEG/RBV therapy are the best candidates to obtain viral eradication [7]. By pooling data from several trials, we estimated that this condition may be achieved by 25-30% of naïve HCV-1 patients in Europe and in Australasia [8].…”

Section: Introductionmentioning

confidence: 99%

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An a priori prediction model of response to peginterferon plus ribavirin dual therapy in naïve patients with genotype 1 chronic hepatitis C

Andriulli

Nardi

Marco

et al. 2014

Digestive and Liver Disease

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Peg-interferon and ribavirin treatment Predictors of sustained virological response, Rapid virological response a b s t r a c t Background: Aim was to select naïve patients with genotype 1 chronic hepatitis C having a high probability of response to Peg-interferon + ribavirin therapy. Methods: In 1073 patients (derivation cohort), predictors of rapid and sustained virological response were identified by logistic analysis; regression coefficients were used to generate prediction models for sustained virological response. Probabilities at baseline and treatment week 4 were utilized to develop a decision rule to select patients with high likelihood of response. The model was then validated in 423 patients (validation cohort). Results: In the derivation cohort, 257 achieved rapid virological response and 818 did not, with sustained virological response rates of 80.2% and 25.4%, respectively; interleukin-28B polymorphisms, fibrosis staging, gamma-glutamyl transferase, and viral load predicted sustained virological response. Assuming a <30% sustained virological response probability for not recommending Peg-interferon + ribavirin, 100 patients (25.6%) in the validation cohort were predicted a priori to fail this regimen. Assuming a ≥80% sustained virological response probability as a threshold to continue with Peg-interferon + ribavirin, 61 patients were predicted to obtain sustained virological response, and 55 of them (90.2%) eventually did. Conclusions: This model uses easily determined variables for a personalized estimate of the probability of sustained virological response with Peg-interferon + ribavirin, allowing to identify patients who may benefit from conventional therapy.

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HCV genotype 1 subtypes (1a and 1b): similarities and differences in clinical features and therapeutic outcome

Andriulli

Morisco²,

Ippolito

et al. 2014

Hepatol Int

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Short title: HCV subtypes 1a and 1b and treatment outcome after peg-interferon and ribavirin Key words: HCV genotype, HCV subtypes, chronic HCV liver disease, sustained virologic response, peg-interferon and ribavirin. Abstract words count: 254Full text words count: Tables # 2 o3 Figures # 2 Conclusion: in Italy HCV-1 subtype 1a prevails in young, male patients with less advanced liver damage, findings which imply a more recent spreading of the infection with this viral strain. The two HCV-1 subtypes appear equally responsive to Peg-IFN/RIBA, with IL28B genotyping and monitoring of RVR mostly influencing the therapeutic response.

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Identification of naïve HCV-1 patients with chronic hepatitis who may benefit from dual therapy with peg-interferon and ribavirin

Abstract: The pool of HCV genotype 1 patients likely to be cured by peg-interferon and ribavirin remains to be quantified

Cited by 24 publications

References 22 publications

Hepatitis C virus RNA levels at week-2 of telaprevir/boceprevir administration are predictive of virological outcome

Hepatitis C virus RNA levels at week-2 of telaprevir/boceprevir administration are predictive of virological outcome

An a priori prediction model of response to peginterferon plus ribavirin dual therapy in naïve patients with genotype 1 chronic hepatitis C

HCV genotype 1 subtypes (1a and 1b): similarities and differences in clinical features and therapeutic outcome

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