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R. Focaccia

Bio: R. Focaccia is an academic researcher. The author has contributed to research in topics: Telaprevir & Ribavirin. The author has an hindex of 9, co-authored 12 publications receiving 1876 citations.

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Journal ArticleDOI
TL;DR: Telaprevir combined with peginterferon plus ribavirin significantly improved rates of sustained virologic response in patients with previously treated HCV infection, regardless of whether there was a lead-in phase.
Abstract: Methods In this randomized, phase 3 trial, we evaluated the addition of telaprevir to peginter feron alfa-2a plus ribavirin in patients with HCV genotype 1 infection who had no response or a partial response to previous therapy or who had a relapse after an initial response. A total of 663 patients were assigned to one of three groups: the T12PR48 group, which received telaprevir for 12 weeks and peginterferon plus ribavirin for a total of 48 weeks; the lead-in T12PR48 group, which received 4 weeks of peginterferon plus ribavirin followed by 12 weeks of telaprevir and peginterferon plus ribavirin for a total of 48 weeks; and the control group (PR48), which received peginterferon plus ribavirin for 48 weeks. The primary end point was the rate of sustained virologic response, which was defined as undetectable HCV RNA 24 weeks after the last planned dose of a study drug. Results Rates of sustained virologic response were significantly higher in the two telaprevir groups than in the control group among patients who had a previous relapse (83% in the T12PR48 group, 88% in the lead-in T12PR48 group, and 24% in the PR48 group), a partial response (59%, 54%, and 15%, respectively), and no response (29%, 33%, and 5%, respectively) (P<0.001 for all comparisons). Grade 3 adverse events (mainly anemia, neutropenia, and leukopenia) were more frequent in the telaprevir groups than in the control group (37% vs. 22%). Conclusions Telaprevir combined with peginterferon plus ribavirin significantly improved rates of sustained virologic response in patients with previously treated HCV infection, re gardless of whether there was a lead-in phase. (Funded by Tibotec and Vertex Phar maceuticals; REALIZE ClinicalTrials.gov number, NCT00703118.)

1,558 citations

Journal ArticleDOI
TL;DR: In this retrospective analysis, IL28B genotype did not contribute to outcome prediction in prior treatment-experienced patients treated with a telaprevir-based regimen and thus, may be of limited utility in this setting.

61 citations

Journal ArticleDOI
TL;DR: The Phase 3 study REALIZE evaluated telaprevir (T) in combination with pegylated-IFN alfa-2a (P) and ribavirin (R) in well-characterised prior PR treatment-failure patients with priorPR treatment failure including non-responders (nulland partial- responders) and relapsers.

36 citations


Cited by
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Journal ArticleDOI
TL;DR: The optimal management of patients with acute and chronic HCV infections in 2018 and onwards is described, as well as developments in diagnostic procedures and improvements in therapy and prevention.

2,491 citations

Journal ArticleDOI
TL;DR: Once-daily ledipasvir-sofosbuvir with or without ribavirin for 12 or 24 weeks was highly effective in previously untreated patients with HCV genotype 1 infection.
Abstract: Background In phase 2 studies, treatment with the all-oral combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir resulted in high rates of sustained virologic response among previously untreated patients with hepatitis C virus (HCV) genotype 1 infection. Methods We conducted a phase 3, open-label study involving previously untreated patients with chronic HCV genotype 1 infection. Patients were randomly assigned in a 1:1:1:1 ratio to receive ledipasvir and sofosbuvir in a fixed-dose combination tablet once daily for 12 weeks, ledipasvir–sofosbuvir plus ribavirin for 12 weeks, ledipasvir–sofosbuvir for 24 weeks, or ledipasvir–sofosbuvir plus ribavirin for 24 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy. Results Of the 865 patients who underwent randomization and were treated, 16% had cirrhosis, 12% were black, and 67% had HCV genotype 1a infection. The rates of sustained virologic response were 99% (95% confide...

1,602 citations

Journal ArticleDOI
TL;DR: The Diagnosis and Management of Non-alcoholic Fatty Liver Disease: Practice Guideline by the American Gastroenterological Association, American Association for the Study of Liver Diseases, and American College of GastroEnterology is published.

1,515 citations

01 Jan 2013
TL;DR: The EASL CPGs on the management of HCV infection will be updated on a regular basis upon approval of additional novel therapies, and will apply to therapies that are approved at the time of their publication.
Abstract: Hepatitis C virus (HCV) infection is one of the main causes of chronic liver disease worldwide [1]. The long-term hepatic impact of HCV infection is highly variable, from minimal changes to chronic hepatitis, extensive fibrosis, and cirrhosis with or without hepatocellular carcinoma (HCC). The number of chronically infected persons worldwide may exceed 200 million, but most of them have no knowledge of their infection or of the ensuing hepatic condition. Clinical care for patients with HCV-related liver disease has advanced considerably during the last two decades, as a result of growing knowledge about the mechanisms of the disease, remarkable developments in diagnostic procedures, and advances in therapeutic and preventative approaches. Still, various aspects are not yet completely resolved. These EASL Clinical Practice Guidelines (CPGs) are intended to assist physicians and other healthcare providers, as well as patients and interested individuals, in the clinical decision-making process by describing optimal management of patients with acute and chronic HCV infections. These guidelines apply to therapies that are approved at the time of their publication. Several new therapeutic options have completed phase III development for patients infected with HCV genotype 1 and are currently awaiting licensing and approval in Europe and the United States. Therefore, the EASL CPGs on the management of HCV infection will be updated on a regular basis upon approval of additional novel therapies.

1,407 citations