FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4254100890> ?p ?o ?g. }

• W4254100890 endingPage "1521" @default.
• W4254100890 startingPage "1520" @default.
• W4254100890 abstract "We have read with interest the letter by Pearlman et al. in response to our article entitled “Randomized Trial of Peginterferon Alfa-2b and Ribavirin for 48 or 72 Weeks in Patients With Hepatitis C Virus Genotype 1 and Slow Virologic Response.”1 They strongly disagree with our statement that “extending treatment in slowly responding patients requires reevaluation.” According to the results of our study, in which a slight increase in sustained virologic response (SVR) rates (5%) was observed in slow responders when the treatment was prolonged to 72 weeks (P = 0.644), it is clear that not all patients will benefit from extended therapy. In addition, more therapy discontinuations and an important increase in cost were observed with 72 weeks of treatment; these observations should prompt a reevaluation of therapy prolongation.1 As for the specific points, it was estimated that 120 slow responders would be required to detect a 25% difference in SVR rates between patients treated for 48 weeks and patients treated for 72 weeks (i.e., 45% and 70%, respectively, with a two-sided alpha value of 0.05) with at least 80% power and to avoid a type II error. For this reason, 1400 patients were included, and the large number of centers allowed for rapid enrollment. Overall, 73 centers enrolled the 120 slow responders. The proportion of slow responders in different studies has ranged from 11% to 20%.1-4 Only Pearlman et al.'s study5 had a higher proportion of slow responders (31%), and the authors concluded that this was due to a higher proportion of patients with poor baseline prognostic factors (34% of the patients had a high body mass index >30 kg/m2, 18% had a fasting glucose level >100 mg/dL, 48% were African American, and 26% had advanced fibrosis). However, in their article, the baseline characteristics of the patients were not correlated with the eventual response (e.g., rapid virologic response, slow response, or nonresponse), and this prevented any opportunity for assessing whether the poor baseline prognostic factors were associated with slow responders. However, these poor baseline factors have been associated with nonresponse, but their association with slow response is still unknown. The population of slow responders has not been well characterized, likely because the majority of studies include relatively few slow responders. The percentage of patients with advanced fibrosis or cirrhosis has varied widely in different trials (8%-37%).1-5 In addition, baseline predictors of the virologic response, such as the percentage of patients with advanced liver fibrosis or cirrhosis, pretreatment viral loads, body mass index, and γ-glutamyltransferase levels, have varied significantly between the different trials. Only one study of slow responders reported these variables, and it demonstrated that the proportions of patients with a high body weight and advanced fibrosis were similar for those achieving rapid virologic response and slow responders.4 Because the majority of the studies did not include African American patients and did not report SVR results according to body weight, baseline glucose levels, insulin resistance, and advanced fibrosis, it is not possible to determine whether patients with these poor prognostic factors were more often slow responders and, more importantly, whether they could have benefited from extended therapy. In other words, can extending the duration of therapy to 72 weeks increase SVR rates among patients with advanced age, a higher body weight, advanced fibrosis, high levels of fasting glucose, and a slow virologic response? As for the exclusion of patients weighing more than 125 kg in our study, the reason was our desire to evaluate the effect of an adequate dosage of ribavirin on SVR in a way similar to that used in the Individualized Dosing Efficacy Versus Flat Dosing to Assess Optimal Pegylated Interferon Therapy study.6 In addition, our study was conducted in countries outside the United States; these countries have far fewer obese patients (>125 kg) and no African American patients. Hence, patients with these characteristics were not included in our study. Finally, two different groups have examined the use of other time points for hepatitis C virus RNA levels as thresholds for selecting patients for treatment extension to 72 weeks, but the advantage is unclear and seems limited.7, 8 For this reason, we discussed only the most relevant aspects. The level of evidence supporting an extended duration of standard-of-care therapy is now much weaker. There exists a need to characterize the baseline prognostic factors of slow responders to determine if patients with poor prognostic factors benefit from an extended treatment duration in comparison with those with more favorable prognostic factors. Maria Buti M.D.* , Rafael Esteban M.D.* , * Liver Unit, Vall d'Hebron University Hospital, Barcelona, Spain, Network Center for Biomedical Research in Hepatic and Digestive Diseases, Barcelona, Spain." @default.
• W4254100890 created "2022-05-12" @default.
• W4254100890 creator A5047015665 @default.
• W4254100890 creator A5079557826 @default.
• W4254100890 date "2010-09-28" @default.
• W4254100890 modified "2023-10-04" @default.
• W4254100890 title "Reply:" @default.
• W4254100890 doi "https://doi.org/10.1002/hep.23951" @default.
• W4254100890 hasPublicationYear "2010" @default.
• W4254100890 type Work @default.
• W4254100890 citedByCount "0" @default.
• W4254100890 crossrefType "journal-article" @default.
• W4254100890 hasAuthorship W4254100890A5047015665 @default.
• W4254100890 hasAuthorship W4254100890A5079557826 @default.
• W4254100890 hasBestOaLocation W42541008901 @default.
• W4254100890 hasConcept C126322002 @default.
• W4254100890 hasConcept C203014093 @default.
• W4254100890 hasConcept C2522874641 @default.
• W4254100890 hasConcept C2780040827 @default.
• W4254100890 hasConcept C3020491458 @default.
• W4254100890 hasConcept C71924100 @default.
• W4254100890 hasConcept C90924648 @default.
• W4254100890 hasConceptScore W4254100890C126322002 @default.
• W4254100890 hasConceptScore W4254100890C203014093 @default.
• W4254100890 hasConceptScore W4254100890C2522874641 @default.
• W4254100890 hasConceptScore W4254100890C2780040827 @default.
• W4254100890 hasConceptScore W4254100890C3020491458 @default.
• W4254100890 hasConceptScore W4254100890C71924100 @default.
• W4254100890 hasConceptScore W4254100890C90924648 @default.
• W4254100890 hasIssue "4" @default.
• W4254100890 hasLocation W42541008901 @default.
• W4254100890 hasOpenAccess W4254100890 @default.
• W4254100890 hasPrimaryLocation W42541008901 @default.
• W4254100890 hasRelatedWork W157323825 @default.
• W4254100890 hasRelatedWork W1985882441 @default.
• W4254100890 hasRelatedWork W2150875695 @default.
• W4254100890 hasRelatedWork W2252432555 @default.
• W4254100890 hasRelatedWork W2368217940 @default.
• W4254100890 hasRelatedWork W2379273009 @default.
• W4254100890 hasRelatedWork W2401212871 @default.
• W4254100890 hasRelatedWork W2418726410 @default.
• W4254100890 hasRelatedWork W2461318346 @default.
• W4254100890 hasRelatedWork W2185961102 @default.
• W4254100890 hasVolume "52" @default.
• W4254100890 isParatext "false" @default.
• W4254100890 isRetracted "false" @default.
• W4254100890 workType "article" @default.