Publicação: Intensified peginterferon α-2a dosing increases sustained virologic response rates in heavy, high viral load hepatitis c genotype 1 patients with high low-density lipoprotein
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BACKGROUND AND GOAL: Patients infected with hepatitis C virus (HCV) with elevated low-density lipoprotein (LDL) levels achieve higher sustained virologic response (SVR) rates after peginterferon (PegIFN)/ribavirin treatment versus patients with lower LDL. Our aim was to determine whether SVR rates in patients with low/elevated LDL can be improved by dose intensification. STUDY: In PROGRESS, genotype 1 patients with baseline HCV RNA≥400,000 IU/mL and body weight ≥85 kg were randomized to 48 weeks of 180 μg/wk PegIFN α-2a (40 kDa) plus ribavirin (A: 1200 mg/d; B: 1400/1600 mg/d) or 12 weeks of 360 μg/wk PegIFN α-2a followed by 36 weeks of 180 μg/wk, plus ribavirin (C: 1200 mg/d; D: 1400/1600 mg/d). This retrospective analysis assessed SVR rates among patients with low (<100 mg/dL) or elevated (≥100 mg/dL) LDL. Patients with high LDL (n=256) had higher baseline HCV RNA (5.86×10 IU/mL) versus patients with low LDL (n=262; 4.02×10 IU/mL; P=0.0003). RESULTS: Multiple logistic regression analysis identified a significant interaction between PegIFN α-2a dose and LDL levels on SVR (P=0.0193). The only treatment-related SVR predictor in the nested multiple logistic regression was PegIFN α-2a dose among patients with elevated LDL (P=0.0074); therefore, data from the standard (A+B) and induction (C+D) dose arms were pooled. Among patients with low LDL, SVR rates were 40% and 35% in the standard and induction-dose groups, respectively; SVR rates in patients with high LDL were 44% and 60% (P=0.014), respectively. CONCLUSIONS: Intensified dosing of PegIFN α-2a increases SVR rates in patients with elevated LDL even with the difficult-to-cure characteristics of genotype 1, high baseline viral load, and high body weight. Copyright © 2013 by Lippincott Williams & Wilkins.
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chronic hepatitis C, low-density lipoprotein, pegylated interferon, ribavirin, sustained virologic response, low density lipoprotein, peginterferon alpha2a, peginterferon alpha2a plus ribavirin, adult, aged, alopecia, anemia, anorexia, arthralgia, asthenia, body weight, chill, coughing, depression, diarrhea, drug fatality, drug safety, drug tolerability, dry skin, fatigue, female, fever, genotype, hepatitis C, human, injection site erythema, insomnia, irritability, major clinical study, male, myalgia, nausea, neutropenia, priority journal, pruritus, rash, relapse, side effect, treatment duration, treatment response, virus load, vomiting, weight reduction, xerostomia, Adolescent, Adult, Aged, Aged, 80 and over, Antiviral Agents, Body Weight, Cholesterol, LDL, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Genotype, Hepacivirus, Hepatitis C, Humans, Interferon-alpha, Logistic Models, Male, Middle Aged, Polyethylene Glycols, Randomized Controlled Trials as Topic, Recombinant Proteins, Retrospective Studies, Ribavirin, RNA, Viral, Treatment Outcome, Viral Load, Young Adult
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Journal of Clinical Gastroenterology, v. 47, n. 3, p. 271-279, 2013.
