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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
  • Brooke Army Medical Center
  • Bon Secours Health System
  • Ministry of Defence of the Russian Federation
  • Medical University of Silesia
  • Fundacion de Investigación de Diego Santurce
  • Universidade Estadual Paulista (UNESP)
  • Hospital de Clinicas de Porto Alegre
  • IST GmbH
  • University of Pennsylvania
  • 0192-0790
  • 1539-2031
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.
Issue Date: 
Journal of Clinical Gastroenterology, v. 47, n. 3, p. 271-279, 2013.
Time Duration: 
  • 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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Appears in Collections:Artigos, TCCs, Teses e Dissertações da Unesp

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