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47 protocols using pegasys

1

Peg-IFN, ADV, and TDF in Chronic HBV

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Patients were randomly assigned (1:1:1) to receive pegylated interferon alfa-2a (Peg-IFN, Pegasys; F Hoffman–La Roche, Basel, Switzerland) 180 μg/week in combination with either adefovir dipivoxil (ADV, Hepsera; Gilead Sciences, Foster City, CA, USA) 10 mg daily or tenofovir disoproxil fumarate (TDF, Viread; Gilead Sciences, Foster City, CA, USA) 245 mg daily, or no treatment for 48 weeks. Randomisation was stratified according to HBV genotype A, genotype B–G, or indeterminable genotype. Patients who received at least one dose of study medication or attended at least one study visit (no-treatment group) were included in the modified intention to treat analysis (n = 134). Liver biopsies for fibrosis grading were taken at baseline and at week 48.
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2

Chronic HCV Infection: Peripheral B Cell Study

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Peripheral B lymphocytes were studied in 20 patients with chronic HCV infection (anti-HCV+/HCV-RAN+) and 17 age- and sex-matched healthy controls. Twenty HCV patients were treated with Peg-IFN-α-2a (Pegasys, Roche) and RBV for 6–12 months, depending on the different genotypes, and all of them achieved an early virological response (EVR, defined as serum HCV RNA being undetectable, <100 copies/ml, at week 12) and sustained virological response (SVR, defined as HCV RNA remaining undetectable after discontinuation of treatment for at least 6 months), respectively. Basic information on the HCV patients and healthy subjects are described in Table 1. All treatment-naïve patients tested positive for anti-HCV by enzyme-linked immunosorbent assay (Kechuang and Xinhua, Shanghai, China). HCV RNA titers were measured using a fluorescent quantitative transcription polymerase chain reaction (FQ-PCR) assay (Qiagen, Shenzhen, China), with a lower limit of detection of 100 copies/mL. Patients co-infected with hepatitis B, hepatitis D and HIV were excluded. These studies were approved by the Research and Ethical Committee of Tangdu Hospital of the Fourth Military Medical University, and all subjects gave written informed consent in accordance with the Declaration of Helsinki.
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3

Peg-IFN Alpha-2a Add-on Therapy Effectiveness

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This study was a single center, prospective, observational study. After being informed of the benefits and risks of the peg-IFN α-2a therapy, patients were given the choice between receiving either 180 μg of peg-IFN α-2a (Pegasys; Roche, Shanghai, China) add-on therapy once weekly to an ongoing NA regimen (add-on group) or continuous NA monotherapy (monotherapy group). The dosage of peg-IFN α-2a was adjusted to 135 μg/wk if the neutrophil counts were ≤ 0.75 × 109/L or PLT < 50 × 109/L. Peg-IFN α-2a was discontinued if the neutrophil counts were ≤ 0.50 × 109/L, PLT < 25 × 109/L or serious adverse events (AEs) occurred. The total duration of peg-IFN α-2a add-on therapy was 48 wk. All groups were followed up to week 72 (24 wk after discontinuation of peg-IFN α-2a). Patients discontinued the NA therapy if HBsAg was negative at week 72. The primary endpoint was HBsAg clearance at week 72 and the secondary endpoints included the rate of HBsAg clearance at week 48, the rates of HBsAg seroconversion at weeks 48 and 72, HBsAg, ALT and aspartate aminotransferase (AST) dynamics over time and the safety during treatment.
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4

MERS-CoV Treatment Comparison: RBV/rIFN vs. Control

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The main exposure was RBV/rIFN therapy, defined as the use of RBV/rIFN combination, RBV alone, or rIFN alone. The comparator group was the use of neither RBV nor rIFN. Three different types of rIFNs were used in the current cohort: rIFN-α2a (Pegasys, Hoffmann-La Roche, c/o Genentech, South San Francisco, California); rIFN-α2b (PEG-Intron, Merck Sharp & Dohme, Whitehouse Station, New Jersey); and rIFN-β1a (Rebif, Serono, Rockland, Massachusetts). Commonly used dosing protocols for RBV/rIFN for patients with MERS in the participating hospitals are shown in Supplementary Table 1.
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5

Chronic Hepatitis C Treatment Protocol

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Patients with chronic hepatitis C were treated with pegylated IFNα-2a (PegIFNα-2a; 135µg/week for body weight < 60 kg and 180µg/week for body weight ≥ 60 kg, subcutaneously; Pegasys, Roche, Basel, Switzerland) plus weight-based RBV (13–15 mg/kg per day; Zhejiang Chengyi Pharmaceutical Co., Ltd, Zhejiang, China). Treatment continued for 44 weeks after HCV RNA was undetectable. Standard definitions of responses were used. Complete early virological response (cEVR) was defined as undetectable plasma HCV RNA at week 12 during therapy, and sustained virological response (SVR) was defined as undetectable HCV RNA at 24 weeks after planned end of treatment.
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6

Peginterferon and Ribavirin for Chronic Hepatitis C in Hemophilia

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This study was designed as a single-center open-label one-arm observational study of peginterferon α-2a (Pegasys, Roche, Basel, Switzerland) and ribavirin (Copegus, Roche) combination therapy of CHC infection in hemophilia A. The duration on enrollment was 22 months, from March 2007 to December 2008. Eligible patients received 180 µg of peginterferon α-2a subcutaneously once a week in combination with 800-1,200 mg of oral ribavirin per day, according to their genotype and body weight. Patients with virus genotypes 1 or 6 with a weight below 75 kg were given 1,000 mg of oral ribavirin per day, while patients over 75 kg received 1,200 mg of oral ribavirin daily. Patients with virus genotypes 2 or 3 were given a constant ribavirin dose of 800 mg/day. The treatment duration for genotype 1 or 6 infections was 48 weeks, and 24 weeks for patients with genotypes 2 or 3.9
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7

Comparative Evaluation of PEG-IFN Treatments

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PFN α-2a (Pegasys; Hoffman LaRoche, Clifton, NJ) and PFN α-2b (Pegintron; Merck Sharp & Dohme, Boston, MA) were used to treat chronic HCV in the included patients. Patients were recruited from the practices of 2 different clinicians (Clinician A and Clinician B). At the time of treatment prescription, patients were given information about the 2 drugs, and most patients agreed to the clinicians' recommendation regarding the allocation of treatment. The α-2a regimen was recommended for the majority of patients treated by Clinician A, while α-2b was recommended for the majority of patients treated by Clinician B. PEG-IFN α-2a was administered to patients treated in the outpatient department (not allocated by clinicians) who were treated by Clinician A, while PEG-IFN α-2b was administered to those treated by Clinician B. Dosages varied by IFN formulation and by individual patient but, generally, α-2a was administered as a fixed once-weekly dose, while α-2b was administered weekly according to patient body weight.
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8

Hepatitis C Treatment Regimen in Taiwan

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Oral RBV plus subcutaneous PEG-IFN-α-2a (180 μg; Pegasys®; Hoffmann-La Roche, Basel, Switzerland) or subcutaneous PEG-IFN-α-2b (1.5 μg/kg; PegIntron®; Schering-Plough Corp., Kenilworth, NJ, USA) was administered to eligible patients for 6 months. The fixed duration (6 months) without consideration of HCV genotypes is due to restrictions imposed by the reimbursement policy of the Bureau of National Health Insurance in Taiwan. The dose of oral RBV was 800 mg/day for patients who weighed <55 kg, 1,000 mg/day for patients who weighed 55–75 kg, and 1,200 mg/day for patients who weighed >75 kg. Dose adjustments of all drugs and administration of supplemental erythropoietin or blood transfusion were determined according to published practice guidelines.18 (link)–20 (link)
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9

Pegylated Interferon and DAA Therapy Regimens

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Patients received pegIFN- or DAA-based therapy. Those who received pegIFN-based therapy were prescribed pegIFN α-2a (Pegasys, Hoffmann-La Roche, Basel, Switzerland) at a dosage of 180 μg/week or pegIFN α-2b (Peg-Intron, Merck & Co., Inc., Kenilworth, NJ, USA) at a dosage of 1.5 μg/kg/week subcutaneously, and were administered oral RBV at a daily dosage of 1000 mg (body weight < 75 kg) or 1200 mg (body weight ≥ 75 kg) for 24 or 48 weeks depending on each patient’s virologic response at week 4 [12 (link)]. Doses of RBV (mg/kg/day) during treatment were calculated for each patient.
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10

Response-Guided Treatment for HDV Suppression

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The ultimate aim was to achieve complete virological suppression of HDV‐RNA replication. Based on our initial experience we adopted a response‐guided approach.
Patients who achieved virological response on BLV monotherapy at week 24 continued BLV monotherapy and were offered to terminate treatment if HDV‐RNA remained undetectable at least at three time points within 6 months. In patients without further HDV‐RNA decline after week 24–48 combination therapy with PEG‐IFN alfa‐2a (Pegasys®, Roche) was initiated irrespective of the response classification (see Figure 1B).
As safety parameters, routine laboratory parameters including blood cell counts and liver biochemistries were collected. In addition, HBsAg levels were quantified (Architect, Abbott) and bile acid levels were measured.
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