Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin for Treatment-Naïve Hemodialysis Patients With Chronic Hepatitis C

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00491244
• Collaborator: National Science Council, Taiwan (Other), Department of Health, Executive Yuan, R.O.C. (Taiwan) (Other)
• Enrollment: 377
• Location: 1
• Arms: 2
• Duration (Months): 75
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

Chronic hepatitis C virus (HCV) infection is common in dialysis patients. Interferon (IFN)-based treatment for chronic hepatitis C has been the mainstay therapy in immunocompetent patients. In dialysis patients, treatment with conventional or pegylated interferon has also received much attention recently. Two meta-analyses evaluating the efficacy and safety of conventional IFN alfa monotherapy showed that the sustained virologic response (SVR) rates were 37% and 33%, respectively; and the corresponding dropout rates were 17% and 29.6%, respectively.The efficacy and safety of pegylated IFN alfa-2a and 2b in treating dialysis patients showed conflicting results, with a more favorable outcome of patients treated with pegylated IFN alfa-2a (135-180 μg/week: SVR 33-75%, well tolerated) than those treated with pegylated IFN alfa-2b (0.5-1.0 μg/week: SVR 12.5%, poorly tolerated. Currently, IFN-based therapy to treatment HCV infection should be initiated in dialysis stages, because the use of IFN in RT patients harbors high risks of acute graft rejection,and have low response rates under the concomitant use of immunosuppressive agents.

Ribavirin, which has been used in combination with IFN to treat chronic hepatitis C in the general patients and achieve a higher SVR rate than IFN monotherapy, is considered contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe hemolytic anemia. However, some pilot studies evaluating combined conventional IFN alfa plus low dose ribavirin (170-300 mg/day) showed SVR rates of 17%-66% after 24-48 weeks of treatment. In addition, a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 50%. In this study, treatment with pegylated IFN alfa-2a plus low dose ribavirin achieved a higher SVR rate that that with pegylated IFN alfa-2b plus low dose ribavirin (100% vs. 25%).

Based on the long-term favorable outcome in dialysis patients who eradicate HCV, and the superior response of pegylated IFN alfa-2a plus low dose ribavirin to pegylated IFN alfa-2b plus low dose ribavirin in treating dialysis patients with chronic hepatitis C, the aim of the study is to evaluate the efficacy and safety of pegylated IFN alfa-2a plus low dose ribavirin versus pegylated interferon alfa-2a alone in treatment naïve dialysis patients with chronic hepatitis C.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C	Drug: Peginterferon alfa-2a and ribavirin; Drug: Peginterferon alfa-2a	Phase 4

Detailed Description

Chronic hepatitis C virus (HCV) infection is common in dialysis patients, with the reported prevalence varying from 3% to 80% worldwide. (1-3) Although these patients usually have mild symptoms and moderate elevation of alanine transaminase levels, recent international collaborative survey and prospective studies found that anti-HCV seropositivity and positive HCV RNA were risk factors for mortality and hepatocellular carcinoma (HCC). (4-7) Furthermore, progressive hepatic fibrosis, poor patient and graft survival were observer in dialysis patients with HCV infection who undergo renal transplantation (RT), suggesting immunosuppression following RT may worsen the course of hepatic fibrosis and renal graft function. (8-13) These lines of evidence indicate that HCV infection in the dialysis population is an important issue to be tackled.

Interferon (IFN)-based treatment for chronic hepatitis C has been the mainstay therapy in immunocompetent patients. In dialysis patients, treatment with conventional or pegylated interferon has also received much attention recently. Two meta-analyses evaluating the efficacy and safety of conventional IFN alfa monotherapy showed that the sustained virologic response (SVR) rates were 37% and 33%, respectively; and the corresponding dropout rates were 17% and 29.6%, respectively.(14,15) The efficacy and safety of pegylated IFN alfa-2a and 2b in treating dialysis patients showed conflicting results, with a more favorable outcome of patients treated with pegylated IFN alfa-2a (135-180 μg/week: SVR 33-75%, well tolerated) than those treated with pegylated IFN alfa-2b (0.5-1.0 μg/week: SVR 12.5%, poorly tolerated), (16-21) which may result from different pharmacokinetic profiles between these two pegylated IFNs. Currently, IFN-based therapy to treatment HCV infection should be initiated in dialysis stages, because the use of IFN in RT patients harbors high risks of acute graft rejection,(22,23) and have low response rates under the concomitant use of immunosuppressive agents. (24,25) Ribavirin, which has been used in combination with IFN to treat chronic hepatitis C in the general patients and achieve a higher SVR rate than IFN monotherapy, is considered contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe hemolytic anemia. However, some pilot studies evaluating combined conventional IFN alfa plus low dose ribavirin (170-300 mg/day) showed SVR rates of 17%-66% after 24-48 weeks of treatment. (26-28) In addition, a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 50%. (29) In this study, treatment with pegylated IFN alfa-2a plus low dose ribavirin achieved a higher SVR rate that that with pegylated IFN alfa-2b plus low dose ribavirin (100% vs. 25%) Based on the long-term favorable outcome in dialysis patients who eradicate HCV, and the superior response of pegylated IFN alfa-2a plus low dose ribavirin to pegylated IFN alfa-2b plus low dose ribavirin in treating dialysis patients with chronic hepatitis C, the aim of the study is to evaluate the efficacy and safety of pegylated IFN alfa-2a plus low dose ribavirin versus pegylated interferon alfa-2a in treatment naïve dialysis patients with chronic hepatitis C.

Study Design

• Study Type: Interventional
• Actual Enrollment: 377 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin Versus Pegylated Interferon Alfa-2a Alone for Treatment-naïve Hemodialysis Patients With Chronic Hepatitis C
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peginterferon alfa-2a and ribavirin Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)	Drug: Peginterferon alfa-2a and ribavirin; Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks); Other Names: Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) Ribavirin (Copegus, F. Hoffman-LaRoche)
Experimental: Peginterferon alfa-2a Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)	Drug: Peginterferon alfa-2a; Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks); Other Names: Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche)

Outcome Measures

Primary Outcome Measures

1. Sustained Virologic Response (SVR)Rate [1.5 year]

Secondary Outcome Measures

1. Adverse Event (AE)-Related Withdrawal Rate [1.5 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18-65 years old

• Creatinine clearance (Ccr) < 15 ml/min/1.73 m2

• Anti-HCV (Abbott HCV EIA 3.0, Abbott Diagnostic, Chicago, IL) positive > 6 months

• Detectable serum quantitative HCV-RNA (Cobas Taqman HCV test, version 2, Roche Diagnostics) with a dynamic range of 25-391000000 IU/ml

Exclusion Criteria:

• Receiving interferon-based therapy for chronic hepatitis C

• Severe anemia (hemoglobin < 10 g/dL) or hemoglobinopathy

• Neutropenia (neutrophil count, <1,500/mm3)

• Thrombocytopenia (platelet <90,000/ mm3)

• Co-infection with HBV or HIV

• Chronic alcohol abuse (daily consumption > 20 g/day)

• Autoimmune liver disease

• Decompensated liver disease (Child classification B or C)

• Neoplastic disease

• An organ transplant

• Immunosuppressive therapy

• Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus

• Evidence of drug abuse

• Unwilling to have contraception

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital
• National Science Council, Taiwan
• Department of Health, Executive Yuan, R.O.C. (Taiwan)

Investigators

• Study Chair: Chen-Hua Liu, MD, Department of Internal Medicine, National Taiwan Universitys Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Annicchiarico BE, Siciliano M. Pegylated interferon-alpha 2b monotherapy for haemodialysis patients with chronic hepatitis C. Aliment Pharmacol Ther. 2004 Jul 1;20(1):123-4; author reply 124.
• Bruchfeld A, Lindahl K, Reichard O, Carlsson T, Schvarcz R. Pegylated interferon and ribavirin treatment for hepatitis C in haemodialysis patients. J Viral Hepat. 2006 May;13(5):316-21.
• Bruchfeld A, Ståhle L, Andersson J, Schvarcz R. Interferon and ribavirin therapy in dialysis patients with chronic hepatitis C. Nephrol Dial Transplant. 2001 Aug;16(8):1729.
• Bruchfeld A, Ståhle L, Andersson J, Schvarcz R. Ribavirin treatment in dialysis patients with chronic hepatitis C virus infection--a pilot study. J Viral Hepat. 2001 Jul;8(4):287-92.
• Casanovas-Taltavull T, Baliellas C, Benasco C, Serrano TT, Casanova A, Pérez JL, Guerrero L, González MT, Andres E, Gil-Vernet S, Casais LA. Efficacy of interferon for chronic hepatitis C virus-related hepatitis in kidney transplant candidates on hemodialysis: results after transplantation. Am J Gastroenterol. 2001 Apr;96(4):1170-7.
• Chan TM, Ho SK, Tang CS, Tse KC, Lam MF, Lai KN, Yung S. Pilot study of pegylated interferon-alpha 2a in dialysis patients with chronic hepatitis C virus infection. Nephrology (Carlton). 2007 Feb;12(1):11-7.
• Fabrizi F, Dulai G, Dixit V, Bunnapradist S, Martin P. Meta-analysis: interferon for the treatment of chronic hepatitis C in dialysis patients. Aliment Pharmacol Ther. 2003 Dec;18(11-12):1071-81. Review.
• Fabrizi F, Poordad FF, Martin P. Hepatitis C infection and the patient with end-stage renal disease. Hepatology. 2002 Jul;36(1):3-10. Review.
• Hou CH, Chen WY, Kao JH, Chen DS, Yang Y, Chen JJ, Lee SH, Wu DJ, Yang SC. Intrafamilial transmission of hepatitis C virus in hemodialysis patients. J Med Virol. 1995 Apr;45(4):381-5.
• Izopet J, Rostaing L, Sandres K, Cisterne JM, Pasquier C, Rumeau JL, Duffaut M, Durand D, Puel J. Longitudinal analysis of hepatitis C virus replication and liver fibrosis progression in renal transplant recipients. J Infect Dis. 2000 Mar;181(3):852-8.
• Kao JH, Huang CH, Chen W, Tsai TJ, Lee SH, Hung KY, Chen DS. GB virus C infection in hemodialysis patients: molecular evidence for nosocomial transmission. J Infect Dis. 1999 Jul;180(1):191-4.
• Kokoglu OF, Uçmak H, Hosoglu S, Cetinkaya A, Kantarceken B, Buyukbese MA, Isik IO. Efficacy and tolerability of pegylated-interferon alpha-2a in hemodialysis patients with chronic hepatitis C. J Gastroenterol Hepatol. 2006 Mar;21(3):575-80.
• Legendre C, Garrigue V, Le Bihan C, Mamzer-Bruneel MF, Chaix ML, Landais P, Kreis H, Pol S. Harmful long-term impact of hepatitis C virus infection in kidney transplant recipients. Transplantation. 1998 Mar 15;65(5):667-70.
• Magnone M, Holley JL, Shapiro R, Scantlebury V, McCauley J, Jordan M, Vivas C, Starzl T, Johnson JP. Interferon-alpha-induced acute renal allograft rejection. Transplantation. 1995 Apr 15;59(7):1068-70.
• Maisonneuve P, Agodoa L, Gellert R, Stewart JH, Buccianti G, Lowenfels AB, Wolfe RA, Jones E, Disney AP, Briggs D, McCredie M, Boyle P. Cancer in patients on dialysis for end-stage renal disease: an international collaborative study. Lancet. 1999 Jul 10;354(9173):93-9.
• Mathurin P, Mouquet C, Poynard T, Sylla C, Benalia H, Fretz C, Thibault V, Cadranel JF, Bernard B, Opolon P, Coriat P, Bitker MO. Impact of hepatitis B and C virus on kidney transplantation outcome. Hepatology. 1999 Jan;29(1):257-63.
• Morales JM. Hepatitis C virus infection and renal disease after renal transplantation. Transplant Proc. 2004 Apr;36(3):760-2. Review.
• Mousa DH, Abdalla AH, Al-Shoail G, Al-Sulaiman MH, Al-Hawas FA, Al-Khader AA. Alpha-interferon with ribavirin in the treatment of hemodialysis patients with hepatitis C. Transplant Proc. 2004 Jul-Aug;36(6):1831-4.
• Nakayama E, Akiba T, Marumo F, Sato C. Prognosis of anti-hepatitis C virus antibody-positive patients on regular hemodialysis therapy. J Am Soc Nephrol. 2000 Oct;11(10):1896-1902. doi: 10.1681/ASN.V11101896.
• Pereira BJ, Natov SN, Bouthot BA, Murthy BV, Ruthazer R, Schmid CH, Levey AS. Effects of hepatitis C infection and renal transplantation on survival in end-stage renal disease. The New England Organ Bank Hepatitis C Study Group. Kidney Int. 1998 May;53(5):1374-81.
• Potthoff A, Wiegand J, Lüth JB, Wedemeyer H, Manns MP, Tillmann HL. Superiority of standard interferon-alpha2b compared to pegylated interferon-alpha2b (12 kDa) in a hemodialysis patient with chronic hepatitis C? Clin Nephrol. 2005 Mar;63(3):232-5.
• Rostaing L, Izopet J, Baron E, Duffaut M, Puel J, Durand D. Treatment of chronic hepatitis C with recombinant alpha 2b interferon in kidney transplant recipients: preliminary results and side effects. Transplant Proc. 1995 Feb;27(1):948-50.
• Russo MW, Ghalib R, Sigal S, Joshi V. Randomized trial of pegylated interferon alpha-2b monotherapy in haemodialysis patients with chronic hepatitis C. Nephrol Dial Transplant. 2006 Feb;21(2):437-43. Epub 2005 Oct 18.
• Russo MW, Goldsweig CD, Jacobson IM, Brown RS Jr. Interferon monotherapy for dialysis patients with chronic hepatitis C: an analysis of the literature on efficacy and safety. Am J Gastroenterol. 2003 Jul;98(7):1610-5. Review.
• Sporea I, Popescu A, Sirli R, Golea O, Totolici C, Danila M, Vernic C. Pegylated-interferon alpha 2a treatment for chronic hepatitis C in patients on chronic haemodialysis. World J Gastroenterol. 2006 Jul 14;12(26):4191-4.
• Stehman-Breen CO, Emerson S, Gretch D, Johnson RJ. Risk of death among chronic dialysis patients infected with hepatitis C virus. Am J Kidney Dis. 1998 Oct;32(4):629-34.
• Vosnides GG. Hepatitis C in renal transplantation. Kidney Int. 1997 Sep;52(3):843-61.
• Zylberberg H, Nalpas B, Carnot F, Skhiri H, Fontaine H, Legendre C, Kreis H, Bréchot C, Pol S. Severe evolution of chronic hepatitis C in renal transplantation: a case control study. Nephrol Dial Transplant. 2002 Jan;17(1):129-33.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT00491244
• Other Study ID Numbers: 200703010M
• First Posted: Jun 26, 2007
• Last Update Posted: Feb 10, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by National Taiwan University Hospital: Chronic hepatitis C; Hemodialysis; Interferon; Ribavirin
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a

Study Results

Participant Flow

Recruitment Details	Recruitment from 1 June, 2007 to 9 May, 2012 Location: 8 academic centers in Taiwan

Arm/Group Title	Peginterferon and Ribavirin	Peginterferon
Arm/Group Description	Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)	Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
Period Title: Overall Study
STARTED	189	188
COMPLETED	162	168
NOT COMPLETED	27	20

Baseline Characteristics

Arm/Group Title	Peginterferon and Ribavirin	Peginterferon	Total
Arm/Group Description	Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)	Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)	Total of all reporting groups
Overall Participants	189	188	377
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	189 100%	188 100%	377 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51 (10)	51 (11)	51 (10)
Sex: Female, Male (Count of Participants)
Female	76 40.2%	76 40.4%	152 40.3%
Male	113 59.8%	112 59.6%	225 59.7%
Region of Enrollment (participants) [Number]
Taiwan	189 100%	188 100%	377 100%

Outcome Measures

1. Primary Outcome

Title	Sustained Virologic Response (SVR)Rate
Time Frame	1.5 year

Outcome Measure Data

Analysis Population Description

All participants were analyzed if they received at least one dose of the study medication

Arm/Group Title	Peginterferon and Ribavirin	Peginterferon
Arm/Group Description	Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)	Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
Measure Participants	189	188
Number [participants]	130 68.8%	72 38.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peginterferon and Ribavirin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.80
	Confidence Interval	(2-Sided) 95%; 1.46 to 2.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Adverse Event (AE)-Related Withdrawal Rate
Time Frame	1.5 year

Outcome Measure Data

Analysis Population Description

All patients were analyzed if they received at least one dose of the study medication; monitoring the events until the last visit

Arm/Group Title	Peginterferon and Ribavirin	Peginterferon
Arm/Group Description	Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)	Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
Measure Participants	189	188
Advese event related withdrawal rate	12 6.3%	7 3.7%
Non withdrawal	177 93.7%	171 91%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peginterferon and Ribavirin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.35
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.61
	Confidence Interval	(2-Sided) 95%; 0.65 to 4.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	18 months
Arm/Group Title	Peginterferon and Ribavirin		Peginterferon
Arm/Group Description	Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)		Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
All Cause Mortality
	Peginterferon and Ribavirin		Peginterferon
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Peginterferon and Ribavirin		Peginterferon
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/189 (4.2%)		7/188 (3.7%)
Cardiac disorders
Postural dizziness	2/189 (1.1%)	2	0/188 (0%)	0
Gastrointestinal disorders
Intractable diarrhea	1/189 (0.5%)	1	0/188 (0%)	0
Peptic ulcer bleeding	0/189 (0%)	0	1/188 (0.5%)	1
Infections and infestations
Cholangitis	0/189 (0%)	0	1/188 (0.5%)	1
Peritonitis	1/189 (0.5%)	1	0/188 (0%)	0
Pneumonia	2/189 (1.1%)	2	3/188 (1.6%)	3
Salmonella gastroenteritis	0/189 (0%)	0	1/188 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma	1/189 (0.5%)	1	0/188 (0%)	0
Psychiatric disorders
Major depression	0/189 (0%)	0	1/188 (0.5%)	1
Skin and subcutaneous tissue disorders
Stevens-Johnson sybdrome	1/189 (0.5%)	1	0/188 (0%)	0
Other (Not Including Serious) Adverse Events
	Peginterferon and Ribavirin		Peginterferon
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	170/189 (89.9%)		154/188 (81.9%)
Blood and lymphatic system disorders
Anemia	134/189 (70.9%)	134	13/188 (6.9%)	13
Neutropenia	30/189 (15.9%)	30	26/188 (13.8%)	26
Thrombocytopenia	19/189 (10.1%)	19	21/188 (11.2%)	21
Gastrointestinal disorders
Anorexia	44/189 (23.3%)	44	38/188 (20.2%)	38
Diarrhea	22/189 (11.6%)	22	20/188 (10.6%)	20
Constipation	16/189 (8.5%)	16	15/188 (8%)	15
Immune system disorders
Flu-like syndrome	47/189 (24.9%)	47	50/188 (26.6%)	50
Nervous system disorders
Fatigue	106/189 (56.1%)	106	97/188 (51.6%)	97
Headache	51/189 (27%)	51	48/188 (25.5%)	48
Insomnia	62/189 (32.8%)	62	66/188 (35.1%)	66
Psychiatric disorders
Irritability	21/189 (11.1%)	21	19/188 (10.1%)	19
Depression	25/189 (13.2%)	25	23/188 (12.2%)	23
Respiratory, thoracic and mediastinal disorders
Cough	26/189 (13.8%)	26	10/188 (5.3%)	10
Skin and subcutaneous tissue disorders
Dermatitis	43/189 (22.8%)	43	38/188 (20.2%)	38
Injection site reaction	27/189 (14.3%)	27	27/188 (14.4%)	27
Hair loss	47/189 (24.9%)	47	43/188 (22.9%)	43

Limitations/Caveats

Open-label trial Results may not be generalizable to peritoneal dialysis patients Higher percentages of favorable IL28B genotypes Secondary endpoint may not be powered to detect the differences

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.