Study of Nitazoxanide, Peginterferon Alfa-2a and Ribaviri... | NCT00495391

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.	Drug: Nitazoxanide Biological: Peginterferon alfa-2a Drug: Ribavirin
2	Placebo Comparator	Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.	Drug: Placebo Biological: Peginterferon alfa-2a Drug: Ribavirin

Name	Type	Description	Arm Group Labels	Other Names
Nitazoxanide	Drug	One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.	1

Measure	Description	Time Frame
Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)	Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.	24 weeks after end of treatment

Measure	Description	Time Frame
End of Treatment Response (HCV RNA Below Lower Limit of Detection)	Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.	At end of treatment
Early Virologic Response (HCV RNA Below Lower Limit of Detection)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic hepatitis C genotype 1.
Failed to respond to ≥12 weeks of peginterferon and ribavirin (<2 log10 drop in Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 12 or detectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 24).

Exclusion Criteria:

Females of child-bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active.
Other causes of liver disease including autoimmune hepatitis.
Transplant recipients receiving immune suppression therapy.
Screening tests positive for Anti-Hepatitis A Virus Immunoglobulin M Antibody (anti-HAV IgM Ab), Hepatitis B's antigen (HBsAg), Anti-Hepatitis B core antigen Immunoglobulin M Antibody (anti-HBc IgM Ab) or Anti-Human Immunodeficiency Virus Antibody (anti-HIV Ab).
Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, Child-Turcotte-Pugh (CTP) score >6 or Model for End-stage Liver Disease (MELD) score >8.
Alcohol consumption of >40 grams per day or an alcohol use pattern that will interfere with the study.
Absolute neutrophil count <1500 cells/mm3; platelet count <135,000 cells/mm3; hemoglobin <12 g/dL for women and <13 g/dL for men; or serum creatinine concentration ≥1.5 times Upper Limit of Normal (ULN).
Hypothyroidism or hyperthyroidism not effectively treated with medication.
Hemoglobin A1C (HgbA1c) >7.5 or history of diabetes mellitus.
Body Mass Index (BMI) >28.
History or other clinical evidence of significant or unstable cardiac disease.
History or other clinical evidence of chronic pulmonary disease associated with functional impairment.
Serious or severe bacterial infection(s).
Ulcerative or hemorrhagic/ischemic colitis.
Pancreatitis.
History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization.
History of uncontrolled severe seizure disorder.
Requires concomitant theophylline or methadone.
History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids.
History or other evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension.
Hemoglobinopathies.
History of hypersensitivity or intolerance to nitazoxanide or any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectable solution or ribavirin tablets.

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
David Nelson, MD	University of Florida Hepatology	Principal Investigator
Stephen Harrison, MD	Brooke Army Medical Center	Principal Investigator
Arthur Berman, DO	Florida Center for Gastroenterology	Principal Investigator
Ronald Pruitt, MD	Nashville Medical Research Institute	Principal Investigator
Ahmed Aijaz, MD	Stanford University	Principal Investigator
Ramsey Cheung, MD	VA Palo Alto Health Care System	Principal Investigator
Ira Jacobson, MD	Weill Medical College of Cornell University	Principal Investigator
Mitchell Shiffman, MD	McGuire VA Medical Center	Principal Investigator
Joseph Lim, MD	Yale University Digestive Diseases	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
VA Palo Alto Healthcare System		Palo Alto	California	94304	United States
Stanford University School of Medicine

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	NTZ+PR	Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	NTZ+PR	Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
BG001	Placebo+PR	Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks. Placebo : One oral placebo tablet twice daily for 52 weeks.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00042 BG00122 BG00264

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)

Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.

Posted

Number

participants

24 weeks after end of treatment

ID	Title	Description
OG000	NTZ+PR	Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
OG001	Placebo+PR	Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks. Placebo : One oral placebo tablet twice daily for 52 weeks.

Units	Counts
Participants	OG00042 OG00122

Title

Denominators

Categories

Responders

Title	Measurements
	OG0003 OG0010

Non-responders

Title	Measurements
	OG000

Secondary

End of Treatment Response (HCV RNA Below Lower Limit of Detection)

Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.

Posted

Number

participants

At end of treatment

ID	Title	Description
OG000	NTZ+PR	Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
OG001	Placebo+PR	Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks. Placebo : One oral placebo tablet twice daily for 52 weeks.

Secondary

Early Virologic Response (HCV RNA Below Lower Limit of Detection)

Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.

Posted

Number

participants

After 12 weeks combination treatment

ID	Title	Description
OG000	NTZ+PR	Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
OG001	Placebo+PR	Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks. Placebo : One oral placebo tablet twice daily for 52 weeks.

Secondary

Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)

Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.

Posted

Number

participants

After 4 weeks combination treatment

ID	Title	Description
OG000	NTZ+PR	Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
OG001	Placebo+PR	Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks. Placebo : One oral placebo tablet twice daily for 52 weeks.

Secondary

Changes in ALT

This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.

Posted

Number

participants

From baseline to week 8

ID	Title	Description
OG000	NTZ+PR	Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
OG001	Placebo+PR	Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks. Placebo : One oral placebo tablet twice daily for 52 weeks.

Secondary

Changes in ALT

This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.

Posted

Number

participants

From baseline to week 16

ID	Title	Description
OG000	NTZ+PR	Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
OG001	Placebo+PR	Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks. Placebo : One oral placebo tablet twice daily for 52 weeks.

Secondary

Changes in ALT

This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.

Posted

Number

participants

From baseline to end of treatment

ID	Title	Description
OG000	NTZ+PR	Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
OG001	Placebo+PR	Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks. Placebo : One oral placebo tablet twice daily for 52 weeks.

Secondary

Changes in ALT

This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.

Posted

Number

participants

From baseline to end of follow up

ID	Title	Description
OG000	NTZ+PR	Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
OG001	Placebo+PR	Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks. Placebo : One oral placebo tablet twice daily for 52 weeks.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NTZ+PR	Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.			1	42	42	42
EG001	Placebo+PR	Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks. Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks. Placebo : One oral placebo tablet twice daily for 52 weeks.			1	22	20	22

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Asthenia	General disorders	COSTART	Systematic Assessment	EG00023 events23 affected42 at risk EG00110 events10 affected22 at risk
Pain Abdo	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0009 events9 affected42 at risk EG0012 events2 affected22 at risk
Headache	General disorders	COSTART	Systematic Assessment	EG0009 events9 affected42 at risk EG0016 events6 affected22 at risk
Pain Back	General disorders	COSTART	Systematic Assessment	EG0006 events6 affected42 at risk EG0010 events0 affected22 at risk
Flu Synd	General disorders	COSTART	Systematic Assessment	EG0005 events5 affected42 at risk EG0012 events2 affected22 at risk
Diarrhea	Gastrointestinal disorders	COSTART	Systematic Assessment	EG00017 events17 affected42 at risk EG0013 events3 affected22 at risk
Nausea	Gastrointestinal disorders	COSTART	Systematic Assessment	EG00010 events10 affected42 at risk EG0014 events4 affected22 at risk
Anorexia	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0006 events6 affected42 at risk EG0011 events1 affected22 at risk
Constip	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0005 events5 affected42 at risk EG0012 events2 affected22 at risk
Liver Func Abnorm	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0004 events4 affected42 at risk EG0011 events1 affected22 at risk
Dry Mouth	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected42 at risk EG0013 events3 affected22 at risk
Leukopenia	Blood and lymphatic system disorders	COSTART	Systematic Assessment	EG00020 events20 affected42 at risk EG0018 events8 affected22 at risk
Thrombocytopenia	Blood and lymphatic system disorders	COSTART	Systematic Assessment	EG00012 events12 affected42 at risk EG0013 events3 affected22 at risk
Anemia	Blood and lymphatic system disorders	COSTART	Systematic Assessment	EG00011 events11 affected42 at risk EG0015 events5 affected22 at risk
Agitation	Nervous system disorders	COSTART	Systematic Assessment	EG00012 events12 affected42 at risk EG0016 events6 affected22 at risk
Depression	Nervous system disorders	COSTART	Systematic Assessment	EG0008 events8 affected42 at risk EG0015 events5 affected22 at risk
Insomnia	Nervous system disorders	COSTART	Systematic Assessment	EG0008 events8 affected42 at risk EG0014 events4 affected22 at risk
Anxiety	Nervous system disorders	COSTART	Systematic Assessment	EG0001 events1 affected42 at risk EG0014 events4 affected22 at risk
Dizziness	Nervous system disorders	COSTART	Systematic Assessment	EG0007 events7 affected42 at risk EG0013 events3 affected22 at risk
Rash	Skin and subcutaneous tissue disorders	COSTART	Systematic Assessment	EG0009 events9 affected42 at risk EG0015 events5 affected22 at risk
Skin Dry	Skin and subcutaneous tissue disorders	COSTART	Systematic Assessment	EG0007 events7 affected42 at risk EG0012 events2 affected22 at risk
Pruritus	Skin and subcutaneous tissue disorders	COSTART	Systematic Assessment	EG0005 events5 affected42 at risk EG0012 events2 affected22 at risk
Alopecia	Skin and subcutaneous tissue disorders	COSTART	Systematic Assessment	EG0004 events4 affected42 at risk EG0013 events3 affected22 at risk
Pharyngitis	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0006 events6 affected42 at risk EG0011 events1 affected22 at risk
Rhinitis	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0004 events4 affected42 at risk EG0013 events3 affected22 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0003 events3 affected42 at risk EG0013 events3 affected22 at risk
Cough Inc	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0003 events3 affected42 at risk EG0013 events3 affected22 at risk
Albuminuria	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0006 events6 affected42 at risk EG0013 events3 affected22 at risk
Myalgia	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0007 events7 affected42 at risk EG0012 events2 affected22 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0004 events4 affected42 at risk EG0010 events0 affected22 at risk
Cramps Leg	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0004 events4 affected42 at risk EG0010 events0 affected22 at risk
Polyuria	Renal and urinary disorders	COSTART	Systematic Assessment	EG0005 events5 affected42 at risk EG0012 events2 affected22 at risk

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pyelonephritis	Renal and urinary disorders	COSTART	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected22 at risk
Kidney Calculus	Renal and urinary disorders	COSTART	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected22 at risk
Edema Larynx	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected42 at risk EG0011 events1 affected22 at risk

ID	Term
C041747	nitazoxanide
C100416	peginterferon alfa-2a
D012254	Ribavirin