Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Geno... | NCT00987337

Label	Type	Description	Intervention Names
Arm A	Experimental	Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4) - or - Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks (subjects with detectable HCV RNA at week 4)	Drug: Filibuvir
Arm B	Experimental	Filibuvir 600 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4) - or - Filibuvir 600 mg BID + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks (subjects with detectable HCV RNA at week 4)	Drug: Filibuvir
Arm C	Placebo Comparator	Placebo + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Filibuvir	Drug	300 mg BID	Arm A
Filibuvir

Measure	Description	Time Frame
Percentage of Participants With Sustained Viral Response (SVR) at Week 72	For participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24, SVR was defined as undetectable plasma HCV RNA levels (<15 IU/mL) at both Week 24 (End of Treatment [EOT]) and Week 72, regardless of the HCV RNA levels between Week 24 and 72. For participants who received filibuvir, had detectable HCV RNA at Week 4 or later and discontinued therapy at Week 48 or who received placebo, SVR was defined as undetectable plasma HCV RNA levels (<15 IU/mL) at both Week 48 (EOT) and Week 72, regardless of the HCV RNA levels between Week 48 and 72.	Week 72

Measure	Description	Time Frame
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12, 24 and 48	Percentage of participants with undetectable HCV RNA at Week 4 (rapid viral response [RVR]), Week 12 (early viral response [EVR]), Week 24 and Week 48 were summarized. Undetectable HCV RNA was defined as plasma HCV RNA levels <15 IU/mL.	Week 4, 12, 24, 48

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Anaheim	California	92801	United States
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
24927607	Derived	Rodriguez-Torres M, Yoshida EM, Marcellin P, Srinivasan S, Purohit VS, Wang C, Hammond JL. A phase 2 study of filibuvir in combination with pegylated IFN alfa and ribavirin for chronic HCV. Ann Hepatol. 2014 Jul-Aug;13(4):364-75.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 milligram (mg) tablet orally twice daily as blinded therapy along with pegylated interferon alpha-2a (pegIFN alpha-2a) 180 microgram (mcg) subcutaneously once weekly and ribavirin (RBV) 1000 milligram per day (mg/day) to participants weighing less than or equal to(<=) 75 kilogram (kg) or RBV 1200 mg/day to participants weighing greater than (>) 75 kg, orally in 2 divided doses up to Week 24. Participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) (HCV RNA <15 international units/milliliter [IU/mL]) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (greater than or equal to [>=] 15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75kg or RBV 1200 mg/day if participant weighed >75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.

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

Percentage of Participants With Sustained Viral Response (SVR) at Week 72

For participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24, SVR was defined as undetectable plasma HCV RNA levels (<15 IU/mL) at both Week 24 (End of Treatment [EOT]) and Week 72, regardless of the HCV RNA levels between Week 24 and 72. For participants who received filibuvir, had detectable HCV RNA at Week 4 or later and discontinued therapy at Week 48 or who received placebo, SVR was defined as undetectable plasma HCV RNA levels (<15 IU/mL) at both Week 48 (EOT) and Week 72, regardless of the HCV RNA levels between Week 48 and 72.

ITT population included all randomized participants who took at least 1 dose of study drug. If a participant had a missing value at Week 72, participant was considered a failure; if a participant had achieved SVR but died or discontinued within same time period, the participant was considered a success.

Posted

Number

percentage of participants

Week 72

ID	Title	Description
OG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
OG001	Filibuvir 600 mg Plus pegIFN/RBV	Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
OG002	Placebo Plus pegIFN/RBV	Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.

Units	Counts
Participants	OG00096 OG00196 OG00296

Title

Denominators

Categories

Title	Measurements
	OG00041.7 OG00139.6 OG00245.8

Secondary

Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12, 24 and 48

Percentage of participants with undetectable HCV RNA at Week 4 (rapid viral response [RVR]), Week 12 (early viral response [EVR]), Week 24 and Week 48 were summarized. Undetectable HCV RNA was defined as plasma HCV RNA levels <15 IU/mL.

ITT population included all randomized participants who took at least 1 dose of study drug. Last observation carried forward (LOCF) method was used to impute missing values for participants who did not discontinue from study. Participants who discontinued early from the study were considered not to have undetectable HCV RNA.

Posted

Number

percentage of participants

Week 4, 12, 24, 48

ID	Title	Description
OG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
OG001

Secondary

Percentage of Participants With Sustained Viral Response at 12 Weeks Following Completion of Therapy (SVR12)

A participant was considered to have achieved SVR12 if the plasma HCV RNA levels were <15 IU/mL at both the end of treatment (Week 24 or 48, depending on the time of therapy discontinuation based on HCV RNA levels during therapy) and 12 weeks following the completion of therapy (Week 36 for participants who ended therapy at Week 24; Week 60 for participants who ended therapy at Week 48). Overall percentage of participants with SVR12 was summarized.

ITT population. Participant with missing HCV RNA values at end of treatment and all follow-up visits or at the specified time point and all subsequent visits was considered not to have undetectable HCV RNA. Missing HCV RNA value at 12 weeks following completion of therapy was imputed using value of subsequent follow-up visit, if available.

Posted

Number

percentage of participants

12 weeks after completion of therapy (Week 36 or 60)

ID	Title	Description
OG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.

Secondary

Percentage of Participants With Sustained Viral Response at 24 Weeks Following Completion of Therapy (SVR24)

SVR24 was summarized only for those participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24 and all participants who received placebo for 48 weeks. A participant was considered to have achieved SVR24 if the plasma HCV RNA levels were <15 IU/mL at both the end of treatment (Week 24 for filibuvir participants who ended therapy at Week 24 and Week 48 for participants who received placebo) and 24 weeks following the completion of therapy (Week 48 for filibuvir participants who ended therapy at Week 24; Week 72 for placebo participants who ended therapy at Week 48).

ITT population.N (number of participants analyzed)=evaluable participants for the measure. Missing HCV RNA value at EOT, all follow-up visits/at specified time point, all subsequent visits was considered not to have undetectable HCV RNA.Missing HCV RNA value at 24 weeks after EOT was imputed using value of subsequent follow-up visit, if available.

Posted

Number

percentage of participants

24 weeks after completion of therapy (Week 48 or 72)

ID	Title	Description
OG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72.

Secondary

Percentage of Participants With Breakthrough Viremia

A participant was considered to have breakthrough viremia if there was a >2 log10 increase from nadir in HCV RNA concentration while on treatment or HCV RNA that became undetectable with treatment but then became persistently detectable (2 or more consecutive viral RNA measurements >1000 IU/mL) again during treatment. Overall percentage of participants with breakthrough viremia was summarized.

ITT population included all randomized participants who took at least 1 dose of study drug.

Posted

Number

percentage of participants

Baseline up to Week 48

ID	Title	Description
OG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
OG001	Filibuvir 600 mg Plus pegIFN/RBV

Secondary

Percentage of Participants With Relapsed Response

A participant was considered to have relapsed response if the plasma HCV RNA levels were undetectable at end of treatment (Week 24 or 48, depending on the time of therapy discontinuation based on HCV RNA levels during therapy) but detectable (>=15 IU/mL) during the off-treatment follow-up period up to Week 72. Overall percentage of participants with relapsed response was summarized.

ITT population included all randomized participants who took at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Participant with all the HCV RNA values missing during follow-up was imputed as having relapsed.

Posted

Number

percentage of participants

Week 24 or Week 48 up to Week 72

ID	Title	Description
OG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.

Secondary

Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12 and 24

Plasma HCV RNA levels were measured using the Roche COBAS TaqMan assay (limit of detection: 15 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.

ITT population included all randomized participants who took at least 1 dose of study drug. LOCF method was used for imputing missing values for participants who did not discontinue from study. Final value was imputed as baseline for participants who discontinued before the time point of interest.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline, Week 4, 12, 24

ID	Title	Description
OG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
OG001	Filibuvir 600 mg Plus pegIFN/RBV

Secondary

Number of Adverse Events (AEs) by Severity (All Causality)

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). The most severe grade was used in case of multiple occurrences of the same event.

Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.

Posted

Number

adverse events

Baseline up to Week 72

ID	Title	Description
OG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug (Any Therapy)

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 72 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial. Treatment-related were events considered related to study drug by the investigator. Number of participants with treatment related TEAEs and all causality TEAEs were summarized.

Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.

Posted

Number

participants

Baseline up to Week 72

ID	Title	Description
OG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.

Secondary

Number of Participants Who Discontinued Study Due to Adverse Events (AEs)

Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.

Posted

Number

participants

Baseline up to Week 72

ID	Title	Description
OG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
OG001	Filibuvir 600 mg Plus pegIFN/RBV

Secondary

Number of Participants With Dose Reduction or Temporary Discontinuation Due to Adverse Events (AEs)

Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.

Posted

Number

participants

Baseline up to Week 72

ID	Title	Description
OG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
OG001	Filibuvir 600 mg Plus pegIFN/RBV

Secondary

Number of Participants With Laboratory Test Abnormalities by Severity

Number of participants with laboratory abnormalities by Division of Auto Immune Disease Syndrome (DAIDS) grade of 4; 3 or 4; 2, 3 or 4 was summarized. Abnormal laboratory values refers to a DAIDS grade greater than 0, where grade 1= mild, grade 2= moderate, grade 3= severe and grade 4 = potentially life-threatening.

Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Posted

Number

participants

Baseline up to Week 72

ID	Title	Description
OG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
OG001	Filibuvir 600 mg Plus pegIFN/RBV

Secondary

Plasma Concentration of Filibuvir, Pegylated Interferon and Ribavirin

Data could not be summarized due to sparse sampling time points adopted for this study.

Posted

Week 0 (pre-dose), Week 2, 4, 8, 12, 16, 20, 24, 48 (only for those participants who received treatment till Week 48) post-dose

ID	Title	Description
OG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
OG001	Filibuvir 600 mg Plus pegIFN/RBV	Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0010 affected96 at risk EG0021 affected96 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Appendicitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Appendicitis perforated	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0010 affected96 at risk EG0021 affected96 at risk
Bacterial abscess central nervous system	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected96 at risk EG0020 affected96 at risk
Lymph node tuberculosis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0010 affected96 at risk EG0021 affected96 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected96 at risk EG0020 affected96 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Actinomyces test positive	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected96 at risk EG0020 affected96 at risk
Blood urea nitrogen/creatinine ratio increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected96 at risk EG0020 affected96 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected96 at risk EG0020 affected96 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0010 affected96 at risk EG0021 affected96 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Loss of consciousness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected96 at risk EG0020 affected96 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Cardiac neurosis	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk
Depression	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected96 at risk EG0020 affected96 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected96 at risk EG0020 affected96 at risk
Pulmonary calcification	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected96 at risk EG0020 affected96 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0010 affected96 at risk EG0021 affected96 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0010 affected96 at risk EG0021 affected96 at risk
Pyoderma gangrenosum	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0020 affected96 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00015 affected96 at risk EG00111 affected96 at risk EG00216 affected96 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected96 at risk EG0015 affected96 at risk EG0026 affected96 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected96 at risk EG0013 affected96 at risk EG0023 affected96 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00015 affected96 at risk EG00111 affected96 at risk EG00220 affected96 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected96 at risk EG0016 affected96 at risk EG0023 affected96 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected96 at risk EG0025 affected96 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected96 at risk EG0013 affected96 at risk EG0025 affected96 at risk
Hypothyroidism	Endocrine disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected96 at risk EG0026 affected96 at risk
Dry eye	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected96 at risk EG0013 affected96 at risk EG0025 affected96 at risk
Vision blurred	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected96 at risk EG0015 affected96 at risk EG0025 affected96 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0006 affected96 at risk EG0013 affected96 at risk EG0024 affected96 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00011 affected96 at risk EG00110 affected96 at risk EG0024 affected96 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected96 at risk EG0017 affected96 at risk EG0024 affected96 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0007 affected96 at risk EG0013 affected96 at risk EG00210 affected96 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00014 affected96 at risk EG00110 affected96 at risk EG00217 affected96 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0007 affected96 at risk EG0017 affected96 at risk EG0024 affected96 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected96 at risk EG0016 affected96 at risk EG0027 affected96 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00020 affected96 at risk EG00135 affected96 at risk EG00230 affected96 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected96 at risk EG0012 affected96 at risk EG0025 affected96 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0009 affected96 at risk EG00111 affected96 at risk EG00213 affected96 at risk
Asthenia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00016 affected96 at risk EG00119 affected96 at risk EG00220 affected96 at risk
Chills	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00011 affected96 at risk EG00114 affected96 at risk EG00212 affected96 at risk
Fatigue	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00036 affected96 at risk EG00137 affected96 at risk EG00236 affected96 at risk
Influenza like illness	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00015 affected96 at risk EG00114 affected96 at risk EG00219 affected96 at risk
Injection site reaction	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected96 at risk EG0014 affected96 at risk EG0025 affected96 at risk
Irritability	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00014 affected96 at risk EG00119 affected96 at risk EG00215 affected96 at risk
Oedema peripheral	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected96 at risk EG0017 affected96 at risk EG0024 affected96 at risk
Pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected96 at risk EG0015 affected96 at risk EG0028 affected96 at risk
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00014 affected96 at risk EG00114 affected96 at risk EG00215 affected96 at risk
Bronchitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0004 affected96 at risk EG0015 affected96 at risk EG0021 affected96 at risk
Influenza	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0003 affected96 at risk EG0014 affected96 at risk EG0025 affected96 at risk
Weight decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00013 affected96 at risk EG0017 affected96 at risk EG0025 affected96 at risk
White blood cell count decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected96 at risk EG0025 affected96 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG00020 affected96 at risk EG00116 affected96 at risk EG00223 affected96 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00013 affected96 at risk EG00117 affected96 at risk EG00216 affected96 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0008 affected96 at risk EG0018 affected96 at risk EG0028 affected96 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00017 affected96 at risk EG00120 affected96 at risk EG00225 affected96 at risk
Disturbance in attention	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected96 at risk EG0017 affected96 at risk EG0021 affected96 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected96 at risk EG0018 affected96 at risk EG00212 affected96 at risk
Dysgeusia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00016 affected96 at risk EG00124 affected96 at risk EG0025 affected96 at risk
Headache	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00028 affected96 at risk EG00133 affected96 at risk EG00235 affected96 at risk
Syncope	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected96 at risk EG0011 affected96 at risk EG0021 affected96 at risk
Anxiety	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0006 affected96 at risk EG0013 affected96 at risk EG0027 affected96 at risk
Depression	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG00021 affected96 at risk EG00110 affected96 at risk EG00212 affected96 at risk
Insomnia	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG00024 affected96 at risk EG00131 affected96 at risk EG00228 affected96 at risk
Sleep disorder	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected96 at risk EG0012 affected96 at risk EG0024 affected96 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00015 affected96 at risk EG00118 affected96 at risk EG00221 affected96 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0009 affected96 at risk EG0019 affected96 at risk EG00218 affected96 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0006 affected96 at risk EG0016 affected96 at risk EG0024 affected96 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected96 at risk EG0015 affected96 at risk EG0027 affected96 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected96 at risk EG0016 affected96 at risk EG0028 affected96 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00018 affected96 at risk EG00116 affected96 at risk EG00224 affected96 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected96 at risk EG0025 affected96 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00020 affected96 at risk EG00113 affected96 at risk EG00219 affected96 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0006 affected96 at risk EG0015 affected96 at risk EG0022 affected96 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected96 at risk EG0015 affected96 at risk EG0023 affected96 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected96 at risk EG0011 affected96 at risk EG0025 affected96 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00027 affected96 at risk EG00129 affected96 at risk EG00219 affected96 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected96 at risk EG00122 affected96 at risk EG00218 affected96 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected96 at risk EG0013 affected96 at risk EG0026 affected96 at risk

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections

ID	Title	Description
BG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
BG001	Filibuvir 600 mg Plus pegIFN/RBV	Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
BG002	Placebo Plus pegIFN/RBV	Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Filibuvir 300 mg Plus pegIFN/RBV	Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.	14	96	85	96
EG001	Filibuvir 600 mg Plus pegIFN/RBV	Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.	6	96	89	96
EG002	Placebo Plus pegIFN/RBV	Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.	6	96	90	96