Trial Outcomes & Findings for An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1 (NCT NCT01508130)

Last Updated: 2017-04-10

Results Overview

Time to premature treatment discontinuation for any reason (weeks) was calculated as follows: date of treatment discontinuation for any reason - first treatment administration date + 1/7. The estimated survivorship curves were obtained from Kaplan-Meier maximum likelihood estimates for each treatment group. Participants who completed the study treatment (including those who shorten the treatment based on response-guided therapy) were censored on their last dosing date.

Recruitment status

COMPLETED

Target enrollment

672 participants

Primary outcome timeframe

Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)

Results posted on

2017-04-10

Participant Flow

A total of 672 participants were enrolled at 64 study sites in the U.S between 20 January 2012 and 8 February 2013.

Out of 672 participants, one was not eligible to receive triple therapy (pegylated interferon alfa \[PegIFN\], ribavirin \[RBV\], and telaprevir or boceprevir) and 17 who received only dual therapy (PegIFN + RBV) were excluded from all analyses. A total of 635 participants were included in modified all treated (mTRT) population.

Participant milestones

Participant milestones
Measure	PegIFN + RBV + TEL As per the standard of care and U.S. labeling, participants received PegIFN + RBV + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Overall Study STARTED	493	142
Overall Study mTRT	493	142
Overall Study COMPLETED	266	73
Overall Study NOT COMPLETED	227	69

Reasons for withdrawal

Reasons for withdrawal
Measure	PegIFN + RBV + TEL As per the standard of care and U.S. labeling, participants received PegIFN + RBV + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Overall Study Adverse Event	81	28
Overall Study Death	3	1
Overall Study Protocol Violation	2	0
Overall Study Lost to Follow-up	25	2
Overall Study Withdrawal by Subject	3	3
Overall Study Subject's substantial non-compliance	25	9
Overall Study Insufficient therapeutic response	74	23
Overall Study Administrative	14	3

Baseline Characteristics

An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PegIFN + RBV + TEL n=493 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.	Total n=635 Participants Total of all reporting groups
Age, Continuous	52.0 years STANDARD_DEVIATION 10.3 • n=5 Participants	51.6 years STANDARD_DEVIATION 10.0 • n=7 Participants	51.9 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	209 Participants n=5 Participants	56 Participants n=7 Participants	265 Participants n=5 Participants
Sex: Female, Male Male	284 Participants n=5 Participants	86 Participants n=7 Participants	370 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)

Population: modified all-treated (mTRT) population: It included all enrolled participants who had an hepatitis C Virus Ribo Nucleic Acid (HCV RNA) of 50 IU/mL or more just prior to start chronic hepatitis C (CHC) therapy, received 1 triple therapy (PegIFN, RBV, and TEL or BOC), and treatment documentation was sufficient for assignment to treatment groups.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=493 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Time to Premature Treatment Discontinuation Due to Any Reason	40.0 weeks Interval 34.0 to An upper limit of CI was non-estimable due to insufficient number of participants with events.	40.6 weeks Interval 32.3 to 48.1

PRIMARY outcome

Timeframe: 12 weeks or later post-completion of the treatment period

Population: mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.

SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=493 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Number of Participants With Sustained Virologic Response (SVR) at 12 Weeks or Later After Completion of the Treatment Period	160 participants	39 participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period

VR was defined as undetectable HCV RNA (i.e.,HCV RNA less than 50 IU/mL)

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=493 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Number of Participants With Virologic Response (VR) Week 16, n= 266, 91	244 participants	86 participants
Number of Participants With Virologic Response (VR) Week 2, n= 479, 138	104 participants	3 participants
Number of Participants With Virologic Response (VR) Week 4, n= 446, 137	348 participants	19 participants
Number of Participants With Virologic Response (VR) Week 6, n= 397, 128	327 participants	33 participants
Number of Participants With Virologic Response (VR) Week 8, n= 383, 125	349 participants	87 participants
Number of Participants With Virologic Response (VR) Week 12, n= 359, 113	337 participants	102 participants
Number of Participants With Virologic Response (VR) Week 20, n= 224, 80	209 participants	75 participants
Number of Participants With Virologic Response (VR) Week 24, n= 190, 70	176 participants	67 participants
Number of Participants With Virologic Response (VR) Week 28, n= 115, 29	105 participants	26 participants
Number of Participants With Virologic Response (VR) Week 32, n= 84, 23	78 participants	20 participants
Number of Participants With Virologic Response (VR) Week 36, n= 60, 16	56 participants	14 participants
Number of Participants With Virologic Response (VR) Week 40, n= 35, 10	33 participants	9 participants
Number of Participants With Virologic Response (VR) Week 44, n= 24, 6	23 participants	5 participants
Number of Participants With Virologic Response (VR) Week 48, n= 13, 1	13 participants	1 participants
Number of Participants With Virologic Response (VR) 12 weeks post-completion, n= 187, 53	160 participants	39 participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

VRVR was defined as HCV RNA \< 50 IU/mL at treatment Week 2; RVR as HCV RNA \< 50 IU/mL by treatment Week 4, but no HCV RNA \< 50 IU/mL at Week 2; Week 8 VR as HCV RNA \< 50 IU/mL by study Week 8 but no HCV RNA \< 50 IU/mL at Weeks 2 to 4; cEVR as HCV RNA \< 50 IU/mL by treatment Week 12 but no HCV RNA \< 50 IU/mL at Weeks 2 to 8; and pEVR as at least a 2 log10 decrease in HCV RNA by treatment Week 12 but no HCV RNA \< 50 IU/mL at Weeks 2 to 12.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=493 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above VRVR, Week 2, n= 479, 138	104 participants	3 participants
Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above RVR, Week 4, n= 446, 137	252 participants	16 participants
Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above VR Week 8, n= 383, 125	28 participants	56 participants
Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above cEVR, Week 12, n= 359, 113	17 participants	18 participants
Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above pEVR, Weeks 2 to 12, n= 359, 113	4 participants	4 participants
Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above None of above, Weeks 2 to 12, n= 359, 113	7 participants	7 participants

SECONDARY outcome

Timeframe: Up to Week 48

The extended VR is defined as initial HCV RNA \< 50 IU/mL during Weeks 2 to 24 and remaining HCV RNA \< 50 IU/mL at all subsequent assessments; virologic breakthrough/rebound is defined as detectable HCV RNA during the treatment period in participants with prior non-detectable HCV RNA or increase of HCV RNA by \>=1 log10 above nadir for direct-acting antiviral (DAA) tripe therapies (PegIFN + RBV + TEL or PegIFN + RBV + BOC); virologic relapse is defined as detectable HCV RNA during the treatment-free follow-up period in participants with HCV RNA \< 50 IU/mL at EoT; non-responder is defined as participants who never achieved undetectable HCV-RNA during the 48 weeks of treatment.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=493 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder Extended VR, n= 491, 142	159 participants	39 participants
Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder Virologic breakthrough/rebound, n= 491, 142	52 participants	15 participants
Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder Virologic relapse, n= 491, 142	174 participants	52 participants
Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder Non-responders, n= 479, 138	34 participants	16 participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 8, and 12

SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period. The predictors defined as participants with virological response (HCV RNA \< 50 IU/mL at any visit), or with virological response at Week 12 (HCV-RNA \< 50 IU/mL or unquantifiable or HCV-RNA \>=2 log10 drop from baseline). Positive predictive value is the probability that participants with a positive screening test truly have the disease. Negative predictive value is the probability that participants with a negative screening test truly don't have the disease.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=493 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Predictors of Sustained Virologic Response by Week Week 2, positive predictors, n=104, 3	43 participants	1 participants
Predictors of Sustained Virologic Response by Week Week 4, positive predictors, n=350, 19	138 participants	10 participants
Predictors of Sustained Virologic Response by Week Week 6, positive predictors, n=336, 33	142 participants	17 participants
Predictors of Sustained Virologic Response by Week Week 8, positive predictors, n=355, 88	147 participants	33 participants
Predictors of Sustained Virologic Response by Week Week 12, positive predictors, n=348, 102	146 participants	36 participants
Predictors of Sustained Virologic Response by Week VR, Week 12, positive predictors, n=347, 106	146 participants	37 participants
Predictors of Sustained Virologic Response by Week Week 2, negative predictors, n=375, 135	258 participants	97 participants
Predictors of Sustained Virologic Response by Week Week 4, negative predictors, n=96, 118	74 participants	89 participants
Predictors of Sustained Virologic Response by Week Week 6, negative predictors, n=61, 95	50 participants	74 participants
Predictors of Sustained Virologic Response by Week Week 8, negative predictors, n=28, 37	24 participants	32 participants
Predictors of Sustained Virologic Response by Week Week 12, negative predictors, n=11, 11	11 participants	9 participants
Predictors of Sustained Virologic Response by Week VR, Week 12, negative predictors, n=12, 7	12 participants	6 participants

SECONDARY outcome

Timeframe: Week 12

Participants for VR to prior therapy (PegIFN + RBV) were categorized as: relapse (who completed the previous treatment with HCV RNA undetectable, but relapsed with detectable HCV RNA once treatment was discontinued), breakthrough (HCV RNA undetectable, followed by detectable HCV RNA during on-treatment period), null responder (completed at least 12 weeks of treatment with HCV RNA decrease \< 2 log10 at Week 12), partial responder (HCV RNA decrease \> 2 log10 by Week 12 of treatment and HCV RNA remained detectable), unknown response (completed previous treatment, but treatment response based on HCV RNA determinations was not available), and prior intolerant (treated previously, but discontinued due to adverse event or participant's choice prior to completion of therapy). Participants categorized into 3 genotypes (CC, CT and TT) based on single nucleotide polymorphism in the Interleukin 28B (IL28B) gene.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=493 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) Sex : Female, n = 209, 56	76 participants	22 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) Sex: Male, n = 284, 86	84 participants	17 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) Age: < 50 years, n = 144, 47	49 participants	14 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) Age: >= 50 years, n = 349, 95	111 participants	25 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) Race: White, n = 336, 102	112 participants	31 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) Race: non-white, n = 157, 40	48 participants	8 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) Ethnicity: Hispanic or Latino, n = 42, 11	21 participants	2 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) Ethnicity: Not Hispanic or Latino, n = 450, 128	139 participants	36 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) Ethnicity: Unknown, n = 1, 3	0 participants	1 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) HCV Genotype: 1a, n = 350, 94	109 participants	28 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) HCV Genotype: 1b, n = 96, 30	43 participants	7 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) HCV Genotype: Other(2,3,4) , n = 45, 17	7 participants	4 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) HCV Genotype: missing, n = 2, 1	1 participants	0 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) IL28B Genotype: CC, n = 37, 12	17 participants	6 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) IL28B Genotype: CT, n = 85, 31	28 participants	8 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) IL28B Genotype: TT, n = 24, 6	5 participants	1 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) IL28B Genotype: not available, n = 347, 93	110 participants	24 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) VR to Prior Therapy: relapser, n = 64, 21	26 participants	7 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) VR to Prior Therapy: breakthrough, n = 3, 2	2 participants	1 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) VR to Prior Therapy: null responder, n = 62, 10	11 participants	1 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) VR to Prior Therapy: partial responder, n = 29, 7	8 participants	1 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) VR to Prior Therapy: unknown response, n = 21, 1	11 participants	0 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) VR to Prior Therapy: prior intolerant, n = 22, 14	5 participants	1 participants
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) VR to Prior Therapy: missing, n = 291, 87	97 participants	28 participants

SECONDARY outcome

Timeframe: Up to Week 48

The undetectable HCV RNA means HCV RNA values less than 50 IU/mL. This outcome measure was calculated as the duration of participant's first date of undetectable HCV RNA and the date of the participant's last dose.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=159 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=39 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Duration of Viral Undetectability During Treatment for Participants With HCV RNA Undetectable During Treatment by Trial Treatment	22.1 weeks Interval 0.0 to 52.0	23.0 weeks Interval 5.0 to 44.0

SECONDARY outcome

Timeframe: Up to Week 48

The participants discontinued the study treatment due to lack of efficacy of study treatment. Time to premature treatment discontinuation due to lack of efficacy (weeks) = (date of treatment discontinuation due to lack of efficacy - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=493 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Time to Premature Treatment Discontinuation Due to Lack of Efficacy	NA Weeks Interval 0.1 to 64.3 Median was non-estimable due to insufficient number of participants with premature treatment discontinuation.	NA Weeks Interval 3.9 to 50.7 Median was non-estimable due to insufficient number of participants with premature treatment discontinuation.

SECONDARY outcome

Timeframe: Up to Week 48

The participants discontinued the study treatment due to intolerance of the study treatment. Time to premature treatment discontinuation due to intolerance (weeks) = (date of treatment discontinuation due to lack of intolerance - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=493 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Time to Premature Treatment Discontinuation Due to Intolerance	NA Weeks Interval 0.1 to 64.3 Median was non-estimable due to insufficient number of participants with premature treatment discontinuation.	NA Weeks Interval 3.9 to 50.7 Median was non-estimable due to insufficient number of participants with premature treatment discontinuation.

SECONDARY outcome

Timeframe: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)

Population: Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. "n" denotes number of participants who were available at the indicated time points for each arm.

Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir is calculated as the number of weeks between the start and end of treatment.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=490 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Treatment Duration, as Measure of Extent of Exposure to Study Medication PegIFN alfa-2a, n = 465, 127	26.0 Weeks Standard Error 0.71	26.8 Weeks Standard Error 1.16
Treatment Duration, as Measure of Extent of Exposure to Study Medication PegIFN alfa-2b, n = 28, 15	23.2 Weeks Standard Error 2.58	34.0 Weeks Standard Error 3.12
Treatment Duration, as Measure of Extent of Exposure to Study Medication Ribavirin, n = 490, 142	26.1 Weeks Standard Error 0.69	27.6 Weeks Standard Error 1.11
Treatment Duration, as Measure of Extent of Exposure to Study Medication Telaprevir, n = 490, NA	13.4 Weeks Standard Error 0.39	NA Weeks Standard Error NA Not applicable for this group.
Treatment Duration, as Measure of Extent of Exposure to Study Medication Boceprevir, n = NA, 142	NA Weeks Standard Error NA Not applicable for this group.	22.1 Weeks Standard Error 1.07

SECONDARY outcome

Timeframe: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)

Extent of exposure is defined as the duration of the treatment administered during the study. The mean cumulative doses of PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir were presented.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=490 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication Boceprevir, n = NA, 142	NA Micrograms Standard Deviation NA Not applicable for this group.	52979.7 Micrograms Standard Deviation 30728.6
Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication PegIFN alfa-2a, n = 465, 127	4504.5 Micrograms Standard Deviation 2679.7	4478.1 Micrograms Standard Deviation 2275.6
Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication PegIFN alfa-2b, n = 28, 15	3234.5 Micrograms Standard Deviation 2008.5	4239.1 Micrograms Standard Deviation 1723.5
Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication Ribavirin, n = 490, 142	24991.1 Micrograms Standard Deviation 16058.1	26215.9 Micrograms Standard Deviation 14292.7
Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication Telaprevir, n = 490, NA	29734.2 Micrograms Standard Deviation 18776.5	NA Micrograms Standard Deviation NA Not applicable for this group.

SECONDARY outcome

Timeframe: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)

Extent of exposure is defined as the duration of the treatment administered during the study. Degree of dose reduction was calculated as actual exposure/target exposure × 100%. Target exposure was defined as the actual received treatment duration multiplied by the initial assigned dose. Actual exposure was defined as cumulative dose during the treatment period.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=490 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication PegIFN alfa-2a, n = 465, 127	102.5 Percentage of dose reduction Standard Deviation 10.1	104.8 Percentage of dose reduction Standard Deviation 15.5
Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication PegIFN alfa-2b, n = 28, 15	101.2 Percentage of dose reduction Standard Deviation 6.0	111.7 Percentage of dose reduction Standard Deviation 23.6
Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication Ribavirin, n = 490, 142	116.8 Percentage of dose reduction Standard Deviation 26.6	118.2 Percentage of dose reduction Standard Deviation 25.6
Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication Telaprevir, n = 490, NA	100.0 Percentage of dose reduction Standard Deviation 0.00	NA Percentage of dose reduction Standard Deviation NA Not applicable for this group.
Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication Boceprevir, n = NA, 142	NA Percentage of dose reduction Standard Deviation NA Not applicable for this group.	99.8 Percentage of dose reduction Standard Deviation 1.9

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 24

Compliance was assessed based on the number of participants who received the planned study treatment (PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir) during the treatment period.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=490 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Compliance of Study Treatment Boceprevir Week 12; n = NA, 101	NA participants Not applicable for this group.	89 participants
Compliance of Study Treatment PegIFN Week 4; n = 345, 114	342 participants	113 participants
Compliance of Study Treatment PegIFN Week 8; n = 319, 107	312 participants	103 participants
Compliance of Study Treatment PegIFN Week 12; n = 310, 106	304 participants	101 participants
Compliance of Study Treatment PegIFN Week 24; n = 265, 88	259 participants	83 participants
Compliance of Study Treatment Ribavirin Week 4; n = 337, 111	331 participants	105 participants
Compliance of Study Treatment Ribavirin Week 8; n = 293, 101	281 participants	100 participants
Compliance of Study Treatment Ribavirin Week 12; n = 288, 98	279 participants	93 participants
Compliance of Study Treatment Ribavirin Week 24; n = 187, 77	180 participants	69 participants
Compliance of Study Treatment Telaprevir Week 4; n = 340, NA	329 participants	NA participants Not applicable for this group.
Compliance of Study Treatment Telaprevir Week 8; n = 309, NA	289 participants	NA participants Not applicable for this group.
Compliance of Study Treatment Telaprevir Week 12; n = 273, NA	255 participants	NA participants Not applicable for this group.
Compliance of Study Treatment Telaprevir Week 24; n = 68, NA	67 participants	NA participants Not applicable for this group.
Compliance of Study Treatment Boceprevir Week 4; n = NA, 34	NA participants Not applicable for this group.	33 participants
Compliance of Study Treatment Boceprevir Week 8; n = NA, 103	NA participants Not applicable for this group.	93 participants
Compliance of Study Treatment Boceprevir Week 24; n = NA, 82	NA participants Not applicable for this group.	70 participants

SECONDARY outcome

Timeframe: Up to 48 weeks (included 12 weeks of triple therapy + additional 12/36 weeks of dual therapy)

As per the U.S. labeling, participants with treatment-naive, prior relapse (TN-PR) and prior partial or null responder (PP/NR) received PegIFN + RBV + TEL (triple therapy) for 12 weeks; followed additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=490 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label TN-PR, 12 weeks, n = 352	190 participants	—
Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label TN-PR, additional 12 weeks, n = 352	75 participants	—
Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label TN-PR, additional 36 weeks, n = 352	8 participants	—
Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label PP/NR, 12 weeks, n = 90	58 participants	—
Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label PP/NR, additional 36 weeks, n = 90	25 participants	—

SECONDARY outcome

Timeframe: Up to 48 weeks (included 4 weeks of dual therapy + additional 28/36 weeks of triple therapy and/or additional dual therapy up to Week 48)

Population: The safety population was defined as all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. "n" denotes number of participants who were available at the indicated time points for each arm.

As per the U.S. labeling, participants with cirrhosis (C); non-cirrhotic/treatment-naïve (NC/TN); and non-cirrhotic/previous partial responders or relapsers (NC/PPR or R) received first 4 weeks of dual therapy, followed by additional 28 or 36 weeks of PegIFN + RBV + BOC (triple therapy) and/or then completed dual therapy through Week 48 depending on viral response and prior response status.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=142 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label NC/TN, 4 weeks, n = 60	59 participants	—
Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label NC/TN, additional 28 weeks, n = 24	15 participants	—
Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label NC/TN, additional 36 weeks, n = 7	1 participants	—
Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label NC/TN, dual therapy through 48 week, n = 7	2 participants	—
Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label NC/PPR or R, 4 weeks, n = 17	17 participants	—
Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label NC/PPR, additional 36 weeks, n = 7	3 participants	—
Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label NC/PPR, dual therapy through 48 week, n = 3	1 participants	—
Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label C, completed 44 weeks, n = 34	1 participants	—

SECONDARY outcome

Timeframe: Up to 48 weeks

Population: Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment.

The dose reduction was done because of safety-related reasons (AEs) including alanine aminotransferase disorder, anemia, neutropenia, thrombocytopenia, and rash.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=490 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Number of Participants With Safety-related Dose Reductions	190 participants	70 participants

SECONDARY outcome

Timeframe: Up to 48 weeks

Population: Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=490 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Number of Participants With Premature Treatment Discontinuation Due to Adverse Events (AEs)	80 participants	28 participants

SECONDARY outcome

Timeframe: Up to 12 weeks post-treatment

Population: Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. All 671 participants received at least one dose of study drug; however, 632 of these participants were included in the safety population.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=490 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Number of Participants With Any AEs and Serious Adverse Events (SAEs) Any AEs	470 participants	142 participants
Number of Participants With Any AEs and Serious Adverse Events (SAEs) Any SAEs	76 participants	16 participants

SECONDARY outcome

Timeframe: Baseline (Day 1 ), Weeks 2, 4, 6, 8, 12, 16, 24, 36, 48, 12 weeks post-treatment

WPAI-AS is a 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Each sub-scores was scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	PegIFN + RBV + TEL n=493 Participants As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	PegIFN + RBV + BOC n=142 Participants As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 6, Overall work impairment (n = 25, 4)	32.9 units on a scale Standard Error 6.02	24.7 units on a scale Standard Error 15.46
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 6, Activity impairment (n = 75, 29)	17.9 units on a scale Standard Error 3.76	21.9 units on a scale Standard Error 6.10
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 8, Work Time Missed (; n = 48, 10)	24.1 units on a scale Standard Error 5.03	0.2 units on a scale Standard Error 11.50
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 2, Work Time Missed, n = 37, 7	14.6 units on a scale Standard Error 3.09	13.8 units on a scale Standard Error 6.98
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 2, Impairment While Working (n = 36, 8)	9.3 units on a scale Standard Error 3.79	19.6 units on a scale Standard Error 8.18
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 2, Overall work impairment (n = 35, 7)	11.8 units on a scale Standard Error 4.31	26.8 units on a scale Standard Error 9.91
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 2, Activity impairment (n = 93, 33)	16.7 units on a scale Standard Error 2.75	16.0 units on a scale Standard Error 4.63
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 4, Work Time Missed (n = 58, 16)	10.8 units on a scale Standard Error 3.68	13.2 units on a scale Standard Error 7.07
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 4, Impairment While Working (n = 55, 16)	21.8 units on a scale Standard Error 3.89	20.1 units on a scale Standard Error 7.28
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 4, Overall work impairment (n = 55, 16)	25.3 units on a scale Standard Error 4.25	22.6 units on a scale Standard Error 7.95
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 4, Activity impairment (n = 142, 49)	23.0 units on a scale Standard Error 2.73	11.5 units on a scale Standard Error 4.67
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 6, Work Time Missed (n = 25, 4)	10.8 units on a scale Standard Error 4.34	31.0 units on a scale Standard Error 11.14
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 6, Impairment While Working (n = 25, 4)	25.5 units on a scale Standard Error 6.36	0.6 units on a scale Standard Error 16.40
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 8, Impairment While Working (n = 45, 11)	29.1 units on a scale Standard Error 3.77	7.1 units on a scale Standard Error 7.88
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 8, Overall work impairment (n = 44, 10)	37.1 units on a scale Standard Error 4.15	7.5 units on a scale Standard Error 9.13
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 8, Activity impairment (n = 109, 40)	30.7 units on a scale Standard Error 3.20	21.2 units on a scale Standard Error 5.32
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 12, Work Time Missed (n = 50, 11)	17.6 units on a scale Standard Error 4.72	-3.7 units on a scale Standard Error 10.24
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 12, Impairment While Working (n = 46, 10)	28.2 units on a scale Standard Error 4.39	9.5 units on a scale Standard Error 9.57
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 12, Overall work impairment (n = 46,11)	34.1 units on a scale Standard Error 4.43	2.8 units on a scale Standard Error 9.25
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 12, Activity impairment (n = 119, 41)	27.3 units on a scale Standard Error 2.99	20.8 units on a scale Standard Error 5.12
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 16, Work Time Missed (n = 31, 10)	1.5 units on a scale Standard Error 5.56	7.4 units on a scale Standard Error 10.11
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 16, Impairment While Working (n = 32, 10)	21.0 units on a scale Standard Error 5.94	19.9 units on a scale Standard Error 11.0
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 16, Overall work impairment (n = 31, 10)	23.9 units on a scale Standard Error 6.43	16.1 units on a scale Standard Error 11.69
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 16, Activity impairment (n = 87, 36)	22.7 units on a scale Standard Error 3.90	19.7 units on a scale Standard Error 6.11
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 24, Work Time Missed (n = 22, 7)	2.9 units on a scale Standard Error 5.09	17.0 units on a scale Standard Error 9.32
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 24, Impairment While Working (n = 21, 7)	18.1 units on a scale Standard Error 8.35	11.5 units on a scale Standard Error 15.01
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 24, Overall work impairment (n = 21, 7)	16.0 units on a scale Standard Error 7.59	25.3 units on a scale Standard Error 13.64
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 24, Activity impairment (n = 75, 35)	14.5 units on a scale Standard Error 3.97	13.0 units on a scale Standard Error 5.83
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 36, Work Time Missed (n = 10, 1)	2.8 units on a scale Standard Error 6.74	9.5 units on a scale Standard Error 26.28
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 36, Impairment While Working (n = 9, 1)	14.4 units on a scale Standard Error 12.91	40.0 units on a scale Standard Error 47.92
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 36, Overall work impairment (n = 10, 1)	13.5 units on a scale Standard Error 14.16	34.1 units on a scale Standard Error 55.23
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 36, Activity impairment (n = 28, 8)	16.2 units on a scale Standard Error 6.21	10.9 units on a scale Standard Error 12.04
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 48, Work Time Missed (n = 4, 1)	3.6 units on a scale Standard Error 50.76	119.0 units on a scale Standard Error 181.99
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 48, Impairment While Working (n = 3, 1)	71.8 units on a scale Standard Error 52.43	-5.4 units on a scale Standard Error 145.43
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 48, Overall work impairment (n = 4, 1)	71.8 units on a scale Standard Error 48.32	-67.1 units on a scale Standard Error 173.24
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Wk 48, Activity impairment (n = 8, 1)	35.4 units on a scale Standard Error 14.41	37.1 units on a scale Standard Error 59.10
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) EOT visit, Work Time Missed (n = 49, 10)	8.4 units on a scale Standard Error 3.20	5.0 units on a scale Standard Error 7.30
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) EOT visit, Impairment While Working (n = 47, 10)	20.8 units on a scale Standard Error 4.10	15.5 units on a scale Standard Error 9.15
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) EOT visit, Overall work impairment (n = 48, 10)	24.2 units on a scale Standard Error 4.45	16.2 units on a scale Standard Error 10.04
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) EOT visit, Activity impairment (n = 143, 44)	18.7 units on a scale Standard Error 2.97	14.8 units on a scale Standard Error 5.43
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) 12 Wks in FU, Work Time Missed (n = 19, 3)	16.8 units on a scale Standard Error 8.11	-32.6 units on a scale Standard Error 21.41
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) 12 Wks in FU, Impairment While Working (n = 19, 3)	1.5 units on a scale Standard Error 3.51	3.6 units on a scale Standard Error 9.50
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) 12 Wks in FU, Overall work impairment (n = 18, 3)	13.6 units on a scale Standard Error 9.17	-24.5 units on a scale Standard Error 24.09
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) 12 Wks in FU, Activity impairment (n = 67, 17)	0.8 units on a scale Standard Error 3.86	-11.5 units on a scale Standard Error 7.66

Adverse Events

PegIFN + RBV + TEL

Serious events: 76 serious events

Other events: 470 other events

Deaths: 0 deaths

PegIFN + RBV + BOC

Serious events: 16 serious events

Other events: 142 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 61 6878333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER