Trial Outcomes & Findings for Evaluating the Effectiveness of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus (HCV) Infection in Adults With HIV and HCV Infection (NCT NCT01482767)

Last Updated: 2021-11-04

Results Overview

SVR24 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 24 weeks after treatment discontinuation. Participants without HCV RNA for SVR24 determination were considered not to have achieved SVR24.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

262 participants

Primary outcome timeframe

24 weeks after treatment discontinuation

Results posted on

2021-11-04

Participant Flow

Participants were enrolled from May 2012 to December 2013 at 42 U.S. sites.

Participant milestones

Participant milestones
Measure	HCV Treatment-Naive (Group A) Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.	HCV Treatment-Experienced (Group B) Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Overall Study STARTED	135	127
Overall Study COMPLETED	81	78
Overall Study NOT COMPLETED	54	49

Reasons for withdrawal

Reasons for withdrawal
Measure	HCV Treatment-Naive (Group A) Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.	HCV Treatment-Experienced (Group B) Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Overall Study Death	1	1
Overall Study Withdrawal by Subject	7	5
Overall Study Lost to Follow-up	12	6
Overall Study Adverse Event	0	3
Overall Study Site closure	22	14
Overall Study Non-adherence to study requirements	4	7
Overall Study Alternate HCV treatment	7	8
Overall Study Ineligible	0	5
Overall Study Nurse error	1	0

Baseline Characteristics

Evaluating the Effectiveness of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus (HCV) Infection in Adults With HIV and HCV Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HCV Treatment-Naive (Group A) n=135 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.	HCV Treatment-Experienced (Group B) n=122 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.	Total n=257 Participants Total of all reporting groups
Age, Continuous	51 years n=5 Participants	53 years n=7 Participants	52 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	110 Participants n=5 Participants	93 Participants n=7 Participants	203 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	28 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	117 Participants n=5 Participants	93 Participants n=7 Participants	210 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	73 Participants n=5 Participants	53 Participants n=7 Participants	126 Participants n=5 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	58 Participants n=7 Participants	115 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	135 participants n=5 Participants	122 participants n=7 Participants	257 participants n=5 Participants
Intravenous Drug Use History Never	71 participants n=5 Participants	70 participants n=7 Participants	141 participants n=5 Participants
Intravenous Drug Use History Previously	64 participants n=5 Participants	52 participants n=7 Participants	116 participants n=5 Participants
Cirrhosis Status at Screening Cirrhotic	18 participants n=5 Participants	38 participants n=7 Participants	56 participants n=5 Participants
Cirrhosis Status at Screening Non-cirrhotic	117 participants n=5 Participants	84 participants n=7 Participants	201 participants n=5 Participants
HCV RNA at Entry	6.7 log10 IU/mL n=5 Participants	6.9 log10 IU/mL n=7 Participants	6.8 log10 IU/mL n=5 Participants
ART Regimen at Entry EFV + 2 NRTIs	58 participants n=5 Participants	51 participants n=7 Participants	109 participants n=5 Participants
ART Regimen at Entry RAL + 2 NRTIs	47 participants n=5 Participants	45 participants n=7 Participants	92 participants n=5 Participants
ART Regimen at Entry LPV/RTV + 2 NRTIs	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
ART Regimen at Entry ATV/RTV + 2 NRTIs	18 participants n=5 Participants	10 participants n=7 Participants	28 participants n=5 Participants
ART Regimen at Entry DRV/RTV + 2 NRTIs	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
ART Regimen at Entry Not on ART	2 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants
CD4 Cell Count at Entry	646 cells/mm^3 n=5 Participants	622 cells/mm^3 n=7 Participants	625 cells/mm^3 n=5 Participants
HIV-1 RNA Quantitation at Entry Unquantifiable	133 participants n=5 Participants	113 participants n=7 Participants	246 participants n=5 Participants
HIV-1 RNA Quantitation at Entry Quantifiable	0 participants n=5 Participants	9 participants n=7 Participants	9 participants n=5 Participants
HIV-1 RNA Quantitation at Entry Unknown	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks after treatment discontinuation

Population: All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).

Outcome measures

Outcome measures
Measure	HCV Treatment-Naive (Group A) n=135 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.	HCV Treatment-Experienced (Group B) n=122 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)	34.8 percentage of participants Interval 27.3 to 43.2	25.4 percentage of participants Interval 18.5 to 33.8

SECONDARY outcome

Timeframe: From study treatment dispensation to Week 72

Population: All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).

Number of participants who experienced an AE (sign or symptom or laboratory abnormality) of Grade 3 or higher at any time after baseline while on study. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.

Outcome measures

Outcome measures
Measure	HCV Treatment-Naive (Group A) n=135 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.	HCV Treatment-Experienced (Group B) n=122 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)	74.1 percentage of participants Interval 66.1 to 80.7	73.8 percentage of participants Interval 65.3 to 80.8

SECONDARY outcome

Timeframe: 12 weeks after treatment discontinuation

Population: All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).

SVR12 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 12 weeks after treatment discontinuation. Participants without HCV RNA for SVR12 determination were considered not to have achieved SVR12.

Outcome measures

Outcome measures
Measure	HCV Treatment-Naive (Group A) n=135 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.	HCV Treatment-Experienced (Group B) n=122 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)	35.6 percentage of participants Interval 28.0 to 43.9	30.3 percentage of participants Interval 22.9 to 39.0

SECONDARY outcome

Timeframe: Entry and weeks (W) 4, 8, 12, 24, 28, 40, 48, 52, 60, 72

Population: All eligible participants with HIV-1 RNA result available at the respective visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.

HIV-1 RNA testing was performed with Abbott RealTime HIV-1 assay (LLOQ=40 copies/mL) or with Roche COBAS AmpliPrep/Taqman HIV-1 assay (LLOQ=20 copies/mL).

Outcome measures

Outcome measures
Measure	HCV Treatment-Naive (Group A) n=135 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.	HCV Treatment-Experienced (Group B) n=122 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Percentage of Participants With HIV-1 Viral Load <50 Copies/mL W0 HIV-1 RNA (A: n=133, B: n=122)	100.0 percentage of participants	92.6 percentage of participants
Percentage of Participants With HIV-1 Viral Load <50 Copies/mL W40 HIV-1 RNA (A: n=52, B: n=38)	92.3 percentage of participants	100.0 percentage of participants
Percentage of Participants With HIV-1 Viral Load <50 Copies/mL W48 HIV-1 RNA (A: n=23, B: n=33)	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants With HIV-1 Viral Load <50 Copies/mL W52 HIV-1 RNA (A: n=24, B: n=0)	100.0 percentage of participants	NA percentage of participants Group B participants did not have a study visit at Week 52.
Percentage of Participants With HIV-1 Viral Load <50 Copies/mL W72 HIV-1 RNA (A: n=34, B: n=27)	97.1 percentage of participants	100.0 percentage of participants
Percentage of Participants With HIV-1 Viral Load <50 Copies/mL W4 HIV-1 RNA (A: n=123, B: n=114)	98.4 percentage of participants	96.5 percentage of participants
Percentage of Participants With HIV-1 Viral Load <50 Copies/mL W8 HIV-1 RNA (A: n=117, B: n=104)	100.0 percentage of participants	96.2 percentage of participants
Percentage of Participants With HIV-1 Viral Load <50 Copies/mL W12 HIV-1 RNA (A: n=108, B: n=99)	98.1 percentage of participants	98.0 percentage of participants
Percentage of Participants With HIV-1 Viral Load <50 Copies/mL W24 HIV-1 RNA (A: n=62, B: n=52)	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants With HIV-1 Viral Load <50 Copies/mL W28 HIV-1 RNA: (A: n=54, B: n=45)	98.1 percentage of participants	100.0 percentage of participants
Percentage of Participants With HIV-1 Viral Load <50 Copies/mL W60 HIV-1 RNA (A: n=40, B: n=36)	100.0 percentage of participants	97.2 percentage of participants

SECONDARY outcome

Timeframe: Entry and weeks (W) 8, 12, 24, 28, 40, 48, 52, 60, 72

Population: All eligible participants enrolled with CD4 result available from entry and the respective post-entry visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.

Change in CD4 T-cell count was calculated as value at the post entry visit minus the value at entry.

Outcome measures

Outcome measures
Measure	HCV Treatment-Naive (Group A) n=135 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.	HCV Treatment-Experienced (Group B) n=122 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
CD4+ T-Cell Count (CD4) Change From Baseline W8 CD4 change (A: n=115, B: n=101)	-174 cells/mm^3 Interval -285.0 to -77.0	-170 cells/mm^3 Interval -290.0 to -83.0
CD4+ T-Cell Count (CD4) Change From Baseline W24 CD4 change (A: n=61, B: n=52)	-277 cells/mm^3 Interval -402.0 to -143.0	-263 cells/mm^3 Interval -418.0 to -184.0
CD4+ T-Cell Count (CD4) Change From Baseline W28 CD4 change (A: n=53, B: n=44)	-304 cells/mm^3 Interval -441.0 to -157.0	-284 cells/mm^3 Interval -412.0 to -227.0
CD4+ T-Cell Count (CD4) Change From Baseline W40 CD4 change (A: n=50, B: n=37)	-128 cells/mm^3 Interval -234.0 to -47.0	-276 cells/mm^3 Interval -368.0 to -180.0
CD4+ T-Cell Count (CD4) Change From Baseline W48 CD4 change (A: n=22, B: n=35)	-220 cells/mm^3 Interval -420.0 to -77.0	-237 cells/mm^3 Interval -352.0 to -147.0
CD4+ T-Cell Count (CD4) Change From Baseline W12 CD4 change (A: n=106, B: n=95)	-194 cells/mm^3 Interval -342.0 to -101.0	-202 cells/mm^3 Interval -331.0 to -90.0
CD4+ T-Cell Count (CD4) Change From Baseline W52 CD4 change (A: n=23, B: n=0)	-24 cells/mm^3 Interval -174.0 to 75.0	NA cells/mm^3 Group B participants did not have a study visit at Week 52.
CD4+ T-Cell Count (CD4) Change From Baseline W60 CD4 change (A: n=39, B: n=36)	-34 cells/mm^3 Interval -210.0 to 107.0	-79 cells/mm^3 Interval -146.0 to 40.0
CD4+ T-Cell Count (CD4) Change From Baseline W72 CD4 change (A: n=33, B: n=27)	8 cells/mm^3 Interval -123.0 to 77.0	-15 cells/mm^3 Interval -129.0 to 124.0

SECONDARY outcome

Timeframe: Weeks (W) 4, 8, 12

Population: All eligible participants with HCV RNA result available at the respective visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.

Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0.

Outcome measures

Outcome measures
Measure	HCV Treatment-Naive (Group A) n=135 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.	HCV Treatment-Experienced (Group B) n=122 Participants Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Number of Participants With Undetectable HCV RNA at Week 4, 8 and 12 Study Visits W4 HCV RNA (A: n=122, B: n=116)	9 participants	3 participants
Number of Participants With Undetectable HCV RNA at Week 4, 8 and 12 Study Visits W8 HCV RNA (A: n=117, B: n=104)	48 participants	28 participants
Number of Participants With Undetectable HCV RNA at Week 4, 8 and 12 Study Visits W12 HCV RNA (A: n=109, B: n=99)	68 participants	43 participants

SECONDARY outcome

Timeframe: Weeks (W) 16, 20, 24, and 28

Population: This outcome measure was intended for a potential interim analysis which was not conducted.

Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0. This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From study treatment dispensation to Week 28

Population: This outcome measure was intended for a potential interim analysis which was not conducted.

This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted. Refer to Outcome Measure 2 above for the safety outcome that includes the whole study duration from entry to week 72.

Outcome measures

Outcome data not reported

Adverse Events

HCV Treatment-Naive (Group A)

Serious events: 32 serious events

Other events: 135 other events

Deaths: 0 deaths

HCV Treatment-Experienced (Group B)

Serious events: 31 serious events

Other events: 120 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

ACTG ClinicalTrials.gov Coordinator

ACTG Network Coordinating Center, Social and Scientific Systems, Inc.

Phone: (301) 628-3313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	HCV Treatment-Naive (Group A) n=135 participants at risk Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.	HCV Treatment-Experienced (Group B) n=122 participants at risk Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Blood and lymphatic system disorders Anaemia	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	3.3% 4/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Blood and lymphatic system disorders Leukopenia	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Blood and lymphatic system disorders Lymphadenitis	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Blood and lymphatic system disorders Neutropenia	3.0% 4/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	7.4% 9/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Blood and lymphatic system disorders Pancytopenia	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Cardiac disorders Cardiac failure congestive	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Gastrointestinal disorders Diarrhoea	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Gastrointestinal disorders Pancreatitis acute	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
General disorders Asthenia	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	1.6% 2/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
General disorders Chest pain	1.5% 2/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
General disorders Injection site mass	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
General disorders Non-cardiac chest pain	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
General disorders Pyrexia	1.5% 2/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Hepatobiliary disorders Cholecystitis acute	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	1.6% 2/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Hepatobiliary disorders Liver disorder	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Abscess	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Cellulitis	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	1.6% 2/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Injection site cellulitis	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Lobar pneumonia	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Perinephric abscess	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Pneumonia	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Pneumonia bacterial	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Pyelonephritis	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Sepsis syndrome	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Septic shock	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Subcutaneous abscess	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Toxoplasmosis	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Injury, poisoning and procedural complications Heat illness	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Injury, poisoning and procedural complications Overdose	2.2% 3/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Haemoglobin decreased	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Lipase increased	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	1.6% 2/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Neutrophil count decreased	0.00% 0/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.82% 1/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Metabolism and nutrition disorders Hypophosphataemia	0.74% 1/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.

Other adverse events
Measure	HCV Treatment-Naive (Group A) n=135 participants at risk Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.	HCV Treatment-Experienced (Group B) n=122 participants at risk Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Gastrointestinal disorders Abdominal pain	5.9% 8/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	5.7% 7/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Gastrointestinal disorders Diarrhoea	6.7% 9/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	10.7% 13/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Gastrointestinal disorders Nausea	20.7% 28/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	23.0% 28/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Gastrointestinal disorders Vomiting	13.3% 18/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	10.7% 13/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
General disorders Asthenia	2.2% 3/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	5.7% 7/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
General disorders Chills	12.6% 17/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	13.1% 16/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
General disorders Fatigue	32.6% 44/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	27.9% 34/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
General disorders Malaise	5.2% 7/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	5.7% 7/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
General disorders Pain	3.0% 4/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	6.6% 8/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
General disorders Pyrexia	9.6% 13/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	9.8% 12/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Alanine aminotransferase increased	53.3% 72/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	54.1% 66/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Aspartate aminotransferase increased	70.4% 95/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	73.0% 89/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Blood albumin decreased	5.9% 8/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	4.9% 6/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Blood alkaline phosphatase increased	7.4% 10/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	14.8% 18/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Blood bicarbonate decreased	9.6% 13/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	8.2% 10/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Blood bilirubin increased	23.7% 32/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	30.3% 37/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Blood creatinine increased	20.0% 27/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	17.2% 21/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Blood glucose decreased	8.1% 11/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	3.3% 4/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Blood glucose increased	19.3% 26/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	23.8% 29/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Blood phosphorus decreased	7.4% 10/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	7.4% 9/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Blood potassium decreased	6.7% 9/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	7.4% 9/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Blood sodium decreased	8.1% 11/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	11.5% 14/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Blood uric acid increased	8.1% 11/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	17.2% 21/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Haemoglobin decreased	54.8% 74/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	55.7% 68/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Lipase abnormal	8.9% 12/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	16.4% 20/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Lipase increased	4.4% 6/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	9.8% 12/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Neutrophil count decreased	85.2% 115/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	77.9% 95/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Platelet count decreased	50.4% 68/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	59.8% 73/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations Weight decreased	14.8% 20/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	21.3% 26/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Investigations White blood cell count decreased	25.9% 35/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	27.9% 34/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Metabolism and nutrition disorders Decreased appetite	11.9% 16/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	11.5% 14/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Musculoskeletal and connective tissue disorders Arthralgia	4.4% 6/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	8.2% 10/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Musculoskeletal and connective tissue disorders Myalgia	8.1% 11/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	11.5% 14/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Musculoskeletal and connective tissue disorders Pain in extremity	3.0% 4/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	10.7% 13/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Nervous system disorders Dizziness	5.2% 7/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	7.4% 9/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Nervous system disorders Headache	9.6% 13/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	13.1% 16/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Psychiatric disorders Anxiety	7.4% 10/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	4.1% 5/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Psychiatric disorders Depression	7.4% 10/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	5.7% 7/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Respiratory, thoracic and mediastinal disorders Cough	3.7% 5/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	10.7% 13/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.7% 9/135 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	8.2% 10/122 • From study treatment dispensation to Week 72. The protocol required reporting of signs/symptoms \>=Grade 2, laboratory results \>=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.