Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)

Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01399619

Enrollment

310

Registered

2011-07-22

Start date

2011-09-30

Completion date

2014-06-30

Last updated

2016-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Brief summary

the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV

Interventions

DRUGPegIFN/RBV

PegIFN/RBV for 24 or 48w

DRUGBI201335

BI201335 for 12w

DRUGBI201335 24W

BI201335 for 24w

DRUGBi 201335

BI 201335 for 24 w

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Chronic hepatitis C (HCV) genotype 1 infection 2. Chronic Human Immunodeficiency Virus (HIV) -1 infection 3. HCV treatment naive or HCV treatment experienced but only relapsers 4. Age 18 to 70 years 5. Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy (HAART) 6. Karnofsky score \>70 7. HCV viral load \>1.000 IU/mL

Exclusion criteria

1. HCV infection of mixed genotype (1/2, 1/3, 1/4) 2. Evidence of acute or chronic liver due to chronic HCV infection 3. Hepatitis B virus (HBV) infection with presence of HBs-Ag 4. Active malignancy or history or malignancy within the last 5 years 5. Received concomitant systemic antiviral (other than antiretroviral), hematopoietic growth factor or immunomodulatory treatment in 28 days prior enrolment. 6. Decompensated liver disease,as evidenced by ascites, hepatic encephalopathy, esophageal variceal bleeding, and/or laboratory values that add up to \>/= 7 points according tho the Child-Turcotte-Pugh classification 7. Hemoglobin \</=11g/dL for women and \</= 12 g/dL for men 8. Patients with stable cardiac disease and Hemoglobin \<12g/dL 9. Known hypersensitivity to any ingredient of the study drugs

Design outcomes

Primary

Measure	Time frame	Description
Sustained Virological Response (SVR12)	60 weeks	Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level \<25 IU/mL, undetected 12 weeks after the planned end of treatment.

Secondary

Measure	Time frame	Description
Early Treatment Success (ETS)	Week 4, week 8 and week 60	Early Treatment Success (ETS): Plasma HCV RNA level\<25 IU/mL (detected or undetected) at Week 4 and HCV RNA\< 25 IU/mL, undetected at Week 8
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	48 weeks	The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	48 weeks	The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	60 weeks	The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
Virological Response 24 Weeks Post Treatment (SVR24)	72 weeks	Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level\<25IU/mL (undetected) 24 weeks after the planned end of treatment.
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	48 weeks	The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	48 weeks	The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	60 weeks	The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	60 weeks	The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	60 weeks	The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.

Countries

Brazil, France, Germany, Italy, Spain, Switzerland, United Kingdom, United States

Participant flow

Participants by arm

Arm	Count
Faldaprevir 120mg - 24W Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.	123
Faldaprevir 240mg -T patient to receive Faldaprevir 240 mg once a day for 12 or 24 weeks and PegIFN/RBV for 24 or 48 weeks + patients who received Faldaprevir 240 mg and discontinued prior to week 12.	185
Total	308

Withdrawals & dropouts

Period	Reason	FG000	FG002	FG003
Overall Study	Adverse Event	10	4	10
Overall Study	Lack of Efficacy	9	5	0
Overall Study	Not treated	0	0	2
Overall Study	Protocol Violation	0	0	1
Overall Study	Withdrawal by Subject	6	3	4

Baseline characteristics

Characteristic	Faldaprevir 120mg - 24W	Faldaprevir 240mg -T	Total
Age, Continuous	47.6 years STANDARD_DEVIATION 7.63	46.5 years STANDARD_DEVIATION 8.36	46.9 years STANDARD_DEVIATION 8.08
Sex: Female, Male Female	20 Participants	40 Participants	60 Participants
Sex: Female, Male Male	103 Participants	145 Participants	248 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	116 / 123	80 / 84	84 / 86	178 / 185
serious Total, serious adverse events	17 / 123	5 / 84	5 / 86	15 / 185

Outcome results

Primary

Sustained Virological Response (SVR12)

Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level \<25 IU/mL, undetected 12 weeks after the planned end of treatment.

Time frame: 60 weeks

Population: FAS

Arm	Measure	Value (NUMBER)
Faldaprevir 120mg - 24W	Sustained Virological Response (SVR12)	70.7 percentage of participants
Faldaprevir 240mg - 12W	Sustained Virological Response (SVR12)	78.6 percentage of participants
Faldaprevir 240mg - 24W	Sustained Virological Response (SVR12)	76.7 percentage of participants
Faldaprevir 240mg -T	Sustained Virological Response (SVR12)	72.4 percentage of participants
Faldaprevir - Total	Sustained Virological Response (SVR12)	71.8 percentage of participants

Comparison: the SVR12 rate in total Faldaprevir group compared with the historical rate of 40%.p-value: <0.0001normal approximation

Secondary

Early Treatment Success (ETS)

Early Treatment Success (ETS): Plasma HCV RNA level\<25 IU/mL (detected or undetected) at Week 4 and HCV RNA\< 25 IU/mL, undetected at Week 8

Time frame: Week 4, week 8 and week 60

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Faldaprevir 120mg - 24W	Early Treatment Success (ETS)	number of subjects with ETS =yes	95 participants
Faldaprevir 120mg - 24W	Early Treatment Success (ETS)	number of subjects with SVR12 among ETS=yes group	83 participants
Faldaprevir 240mg - 12W	Early Treatment Success (ETS)	number of subjects with ETS =yes	70 participants
Faldaprevir 240mg - 12W	Early Treatment Success (ETS)	number of subjects with SVR12 among ETS=yes group	62 participants
Faldaprevir 240mg - 24W	Early Treatment Success (ETS)	number of subjects with ETS =yes	73 participants
Faldaprevir 240mg - 24W	Early Treatment Success (ETS)	number of subjects with SVR12 among ETS=yes group	63 participants
Faldaprevir 240mg -T	Early Treatment Success (ETS)	number of subjects with SVR12 among ETS=yes group	127 participants
Faldaprevir 240mg -T	Early Treatment Success (ETS)	number of subjects with ETS =yes	150 participants
Faldaprevir - Total	Early Treatment Success (ETS)	number of subjects with ETS =yes	245 participants
Faldaprevir - Total	Early Treatment Success (ETS)	number of subjects with SVR12 among ETS=yes group	210 participants

Secondary

The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes

The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.

Time frame: 48 weeks

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, BL elevated to EOT normal	45 participants
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes	87 participants
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, BL normal to EOT normal	29 participants
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, No BL or EoT data	0 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, BL normal to EOT normal	16 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes	66 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, BL elevated to EOT normal	34 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, No BL or EoT data	0 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes	66 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, No BL or EoT data	0 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, BL normal to EOT normal	26 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, BL elevated to EOT normal	32 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes	134 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, No BL or EoT data	1 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, BL elevated to EOT normal	66 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, BL normal to EOT normal	43 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, No BL or EoT data	1 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes	221 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, BL normal to EOT normal	72 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes	SVR12=yes, BL elevated to EOT normal	111 participants

Secondary

The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no

The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.

Time frame: 48 weeks

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no	36 participants
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL normal to EoT normal	18 participants
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL elevated to EoT normal	12 participants
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, no BL or EoT data available	2 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no	18 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, no BL or EoT data available	0 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL normal to EoT normal	5 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL elevated to EoT normal	8 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, no BL or EoT data available	0 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL normal to EoT normal	5 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL elevated to EoT normal	9 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no	20 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no	51 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL normal to EoT normal	18 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, no BL or EoT data available	0 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL elevated to EoT normal	21 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, no BL or EoT data available	2 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL elevated to EoT normal	33 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL normal to EoT normal	36 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no	SVR12=no	87 participants

Secondary

The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no

The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.

Time frame: 60 weeks

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL elevated to SVR12 normal	1 participants
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no	36 participants
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL normal to SVR12 normal	8 participants
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, no ALT data available at SVR12 visit	16 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL normal to SVR12 normal	1 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no	18 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, no ALT data available at SVR12 visit	4 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL elevated to SVR12 normal	6 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no	20 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, no ALT data available at SVR12 visit	6 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL normal to SVR12 normal	3 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL elevated to SVR12 normal	3 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no	51 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, no ALT data available at SVR12 visit	20 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL elevated to SVR12 normal	9 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL normal to SVR12 normal	6 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, no ALT data available at SVR12 visit	36 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no	87 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL normal to SVR12 normal	14 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL elevated to SVR12 normal	10 participants

Secondary

The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes

The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.

Time frame: 60 weeks

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes	87 participants
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL normal to SVR12 normal	28 participants
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL elevated to SVR12 normal	52 participants
Faldaprevir 120mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, no ALT data available at SVR12 visit	4 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes	66 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, no ALT data available at SVR12 visit	0 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL normal to SVR12 normal	17 participants
Faldaprevir 240mg - 12W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL elevated to SVR12 normal	46 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, no ALT data available at SVR12 visit	1 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL normal to SVR12 normal	26 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL elevated to SVR12 normal	35 participants
Faldaprevir 240mg - 24W	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes	66 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes	134 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL normal to SVR12 normal	45 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, no ALT data available at SVR12 visit	1 participants
Faldaprevir 240mg -T	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL elevated to SVR12 normal	81 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, no ALT data available at SVR12 visit	5 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL elevated to SVR12 normal	133 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL normal to SVR12 normal	73 participants
Faldaprevir - Total	The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes	221 participants

Secondary

The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no

The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.

Time frame: 48 weeks

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no	36 participants
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL normal to EoT normal	14 participants
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL elevated to EoT normal	12 participants
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, no BL or EoT data available	2 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no	18 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, no BL or EoT data available	0 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL normal to EoT normal	6 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL elevated to EoT normal	6 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, no BL or EoT data available	0 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL normal to EoT normal	7 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL elevated to EoT normal	8 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no	20 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no	51 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL normal to EoT normal	19 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, no BL or EoT data available	0 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL elevated to EoT normal	19 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, no BL or EoT data available	2 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL elevated to EoT normal	31 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no, BL normal to EoT normal	33 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no	SVR12=no	87 participants

Secondary

The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes

The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.

Time frame: 48 weeks

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes	87 participants
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, BL normal to EoT normal	41 participants
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, BL elevated to EoT normal	32 participants
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, no BL or EoT data available	0 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes	66 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, no BL or EoT data available	0 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, BL normal to EoT normal	25 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, BL elevated to EoT normal	25 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, no BL or EoT data available	0 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, BL normal to EoT normal	28 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, BL elevated to EoT normal	27 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes	66 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes	134 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, BL normal to EoT normal	54 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, no BL or EoT data available	1 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, BL elevated to EoT normal	52 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, no BL or EoT data available	1 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, BL elevated to EoT normal	84 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes, BL normal to EoT normal	95 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes	SVR12=yes	221 participants

Secondary

The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no

The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.

Time frame: 60 weeks

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no	36 participants
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL elevated to SVR12 normal	2 participants
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, no AST data available at SVR12 visit	16 participants
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL normal to SVR12 normal	6 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL normal to SVR12 normal	4 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL elevated to SVR12 normal	3 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no	18 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, no AST data available at SVR12 visit	4 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no	20 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL normal to SVR12 normal	6 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL elevated to SVR12 normal	0 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, no AST data available at SVR12 visit	6 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL normal to SVR12 normal	13 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL elevated to SVR12 normal	3 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no	51 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, no AST data available at SVR12 visit	20 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL normal to SVR12 normal	19 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, no AST data available at SVR12 visit	36 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no, BL elevated to SVR12 normal	5 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no	SVR12=no	87 participants

Secondary

The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes

The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.

Time frame: 60 weeks

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes	87 participants
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL normal to SVR12 normal	41 participants
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL elevated to SVR12 normal	36 participants
Faldaprevir 120mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, no AST data available at SVR12 visit	4 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes	66 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, no AST data available at SVR12 visit	0 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL normal to SVR12 normal	27 participants
Faldaprevir 240mg - 12W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL elevated to SVR12 normal	36 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, no AST data available at SVR12 visit	1 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL normal to SVR12 normal	28 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL elevated to SVR12 normal	33 participants
Faldaprevir 240mg - 24W	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes	66 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes	134 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL normal to SVR12 normal	57 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, no AST data available at SVR12 visit	1 participants
Faldaprevir 240mg -T	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL elevated to SVR12 normal	69 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, no AST data available at SVR12 visit	5 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL elevated to SVR12 normal	105 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes, BL normal to SVR12 normal	98 participants
Faldaprevir - Total	The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes	SVR12=yes	221 participants

Secondary

Virological Response 24 Weeks Post Treatment (SVR24)

Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level\<25IU/mL (undetected) 24 weeks after the planned end of treatment.

Time frame: 72 weeks

Population: FAS

Arm	Measure	Value (NUMBER)
Faldaprevir 120mg - 24W	Virological Response 24 Weeks Post Treatment (SVR24)	69.9 percentage of participants
Faldaprevir 240mg - 12W	Virological Response 24 Weeks Post Treatment (SVR24)	78.6 percentage of participants
Faldaprevir 240mg - 24W	Virological Response 24 Weeks Post Treatment (SVR24)	74.4 percentage of participants
Faldaprevir 240mg -T	Virological Response 24 Weeks Post Treatment (SVR24)	71.4 percentage of participants
Faldaprevir - Total	Virological Response 24 Weeks Post Treatment (SVR24)	70.8 percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026

Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Sustained Virological Response (SVR12)

Early Treatment Success (ETS)

The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes

The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no

The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no

The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes

The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no

The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes

The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no

The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes

Virological Response 24 Weeks Post Treatment (SVR24)