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Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01215643
Enrollment
340
Registered
2010-10-06
Start date
2010-10-31
Completion date
2012-05-31
Last updated
2016-08-30

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

Conditions

Chronic Pain, Hepatitis C

Keywords

Chronic hepatitis C genotype 2, Chronic hepatitis C genotype 3, Cyclophilin inhibitor

Brief summary

The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

Interventions

DRUGAlisporivir

ALV 200 mg soft gel capsules administered orally

DRUGPeginterferon alfa-2a

PEG 180 μg administered via subcutaneous (s.c.) injection once weekly

DRUGRibavirin

RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)

Sponsors

Debiopharm International SA
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Chronic hepatitis C viral infection * Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit) * HCV genotype 2 or 3 * No previous treatment for hepatitis C infection

Exclusion criteria

* Evidence of cirrhosis at the time of screening * Evidence of hepatocellular carcinoma at the time of screening * Any other cause of relevant liver disease other than HCV * Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN) * Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)after 4 weeks of treatmentRVR4LOQ was defined as RVR \[serum hepatitis C virus (HCV) ribonucleic acid (RNA) \< the limit of quantification (LOQ), i.e., \< 25 IU/mL\], after 4 weeks of treatment.

Secondary

MeasureTime frameDescription
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)after 4 weeks of treatment—
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)after 4 weeks of treatment—
Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)after 12 weeks of treatmentcEVR12LOQ and cEVR12LOD were defined as cEVR \[serum HCV RNA \< LOQ and \< LOD\] after 12 weeks of treatment, respectively.
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)after 12 weeks of treatment—
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)after 12 weeks of treatment—
Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)at end of treatment, within 24 weeksETR24LOQ and ETR24LOD were defined as ETR \[serum HCV RNA \< LOQ and \< LOD\] after 24 weeks of treatment or when prematurely discontinued.
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)at end of treatment, within 24 weeks—
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)at end of treatment, within 24 weeks—
Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)after 4 weeks of treatmentRVR4LOD was defined as Rapid Viral Response (RVR) \[serum HCV RNA \< the limit of detection (LOD), i.e., \< 10 IU/mL\], after 4 weeks of treatment.
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)12 weeks after the end of treatment—
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)12 weeks after the end of treatment—
Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)24 weeks after the end of treatment—
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)24 weeks after the end of treatment—
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)24 weeks after the end of treatment—
Percentage of Participants With On-treatment Viral Breakthroughwithin 24 weeks of treatmentViral breakthrough was defined as either: * Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or * HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (\< LOD) during treatment
Percentage of Participants With Viral Relapsewithin 24 weeks after the end of treatmentViral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (\< LOD) during treatment.
Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)12 weeks after the end of treatmentSVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) \[serum HCV RNA \< LOQ and \< LOD\] 12 weeks after treatment, respectively.

Countries

Australia, Belgium, Canada, France, Germany, India, Italy, Poland, Puerto Rico, South Korea, Taiwan, Thailand, United Kingdom, United States

Participant flow

Participants by arm

ArmCount
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
83
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
84
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
94
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
39
PEG+RBV
PEG and RBV during Weeks 1 to 24.
40
Total340

Baseline characteristics

CharacteristicALV 1000 mgALV 600 mg+RBVALV 800 mg+RBVALV 600 mg+PEGPEG+RBVTotal
Age, Continuous40.2 years
STANDARD_DEVIATION 11.27
42.8 years
STANDARD_DEVIATION 11.77
42.6 years
STANDARD_DEVIATION 11
43.2 years
STANDARD_DEVIATION 10.56
39.9 years
STANDARD_DEVIATION 11.2
41.8 years
STANDARD_DEVIATION 11.25
Sex: Female, Male
Female
32 Participants28 Participants33 Participants14 Participants16 Participants123 Participants
Sex: Female, Male
Male
51 Participants56 Participants61 Participants25 Participants24 Participants217 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
64 / 8269 / 8476 / 9437 / 3930 / 3710 / 8210 / 8413 / 945 / 392 / 37
serious
Total, serious adverse events
4 / 821 / 849 / 944 / 392 / 372 / 824 / 841 / 940 / 390 / 37

Outcome results

Primary

Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)

RVR4LOQ was defined as RVR \[serum hepatitis C virus (HCV) ribonucleic acid (RNA) \< the limit of quantification (LOQ), i.e., \< 25 IU/mL\], after 4 weeks of treatment.

Time frame: after 4 weeks of treatment

Population: Full Analysis Set (FAS), defined as all participants to whom study treatment was correctly assigned.

ArmMeasureValue (NUMBER)
ALV 1000 mgPercentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)28.4 percentage of participants
ALV 600 mg+RBVPercentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)36.9 percentage of participants
ALV 800 mg+RBVPercentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)41.9 percentage of participants
ALV 600 mg+PEGPercentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)84.6 percentage of participants
PEG+RBVPercentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)72.5 percentage of participants
Secondary

Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)

Time frame: after 12 weeks of treatment

Population: Participants in the Full Analysis Set with genotype 2 HCV infection

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)cEVR12LOQ100.0 percentage of participants
ALV 1000 mgPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)cEVR12LOD100.0 percentage of participants
ALV 600 mg+RBVPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)cEVR12LOQ96.7 percentage of participants
ALV 600 mg+RBVPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)cEVR12LOD83.3 percentage of participants
ALV 800 mg+RBVPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)cEVR12LOQ80.8 percentage of participants
ALV 800 mg+RBVPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)cEVR12LOD80.8 percentage of participants
ALV 600 mg+PEGPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)cEVR12LOD90.9 percentage of participants
ALV 600 mg+PEGPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)cEVR12LOQ100.0 percentage of participants
PEG+RBVPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)cEVR12LOQ84.6 percentage of participants
PEG+RBVPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)cEVR12LOD84.6 percentage of participants
Secondary

Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)

Time frame: after 12 weeks of treatment

Population: Participants in the Full Analysis Set with genotype 3 HCV infection

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)cEVR12LOQ91.4 percentage of participants
ALV 1000 mgPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)cEVR12LOD87.9 percentage of participants
ALV 600 mg+RBVPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)cEVR12LOQ94.4 percentage of participants
ALV 600 mg+RBVPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)cEVR12LOD88.9 percentage of participants
ALV 800 mg+RBVPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)cEVR12LOQ94.0 percentage of participants
ALV 800 mg+RBVPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)cEVR12LOD94.0 percentage of participants
ALV 600 mg+PEGPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)cEVR12LOD82.1 percentage of participants
ALV 600 mg+PEGPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)cEVR12LOQ92.9 percentage of participants
PEG+RBVPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)cEVR12LOQ85.2 percentage of participants
PEG+RBVPercentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)cEVR12LOD81.5 percentage of participants
Secondary

Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)

cEVR12LOQ and cEVR12LOD were defined as cEVR \[serum HCV RNA \< LOQ and \< LOD\] after 12 weeks of treatment, respectively.

Time frame: after 12 weeks of treatment

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)cEVR12LOQ93.8 percentage of participants
ALV 1000 mgPercentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)cEVR12LOD91.4 percentage of participants
ALV 600 mg+RBVPercentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)cEVR12LOQ95.2 percentage of participants
ALV 600 mg+RBVPercentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)cEVR12LOD86.9 percentage of participants
ALV 800 mg+RBVPercentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)cEVR12LOQ90.3 percentage of participants
ALV 800 mg+RBVPercentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)cEVR12LOD90.3 percentage of participants
ALV 600 mg+PEGPercentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)cEVR12LOD84.6 percentage of participants
ALV 600 mg+PEGPercentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)cEVR12LOQ94.9 percentage of participants
PEG+RBVPercentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)cEVR12LOQ85.0 percentage of participants
PEG+RBVPercentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)cEVR12LOD82.5 percentage of participants
Secondary

Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)

ETR24LOQ and ETR24LOD were defined as ETR \[serum HCV RNA \< LOQ and \< LOD\] after 24 weeks of treatment or when prematurely discontinued.

Time frame: at end of treatment, within 24 weeks

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)ETR24LOQ95.1 percentage of participants
ALV 1000 mgPercentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)ETR24LOD92.6 percentage of participants
ALV 600 mg+RBVPercentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)ETR24LOQ96.4 percentage of participants
ALV 600 mg+RBVPercentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)ETR24LOD94.0 percentage of participants
ALV 800 mg+RBVPercentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)ETR24LOQ95.7 percentage of participants
ALV 800 mg+RBVPercentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)ETR24LOD92.5 percentage of participants
ALV 600 mg+PEGPercentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)ETR24LOD92.3 percentage of participants
ALV 600 mg+PEGPercentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)ETR24LOQ94.9 percentage of participants
PEG+RBVPercentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)ETR24LOQ87.5 percentage of participants
PEG+RBVPercentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)ETR24LOD82.5 percentage of participants
Secondary

Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)

Time frame: at end of treatment, within 24 weeks

Population: Participants in the Full Analysis Set with genotype 2 HCV infection

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)ETR24LOQ100.0 percentage of participants
ALV 1000 mgPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)ETR24LOD100.0 percentage of participants
ALV 600 mg+RBVPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)ETR24LOQ96.7 percentage of participants
ALV 600 mg+RBVPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)ETR24LOD96.7 percentage of participants
ALV 800 mg+RBVPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)ETR24LOQ84.6 percentage of participants
ALV 800 mg+RBVPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)ETR24LOD76.9 percentage of participants
ALV 600 mg+PEGPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)ETR24LOD100.0 percentage of participants
ALV 600 mg+PEGPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)ETR24LOQ100.0 percentage of participants
PEG+RBVPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)ETR24LOQ92.3 percentage of participants
PEG+RBVPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)ETR24LOD84.6 percentage of participants
Secondary

Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)

Time frame: at end of treatment, within 24 weeks

Population: Participants in the Full Analysis Set with genotype 3 HCV infection

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)ETR24LOD89.7 percentage of participants
ALV 1000 mgPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)ETR24LOQ93.1 percentage of participants
ALV 600 mg+RBVPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)ETR24LOD92.6 percentage of participants
ALV 600 mg+RBVPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)ETR24LOQ96.3 percentage of participants
ALV 800 mg+RBVPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)ETR24LOQ100.0 percentage of participants
ALV 800 mg+RBVPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)ETR24LOD98.5 percentage of participants
ALV 600 mg+PEGPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)ETR24LOQ92.9 percentage of participants
ALV 600 mg+PEGPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)ETR24LOD89.3 percentage of participants
PEG+RBVPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)ETR24LOQ85.2 percentage of participants
PEG+RBVPercentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)ETR24LOD81.5 percentage of participants
Secondary

Percentage of Participants With On-treatment Viral Breakthrough

Viral breakthrough was defined as either: * Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or * HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (\< LOD) during treatment

Time frame: within 24 weeks of treatment

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
ALV 1000 mgPercentage of Participants With On-treatment Viral Breakthrough2.5 percentage of participants
ALV 600 mg+RBVPercentage of Participants With On-treatment Viral Breakthrough3.6 percentage of participants
ALV 800 mg+RBVPercentage of Participants With On-treatment Viral Breakthrough2.2 percentage of participants
ALV 600 mg+PEGPercentage of Participants With On-treatment Viral Breakthrough5.1 percentage of participants
PEG+RBVPercentage of Participants With On-treatment Viral Breakthrough0.0 percentage of participants
Secondary

Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)

Time frame: after 4 weeks of treatment

Population: Participants in the Full Analysis Set with genotype 2 HCV infection

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)RVR4LOQ21.7 percentage of participants
ALV 1000 mgPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)RVR4LOD13.0 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)RVR4LOQ23.3 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)RVR4LOD10.0 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)RVR4LOQ46.2 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)RVR4LOD26.9 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)RVR4LOD63.6 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)RVR4LOQ81.8 percentage of participants
PEG+RBVPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)RVR4LOQ76.9 percentage of participants
PEG+RBVPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)RVR4LOD53.8 percentage of participants
Secondary

Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)

Time frame: after 4 weeks of treatment

Population: Participants in the Full Analysis Set with genotype 3 HCV infection

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)RVR4LOQ31.0 percentage of participants
ALV 1000 mgPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)RVR4LOD20.7 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)RVR4LOQ44.4 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)RVR4LOD16.7 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)RVR4LOQ40.3 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)RVR4LOD22.4 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)RVR4LOD71.4 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)RVR4LOQ85.7 percentage of participants
PEG+RBVPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)RVR4LOQ70.4 percentage of participants
PEG+RBVPercentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)RVR4LOD63.0 percentage of participants
Secondary

Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)

RVR4LOD was defined as Rapid Viral Response (RVR) \[serum HCV RNA \< the limit of detection (LOD), i.e., \< 10 IU/mL\], after 4 weeks of treatment.

Time frame: after 4 weeks of treatment

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
ALV 1000 mgPercentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)18.5 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)14.3 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)23.7 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)69.2 percentage of participants
PEG+RBVPercentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)60.0 percentage of participants
Secondary

Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)

SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) \[serum HCV RNA \< LOQ and \< LOD\] 12 weeks after treatment, respectively.

Time frame: 12 weeks after the end of treatment

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)SVR12LOQ81.5 percentage of participants
ALV 1000 mgPercentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)SVR12LOD80.2 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)SVR12LOQ84.5 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)SVR12LOD84.5 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)SVR12LOQ80.6 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)SVR12LOD80.6 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)SVR12LOD74.4 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)SVR12LOQ76.9 percentage of participants
PEG+RBVPercentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)SVR12LOQ62.5 percentage of participants
PEG+RBVPercentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)SVR12LOD60.0 percentage of participants
Secondary

Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)

Time frame: 12 weeks after the end of treatment

Population: Participants in the Full Analysis Set with genotype 2 HCV infection

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)SVR12LOQ78.3 percentage of participants
ALV 1000 mgPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)SVR12LOD78.3 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)SVR12LOD76.7 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)SVR12LOQ76.7 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)SVR12LOQ76.9 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)SVR12LOD76.9 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)SVR12LOQ72.7 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)SVR12LOD72.7 percentage of participants
PEG+RBVPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)SVR12LOD53.8 percentage of participants
PEG+RBVPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)SVR12LOQ61.5 percentage of participants
Secondary

Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)

Time frame: 12 weeks after the end of treatment

Population: Participants in the Full Analysis Set with genotype 3 HCV infection

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)SVR12LOD81.0 percentage of participants
ALV 1000 mgPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)SVR12LOQ82.8 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)SVR12LOQ88.9 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)SVR12LOD88.9 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)SVR12LOD82.1 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)SVR12LOQ82.1 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)SVR12LOQ78.6 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)SVR12LOD75.0 percentage of participants
PEG+RBVPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)SVR12LOQ63.0 percentage of participants
PEG+RBVPercentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)SVR12LOD63.0 percentage of participants
Secondary

Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)

Time frame: 24 weeks after the end of treatment

Population: Participants in the Full Analysis Set with genotype 2 HCV infection

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)SVR24LOQ78.3 percentage of participants
ALV 1000 mgPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)SVR24LOD78.3 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)SVR24LOQ76.7 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)SVR24LOD76.7 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)SVR24LOQ76.9 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)SVR24LOD76.9 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)SVR24LOD72.7 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)SVR24LOQ72.7 percentage of participants
PEG+RBVPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)SVR24LOQ53.8 percentage of participants
PEG+RBVPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)SVR24LOD53.8 percentage of participants
Secondary

Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)

Time frame: 24 weeks after the end of treatment

Population: Participants in the Full Analysis Set with genotype 3 HCV infection

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)SVR24LOD81.0 percentage of participants
ALV 1000 mgPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)SVR24LOQ81.0 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)SVR24LOD88.9 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)SVR24LOQ88.9 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)SVR24LOD80.6 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)SVR24LOQ82.1 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)SVR24LOQ82.1 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)SVR24LOD82.1 percentage of participants
PEG+RBVPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)SVR24LOD59.3 percentage of participants
PEG+RBVPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)SVR24LOQ59.3 percentage of participants
Secondary

Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)

Time frame: 24 weeks after the end of treatment

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)SVR24LOQ80.2 percentage of participants
ALV 1000 mgPercentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)SVR24LOD80.2 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)SVR24LOQ84.5 percentage of participants
ALV 600 mg+RBVPercentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)SVR24LOD84.5 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)SVR24LOQ80.6 percentage of participants
ALV 800 mg+RBVPercentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)SVR24LOD79.6 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)SVR24LOD79.5 percentage of participants
ALV 600 mg+PEGPercentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)SVR24LOQ79.5 percentage of participants
PEG+RBVPercentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)SVR24LOQ57.5 percentage of participants
PEG+RBVPercentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)SVR24LOD57.5 percentage of participants
Secondary

Percentage of Participants With Viral Relapse

Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (\< LOD) during treatment.

Time frame: within 24 weeks after the end of treatment

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
ALV 1000 mgPercentage of Participants With Viral Relapse0 to 12 weeks after the end of treatment9.9 percentage of participants
ALV 1000 mgPercentage of Participants With Viral Relapse12 to 24 weeks after the end of treatment1.2 percentage of participants
ALV 600 mg+RBVPercentage of Participants With Viral Relapse0 to 12 weeks after the end of treatment8.3 percentage of participants
ALV 600 mg+RBVPercentage of Participants With Viral Relapse12 to 24 weeks after the end of treatment0.0 percentage of participants
ALV 800 mg+RBVPercentage of Participants With Viral Relapse0 to 12 weeks after the end of treatment6.5 percentage of participants
ALV 800 mg+RBVPercentage of Participants With Viral Relapse12 to 24 weeks after the end of treatment0.0 percentage of participants
ALV 600 mg+PEGPercentage of Participants With Viral Relapse12 to 24 weeks after the end of treatment0.0 percentage of participants
ALV 600 mg+PEGPercentage of Participants With Viral Relapse0 to 12 weeks after the end of treatment10.3 percentage of participants
PEG+RBVPercentage of Participants With Viral Relapse0 to 12 weeks after the end of treatment20.0 percentage of participants
PEG+RBVPercentage of Participants With Viral Relapse12 to 24 weeks after the end of treatment5.0 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026