Trial Outcomes & Findings for Lonafarnib Boosted With Ritonavir With and Without Peginterferon Alfa-2a (PEG IFN-a) in HDV (LOWR-2) (NCT NCT02430194)
NCT ID: NCT02430194
Last Updated: 2023-03-03
Results Overview
Proportion of intent to treat patients with ≥2 log10 decline of HDV RNA from baseline at end of treatment (EOT)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
12-48 weeks
Results posted on
2023-03-03
Participant Flow
Participant milestones
| Measure |
Lonafarnib/Ritonavir - I
lonafarnib 100 mg BID + ritonavir 100 mg QD
lonafarnib: antiviral farnesyl transferase inhibitor
ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
Lonafarnib/Ritonavir - II
lonafarnib 100 mg BID + ritonavir 50 mg BID
lonafarnib: antiviral farnesyl transferase inhibitor
ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
Lonafarnib/Ritonavir - III
lonafarnib 100 mg QD + ritonavir 100 mg QD
lonafarnib: antiviral farnesyl transferase inhibitor
ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
Lonafarnib/Ritonavir - IV
lonafarnib 150 mg QD + ritonavir 100 mg QD
lonafarnib: antiviral farnesyl transferase inhibitor
ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
Lonafarnib/Ritonavir/PEG IFN-alfa-2a - V
lonafarnib 75 mg BID + ritonavir 100 mg BID; + PEG IFN-alfa-2a 180 ug QW on Week 12
lonafarnib: antiviral farnesyl transferase inhibitor
ritonavir: CYP 3A4 inhibitor, lonafarnib booster
PEG IFN-alfa-2a: immunomodulator
|
Lonafarnib/Ritonavir - VI
lonafarnib 25 mg BID + ritonavir 100 mg BID
lonafarnib: antiviral farnesyl transferase inhibitor
ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
Lonafarnib/Ritonavir/PEG IFN-alfa-2a - VII
lonafarnib 50 mg BID + ritonavir 100 mg BID; + PEG IFN-alfa-2a 180 ug QW;
lonafarnib: antiviral farnesyl transferase inhibitor
ritonavir: CYP 3A4 inhibitor, lonafarnib booster
PEG IFN-alfa-2a: immunomodulator
|
Lonafarnib/Ritonavir/PEG IFN-alfa-2a - VIII
lonafarnib 50 mg BID + ritonavir 100 mg BID; + PEG IFN-alfa-2a 180 ug QW on Week 12
lonafarnib: antiviral farnesyl transferase inhibitor
ritonavir: CYP 3A4 inhibitor, lonafarnib booster
PEG IFN-alfa-2a: immunomodulator
|
Lonafarnib/Ritonavir - IX
lonafarnib 50 mg BID + ritonavir 100 mg BID
lonafarnib: antiviral farnesyl transferase inhibitor
ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
Lonafarnib/Ritonavir/PEG IFN-alfa-2a - X
lonafarnib 25 mg BID + ritonavir 100 mg BID + PEG IFN-alfa-2a 180 ug QW
lonafarnib: antiviral farnesyl transferase inhibitor
ritonavir: CYP 3A4 inhibitor, lonafarnib booster
PEG IFN-alfa-2a: immunomodulator
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
5
|
3
|
3
|
6
|
13
|
5
|
7
|
5
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
6
|
11
|
4
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
0
|
0
|
0
|
2
|
1
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lonafarnib Boosted With Ritonavir With and Without Peginterferon Alfa-2a (PEG IFN-a) in HDV (LOWR-2)
Baseline characteristics by cohort
| Measure |
Lonafarnib/Ritonavir - I
n=4 Participants
lonafarnib 100 mg BID + ritonavir 100 mg QD
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
Lonafarnib/Ritonavir - II
n=4 Participants
lonafarnib 100 mg BID + ritonavir 50 mg BID
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
Lonafarnib/Ritonavir - III
n=5 Participants
lonafarnib 100 mg QD + ritonavir 100 mg QD
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
Lonafarnib/Ritonavir - IV
n=3 Participants
lonafarnib 150 mg QD + ritonavir 100 mg QD
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
Lonafarnib/Ritonavir - V
n=3 Participants
lonafarnib 75 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 ug QW on Week 12
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
PEG IFN-a: immunomodulator
|
Lonafarnib/Ritonavir - VI
n=6 Participants
lonafarnib 25 mg BID + ritonavir 100 mg BID
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
Lonafarnib/Ritonavir - VII
n=13 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
Lonafarnib/Ritonavir/PEG IFN-a - VIII
n=5 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 ug QW on Week 12
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
PEG IFN-a: immunomodulator
|
Lonafarnib/Ritonavir/PEG IFN-a - IX
n=7 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 ug QW
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
PEG IFN-a: immunomodulator
|
Lonafarnib/Ritonavir - X
n=5 Participants
lonafarnib 25 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 ug QW
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
PEG IFN-a: immunomodulator
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31 years
n=5 Participants
|
51 years
n=7 Participants
|
61 years
n=5 Participants
|
56 years
n=4 Participants
|
59 years
n=21 Participants
|
49 years
n=8 Participants
|
41 years
n=8 Participants
|
39 years
n=24 Participants
|
50 years
n=42 Participants
|
39 years
n=42 Participants
|
50 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
55 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Turkey
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
6 participants
n=8 Participants
|
13 participants
n=8 Participants
|
5 participants
n=24 Participants
|
7 participants
n=42 Participants
|
5 participants
n=42 Participants
|
55 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 12-48 weeksProportion of intent to treat patients with ≥2 log10 decline of HDV RNA from baseline at end of treatment (EOT)
Outcome measures
| Measure |
Lonafarnib/Ritonavir - I
n=4 Participants
lonafarnib 100 mg BID + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir - II
n=4 Participants
lonafarnib 100 mg BID + ritonavir 50 mg BID for 12 weeks
|
Lonafarnib/Ritonavir - III
n=5 Participants
lonafarnib 100 mg QD + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir - IV
n=3 Participants
lonafarnib 150 mg QD + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - V
n=3 Participants
lonafarnib 75 mg BID + ritonavir 100 mg BID for 12 weeks; + PEG IFN-a 180 ug QW on Week 12-24
|
Lonafarnib/Ritonavir - VI
n=6 Participants
lonafarnib 25 mg BID + ritonavir 100 mg BID for 24 weeks
|
Lonafarnib/Ritonavir - VII
n=13 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID for 24 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - VIII
n=5 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID for 12 weeks; + PEG IFN-a 180 ug QW on Week 12-24
|
Lonafarnib/Ritonavir/PEG IFN-a - IX
n=7 Participants
lonafarnib 25 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 ug QW for 24 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - X
n=5 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 ug QW for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
≥2 log10 Decline of HDV RNA From Baseline at End of Treatment (EOT)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12-48 weeksPopulation: intent to treat population
Proportion of intent to treat patients with HDV RNA below the limit of quantitation at end of treatment
Outcome measures
| Measure |
Lonafarnib/Ritonavir - I
n=4 Participants
lonafarnib 100 mg BID + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir - II
n=4 Participants
lonafarnib 100 mg BID + ritonavir 50 mg BID for 12 weeks
|
Lonafarnib/Ritonavir - III
n=5 Participants
lonafarnib 100 mg QD + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir - IV
n=3 Participants
lonafarnib 150 mg QD + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - V
n=3 Participants
lonafarnib 75 mg BID + ritonavir 100 mg BID for 12 weeks; + PEG IFN-a 180 ug QW on Week 12-24
|
Lonafarnib/Ritonavir - VI
n=6 Participants
lonafarnib 25 mg BID + ritonavir 100 mg BID for 24 weeks
|
Lonafarnib/Ritonavir - VII
n=13 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID for 24 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - VIII
n=5 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID for 12 weeks; + PEG IFN-a 180 ug QW on Week 12-24
|
Lonafarnib/Ritonavir/PEG IFN-a - IX
n=7 Participants
lonafarnib 25 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 ug QW for 24 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - X
n=5 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 ug QW for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
< LLOQ in HDV RNA at End of Treatment (EOT)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12-48 weeksPopulation: intent to treat population
Proportion of intent to treat population who normalize ALT at end of treatment
Outcome measures
| Measure |
Lonafarnib/Ritonavir - I
n=4 Participants
lonafarnib 100 mg BID + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir - II
n=4 Participants
lonafarnib 100 mg BID + ritonavir 50 mg BID for 12 weeks
|
Lonafarnib/Ritonavir - III
n=5 Participants
lonafarnib 100 mg QD + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir - IV
n=3 Participants
lonafarnib 150 mg QD + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - V
n=3 Participants
lonafarnib 75 mg BID + ritonavir 100 mg BID for 12 weeks; + PEG IFN-a 180 ug QW on Week 12-24
|
Lonafarnib/Ritonavir - VI
n=6 Participants
lonafarnib 25 mg BID + ritonavir 100 mg BID for 24 weeks
|
Lonafarnib/Ritonavir - VII
n=13 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID for 24 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - VIII
n=5 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID for 12 weeks; + PEG IFN-a 180 ug QW on Week 12-24
|
Lonafarnib/Ritonavir/PEG IFN-a - IX
n=7 Participants
lonafarnib 25 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 ug QW for 24 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - X
n=5 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 ug QW for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
ALT Normalization at End of Treatment
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-48 weeksPopulation: intent to treat population
mean HDV RNA decline of intent to treat population from baseline to end of treatment
Outcome measures
| Measure |
Lonafarnib/Ritonavir - I
n=4 Participants
lonafarnib 100 mg BID + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir - II
n=4 Participants
lonafarnib 100 mg BID + ritonavir 50 mg BID for 12 weeks
|
Lonafarnib/Ritonavir - III
n=5 Participants
lonafarnib 100 mg QD + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir - IV
n=3 Participants
lonafarnib 150 mg QD + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - V
n=3 Participants
lonafarnib 75 mg BID + ritonavir 100 mg BID for 12 weeks; + PEG IFN-a 180 ug QW on Week 12-24
|
Lonafarnib/Ritonavir - VI
n=6 Participants
lonafarnib 25 mg BID + ritonavir 100 mg BID for 24 weeks
|
Lonafarnib/Ritonavir - VII
n=13 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID for 24 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - VIII
n=5 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID for 12 weeks; + PEG IFN-a 180 ug QW on Week 12-24
|
Lonafarnib/Ritonavir/PEG IFN-a - IX
n=7 Participants
lonafarnib 25 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 ug QW for 24 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - X
n=5 Participants
lonafarnib 50 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 ug QW for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean HDV RNA Decline
|
-1.39 log HDV RNA IU/mL
Standard Error 1.27
|
0.33 log HDV RNA IU/mL
Standard Error 1.08
|
-1.11 log HDV RNA IU/mL
Standard Error 3.1
|
-0.67 log HDV RNA IU/mL
Standard Error 0.24
|
-1.97 log HDV RNA IU/mL
Standard Error 1.6
|
-0.31 log HDV RNA IU/mL
Standard Error 1.61
|
-1.94 log HDV RNA IU/mL
Standard Error 1.3
|
-2.85 log HDV RNA IU/mL
Standard Error 0.49
|
-2.69 log HDV RNA IU/mL
Standard Error 1.66
|
-3.81 log HDV RNA IU/mL
Standard Error 0.94
|
Adverse Events
Lonafarnib/Ritonavir - I
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Lonafarnib/Ritonavir - II
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Lonafarnib/Ritonavir - III
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Lonafarnib/Ritonavir - IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lonafarnib/Ritonavir/PEG IFN-a - V
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lonafarnib/Ritonavir - VI
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Lonafarnib/Ritonavir - VII
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Lonafarnib/Ritonavir/PEG IFN-a - VIII
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Lonafarnib/Ritonavir/PEG IFN-a - IX
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Lonafarnib/Ritonavir/PEG IFN-a - X
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lonafarnib/Ritonavir - I
n=4 participants at risk
lonafarnib 100 mg BID + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir - II
n=4 participants at risk
lonafarnib 100 mg BID + ritonavir 50 mg BID for 12 weeks
|
Lonafarnib/Ritonavir - III
n=5 participants at risk
lonafarnib 100 mg QD + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir - IV
n=3 participants at risk
lonafarnib 150 mg QD + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - V
n=3 participants at risk
lonafarnib 75 mg BID + ritonavir 100 mg BID; + PEG IFN-a 180 ug QW from Week 12-24
|
Lonafarnib/Ritonavir - VI
n=6 participants at risk
lonafarnib 25 mg BID + ritonavir 100 mg BID for 24 weeks
|
Lonafarnib/Ritonavir - VII
n=13 participants at risk
lonafarnib 50 mg BID + ritonavir 100 mg BID for 24 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - VIII
n=5 participants at risk
lonafarnib 50 mg BID + ritonavir 100 mg BID; + PEG IFN-a 180 ug QW from Week 12-24
|
Lonafarnib/Ritonavir/PEG IFN-a - IX
n=7 participants at risk
lonafarnib 25 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 mcg QW for 24 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - X
n=5 participants at risk
lonafarnib 50 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 mcg QW for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/4 • treatment period 12-48 weeks
|
0.00%
0/4 • treatment period 12-48 weeks
|
20.0%
1/5 • treatment period 12-48 weeks
|
0.00%
0/3 • treatment period 12-48 weeks
|
0.00%
0/3 • treatment period 12-48 weeks
|
0.00%
0/6 • treatment period 12-48 weeks
|
0.00%
0/13 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
0.00%
0/7 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
|
General disorders
fatigue
|
0.00%
0/4 • treatment period 12-48 weeks
|
0.00%
0/4 • treatment period 12-48 weeks
|
40.0%
2/5 • treatment period 12-48 weeks
|
0.00%
0/3 • treatment period 12-48 weeks
|
0.00%
0/3 • treatment period 12-48 weeks
|
0.00%
0/6 • treatment period 12-48 weeks
|
0.00%
0/13 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
0.00%
0/7 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
|
Hepatobiliary disorders
hepatic decompensation
|
0.00%
0/4 • treatment period 12-48 weeks
|
0.00%
0/4 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
0.00%
0/3 • treatment period 12-48 weeks
|
0.00%
0/3 • treatment period 12-48 weeks
|
0.00%
0/6 • treatment period 12-48 weeks
|
0.00%
0/13 • treatment period 12-48 weeks
|
20.0%
1/5 • treatment period 12-48 weeks
|
0.00%
0/7 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/4 • treatment period 12-48 weeks
|
0.00%
0/4 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
0.00%
0/3 • treatment period 12-48 weeks
|
0.00%
0/3 • treatment period 12-48 weeks
|
0.00%
0/6 • treatment period 12-48 weeks
|
0.00%
0/13 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
0.00%
0/7 • treatment period 12-48 weeks
|
20.0%
1/5 • treatment period 12-48 weeks
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/4 • treatment period 12-48 weeks
|
0.00%
0/4 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
0.00%
0/3 • treatment period 12-48 weeks
|
0.00%
0/3 • treatment period 12-48 weeks
|
0.00%
0/6 • treatment period 12-48 weeks
|
7.7%
1/13 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
0.00%
0/7 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
|
Nervous system disorders
neuropathy vasculitis
|
0.00%
0/4 • treatment period 12-48 weeks
|
0.00%
0/4 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
0.00%
0/3 • treatment period 12-48 weeks
|
0.00%
0/3 • treatment period 12-48 weeks
|
0.00%
0/6 • treatment period 12-48 weeks
|
0.00%
0/13 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
14.3%
1/7 • treatment period 12-48 weeks
|
0.00%
0/5 • treatment period 12-48 weeks
|
Other adverse events
| Measure |
Lonafarnib/Ritonavir - I
n=4 participants at risk
lonafarnib 100 mg BID + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir - II
n=4 participants at risk
lonafarnib 100 mg BID + ritonavir 50 mg BID for 12 weeks
|
Lonafarnib/Ritonavir - III
n=5 participants at risk
lonafarnib 100 mg QD + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir - IV
n=3 participants at risk
lonafarnib 150 mg QD + ritonavir 100 mg QD for 12 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - V
n=3 participants at risk
lonafarnib 75 mg BID + ritonavir 100 mg BID; + PEG IFN-a 180 ug QW from Week 12-24
|
Lonafarnib/Ritonavir - VI
n=6 participants at risk
lonafarnib 25 mg BID + ritonavir 100 mg BID for 24 weeks
|
Lonafarnib/Ritonavir - VII
n=13 participants at risk
lonafarnib 50 mg BID + ritonavir 100 mg BID for 24 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - VIII
n=5 participants at risk
lonafarnib 50 mg BID + ritonavir 100 mg BID; + PEG IFN-a 180 ug QW from Week 12-24
|
Lonafarnib/Ritonavir/PEG IFN-a - IX
n=7 participants at risk
lonafarnib 25 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 mcg QW for 24 weeks
|
Lonafarnib/Ritonavir/PEG IFN-a - X
n=5 participants at risk
lonafarnib 50 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 mcg QW for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
75.0%
3/4 • treatment period 12-48 weeks
|
50.0%
2/4 • treatment period 12-48 weeks
|
60.0%
3/5 • treatment period 12-48 weeks
|
66.7%
2/3 • treatment period 12-48 weeks
|
100.0%
3/3 • treatment period 12-48 weeks
|
50.0%
3/6 • treatment period 12-48 weeks
|
69.2%
9/13 • treatment period 12-48 weeks
|
100.0%
5/5 • treatment period 12-48 weeks
|
42.9%
3/7 • treatment period 12-48 weeks
|
100.0%
5/5 • treatment period 12-48 weeks
|
|
Gastrointestinal disorders
nausea
|
50.0%
2/4 • treatment period 12-48 weeks
|
50.0%
2/4 • treatment period 12-48 weeks
|
60.0%
3/5 • treatment period 12-48 weeks
|
66.7%
2/3 • treatment period 12-48 weeks
|
100.0%
3/3 • treatment period 12-48 weeks
|
66.7%
4/6 • treatment period 12-48 weeks
|
61.5%
8/13 • treatment period 12-48 weeks
|
80.0%
4/5 • treatment period 12-48 weeks
|
57.1%
4/7 • treatment period 12-48 weeks
|
60.0%
3/5 • treatment period 12-48 weeks
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/4 • treatment period 12-48 weeks
|
25.0%
1/4 • treatment period 12-48 weeks
|
60.0%
3/5 • treatment period 12-48 weeks
|
33.3%
1/3 • treatment period 12-48 weeks
|
0.00%
0/3 • treatment period 12-48 weeks
|
33.3%
2/6 • treatment period 12-48 weeks
|
53.8%
7/13 • treatment period 12-48 weeks
|
20.0%
1/5 • treatment period 12-48 weeks
|
14.3%
1/7 • treatment period 12-48 weeks
|
20.0%
1/5 • treatment period 12-48 weeks
|
|
General disorders
fatigue
|
75.0%
3/4 • treatment period 12-48 weeks
|
75.0%
3/4 • treatment period 12-48 weeks
|
80.0%
4/5 • treatment period 12-48 weeks
|
100.0%
3/3 • treatment period 12-48 weeks
|
100.0%
3/3 • treatment period 12-48 weeks
|
66.7%
4/6 • treatment period 12-48 weeks
|
76.9%
10/13 • treatment period 12-48 weeks
|
100.0%
5/5 • treatment period 12-48 weeks
|
57.1%
4/7 • treatment period 12-48 weeks
|
100.0%
5/5 • treatment period 12-48 weeks
|
|
Gastrointestinal disorders
anorexia
|
75.0%
3/4 • treatment period 12-48 weeks
|
100.0%
4/4 • treatment period 12-48 weeks
|
40.0%
2/5 • treatment period 12-48 weeks
|
100.0%
3/3 • treatment period 12-48 weeks
|
100.0%
3/3 • treatment period 12-48 weeks
|
33.3%
2/6 • treatment period 12-48 weeks
|
61.5%
8/13 • treatment period 12-48 weeks
|
80.0%
4/5 • treatment period 12-48 weeks
|
28.6%
2/7 • treatment period 12-48 weeks
|
80.0%
4/5 • treatment period 12-48 weeks
|
|
Investigations
weight loss
|
75.0%
3/4 • treatment period 12-48 weeks
|
50.0%
2/4 • treatment period 12-48 weeks
|
40.0%
2/5 • treatment period 12-48 weeks
|
100.0%
3/3 • treatment period 12-48 weeks
|
66.7%
2/3 • treatment period 12-48 weeks
|
50.0%
3/6 • treatment period 12-48 weeks
|
53.8%
7/13 • treatment period 12-48 weeks
|
60.0%
3/5 • treatment period 12-48 weeks
|
71.4%
5/7 • treatment period 12-48 weeks
|
60.0%
3/5 • treatment period 12-48 weeks
|
Additional Information
Senior VP, Clinical Development
Eiger BioPharmaceuticals, Inc.
Phone: 1-650-618-1621
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place