Trial Outcomes & Findings for Titrating-Dose of Lonafarnib in Combination With Ritonavir (NCT NCT02527707)
NCT ID: NCT02527707
Last Updated: 2023-06-22
Results Overview
Change from baseline to Week 24 in mean HDV RNA titer following dose escalating from lonafarnib 50 mg BID to 75 mg BID and to 100 mg BID, all boosted with ritonavir 100 mg BID.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Baseline and Week 24 (6 months)
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
Lonafarnib/Ritonavir
Lonafarnib starting at 50 mg twice daily (BID) in combination with ritonavir 100 mg BID and escalating to lonafarnib 75 mg BID and then 100 mg BID as tolerated. The duration of the study for each patient is 6 months of treatment and 6 months follow-up.
lonafarnib: antiviral farnesyltransferase inhibitor
Ritonavir: Cytochromes P450 3A4 inhibitor used to boost lonafarnib
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Lonafarnib/Ritonavir
Lonafarnib starting at 50 mg twice daily (BID) in combination with ritonavir 100 mg BID and escalating to lonafarnib 75 mg BID and then 100 mg BID as tolerated. The duration of the study for each patient is 6 months of treatment and 6 months follow-up.
lonafarnib: antiviral farnesyltransferase inhibitor
Ritonavir: Cytochromes P450 3A4 inhibitor used to boost lonafarnib
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Titrating-Dose of Lonafarnib in Combination With Ritonavir
Baseline characteristics by cohort
| Measure |
Lonafarnib/Ritonavir
n=15 Participants
Lonafarnib starting at 50 mg BID in combination with ritonavir 100 mg BID and escalating to lonafarnib 75 mg BID and then 100 mg BID as tolerated. The duration of the study for each patient is 6 months of treatment and 6 months follow-up.
lonafarnib: antiviral farnesyltransferase inhibitor
Ritonavir: Cytochromes P450 3A4 inhibitor used to boost lonafarnib
|
|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24 (6 months)Change from baseline to Week 24 in mean HDV RNA titer following dose escalating from lonafarnib 50 mg BID to 75 mg BID and to 100 mg BID, all boosted with ritonavir 100 mg BID.
Outcome measures
| Measure |
Lonafarnib/Ritonavir
n=15 Participants
Lonafarnib starting at 50 mg BID in combination with ritonavir 100 mg BID and escalating to lonafarnib 75 mg BID and then 100 mg BID as tolerated. The duration of the study for each patient is 6 months of treatment and 6 months follow-up.
lonafarnib: antiviral farnesyltransferase inhibitor
Ritonavir: Cytochromes P450 3A4 inhibitor used to boost lonafarnib
|
|---|---|
|
Change From Baseline to Week 24 in Mean Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) Titer
|
-1.62 log IU/mL
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline and Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, or Week 24Number of patients with at least 1 log reduction in HDV RNA from baseline by dose level and timepoint
Outcome measures
| Measure |
Lonafarnib/Ritonavir
n=13 Participants
Lonafarnib starting at 50 mg BID in combination with ritonavir 100 mg BID and escalating to lonafarnib 75 mg BID and then 100 mg BID as tolerated. The duration of the study for each patient is 6 months of treatment and 6 months follow-up.
lonafarnib: antiviral farnesyltransferase inhibitor
Ritonavir: Cytochromes P450 3A4 inhibitor used to boost lonafarnib
|
|---|---|
|
Number of Patients With 1 Log Reduction From Baseline by Timepoint
Week 1
|
7 Participants
|
|
Number of Patients With 1 Log Reduction From Baseline by Timepoint
Week 2
|
6 Participants
|
|
Number of Patients With 1 Log Reduction From Baseline by Timepoint
Week 4
|
10 Participants
|
|
Number of Patients With 1 Log Reduction From Baseline by Timepoint
Week 6
|
11 Participants
|
|
Number of Patients With 1 Log Reduction From Baseline by Timepoint
Week 8
|
10 Participants
|
|
Number of Patients With 1 Log Reduction From Baseline by Timepoint
Week 12
|
12 Participants
|
|
Number of Patients With 1 Log Reduction From Baseline by Timepoint
Week 16
|
12 Participants
|
|
Number of Patients With 1 Log Reduction From Baseline by Timepoint
Week 20
|
10 Participants
|
|
Number of Patients With 1 Log Reduction From Baseline by Timepoint
Week 24
|
9 Participants
|
Adverse Events
Lonafarnib/Ritonavir
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lonafarnib/Ritonavir
n=15 participants at risk
Lonafarnib starting at 50 mg BID in combination with ritonavir 100 mg BID and escalating to lonafarnib 75 mg BID and then 100 mg BID as tolerated. The duration of the study for each patient is 6 months of treatment and 6 months follow-up.
lonafarnib: antiviral farnesyltransferase inhibitor
Ritonavir: Cytochromes P450 3A4 inhibitor used to boost lonafarnib
|
|---|---|
|
Injury, poisoning and procedural complications
mandibular fracture)
|
6.7%
1/15 • Number of events 1 • 6 months on treatment, 6 months off-treatment follow-up.
|
Other adverse events
| Measure |
Lonafarnib/Ritonavir
n=15 participants at risk
Lonafarnib starting at 50 mg BID in combination with ritonavir 100 mg BID and escalating to lonafarnib 75 mg BID and then 100 mg BID as tolerated. The duration of the study for each patient is 6 months of treatment and 6 months follow-up.
lonafarnib: antiviral farnesyltransferase inhibitor
Ritonavir: Cytochromes P450 3A4 inhibitor used to boost lonafarnib
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
2/15 • Number of events 2 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
15/15 • Number of events 15 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Gastrointestinal disorders
Nausea
|
53.3%
8/15 • Number of events 8 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
53.3%
8/15 • Number of events 8 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Gastrointestinal disorders
Abdominal Pain
|
40.0%
6/15 • Number of events 6 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
General disorders
Fatigue
|
26.7%
4/15 • Number of events 4 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
General disorders
Asthenia
|
20.0%
3/15 • Number of events 3 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Investigations
Weight Decrease
|
53.3%
8/15 • Number of events 8 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Metabolism and nutrition disorders
Decrease Appetite
|
53.3%
8/15 • Number of events 8 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
2/15 • Number of events 2 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Nervous system disorders
Dysgeusia
|
26.7%
4/15 • Number of events 4 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Nervous system disorders
Dizziness
|
26.7%
4/15 • Number of events 4 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.3%
2/15 • Number of events 2 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Skin and subcutaneous tissue disorders
Acne
|
13.3%
2/15 • Number of events 2 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruitis
|
13.3%
2/15 • Number of events 2 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
3/15 • Number of events 3 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
13.3%
2/15 • Number of events 2 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
General disorders
Chest pain
|
13.3%
2/15 • Number of events 2 • 6 months on treatment, 6 months off-treatment follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
3/15 • Number of events 3 • 6 months on treatment, 6 months off-treatment follow-up.
|
Additional Information
SVP Clinical Development
Eiger BioPharmaceuticals, Inc.
Phone: 1-650-272-6138
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place