Trial Outcomes & Findings for A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection (NCT NCT02765802)

NCT ID: NCT02765802

Last Updated: 2023-01-17

Results Overview

To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a 48 week treatment period. To evaluate the effect of treatment with 2 different doses of Lambda on hepatitis D virus (HDV) ribonucleic acid (RNA) levels.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 33 participants
• Primary outcome timeframe: Week 48 (end of treatment)
• Results posted on: 2023-01-17

Participant Flow

Participant milestones

Measure	Lambda 180 μg Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A	Lambda 120 μg Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A
Overall Study STARTED	14	19
Overall Study COMPLETED	14	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection

Baseline characteristics by cohort

Measure	Peginterferon Lambda-1A 180 μg n=14 Participants Peginterferon Lambda-1A (Lambda) 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.	Peginterferon Lambda-1A 120 μg n=19 Participants Peginterferon Lambda-1A (Lambda) 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.	Total n=33 Participants Total of all reporting groups
Age, Continuous	43.8 years n=5 Participants	36.6 years n=7 Participants	39.7 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	15 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Israel	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Pakistan	4 participants n=5 Participants	11 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment New Zealand	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
log HDV RNA	3.86 log IU/mL n=5 Participants	4.15 log IU/mL n=7 Participants	4.03 log IU/mL n=5 Participants

PRIMARY outcome

Timeframe: Week 48 (end of treatment)

To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a 48 week treatment period.

To evaluate the effect of treatment with 2 different doses of Lambda on hepatitis D virus (HDV) ribonucleic acid (RNA) levels.

Outcome measures

Measure	Lambda 180 μg n=14 Participants Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A	Lambda 120 μg n=19 Participants Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A
Change From Baseline in HDV Viral Load.	-2.14 Change in HDV RNA log IU/mL Standard Deviation 1.81	-1.16 Change in HDV RNA log IU/mL Standard Deviation 2.38

SECONDARY outcome

Timeframe: Week 72 (end of follow-up)

To evaluate the proportion of patients with undetectable HDV RNA 24 weeks after the end of treatment

Outcome measures

Measure	Lambda 180 μg n=14 Participants Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A	Lambda 120 μg n=19 Participants Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A
Change From Baseline in HDV Viral Load	-1.70 Change in HDV RNA log IU/mL Standard Deviation 1.70	-0.66 Change in HDV RNA log IU/mL Standard Deviation 1.57

SECONDARY outcome

Timeframe: Week 72

Durable Virologic Response (DVR) = below the limit of quantitation in HDV RNA at 24 weeks post-treatment

Outcome measures

Measure	Lambda 180 μg n=14 Participants Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A	Lambda 120 μg n=19 Participants Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A
Number of Patients With a Durable Virologic Response	5 Participants	3 Participants

Adverse Events

Lambda 180 μg

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Lambda 120 μg

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lambda 180 μg n=14 participants at risk Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A	Lambda 120 μg n=19 participants at risk Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A
Hepatobiliary disorders jaundice	14.3% 2/14 • Number of events 3 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	21.1% 4/19 • Number of events 6 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Hepatobiliary disorders Drug-Induced Liver Injury (DILI)	0.00% 0/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	5.3% 1/19 • Number of events 1 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.

Other adverse events

Measure	Lambda 180 μg n=14 participants at risk Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A	Lambda 120 μg n=19 participants at risk Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A
Hepatobiliary disorders Jaundice	14.3% 2/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	21.1% 4/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Investigations Alanine Aminotransferase (ALT) increase	35.7% 5/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	15.8% 3/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Investigations Aspartate Aminotransferase (AST) Increase	35.7% 5/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	10.5% 2/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Investigations Blood bilirubin increased	28.6% 4/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	10.5% 2/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Investigations gamma-glutamyl transferase (GGT) increased	14.3% 2/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	10.5% 2/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Investigations international normalized ratio (INR) increased	7.1% 1/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	10.5% 2/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Investigations Neutrophil count decreased	14.3% 2/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	5.3% 1/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 7/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	42.1% 8/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Musculoskeletal and connective tissue disorders Back pain	14.3% 2/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	26.3% 5/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Musculoskeletal and connective tissue disorders Myalgia	50.0% 7/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	26.3% 5/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	21.1% 4/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Nervous system disorders Dizziness	21.4% 3/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	5.3% 1/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Nervous system disorders Dysgeusia	21.4% 3/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	0.00% 0/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Nervous system disorders Headache	85.7% 12/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	47.4% 9/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.1% 1/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	10.5% 2/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	21.4% 3/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	0.00% 0/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Skin and subcutaneous tissue disorders Erythema	14.3% 2/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	10.5% 2/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Skin and subcutaneous tissue disorders Pruritis	28.6% 4/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	5.3% 1/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Gastrointestinal disorders Abdominal pain	7.1% 1/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	10.5% 2/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Gastrointestinal disorders Abdominal pain upper	21.4% 3/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	10.5% 2/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Gastrointestinal disorders Diarrhea	35.7% 5/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	26.3% 5/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Gastrointestinal disorders Dyspepsia	50.0% 7/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	31.6% 6/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Gastrointestinal disorders Nausea	35.7% 5/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	5.3% 1/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Gastrointestinal disorders Vomiting	14.3% 2/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	15.8% 3/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
General disorders Asthenia	14.3% 2/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	5.3% 1/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
General disorders Chills	21.4% 3/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	26.3% 5/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
General disorders Fatigue	57.1% 8/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	15.8% 3/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
General disorders Feeling cold	7.1% 1/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	10.5% 2/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
General disorders Influenza like illness	7.1% 1/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	21.1% 4/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
General disorders Injection site erythema	35.7% 5/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	5.3% 1/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
General disorders Injection site pain	35.7% 5/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	5.3% 1/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
General disorders Injection site pruritis	35.7% 5/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	10.5% 2/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
General disorders Pyrexia	50.0% 7/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	42.1% 8/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Infections and infestations Urinary tract infection	0.00% 0/14 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.	15.8% 3/19 • Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks. Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.

Additional Information

SVP, Clinical Development

Eiger BioPharmaceuticals, Inc

Phone: 1-650-618-1621

Email: info@eigerbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place