Trial Outcomes & Findings for Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy (NCT NCT02868242)

NCT ID: NCT02868242

Last Updated: 2020-03-02

Results Overview

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 50 IU/mL) at 12 weeks after stopping study treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: Posttreatment Week 12
• Results posted on: 2020-03-02

Participant Flow

Participants were enrolled at one study site in Egypt. The first participant was screened on 28 August 2016. The last study visit occurred on 03 February 2019.

24 participants were screened.

Participant milestones

Measure	LDV/SOF LDV/SOF 90/400 mg fixed dose combination (FDC) orally once daily for 12 weeks
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy

Baseline characteristics by cohort

Measure	LDV/SOF n=19 Participants LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Age, Continuous	14 years STANDARD_DEVIATION 1.8 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	16 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race/Ethnicity, Customized White	19 Participants n=93 Participants
IL28B CC	6 Participants n=93 Participants
IL28B CT	12 Participants n=93 Participants
IL28B TT	1 Participants n=93 Participants
HCV RNA	5.3 log10 IU/mL STANDARD_DEVIATION 1.65 • n=93 Participants
HCV RNA Category < 800,000 IU/mL	12 Participants n=93 Participants
HCV RNA Category ≥ 800,000 IU/mL	7 Participants n=93 Participants

PRIMARY outcome

Timeframe: Posttreatment Week 12

Population: Full Analysis Set included participants who took at least 1 dose of study drug.

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 50 IU/mL) at 12 weeks after stopping study treatment.

Outcome measures

Measure	LDV/SOF n=19 Participants LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	100.0 percentage of participants Interval 82.4 to 100.0

PRIMARY outcome

Timeframe: First dose date up to Week 12

Population: Safety Analysis Set included participants who took at least 1 dose of study drug.

Outcome measures

Measure	LDV/SOF n=19 Participants LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event	0 percentage of participants

SECONDARY outcome

Timeframe: Posttreatment Week 4

Population: Participants in the Full Analysis Set were analyzed.

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.

Outcome measures

Measure	LDV/SOF n=19 Participants LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)	100.0 percentage of participants Interval 82.4 to 100.0

SECONDARY outcome

Timeframe: Posttreatment Week 24

Population: Participants in the Full Analysis Set were analyzed.

SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.

Outcome measures

Measure	LDV/SOF n=19 Participants LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)	100.0 percentage of participants Interval 82.4 to 100.0

SECONDARY outcome

Timeframe: Weeks 1, 4, 8, and 12

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	LDV/SOF n=19 Participants LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Percentage of Participants With HCV RNA < LLOQ While on Treatment Week 1	89.5 percentage of participants Interval 66.9 to 98.7
Percentage of Participants With HCV RNA < LLOQ While on Treatment Week 4	100.0 percentage of participants Interval 82.4 to 100.0
Percentage of Participants With HCV RNA < LLOQ While on Treatment Week 8	94.7 percentage of participants Interval 74.0 to 99.9
Percentage of Participants With HCV RNA < LLOQ While on Treatment Week 12	100.0 percentage of participants Interval 82.4 to 100.0

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 4, 8, and 12

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	LDV/SOF n=19 Participants LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
HCV RNA Change From Baseline/Day 1 Change at Week 1	-3.34 log10 IU/mL Standard Deviation 1.730
HCV RNA Change From Baseline/Day 1 Change at Week 4	-3.62 log10 IU/mL Standard Deviation 1.653
HCV RNA Change From Baseline/Day 1 Change at Week 8	-3.36 log10 IU/mL Standard Deviation 1.526
HCV RNA Change From Baseline/Day 1 Change at Week 12	-3.62 log10 IU/mL Standard Deviation 1.653

SECONDARY outcome

Timeframe: Baseline to Posttreatment Week 24

Population: Participants in Full Analysis Set were analyzed.

Virologic failure was defined as:

• On-treatment virologic failure:

• Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
• Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
• Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
• Virologic relapse:

• Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit

Outcome measures

Measure	LDV/SOF n=19 Participants LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Percentage of Participants With Virologic Failure	0 percentage of participants

Adverse Events

LDV/SOF

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	LDV/SOF n=19 participants at risk LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Gastrointestinal disorders Diarrhoea	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Infections and infestations Pneumonia	10.5% 2/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.

Other adverse events

Measure	LDV/SOF n=19 participants at risk LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Blood and lymphatic system disorders Anaemia	10.5% 2/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	15.8% 3/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Gastrointestinal disorders Lip ulceration	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Gastrointestinal disorders Mouth ulceration	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Gastrointestinal disorders Tongue ulceration	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	15.8% 3/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
General disorders Pyrexia	26.3% 5/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Infections and infestations Conjunctivitis	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Infections and infestations Ear infection	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Infections and infestations Oral candidiasis	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Infections and infestations Pneumonia	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Investigations Neutrophil count decreased	10.5% 2/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Metabolism and nutrition disorders Hypophagia	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint effusion	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Nervous system disorders Headache	21.1% 4/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	10.5% 2/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus generalised	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin lesion	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	5.3% 1/19 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24 Safety Analysis Set included participants who took at least 1 dose of study drug.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: GileadClinicalTrials@gilead.com

Results disclosure agreements

• Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
• Publication restrictions are in place

Restriction type: OTHER