Trial Outcomes & Findings for Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection (NCT NCT01924949)

Results Overview

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Posttreatment Week 12

Results posted on

2018-11-19

Participant Flow

Participants were enrolled at 1 study site in the United States. The first participant was screened on 29 July 2013. The last study visit occurred on 18 August 2014.

8 participants were screened.

Participant milestones

Participant milestones
Measure	LDV/SOF 12 Weeks Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LDV/SOF 12 Weeks n=5 Participants LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Age, Continuous	62 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race/Ethnicity, Customized White	5 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	5 participants n=5 Participants
IL28b Status CC	1 participants n=5 Participants
IL28b Status CT	3 participants n=5 Participants
IL28b Status TT	1 participants n=5 Participants
HCV RNA	5.9 log10 IU/mL STANDARD_DEVIATION 0.58 • n=5 Participants
HCV RNA Category < 800,000 IU/mL	3 participants n=5 Participants
HCV RNA Category ≥ 800,000 IU/mL	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Posttreatment Week 12

Population: Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

Outcome measures

Outcome measures
Measure	LDV/SOF 12 Weeks n=5 Participants LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)	100.0 percentage of participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug

Outcome measures

Outcome measures
Measure	LDV/SOF 12 Weeks n=5 Participants LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event	0 percentage of participants

SECONDARY outcome

Timeframe: Posttreatment Weeks 4 and 24

Population: Full Analysis Set

SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

Outcome measures

Outcome measures
Measure	LDV/SOF 12 Weeks n=5 Participants LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) SVR4	100.0 percentage of participants
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) SVR24	100.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	LDV/SOF 12 Weeks n=5 Participants LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Percentage of Participants With HCV RNA < LLOQ on Treatment Week 1	60.0 percentage of participants
Percentage of Participants With HCV RNA < LLOQ on Treatment Week 4	100.0 percentage of participants
Percentage of Participants With HCV RNA < LLOQ on Treatment Week 8	100.0 percentage of participants
Percentage of Participants With HCV RNA < LLOQ on Treatment Week 12	100.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 4, and 8

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	LDV/SOF 12 Weeks n=5 Participants LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
HCV RNA Change From Baseline Change at Week 1	-4.36 log10 IU/mL Standard Deviation 0.463
HCV RNA Change From Baseline Change at Week 4	-4.56 log10 IU/mL Standard Deviation 0.576
HCV RNA Change From Baseline Change at Week 8	-4.56 log10 IU/mL Standard Deviation 0.576

SECONDARY outcome

Timeframe: Baseline to posttreatment Week 24

Population: Full Analysis Set

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

Outcome measures
Measure	LDV/SOF 12 Weeks n=5 Participants LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Percentage of Participants Experiencing Virologic Failure	0 percentage of participants

Adverse Events

LDV/SOF 12 Weeks

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LDV/SOF 12 Weeks n=5 participants at risk LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Cardiac disorders Acute myocardial infarction	20.0% 1/5 • Up to 12 weeks plus 30 days Safety Analysis Set

Other adverse events

Other adverse events
Measure	LDV/SOF 12 Weeks n=5 participants at risk LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Up to 12 weeks plus 30 days Safety Analysis Set
Gastrointestinal disorders Flatulence	20.0% 1/5 • Up to 12 weeks plus 30 days Safety Analysis Set
Gastrointestinal disorders Nausea	20.0% 1/5 • Up to 12 weeks plus 30 days Safety Analysis Set
General disorders Influenza like illness	20.0% 1/5 • Up to 12 weeks plus 30 days Safety Analysis Set
General disorders Pain	20.0% 1/5 • Up to 12 weeks plus 30 days Safety Analysis Set
Injury, poisoning and procedural complications Contusion	20.0% 1/5 • Up to 12 weeks plus 30 days Safety Analysis Set
Investigations Weight increased	20.0% 1/5 • Up to 12 weeks plus 30 days Safety Analysis Set
Musculoskeletal and connective tissue disorders Neck pain	20.0% 1/5 • Up to 12 weeks plus 30 days Safety Analysis Set
Nervous system disorders Dysgeusia	20.0% 1/5 • Up to 12 weeks plus 30 days Safety Analysis Set
Nervous system disorders Headache	20.0% 1/5 • Up to 12 weeks plus 30 days Safety Analysis Set
Skin and subcutaneous tissue disorders Petechiae	20.0% 1/5 • Up to 12 weeks plus 30 days Safety Analysis Set

Additional Information

Clinical Trial Disclosures

Gilead Sciences

Email: [email protected]

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