Trial Outcomes & Findings for Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia (NCT NCT02339038)

NCT ID: NCT02339038

Last Updated: 2018-08-14

Results Overview

The primary outcome was the number of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than the limit of quantification (\<15IU/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 600 participants
• Primary outcome timeframe: At least 12 weeks after completion of medication
• Results posted on: 2018-08-14

Participant Flow

Participant milestones

Measure	Standard of Care Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
Overall Study STARTED	600
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	600

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia

Baseline characteristics by cohort

Measure	Standard of Care n=600 Participants Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	522 Participants n=5 Participants
Age, Categorical >=65 years	78 Participants n=5 Participants
Sex: Female, Male Female	184 Participants n=5 Participants
Sex: Female, Male Male	416 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	589 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	578 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At least 12 weeks after completion of medication

Population: The analyses included all patients who received at least one dose of ledipasvir-sofosbuvir

The primary outcome was the number of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than the limit of quantification (<15IU/mL).

Outcome measures

Measure	Standard of Care n=600 Participants Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs	516 Participants

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 76 other events

Deaths: 8 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standard of Care n=600 participants at risk Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
General disorders Fatigue	7.5% 45/600 • 36 months
Nervous system disorders Headache	6.7% 40/600 • 36 months

Additional Information

Masur, Henry

NIH Clinical Center

Phone: +1 301 496 9320

Email: HMasur@cc.nih.gov

Results disclosure agreements

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