Trial Outcomes & Findings for Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection (NCT NCT03057847)

NCT ID: NCT03057847

Last Updated: 2023-05-06

Results Overview

Number of participants initiating HCV treatment

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 32 participants
• Primary outcome timeframe: Delivery to 10 months postpartum
• Results posted on: 2023-05-06

Participant Flow

Participant milestones

Measure	SOF/VEL Sofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period Sofosbuvir/Velpatasvir: Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Overall Study STARTED	32
Overall Study Treatment Initiation	21
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	SOF/VEL Sofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period Sofosbuvir/Velpatasvir: Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Overall Study Lost to Follow-up	16

Baseline Characteristics

Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection

Baseline characteristics by cohort

Measure	SOF/VEL n=32 Participants Sofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period Sofosbuvir/Velpatasvir: Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Age, Continuous	29.88 years STANDARD_DEVIATION 4.72 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Delivery to 10 months postpartum

Population: Number of participants initiating HCV treatment

Number of participants initiating HCV treatment

Outcome measures

Measure	SOF/VEL n=32 Participants Sofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period Sofosbuvir/Velpatasvir: Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment	21 Participants

SECONDARY outcome

Timeframe: 15 months post-treatment, up to 18 months

Population: Rate of intravenous drug use recidivism by participant self-report and Urine Drug Screening

Rate of intravenous drug use recidivism by participant self-report and Urine Drug Screening

Outcome measures

Measure	SOF/VEL n=16 Participants Sofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period Sofosbuvir/Velpatasvir: Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Intravenous Drug Use Recidivism	3 Participants

SECONDARY outcome

Timeframe: 15 months post-treatment

Count of participants 15 months post-treatment with Hepatitis C Virus reinfection as measured by related lab tests

Outcome measures

Measure	SOF/VEL n=16 Participants Sofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period Sofosbuvir/Velpatasvir: Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
HCV Reinfection	0 Participants

SECONDARY outcome

Timeframe: 15 months post-treatment

Population: Data was not collected and will not be reported due to lack of survey development

Health-related quality of life using Promise 57 scale

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: End of treatment (12 weeks postpartum) up to 18 months

Number of participants with non-detectable Hepatitis C Virus (HCV) Ribonucleic acid (RNA) post-treatment as measured by SVR testing

Outcome measures

Measure	SOF/VEL n=13 Participants Sofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period Sofosbuvir/Velpatasvir: Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Number of Participants Achieving Sustained Virologic Response (SVR)	13 Participants

SECONDARY outcome

Timeframe: End of treatment (12 weeks postpartum)

Number of participants reporting treatment side effects using standardized list

Outcome measures

Measure	SOF/VEL n=21 Participants Sofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period Sofosbuvir/Velpatasvir: Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Number of Participants Reporting Treatment Side Effects	12 Participants

SECONDARY outcome

Timeframe: End of treatment (12 weeks postpartum)

Treatment adherence assessed by missed treatment doses

Outcome measures

Measure	SOF/VEL n=84 doses of treatment medication Sofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period Sofosbuvir/Velpatasvir: Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Number of Missed Treatment Doses	2 doses Interval 0.0 to 5.0

Adverse Events

SOF/VEL

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SOF/VEL n=32 participants at risk Sofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period Sofosbuvir/Velpatasvir: Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Nervous system disorders Headaches	37.5% 12/32 • Number of events 44 • Treatment Initiation, up to 18 months
General disorders Fatigue	21.9% 7/32 • Number of events 22 • Treatment Initiation, up to 18 months
Gastrointestinal disorders Nausea	9.4% 3/32 • Number of events 19 • Treatment Initiation, up to 18 months
Psychiatric disorders Insomnia	6.2% 2/32 • Number of events 5 • Treatment Initiation, up to 18 months
Musculoskeletal and connective tissue disorders Weakness	6.2% 2/32 • Number of events 2 • Treatment Initiation, up to 18 months
General disorders Blood in Stool	3.1% 1/32 • Number of events 1 • Treatment Initiation, up to 18 months
General disorders Teeth sensitivity	3.1% 1/32 • Number of events 1 • Treatment Initiation, up to 18 months
Nervous system disorders Dizziness	3.1% 1/32 • Number of events 2 • Treatment Initiation, up to 18 months

Additional Information

Dr. Elizabeth Krans

University of Pittsburgh

Phone: 412-641-3532

Email: kransee@upmc.edu

Results disclosure agreements

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