Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection

Phase 2

Completed

• Conditions: Hepatitis B
• Interventions: Drug: Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]; Drug: Ledipasvir 90 MG; Drug: Sofosbuvir 400 MG [Sovaldi]

• Registration Number: NCT03312023
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

The goals of therapy against chronic hepatitis B are to decrease the morbidity and mortality related to chronic HBV infection. Currently available antiviral therapy can suppress viral replication but only a small proportion attain functional cure, which is defined as HBV surface antigen-to-antibody seroconversion. Hepatitis B surface antigen (HBsAg) is a marker of persistent hepatitis B infection.

It has been observed that patients who had both hepatitis B and hepatitis C, and who were treated for their hepatitis C with 12 weeks of ledipasvir/sofosbuvir for had a decline in HBsAg levels. This study hypothesizes that a similar decrease would be seen in mono-infected hepatitis B subjects over the course of 12 weeks treatment with ledipasvir/sofosbuvir.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-17
• Study Start: 2018-02-01
• Primary Completion: 2020-08-10
• Study Completion: 2021-06-30
• Results First Submitted: 2021-07-12
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-02
• Last Update Submitted: 2021-08-24
• Results First Posted: 2021-08-25
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (LDV/SOF for low replicative HBV)	Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]	12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B in low replicative state.
Group D (LDV for low replicative HBV)	Ledipasvir 90 MG	12 weeks treatment with ledipasvir for chronic hepatitis B in low replicative state. Randomized 1:1 with Group C.
Group C (SOF for low replicative HBV)	Sofosbuvir 400 MG [Sovaldi]	12 weeks treatment with sofosbuvir (Sovaldi) for chronic hepatitis B in low replicative state. Randomized 1:1 with Group D.
Group B (LDV/SOF for viral suppressed HBV)	Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]	12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B, virally suppressed.

Primary Outcome Measures

Name	Time	Method
Change of Serum Hepatitis B Surface Antigen (HBsAg as Measured in log10 IU/mL) Level as an Indicator of Antiviral Activity of Ledipasvir and/or Sofosbuvir in Subjects With Chronic Hepatitis B From Baseline to End of 12 Weeks Treatment.	12 weeks	Subjects with chronic hepatitis B will be give 12 weeks of ledipasvir and/or sofosbuvir and their HBsAg will be measured at baseline, on each visits during therapy, and at end of therapy (week 12). The change (decline) in HBsAg from baseline to end of the 12 week treatment will be compared.
Incidence of Adverse Events Leading to Permanent Discontinuation of Ledipasvir and/or Sofosbuvir Treatment in Subjects With Chronic Hepatitis B Infection.	12 Weeks	Number of subjects who discontinued study drug due to adverse event

Secondary Outcome Measures

Name	Time	Method
Changes in Serum Hepatitis B Virus DNA Levels (HBV DNA as Measured in IU/mL) With Treatment of Ledipasvir and/or Sofosbuvir From Baseline to End of 12 Weeks of Treatment in Subjects With Chronic Hepatitis B Infection.	12 weeks	Subjects with chronic hepatitis B will be give 12 weeks of ledipasvir and/or sofosbuvir and their serum hepatitis B DNA levels (HBV DNA) will be measured at baseline, on each visits during therapy, and at end of therapy (week 12). The change in HBV DNA levels from baseline to end of the 12 week treatment will be compared.; Note: Group B (virally suppressed HBV subjects) - all had HBV DNA below the limit of detection; Hence, mean change was 0.

Trial Locations

Locations (1)

Institute of Human Virology (IHV), University of Maryland Baltimore; 🇺🇸 Baltimore, Maryland, United States