Phase 2
N=21
Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT03312023 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: 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. — 0.39; 0.40; 0.19; -0.05 Log10 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni] (Drug); Sofosbuvir 400 MG [Sovaldi] (Drug); Ledipasvir 90 MG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
0.39; 0.40; 0.19; -0.05 | — |
| PRIMARY Incidence of Adverse Events Leading to Permanent Discontinuation of Ledipasvir and/or Sofosbuvir Treatment in Subjects With Chronic Hepatitis B Infection. |
0; 0; 0; 0 | — |
| SECONDARY 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. |
0.51; 0; 0.68; 0.21 | — |
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.
Eligibility Criteria
INCLUSION CRITERIA
Participants in Groups A, C & D (Chronic HBV, low replicative state not requiring treatment):
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older at screening
- Diagnosed with chronic hepatitis B infection defined as one of the following:
- HBsAg or HBV DNA positivity for at least 6 months
- Medical records indicating a chronic HBV infection
- HBeAg negative at screening
- HBV DNA > lower level of quantitation (LLOQ)
- Quantitative HBsAg at least 10 IU/mL at screening
- Ability to take oral medication and be willing to adhere to the twelve week study drug regimen
- For females of reproductive potential: usual practice of complete abstinence from sexual intercourse with a member of the opposite sex OR use of at least one form of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 30 days after the end of study drug administration
- For males of reproductive potential: usual practice of complete abstinence from sexual intercourse with a member of the opposite sex OR use of at least one form of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 14 days after the end of study drug administration
- Ability to communicate effectively with the study investigator and key staff
- Medical management provided by a primary care provider
- Ability to store medications at a room temperature of less than 86 degrees Fahrenheit
- Not on antiviral therapy or requiring treatment for HBV during screening
Participants in Group B (Chronic HBV, virally suppressed):
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older at screening
- Diagnosed with chronic hepatitis B infection defined as one of the following:
- HBsAg or HBV DNA positivity for at least 6 months
- Medical records indicating a chronic HBV infection
- Receiving oral anti-HBV medications (either tenofovir alafenamide, tenofovir disoproxil fumarate, entecavir, or a combination of no more than 2 of these agents) for at least three months prior to enrollment
- HBV DNA ˂ lower level of quantitation (LLOQ) at screening and for at least three months prior
- Quantitative HBsAg at least 10 IU/mL at screening
- Ability to take oral medication and be willing to adhere to the twelve week study drug regimen
- For females of reproductive potential: usual practice of complete abstinence from sexual intercourse with a member of the opposite sex OR use of at least one form of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 30 days after the end of study drug administration
- For males of reproductive potential: usual practice of complete abstinence from sexual intercourse with a member of the opposite sex OR use of at least one form of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 14 days after the end of study drug administration
- Ability to communicate effectively with the study investigator and key staff
- Medical management provided by a primary care provider
- Ability to store medications at a room temperature of less than 86 degrees Fahrenheit
EXCLUSION CRITERIA
- Coinfection with hepatitis C, hepatitis D or human immunodeficiency virus (HIV)
- Pregnancy or lactation
- Known allergic reactions to sofosbuvir or ledipasvir
- Treatment with another investigational drug or other intervention within three months
- Evidence of cirrhosis o
Data sourced from ClinicalTrials.gov (NCT03312023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.