Entecavir for Decompensated HBV Cirrhosis

NCT03345498 | Completed

• 1 other identifier: 2016-140-IMP-93
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Entecavir (ETV) and tenofovir (TDF) are the first-line drugs for treatment of chronic hepatitis B virus (HBV) infection. Chronic HBV infection gradually progress to liver cirrhosis. Over time, as liver damage and cirrhosis advance, the illness progress to a stage termed as decompensated cirrhosis, characterized by development of one or more of serious, life-threatening complications (ascites, hepatic encephalopathy, variceal bleeding or jaundice). In HBV related decompensated cirrhosis, antiviral treatment is shown to provide benefit. For HBV related decompensated cirrhosis, EVT is the drug of choice as it has been shown to be effective and safe. The usual dose of ETV for chronic HBV infection is 0.5 mg orally once daily. Somehow, the recommended dose of ETV for decompensated cirrhosis has been 1.0 mg/d. The literature provides no justification for using this double dose of ETV. Since 0.5 mg daily works well in other stages of disease, there is little reason why it should not work well even in treatment-naïve decompensated cirrhosis. Considering the limitations of available literature, physicians' are divided in their opinion about the drug dose and are prescribing either of the two doses of ETV for this group. Hence, there is a need to assess whether the usual 0.5 mg/d of ETV would work as well as the 1.0 mg/d dose of ETV in decompensated cirrhosis due to HBV infection. Investigators planned this open-labeled observational study with objective to compare the efficacy of HBV suppression achieved using 0.5 mg daily and 1.0 mg daily of ETV in HBV-related decompensated cirrhosis by comparing the mean reduction in HBV DNA level from baseline after 24 weeks of treatment. In present study investigators propose to enroll 15 participants in each group who has been started on either doses (0.5 mg and 1.0 mg) of entecavir and measure serum HBV DNA levels in blood specimens (5 ml) will be collected at different time points, i.e. at baseline, 2, 4, 8, 12 and 24 weeks after starting entecavir.

Conditions

Hepatitis B; Liver Cirrhosis

Outcome Measures

Primary Outcomes (2)

• Percent reduction in quantitative HBV DNA levels at 2 weeks post-treatment

  Quantitative HBV DNA will be measured in study participants at 2 weeks post-treatment in participants receiving either intervention. Percent reduction at 2 weeks from baseline level will be compared between interventions.

  2 weeks from start of ETV treatment

• Percent reduction in quantitative HBV DNA levels at 4 weeks post-treatment

  Quantitative HBV DNA will be measured in study participants at 2 weeks post-treatment in participants receiving either 0.5 mg or 1.0 mg daily doses of entecavir. HBV DNA will be measured after 2 weeks of ETV. Percent reductions at 4 weeks from baseline level will be compared.

  4 weeks from start of ETV treatment

Secondary Outcomes (2)

• Percent reduction in quantitative HBV DNA levels at 8, 12 and 24 weeks post-treatment

  8, 12 and 24 weeks from start of ETV treatment

• Change in disease severity as assessed by change in CTP score and change in MELD score

  24 weeks from start of ETV treatment

Study Arms (2)

ETV 0.5 mg

Group of study participants who were started on 0.5 mg/day of entecavir

Drug: Entecavir

ETV 1.0 mg

Group of study participants who were started on 1.0 mg/day of entecavir

Drug: Entecavir

Interventions

Entecavir DRUG

Entecavir is the antiviral drug of choice recommended for hepatitis B virus treatment in presence of decompensated cirrhosis

ETV 0.5 mg; ETV 1.0 mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will consider to enroll the participants with HBV related decompensated CLD and is planned for treatment, based on their clinical conditions, with either 0.5 or 1.0 mg daily doses of Entecavir by the treating physician. For those who agree to participate (by signing an informed consent), clinical and laboratory findings (including baseline HBV DNA level) will be recorded.

You may qualify if:

• Participants with decompensated liver cirrhosis and
• Replicative HBV infection (HBsAg positive, serum HBV DNA titer \>100,000 IU/mL) regardless of HBeAg and anti-HBe test results

You may not qualify if:

• prior exposure to NAs or other specific treatment for HBV infection (e.g. pegylated interferon)
• hepatocellular carcinoma
• co-infection with any other hepatotropic viruses or HIV
• acute-on-chronic liver failure as defined by Asia-Pacific Association for the Study of Liver criteria
• significant alcohol intake or another concomitant hepatobiliary disease
• expected survival below 4 weeks (e.g. hemodynamic instability, active sepsis, hepatorenal syndrome, etc)
• use of immunosuppressive medication or
• portal vein thrombosis.

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

Location

Related Publications (1)

• Goel A, Rungta S, Verma P, Verma A, Verma AN, Rai P, Aggarwal R. Viral suppression is comparable with 0.5 mg and 1.0 mg daily doses of entecavir in treatment-naive HBV-related decompensated cirrhosis. Antivir Ther. 2020;25(5):267-273. doi: 10.3851/IMP3375.

  PMID: 33404519 DERIVED

MeSH Terms

Conditions

Hepatitis B; Liver Cirrhosis

Interventions

entecavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amit Goel, DM

  Associate Professor, Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 17, 2017
• Study Start: January 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)