Rescue Treatment Pattern, Drug Resistance Recurrence, and Direct Medical Costs Associated With Chinese Patients With Chronic Hepatitis B and Drug Resistance to Nucleot(s)Ide Analogue Therapy

Study Overview
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Brief Summary
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The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide analogue (NA) resistance and assess the real-world treatment outcomes and health resources utilization of rescue treatments for drug resistance in a clinical cohort of Chinese patients with chronic hepatitis B (CHB).

Official Title
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Rescue Treatment Pattern, Drug Resistance Recurrence, and Direct Medical Costs Associated With Chinese Patients With Chronic Hepatitis B and Drug Resistance to Nucleot(s)Ide Analogue Monotherapy: A Retrospective Cohort Study

Conditions
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Hepatitis B

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CHB patient with drug resistance confirmed by hepatitis B virus (HBV) gene mutation and virological breakthrough Patient receiving rescue treatments for drug resistance to previous NA therapy for CHB Patient who was regularly followed at least every 6 months for drug resistance at the tertiary liver clinic of SXH Exclusion Criteria: Patient with a diagnosis of hepatocellular carcinoma, decompensated cirrhosis, and/or liver transplantation prior to the development of drug resistance to NA therapy for CHB Patient with co-infection with hepatitis C virus, hepatitis D virus, and/or human immunodeficiency virus Patient with life expectancy less than 6 months after the date of the first laboratory test indicating drug resistance Other protocol defined inclusion/exclusion criteria could apply
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chinese Patients With CHB and Drug Resistance to NA Therapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direct medical costs associated with CHB patients who were regularly followed for drug resistance to NA therapy at the tertiary liver clinic of the Second Xiangya Hospital (SXH) in Changsha, Hunan, China |  | Retrospectively collected from March 31, 2008 to August 15, 2016 | 
| Rescue treatments effect on direct medical costs associated with CHB patients who were followed for drug resistance to NA therapy at the tertiary liver clinic of SXH |  | Retrospectively collected from March 31, 2008 to August 15, 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue treatment patterns associated with CHB patients who were regularly followed for their drug resistance to NA therapy at the tertiary liver clinic of SXH |  | Retrospectively collected from March 31, 2008 to August 15, 2016 | 
| Virological response recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH |  | Retrospectively collected from March 31, 2008 to August 15, 2016 | 
| Biochemical response recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH |  | Retrospectively collected from March 31, 2008 to August 15, 2016 | 
| Drug resistance recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH |  | Retrospectively collected from March 31, 2008 to August 15, 2016 | 
| Rescue treatments effect on liver-related complications in CHB patients who were followed up for drug resistance to NA therapy at the tertiary liver clinic of SXH |  | Retrospectively collected from March 31, 2008 to August 15, 2016 | 
| Rescue treatments effect on mortality in CHB patients who were followed up for drug resistance to NA therapy at the tertiary liver clinic of SXH |  | Retrospectively collected from March 31, 2008 to August 15, 2016 |