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To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy, de novo LAM + Adefovir [ADV] combination, and early add-on of ADV) among chronic hepatitis B (CHB) patients who are naive to NUC at enrollment to this study
Sampling Method: Consecutive patient sampling
Biospecimen Retention: Blood samples for HBV viral load testing along the treatment period of this study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHB patients who are naive to NUC treatment | CHB patients who are naive to NUC at enrollment and be treated at hospitals at tier 2 cities in China |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who achieve virology response (defined as HBV DNA < 300 copies/mL) by ETV monotherapy in comparison with LAM-based therapy | Virology response is defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) < 300 copies/mL by a highly sensitive assay such as Roche COBAS or Abbott Real Time Polymerase chain reaction (PCR) performed in a one central laboratory | 48 weeks after initial NUC antiviral therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Mean HBV DNA reductions after 48 weeks of treatment from baseline for ETV and LAM-based therapy patients (stratifying by the 3 LAM-based subgroups) | Baseline (Day 1) and 48 weeks | |
| Proportion of patients who achieve virology response by ETV in comparison with LAM-based therapy after 24 weeks and 96 weeks of treatment (stratifying by the 3 LAM based subgroups) |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitals in Chinese tier 2 cities. The definition of these hospitals is the following:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Beijing | Beijing Municipality | 100050 | China | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33090970 | Derived | Jia J, Shang J, Tang H, Jiang J, Ning Q, Dou X, Zhang S, Zhang M, Han T, Tan D, Zhou X, Chen G, Sheng J, Su Z, Chen H, Dai E, Ye Y, Guo Y, Shen Y, Yuan J, Wei Z, Zhu S; EVOLVE Study Group. Long-term outcomes in Chinese patients with chronic hepatitis B receiving nucleoside/nucleotide analogue therapy in real-world clinical practice: 5-year results from the EVOLVE study. Antivir Ther. 2020;25(6):293-304. doi: 10.3851/IMP3372. | |
| 29116050 |
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Serum
| 24 weeks and 96 weeks |
| Proportion of patients who modify their initial treatment options to manage suboptimal response or resistance after 24 weeks, 48 weeks, and 96 weeks of treatment among all treatment options | 24 weeks, 48 weeks and 96 weeks |
| Proportion of patients who achieve virology response among other treatment options, including ADV, LdT, and combinations of NUCs, after 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks of treatment | HBV DNA levels at week 24 will be analyzed at the laboratories of hospitals where the patients are treated while evaluation of HBV DNA levels after 48 and 96 weeks of treatment will be conducted at the central laboratory | 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks |
| Cumulative incidence of patients who develop viral breakthrough and/or genotypic resistance | 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks |
| Cumulative incidence of clinical outcome (eg, HCC, death, decompensated cirrhosis) in ETV arm versus LAM-based and other treatment arms | 48 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks |
| Chongqing |
| Chongqing Municipality |
| 400038 |
| China |
| Local Institution | Chongqing | Chongqing Municipality | 710032 | China |
| Local Institution | Fuzhou | Fujian | 350000 | China |
| Local Institution | Quanzhou | Fujian | 362002 | China |
| Local Institution | Xiamen | Fujian | 1361009 | China |
| Local Institution | Foshan | Guangdong | 528000 | China |
| Local Institution | Shenzhen | Guangdong | 528000 | China |
| Local Institution | Nanning | Guangxi | 530000 | China |
| Local institution | Guiyang | Guizhou | 550000 | China |
| Local Institution | Guiyang | Guizhou | 55000 | China |
| Local Institution | Haikou | Hainan | 570100 | China |
| Local Institution | Baoding | Hebei | 071000 | China |
| Local Institution | Shijiazhuang | Hebei | 050000 | China |
| Local Institution | Daqing | Heilongjiang | 163461 | China |
| Local Institution | Haerbin | Heilongjiang | 150086 | China |
| Local Institution | Zhengzhou | Henan | 430000 | China |
| Local Institution | Zhengzhou | Henan | 450000 | China |
| Local Institution | Shiyan | Hubei | 430000 | China |
| Local Institution | Wuhan | Hubei | 430022 | China |
| Local Institution | Wuhan | Hubei | 430032 | China |
| Local Institution | Changsha | Hunan | 410006 | China |
| Local Institution | Changsha | Hunan | 410008 | China |
| Local Institution | Changsha | Hunan | 410013 | China |
| Local Institution | Ordos | Inner Mongolia | 17000 | China |
| Local Institution | Changshu | Jiangsu | 215500 | China |
| Local Institution | Changzhou | Jiangsu | 213001 | China |
| Local Institution | Nanjing | Jiangsu | 210000 | China |
| Local Institution | Suzhou | Jiangsu | 215000 | China |
| Local Institution | Nangchang | Jiangxi | 330006 | China |
| Local Institution | Changchun | Jilin | 130000 | China |
| Local institution | Yanji | Jilin | 133000 | China |
| Local Institution | Dalian | Liaoning | 116001 | China |
| Local Instution | Fushun | Liaoning | 113000 | China |
| Local Institution | Shengyang | Liaoning | China |
| Local Institution | Shenyang | Liaoning | 110006 | China |
| Local Institution | Yinchuan | Ningxia | 750000 | China |
| Local Institution | Jinan | Shandong | 250000 | China |
| Local Institution | Qingdao | Shandong | 266000 | China |
| Local Institution | Yantai | Shandong | 264001 | China |
| Local Institution | Taiyuan | Shanxi | 030000 | China |
| Local Institution | Taiyuan | Shanxi | 30000 | China |
| Local Institution | Xi’an | Shanxi | 710032 | China |
| Local Institution | Xi’an | Shanxi | 710061 | China |
| Local Institution | Chengdu | Sichuan | 610041 | China |
| Local Institution | Chengdu | Sichuan | 610072 | China |
| Local Institution | Tianjin | Tianjin Municipality | 300000 | China |
| Local Institution | Ürümqi | Xinjiang | 830001 | China |
| Local Institution | Ürümqi | Xinjiang | 830052 | China |
| Local institution | Hangzhou | Zhejiang | 310000 | China |
| Local Institution | Hangzhou | Zhejiang | 310006 | China |
| Local Institution | Hangzhou | Zhejiang | 310023 | China |
| Local Institution | Jinghua | Zhejiang | 300000 | China |
| Local Institution | Ningbo | Zhejiang | 315010 | China |
| Derived |
| Jia J, Tang H, Ning Q, Jiang J, Dou X, Zhang M, Zhang S, Shang J, Lu W, Ye Y, Wang X, Li M, Liu J, Bo Q, Tan W; EVOLVE Study Group. Real-world evidence for nucleoside/nucleotide analogues in a 5-year multicentre study of antiviral-naive chronic hepatitis B patients in China: 52-week results. Antivir Ther. 2018;23(3):201-209. doi: 10.3851/IMP3205. |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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