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Antiviral resistance remains an important issue for long-term NA therapy. For lamivudine (LAM), the rtM204V/I and rtL180M mutations occur in more than 70% after 5 years of therapy. In Korea, primarily owing to limited subsidization policy in the health insurance system, many patients with LMV-resistance had been treated with either rescue ADV or ETV 1.0 mg monotherapy, ultimately leading to the higher prevalence of MDR strain. For those patients, rescue therapies of combining ADV with either ETV or LAM had been tried, but frequently with suboptimal responses. Rescue TDF monotherapy or TDF-based combination therapy are available in Korea for patients who had "difficult-to-treat" antiviral resistance owing to prior treatment failures. However, which is the better has not been evaluated yet. A long-term efficacy and safety of TDF-based rescue therapies in real practice for those patients should be necessary to revise the Korean guideline for the treatment of chronic hepatitis B in near future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TDF monotherapy | TDF monotherapy - treated by tenofovir alone patients with CHB receiving rescue TDF (300mg once daily) monotherapy | ||
| TDF-based combination therapy | TDF-based combination therapy - treated by tenofovir based combination therapy. patients with CHB receiving rescue TDF-based combination therapy (TDF 300mg once daily with any other nucleoside analogue such as lamivudine 100mg, telbivudine 600mg, or entecavir 1.0 mg once daily). |
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who achieve a sustained HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) at each year during the on treatment follow-up period. | The viral response which is defined as serum HBV DNA < 60 IU/mL | 1, 2, and 3 years after the treatment initiation. |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic hepatitis B patients who had "difficult-to-treat" antiviral resistance owing to prior treatment failures
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22267469 | Background | Lim YS, Lee TH, Heo NY, Shim JH, Lee HC, Suh DJ. Entecavir plus adefovir combination treatment for chronic hepatitis B patients after failure of nucleoside/nucleotide analogues. Antivir Ther. 2012;17(1):53-60. doi: 10.3851/IMP1914. | |
| 19998272 | Background | van Bommel F, de Man RA, Wedemeyer H, Deterding K, Petersen J, Buggisch P, Erhardt A, Huppe D, Stein K, Trojan J, Sarrazin C, Bocher WO, Spengler U, Wasmuth HE, Reinders JG, Moller B, Rhode P, Feucht HH, Wiedenmann B, Berg T. Long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside/nucleotide analogues. Hepatology. 2010 Jan;51(1):73-80. doi: 10.1002/hep.23246. |
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| 18199519 | Background | Tan J, Degertekin B, Wong SN, Husain M, Oberhelman K, Lok AS. Tenofovir monotherapy is effective in hepatitis B patients with antiviral treatment failure to adefovir in the absence of adefovir-resistant mutations. J Hepatol. 2008 Mar;48(3):391-8. doi: 10.1016/j.jhep.2007.09.020. Epub 2008 Jan 3. |
| 20600025 | Background | Berg T, Marcellin P, Zoulim F, Moller B, Trinh H, Chan S, Suarez E, Lavocat F, Snow-Lampart A, Frederick D, Sorbel J, Borroto-Esoda K, Oldach D, Rousseau F. Tenofovir is effective alone or with emtricitabine in adefovir-treated patients with chronic-hepatitis B virus infection. Gastroenterology. 2010 Oct;139(4):1207-17. doi: 10.1053/j.gastro.2010.06.053. Epub 2010 Jun 20. |