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Title: Tenofovir disoproxil fumarate rescue therapy following failure of both lamivudine and adefovir dipivoxil in chronic hepatitis B.
Austin Authors: Patterson, S J;George, J;Strasser, S I;Lee, A U;Sievert, W;Nicoll, A J;Desmond, Patricia M;Roberts, S K;Locarnini, S;Bowden, S;Angus, Peter W 
Affiliation: Victorian Liver Transplant Unit
Issue Date: 29-Oct-2010
Publication information: Gut 2010; 60(2): 247-54
Abstract: To determine the efficacy of tenofovir disoproxil fumarate (TDF) in adults with chronic hepatitis B virus (HBV) infection who had previously failed lamivudine (LAM) and had significant viral replication (HBV DNA >10⁵ copies/ml if HBeAg positive, > 10⁴ copies/ml if HBeAg negative) despite at least 24 weeks of treatment with adefovir dipivoxil (ADV).A prospective open-label study of TDF 300 mg daily. Patients receiving combination ADV/LAM prior to baseline were switched to TDF/LAM.Multiple tertiary referral centres.Sixty patients were enrolled. The median age was 48.5 years (range 21e80), 46 (77%) were male and 40 (67%) were HBeAg positive. Thirty-eight patients (63%) were switched from ADV to TDF, the remainder from ADV/LAM to TDF/LAM. At baseline, substitutions conferring resistance to LAM or ADV were present in 20 patients (33%) and 17 patients (28%), respectively. The median baseline viral load was 5.33 log₁₀ IU/ml (range 2.81-8.04). Patients initially treated with TDF monotherapy with persistent viral replication at or after 24 weeks were switched to TDF/LAM. The main outcome measures were change in HBV viral load from baseline and percentage of patients achieving an undetectable viral load (<15 IU/ml).Results are reported at 96 weeks of treatment. One patient discontinued TDF at 10 days due to rash. The time-weighted change in viral load from baseline to week 12 was -2.19 log10 IU/ml overall. The median change in HBV DNA from baseline to weeks 12, 24, 48 and 96 was -2.86, -3.23, -3.75 and -4.03 log₁₀ IU/ml, respectively. At 48 and 96 weeks, 27/59 (46%) and 38/59 (64%) patients achieved a HBV DNA <15 IU/ml. The response was independent of baseline LAM therapy or mutations conferring ADV resistance.In heavily pretreated patients with a high rate of genotypic resistance, TDF retains significant activity against HBV although this appears diminished in comparison with studies of naïve patients.
DOI: 10.1136/gut.2010.223206
Journal: Gut
Type: Journal Article
Subjects: Adenine.adverse effects.analogs & derivatives.therapeutic use
Aged, 80 and over
DNA, Viral.blood
Drug Resistance, Viral.genetics
Epidemiologic Methods
Hepatitis B virus.drug effects.genetics.isolation & purification
Hepatitis B, Chronic.drug therapy.virology
Lamivudine.therapeutic use
Middle Aged
Organophosphonates.adverse effects.therapeutic use
Reverse Transcriptase Inhibitors.adverse effects.therapeutic use
Salvage Therapy.methods
Treatment Failure
Treatment Outcome
Viral Load
Young Adult
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