标题: Response to tenofovir monotherapy in chronic hepatitis B patients with prior sub [打印本页] 作者: StephenW 时间: 2012-2-24 06:05 标题: Response to tenofovir monotherapy in chronic hepatitis B patients with prior sub
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http://www.ncbi.nlm.nih.gov/pubmed/22329376 J Viral Hepat. 2012 Mar;19(3):213-9. doi: 10.1111/j.1365-2893.2011.01533.x. Epub 2011 Oct 17.
Response to tenofovir monotherapy in chronic hepatitis B patients with prior suboptimal response to entecavir.Pan CQ, Hu KQ, Yu AS, Chen W, Bunchorntavakul C, Reddy KR.
Source
Division of Liver Diseases, Department of Medicine, The Mount Sinai Medical Center, Mount Sinai School of Medicine, NY, USA
University of California, Irvine Medical Center, Orange County, CA, USA
Pacific Gastroenterology and Endoscopy, San Jose, Santa Clara County, CA, USA Newark Beth Israel Medical Center, Newark, NJ, USA
Rajavithi Hospital, Rangsit University, Bangkok, Thailand
University of Pennsylvania, Philadelphia, PA, USA.
Abstract
Summary. Both entecavir (ETV) and tenofovir (TDF) are potent antiviral agents for hepatitis B virus (HBV). Suboptimal response (SOR) following antiviral therapy is associated with an increased risk of subsequent treatment failure and viral resistance. It remains unclear whether switching to TDF is a reasonable approach in patients with SOR to ETV treatment. This study was aimed to determine how HBV patients with SOR to ETV respond to TDF monotherapy. Data of patients with SOR to ETV (failure to achieve >1 log(10) HBV-DNA reduction during the last 24 weeks of ETV treatment) who were switched to TDF monotherapy during 2005 and 2010 were reviewed. Treatment adherence was assessed by pill-count. Fourteen patients (2.9%) were identified from a total cohort of 482 ETV-treated patients. All 14 patients were Chinese and were infected with HBV genotype C (71%) or B (29%). Nine patients were men, and the median age was 41.5 years (19-64). Twelve were treatment naïve (one lamivudine- and one peginterferon-experienced patient); 85.7% were HBeAg positive. The median baseline HBV-DNA was 7.55 (5.30-9.40) log(10) copies/mL, and 57% had abnormal serum alanine aminotransferase (ALT) levels. Precore and/or basal core promoter mutations were detected in four patients, whereas no genotypic resistance was detected at baseline and before switching to TDF. The median duration of ETV treatment was 64.5 (26-126) weeks. The median HBV-DNA at the time of switching to TDF was 3.69 (3.00-4.90) log(10) copies/mL. The median HBV-DNA reduction from baseline and during the last 6-month observation period prior to switching to TDF was 4.04 (0.51-6.06) log(10) and 0.43 (-0.09-1.13) log(10) copies/mL, respectively. After the switching to TDF, all 14 patients (100%) achieved undetectable HBV-DNA and ALT normalization within a median duration of 30 weeks. In 12 patients who were HBeAg positive, HBeAg seroconversion was observed in two patients after TDF treatment of 75- and 84-weeks duration. There was no virological breakthrough observed after switching to TDF with a median follow-up period of 50 (24-160) weeks. TDF treatment was safe and well tolerated. In conclusion, suboptimal response to ETV is rare (approximately 3%). TDF monotherapy is safe and very effective in the management of HBV patients with SOR to ETV.
研究对象包括:2005-2010年期间,出现恩替SOR(6个月恩替dna下降不超过1次方)换替诺单药治疗的患者。治疗依从性通过药片计数衡量(Treatment adherence was assessed by pill-count)。其中9人男性,平均年龄41.5岁 (19-64)。12人是初治(1人有拉米治疗史,1人有干扰治疗史);85.7%患者为e抗原阳性。HBV-DNA平均基线7.55 (5.30-9.40) log(10) copies/mL,57%患者ALT正常。4名患者检测出前c区和/或基本c区变异,换替诺之前都没有检测出耐药(whereas no genotypic resistance was detected at baseline and before switching to TDF)。恩替平均治疗期为64.5 (26-126)周。换单替诺时HBV-DNA平均基线是3.69 (3.00-4.90) log(10) copies/mL。