Costa Anna Maria N, L 'italien Gilbert, Nita Marcelo Eidi, Araujo Evaldo Stanislau A
Global Development and Medical Affairs da Bristol-Myers Squibb Company, São Paulo, SP, Brazil.
Braz J Infect Dis. 2008 Oct;12(5):368-73. doi: 10.1590/s1413-86702008000500005.
Hepatitis B virus infection is an important public-health issue. Chronic patients have a higher risk of death due to complications, which increases health-care expenses in. Cost-effectiveness analysis of entecavir (ETV) versus lamivudine (LVD) for treatment of chronic hepatitis B, in e antigen (AgHBe)-positive and negative patients, based on two phase 3, controlled and randomized studies. A decision analysis model was developed, using the following endpoints: cost per patient with undetectable viral load and cost per quality life year (QALY) gained. Risks for complications (compensated or decompensated cirrhosis and hepatocellular carcinoma) were based on the cohort study REVEAL, published in 2006. The REVEAL parameters were applied to the results of the viral load levels obtained from the clinical assay data. The complication costs were based on a study of the disease cost conducted in Brazil, in 2005. The cost data were obtained predominantly from Sistema Unico de Saúde [SUS - Brazilian public health system] payment tables and drug price lists. The utility data were obtained from literature and life expectancy information was based on IBGE data. The analysis perspective was that of SUS. A discount rate of 3% per year was used. For the horizon of time of 10 years, the ETV had an incremental cost of approximately two million Brazilian Reais (R$) compared to LVD. Reducing the number of complications, ETV treatment reduced costs by around 3 million, reducing final costs by 1 million, for AgHBe-positive patients. ETV also reduced the incremental cost per QALY gained. ETV was found to be the most cost-effective alternative for AgHBe-positive and negative patients.
乙型肝炎病毒感染是一个重要的公共卫生问题。慢性患者因并发症导致死亡的风险更高，这增加了医疗费用。基于两项3期对照随机研究，对恩替卡韦（ETV）与拉米夫定（LVD）治疗e抗原（AgHBe）阳性和阴性慢性乙型肝炎患者进行成本效益分析。开发了一个决策分析模型，使用以下终点：病毒载量不可检测的患者的成本以及每获得一个质量调整生命年（QALY）的成本。并发症（代偿性或失代偿性肝硬化和肝细胞癌）的风险基于2006年发表的队列研究REVEAL。将REVEAL参数应用于从临床检测数据获得的病毒载量水平结果。并发症成本基于2005年在巴西进行的疾病成本研究。成本数据主要从单一卫生系统[SUS - 巴西公共卫生系统]支付表和药品价格清单中获得。效用数据从文献中获得，预期寿命信息基于巴西地理与统计研究所（IBGE）的数据。分析视角为SUS。使用每年3%的贴现率。在10年的时间范围内，与LVD相比，ETV的增量成本约为200万巴西雷亚尔（R$）。对于AgHBe阳性患者，通过减少并发症数量，ETV治疗使成本降低了约300万，最终成本降低了100万。ETV还降低了每获得一个QALY的增量成本。结果发现，对于AgHBe阳性和阴性患者，ETV是最具成本效益的选择。
