Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA, USA.
Y. R. Gaitonde Centre for AIDS Research and Education, Voluntary Health Services, Chennai, India.
J Int AIDS Soc. 2018 Mar;21(3):e25085. doi: 10.1002/jia2.25085.
Dolutegravir (DTG)-based antiretroviral therapy (ART) is recommended for first-line HIV treatment in the US and Europe. Efavirenz (EFV)-based regimens remain the standard of care (SOC) in India. We examined the clinical and economic impact of DTG-based first-line ART in the setting of India's recent guidelines change to treating all patients with HIV infection regardless of CD4 count.
We used a microsimulation of HIV disease, the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-International model, to project outcomes in ART-naive patients under two strategies: (1) SOC: EFV/tenofovir disoproxil fumarate (TDF)/lamivudine (3TC); and (2) DTG: DTG + TDF/3TC. Regimen-specific inputs, including virologic suppression at 48 weeks (SOC: 82% vs. DTG: 90%) and annual costs ($98 vs. $102), were informed by clinical trial data and other sources and varied widely in sensitivity analysis. We compared incremental cost-effectiveness ratios (ICERs), measured in $/year of life saved (YLS), to India's per capita gross domestic product ($1600 in 2015). We compared the budget impact and HIV transmission effects of the two strategies for the estimated 444,000 and 916,000 patients likely to initiate ART in India over the next 2 and 5 years.
Compared to SOC, DTG improved 5-year survival from 76.7% to 83.0%, increased life expectancy from 22.0 to 24.8 years (14.0 to 15.5 years, discounted), averted 13,000 transmitted HIV infections over 5 years, increased discounted lifetime care costs from $3040 to $3240, and resulted in a lifetime ICER of $130/YLS, less than 10% of India's per capita GDP in 2015. DTG maintained an ICER below 50% of India's per capita GDP as long as the annual three-drug regimen cost was ≤$180/year. Over a 2- or 5-year horizon, total undiscounted outlays for HIV-related care were virtually the same for both strategies.
A generic DTG-based regimen is likely to be cost-effective and should be recommended for initial therapy of HIV infection in India.
在 美国 和 欧洲 ，多替拉韦（DTG）为一线抗逆转录病毒治疗（ART）推荐药物。在 印度 ，依非韦伦（EFV）为基础的方案仍是标准治疗（SOC）。我们考察了 DTG 为基础的一线 ART 在印度最近的治疗指南改变后的临床和经济影响，即对所有 HIV 感染患者无论 CD4 计数如何都进行治疗。
我们使用 HIV 疾病的微观模拟，即预防艾滋病并发症的成本效益（CEPAC）-国际模型，来预测两种策略下的 ART 初治患者的结局：（1）SOC：依非韦伦/富马酸替诺福韦二吡呋酯（TDF）/拉米夫定（3TC）；（2）DTG：DTG+TDF/3TC。方案特异性输入，包括 48 周时的病毒学抑制率（SOC：82%与 DTG：90%）和每年的费用（SOC：98 美元与 DTG：102 美元），来源于临床试验数据和其他来源，并在敏感性分析中差异很大。我们比较了增量成本效益比（ICER），以印度人均国内生产总值（2015 年为 1600 美元）来衡量每年每节省 1 个生命年（YLS）的成本。我们比较了这两种策略的预算影响和 HIV 传播效果，它们适用于未来 2 年和 5 年内印度预计有 444000 名和 916000 名新开始接受 ART 的患者。
与 SOC 相比，DTG 将 5 年生存率从 76.7%提高到 83.0%，将预期寿命从 22.0 年延长到 24.8 年（未贴现，14.0 至 15.5 年），5 年内避免了 13000 例 HIV 传播感染，增加了 3040 美元至 3240 美元的贴现终身护理费用，导致终生 ICER 为 130 美元/YLS，低于 2015 年印度人均 GDP 的 10%。只要每年三药方案的费用≤180 美元/年，DTG 的 ICER 就一直保持在印度人均 GDP 的 50%以下。在 2 年或 5 年的时间内，两种策略的 HIV 相关护理总无贴现支出几乎相同。
一种通用的 DTG 为基础的方案很可能具有成本效益，应推荐用于印度的 HIV 感染初始治疗。
