美国开始 HIV 暴露前预防（PrEP）的高危女性和男性的健康相关生活质量无变化：来自 HPTN 069/ACTG A5305 的结果。
No change in health-related quality of life for at-risk U.S. women and men starting HIV pre-exposure prophylaxis (PrEP): Findings from HPTN 069/ACTG A5305.
机构信息
Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, United States of America.
Department of Healthcare Policy and Research, Weill Cornell Medicine, New York, New York, United States of America.
出版信息
PLoS One. 2018 Dec 26;13(12):e0206577. doi: 10.1371/journal.pone.0206577. eCollection 2018.
INTRODUCTION
Tenofovir (TDF)-containing PrEP is effective for HIV prevention, but its effect on health-related quality of life (QOL) is unknown. Using data from HPTN 069/ACTG A5305, a randomized study of potential PrEP regimens comparing maraviroc alone, or together with TDF or emtricitabine (FTC), to TDF + FTC (control), we evaluated the impact of these regimens on QOL in at-risk HIV-uninfected U.S. women and men.
METHODS
QOL was measured at baseline (before starting medications) and every 8 weeks through week 48 using the EQ-5D-3L. Responses were converted to a scale from 0.0 (death) to 1.0 (perfect health), using published valuation weights. Mean scores were compared between groups at each time point using nonparametric testing. Multivariable linear regression was used to adjust for potential confounders.
RESULTS
We analyzed 186 women (median age 35 years, 65% black, 17% Hispanic) and 405 men (median age 30 years, 28% black, 22% Hispanic), including 9 transgender participants analyzed based on sex-at-birth. Mean baseline QOL was 0.91 for women and 0.95 for men. There were minimal changes in mean QOL over time for any regimen (women: p = 0.29; men: p = 0.14). There were no significant differences between participants who continued the regimen compared to participants who discontinued early (women: p = 0.61; men: p = 0.1). Mean QOL did not differ significantly by regimen at any time point, both unadjusted and after adjustment for age, race/ethnicity, adherence, and use of alcohol, marijuana, opiates, and other substances.
CONCLUSIONS
QOL in at-risk individuals starting candidate PrEP regimens in a clinical trial is similar to the general population and maintained over time. This finding did not vary among regimens or when adjusted for demographics, adherence, and substance use. Our findings are the first to show that starting a candidate PrEP regimen in at-risk HIV-uninfected U.S. women and men was not associated with significant changes in QOL.
TRIAL REGISTRATION
Clinicaltrials.gov NCT01505114.
简介
含替诺福韦（TDF）的 PrEP 对预防 HIV 有效，但它对健康相关生活质量（QOL）的影响尚不清楚。利用 HPTN 069/ACTG A5305 的数据，这是一项对潜在 PrEP 方案的随机研究，比较了单独使用马拉维若、与 TDF 或恩曲他滨（FTC）联合使用，以及与 TDF+FTC（对照）相比，评估了这些方案对处于 HIV 感染风险中的美国女性和男性的 QOL 的影响。
方法
使用 EQ-5D-3L 在基线（开始服用药物前）和第 48 周的每 8 周进行 QOL 测量。使用已发表的估值权重，将反应从 0.0（死亡）转换为 1.0（完全健康）。使用非参数检验比较每个时间点的组间差异。使用多变量线性回归调整潜在混杂因素。
结果
我们分析了 186 名女性（中位年龄 35 岁，65%为黑人，17%为西班牙裔）和 405 名男性（中位年龄 30 岁，28%为黑人，22%为西班牙裔），包括 9 名基于出生时性别的跨性别参与者。女性的平均基线 QOL 为 0.91，男性为 0.95。任何方案的平均 QOL 随时间的变化都很小（女性：p=0.29；男性：p=0.14）。与早期停药的参与者相比，继续方案的参与者没有显著差异（女性：p=0.61；男性：p=0.1）。在任何时间点，不考虑方案，无论是未调整还是调整了年龄、种族/民族、依从性以及酒精、大麻、阿片类药物和其他物质的使用，QOL 均无显著差异。
结论
在临床试验中开始候选 PrEP 方案的高危个体的 QOL 与一般人群相似，并随着时间的推移保持稳定。这一发现不因方案而异，也不因调整人口统计学、依从性和物质使用而改变。我们的研究结果首次表明，在美国 HIV 未感染者中开始候选 PrEP 方案不会导致 QOL 发生显著变化。
试验注册
Clinicaltrials.gov NCT01505114。
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