Tsui Judith I, Ludwig-Barron Natasha T, James Jocelyn R, Heo Moonseong, Sivaraj Laksika B, Arnsten Julia, Lum Paula J, Taylor Lynn E, Mehta Shruti H, Falade-Nwulia Oluwaseun, Feinberg Judith, Kim Arthur Y, Norton Brianna, Page Kimberly, Litwin Alain H
Department of Medicine, Division of General Internal Medicine, University of Washington, Harborview Adult Medicine Clinic, Seattle, WA (JIT, JRJ); Center for AIDS Prevention Studies, Department of Medicine, University of California San Francisco, San Francisco, CA (NTL-B); Department of Public Health Sciences, Clemson University, Clemson, SC (MH, LBS); Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY (JA, BN); Department of Medicine, University of California, San Francisco, San Francisco, CA (PJL); Department of Pharmacy Practice and Clinical Research, University of Rhode Island, Kingston, RI (LET); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (SHM); Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD (OF-N); Department of Behavioral Medicine & Psychiatry and Department of Medicine, Infectious Diseases, West Virginia University School of Medicine, Morgantown, WV (JF); Division of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, MA (AYK); Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM (KP); Department of Medicine, Clemson University, Clemson, SC (AHL); Department of Medicine, University of South Carolina School of Medicine, Greenville, SC (AHL); Department of Medicine, Prisma Health, Greenville, SC (LBS, AHL).
J Addict Med. 2025;19(3):248-253. doi: 10.1097/ADM.0000000000001398. Epub 2024 Oct 30.
Questions remain on the relationship between pain and hepatitis C virus cure among persons who inject drugs (PWID). This study aimed to explore whether achieving hepatitis C virus cure reduced pain severity.
Prespecified secondary analysis utilized data from a pragmatic clinical trial of care delivery models that enrolled PWIDs between 2016 and 2018 and treated with sofosbuvir/velpatasvir. Current pain severity (0-100) was assessed before and after treatment and 5-point Likert pain scales were used to determine moderate or greater current pain at baseline; the duration and etiology of current pain were not assessed. We used generalized mixed-effects linear models to test whether achieving sustained virologic response (SVR), that is, cure, was associated with lower numeric pain scores (primary outcome) posttreatment, adjusting for potential confounders (age, sex, intervention assignment, time/visit, and baseline pain severity category) and to examine changes in pain over time. Adjusted means estimated from a fitted model for pain severity at each visit were compared between participants who did and did not achieve SVR, both for the sample overall and for the subsample of participants who reported moderate or greater pain at baseline.
Of the 501 participants who were randomized, treated with DAAs and had SVR data, moderate or greater pain was reported at baseline in 174 (34.7%) of participants. Numeric pain severity did not significantly differ by SVR status at any study visit except for the week 48 visit from baseline, when the estimated pain score was significantly higher for those who failed treatment (38.0 vs 26.3, P = 0.033). Among the subsample with baseline moderate or greater pain, pain severity scores were significantly lower in subsequent visits compared to the baseline visit, with the exception of week 48 among participants who did not achieve SVR.
Among PWID, achieving SVR did not improve pain severity. However, participants who failed treatment had significantly greater pain at the visit immediately following visit for SVR, which may relate to adverse psychological effects of treatment failure. Among those with baseline moderate or greater pain, pain scores declined post treatment, suggesting that treatment itself (irrespective of SVR) may be associated with improved pain.
在注射吸毒者（PWID）中，疼痛与丙型肝炎病毒治愈之间的关系仍存在疑问。本研究旨在探讨实现丙型肝炎病毒治愈是否能降低疼痛严重程度。
预先设定的二次分析利用了一项护理提供模式实用临床试验的数据，该试验在2016年至2018年期间招募了PWID，并使用索磷布韦/维帕他韦进行治疗。在治疗前后评估当前疼痛严重程度（0 - 100），并使用5点李克特疼痛量表来确定基线时中度或更严重的当前疼痛；未评估当前疼痛的持续时间和病因。我们使用广义混合效应线性模型来测试实现持续病毒学应答（SVR），即治愈，是否与治疗后较低的数字疼痛评分（主要结局）相关，同时调整潜在混杂因素（年龄、性别、干预分配、时间/就诊次数和基线疼痛严重程度类别），并检查疼痛随时间的变化。比较了达到和未达到SVR的参与者在每次就诊时根据拟合模型估计的疼痛严重程度调整均值，包括整个样本以及基线时报告中度或更严重疼痛的参与者子样本。
在501名随机分组、接受直接抗病毒药物（DAA）治疗并拥有SVR数据的参与者中，174名（34.7%）参与者在基线时报告有中度或更严重疼痛。除了从基线开始的第48周就诊时，治疗失败的参与者估计疼痛评分显著更高（38.0对26.3，P = 0.033）外，在任何研究就诊时，数字疼痛严重程度在达到SVR和未达到SVR的状态之间均无显著差异。在基线时中度或更严重疼痛的子样本中，与基线就诊相比，后续就诊时疼痛严重程度评分显著更低，但未达到SVR的参与者在第48周除外。
在PWID中，实现SVR并未改善疼痛严重程度。然而，治疗失败的参与者在达到SVR就诊后的紧接着那次就诊时疼痛明显更严重，这可能与治疗失败的不良心理影响有关。在基线时中度或更严重疼痛的参与者中，治疗后疼痛评分下降，表明治疗本身（无论是否达到SVR）可能与疼痛改善有关。
