粪便中奈韦拉平缓释片残留的存在及其对HIV-1感染患者病毒学结局的影响：一项前瞻性队列研究。
Presence of Tablet Remnants of Nevirapine Extended-Release in Stools and Its Impact on Virological Outcome in HIV-1-Infected Patients: A Prospective Cohort Study.
作者信息
Lee Yi-Chieh, Lin Shu-Wen, Chen Mao-Yuan, Chang Sui-Yuan, Kuo Ching-Hua, Sheng Wang-Huei, Hsieh Szu-Min, Sun Hsin-Yun, Chang Hsi-Yen, Wu Mon-Ro, Liu Wen-Chun, Wu Pei-Ying, Yang Shang-Ping, Zhang Jun-Yu, Su Yi-Ching, Luo Yi-Zhen, Hung Chien-Ching, Chang Shan-Chwen
机构信息
Department of Internal Medicine, Lotung Poh-Ai Hospital, Lo-Hsu Foundation, Inc., I-Lan, Taiwan.
Department of Pharmacy, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; Graduate Institute of Clinical Pharmacy, National Taiwan University College of Medicine, Taipei, Taiwan.
出版信息
PLoS One. 2015 Oct 14;10(10):e0140574. doi: 10.1371/journal.pone.0140574. eCollection 2015.
BACKGROUND
Nevirapine extended-release (NVP-XR) taken once daily remains an effective antiretroviral agent for patients infected with HIV-1 strains that do not harbor resistance mutations. Presence of tablet remnants of NVP XR in stools was reported in 1.19% and 3.05% of subjects in two clinical trials. However, the prevalence may have been underestimated because the information was retrospectively collected in the studies.
METHODS
Between April and December 2014, we prospectively inquired about the frequency of noticing tablet remnants of NVP XR in stools in HIV-1-infected patients who switched to antiretroviral regimens containing NVP XR plus 2 nucleos(t)ide reverse-transcriptase inhibitors. Patients were invited to participate in therapeutic drug monitoring of plasma concentrations of NVP 12 or 24 hours after taking the previous dose (C12 and C24, respectively) of NVP XR using high-performance liquid chromatography. The information on clinical characteristics, including plasma HIV RNA load and CD4 lymphocyte count, at baseline and during follow-up was recorded.
RESULTS
During the 9-month study period, 272 patients switched to NVP XR-based regimens and 60 (22.1%) noticed tablet remnants of NVP XR in stools, in whom 54.2% reported noticing the tablet remnants at least once weekly. Compared with patients who did not notice tablet remnants, those who noticed tablet remnants had a higher mean CD4 lymphocyte count (629 vs 495 cells/mm3, P = 0.0002) and a similar mean plasma HIV RNA load (1.57 vs 1.61 log10 copies/mL, P = 0.76) on switch. At about 12 and 24 weeks after switch, patients who noticed tablet remnants continued to have a similar mean plasma HIV RNA load (1.39 vs 1.43 log10 copies/mL, P = 0.43; and 1.30 vs 1.37 log10 copies/mL, P = 0.26, respectively), but had a lower median NVP C12 (3640 vs 4730 ng/mL, P = 0.06), and a similar median NVP C24 (3220 vs 3330 ng/ml, P = 0.95) when compared with those who did not notice tablet remnants.
CONCLUSIONS
The presence of tablet remnants of NVP XR in stools is not uncommon in HIV-1-infected Taiwanese patients receiving NVP XR-based antiretroviral regimens, which does not have an adverse impact on the virological and immunological outcomes.
背景
对于未携带耐药突变的HIV-1感染患者，每日服用一次的奈韦拉平缓释片（NVP-XR）仍是一种有效的抗逆转录病毒药物。在两项临床试验中，分别有1.19%和3.05%的受试者粪便中出现了NVP XR片剂残渣。然而，由于这些信息是在研究中回顾性收集的，患病率可能被低估了。
方法
在2014年4月至12月期间，我们前瞻性地询问了转换为含NVP XR加2种核苷（酸）逆转录酶抑制剂的抗逆转录病毒方案的HIV-1感染患者粪便中发现NVP XR片剂残渣的频率。患者被邀请在服用前一剂NVP XR 12或24小时后（分别为C12和C24）使用高效液相色谱法参与血浆NVP浓度的治疗药物监测。记录了基线和随访期间包括血浆HIV RNA载量和CD4淋巴细胞计数在内的临床特征信息。
结果
在9个月的研究期间，272例患者转换为基于NVP XR的方案，60例（22.1%）在粪便中发现了NVP XR片剂残渣，其中54.2%的患者报告至少每周发现一次片剂残渣。与未发现片剂残渣的患者相比，发现片剂残渣的患者转换时的平均CD4淋巴细胞计数更高（629对495个细胞/mm³，P = 0.0002），血浆HIV RNA平均载量相似（1.57对1.61 log10拷贝/mL，P = 0.76）。在转换后约12周和24周时，发现片剂残渣的患者血浆HIV RNA平均载量仍相似（分别为1.39对1.43 log10拷贝/mL，P = 0.43；以及1.30对1.37 log10拷贝/mL，P = 0.26），但与未发现片剂残渣的患者相比，NVP C12中位数较低（3640对4730 ng/mL，P = 0.06），NVP C24中位数相似（3220对3330 ng/ml，P = 0.95）。
结论
在接受基于NVP XR的抗逆转录病毒方案的台湾HIV-1感染患者中，粪便中出现NVP XR片剂残渣并不罕见，这对病毒学和免疫学结果没有不利影响。
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