Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Medicine Quality Research Group, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People's Democratic Republic.
Nuffield Department of Medicine, Infectious Diseases Data Observatory (IDDO)/WorldWide Antimalarial Resistance Network (WWARN),Medicine Quality Research Group, Oxford University Centre for Tropical Medicine and Global Health, Oxford, UK.
BMJ Glob Health. 2023 Mar;8(3). doi: 10.1136/bmjgh-2022-011423.
Substandard and falsified (SF) antiretrovirals (ARVs) risk poor outcomes and drug resistance, potentially affecting millions of people in need of treatment and prevention. We assessed the available evidence on SF ARV and related medical devices to discuss their potential public health impact.
Searches were conducted in Embase, PubMed, Google, Google Scholar, Web of Science and websites with interest in ARV quality in English and French up to 30 November 2021. Publications reporting on the prevalence of SF ARV were assessed in a quantitative analysis using the Medicine Quality Assessment Reporting Guidelines (MEDQUARG).
We included 205 publications on SF ARV and 11 on SF medical devices. Nineteen prevalence surveys of SF ARV, published between 2003 and 2021, were included, with no surveys relevant to SF medical devices. The prevalence survey sample size ranged from 3 to 2630 samples (median (Q1-Q3): 16.0 (10.5-44.5); 3 (15.8%) used random outlet sampling methods. Of the 3713 samples included in the prevalence surveys, 1.4% (n=51) failed at least one test. Efavirenz, nevirapine and lamivudine-nevirapine-stavudine combination were the most surveyed ARV with failure frequencies of 3.6% (7/193), 2.6% (5/192) and 2.8% (5/177), respectively. The median (Q1%-Q3%) concordance with the MEDQUARG criteria was 42.3% (34.6%-55.8%).
These results suggest that there are few data in the public domain of the quality of ARV in supply chains; the proportion of SF ARV is relatively low in comparison to other classes of essential medicines. Even a low proportion of the ARV supply chain being poor quality could make a large difference in the HIV/AIDS international landscape. The 95-95-95 target for 2026 and other international targets could be greatly hampered if even 1% of the millions of people taking ARV (for both prevention and prophylaxis) receive medicines that do not meet quality standards. More surveillance of SF ARV is needed to ensure issues are detected.
劣质和假冒（SF）抗逆转录病毒药物（ARV）存在治疗效果不佳和耐药的风险，可能影响到数百万需要治疗和预防的患者。我们评估了 SF ARV 和相关医疗器械的现有证据，以探讨其潜在的公共卫生影响。
我们在 Embase、PubMed、Google、Google Scholar、Web of Science 以及英语和法语的 ARV 质量相关网站上进行了搜索，截至 2021 年 11 月 30 日。我们使用《医学质量评估报告指南》（MEDQUARG）对报告 SF ARV 流行率的出版物进行了定量分析。
我们纳入了 205 篇关于 SF ARV 和 11 篇关于 SF 医疗器械的出版物。纳入了 19 项关于 SF ARV 的流行率调查，发表时间为 2003 年至 2021 年，没有与 SF 医疗器械相关的调查。流行率调查样本量范围为 3 至 2630 个样本（中位数（Q1-Q3）：16.0（10.5-44.5）；3（15.8%）采用随机出口抽样方法。在纳入的 3713 个样本中，有 1.4%（n=51）至少有一项检测失败。接受调查的 ARV 中，依非韦伦、奈韦拉平、拉米夫定-奈韦拉平-司他夫定联合制剂的失败频率分别为 3.6%（7/193）、2.6%（5/192）和 2.8%（5/177）。与 MEDQUARG 标准的一致性中位数（Q1%-Q3%）为 42.3%（34.6%-55.8%）。
这些结果表明，关于供应链中 ARV 质量的公共领域数据较少；与其他基本药物类别相比，SF ARV 的比例相对较低。即使是 ARV 供应链中很小比例的劣质产品，也可能对国际艾滋病大环境产生重大影响。如果即使有 1%的接受 ARV（用于预防和预防）的数百万人服用不符合质量标准的药物，那么 2026 年 95-95-95 目标和其他国际目标可能会受到极大阻碍。需要对 SF ARV 进行更多监测，以确保发现问题。
