2015年10月28日 星期三

EMA 對部分抗愛滋藥物移除其乳酸中毒與脂肪萎縮之安全警訊 (EMA Remove Lipoatrophy & Lactic Acidosis Warnings on Several HIV Drugs)

核酸 or 核苷酸反轉錄酶抑制劑 (nucleoside, or nucleotide analog reverse-transcriptase inhibitors; NRTIs, or NtRTIs) 是治療愛滋病常見的治療藥物組合。這類藥物常見的藥物不良反應包括腸胃道不適脂肪萎縮 (lipoatrophy),以及少見但致命的乳酸中毒 (lactic acidosis)

雖說少見,但約莫半年前,我的好朋友就曾遇過一位服用 Combivir (lamivudine / zidovudine) & atazanavir/ritonavir 數個月後發生乳酸中毒致死的案例;當時,ADR 小組與感染科醫師評估後,認為此次乳酸中毒應是肇因於 zidovudine 所導致的藥物不良反應。

上週 (2015-10-22),歐洲藥物管理局 (European Medicine Agency, EMA) 根據藥物安全監視風險評估委員會 (The Pharmacovigilance Risk Assessment Committee, PRAC) 的回顧綜論,裁定除了 stavudine (d4T; Zerit), zidovudine (AZT; Retrovir) 以及 didanosine (ddI; Videx) 之外,其餘 NRTI or NtRTI 造成脂肪萎縮或乳酸中毒的相關性並不高,不屬於 class effect,故將其餘藥物的相關副作用警示移除。

  • For lactic acidosis, the following medicines no longer require a class warning:  abacavir (Ziagen), emtricitabine (Emtriva), lamivudine (3TC, Epivir), Atripla (efavirenz, emtricitabine, and tenofovir), Eviplera (rilpivirine, emtricitabine & tenofovir), Kivexa (abacavir & lamivudine), Triumeq (dolutegravir, abacavir & lamivudine), Truvada (emtricitabine & tenofovir), Stribild (cobicistat, elvitegravir, emtricitabine & tenofovir).
  • ... Combivir (lamivudine & zidovudine), Trizivir (abacavir, lamivudine & zidovudine) & stavudine (Zerit) will now have a warning about fat loss (lipoatrophy) & will also retain the lactic acidosis warning.

隨著藥物科技的進步,tenofovir, emtricitabine 等新一代的 NRTI / NtRTI 的療效與對抗藥性病毒株的壓制力,幾乎都有神勇的表現;但相對上,新一代的藥物的治療單價也較高(如果要使用 raltegravir 作為 third drug,那治療骨架 (back-bone) 就幾乎只能挑 combivir,才不會讓當月藥費爆表),而即便新一代 NRTI / NtRTI 的安全性與耐受性普遍較佳,我們仍須審慎注意患者是否出現過敏、腎毒性等副作用。

這次 EMA 根據 PRAC 的報告修改 NRTI & NtRTI 的警訊內容,能幫助我們釐清脂肪萎縮與乳酸中毒此兩樣副作用並不是所謂的 "class effect",而是屬於 "stavudine, zidovudine & didanosine" 較容易產生的藥物不良反應。此舉能讓我們對這些藥物的安全性有更進一步的掌握,使我們在事前選擇藥物,或是事後評估 ADR 時,能做出更好的考量與分析。


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