Predescu O, Streba Letiţia Adela-Maria, Irimia Eugenia, Streba Liliana, Mogoantă L
Research Center for Microscopic Morphology and Immunology, University of Medicine and Pharmacy of Craiova, Craiova, Romania.
Rom J Morphol Embryol. 2012;53(3):497-502.
Adverse effects appearing during combined peg-Interferon and Ribavirin antiviral treatment against chronic infection with the hepatitis C virus are a major cause for treatment failures and abrupt interruption. In the prospect of the imminent introduction of new direct acting antiviral agents, with demonstrated higher rates of adverse effects, our study aimed to assess the severity and incidence of several types of adverse effects in a cohort of genotype 1 infected Romanian patients.
We prospectively included a total of 150 patients (45 men), aged 25 to 64 years, who received combined peg-Interferon and Ribavirin antiviral treatment for chronic hepatitis C. Out of these, 145 patients also had liver biopsies prior to treatment initiation. We recorded their viral loads, hemoglobin values and thrombocyte counts, as well as any dermatological, psychiatric or constitutional adverse effect after twelve doses, eight and twelve months of treatment, with two follow-up examinations at three and six months after treatment completion.
Viral loads significantly decreased after 12 doses of treatment, in the end a total of six patients (two men and four women) being declared non-responders. Hemoglobin values and thrombocyte counts significantly decreased during treatment (p<0.0001), with their values being restored to pre-treatment levels during the follow-up period. We did not find significant differences between the 12-doses, 8 and 12 months values during treatment (p>0.05). We recorded 43 cases (11 men and 32 women) presenting with rashes, drug eruptions and erythema. We only encountered grade 1 and 2 dermatological adverse effects. Psychiatric effects were present in 34 cases (10 men and 24 women, 22.6% of the group) and manifested as mild depressions, which did not require specific medication or antiviral dose adjustment. Patients also presented headaches (80.6%), fatigue (71.3%), nausea (47.3%), arthralgias (35.3%) and fever (30%).
We did not encounter severe hematological adverse effects that would require Ribavirin dosage adjustments. Cutaneous and psychiatric adverse effects were also present in a significant number of patients; however, their severity did not influence the continuity or outcome of the antiviral treatment. Other constitutional effects were also present with no direct consequence on the course of treatment. Future agents employed in antiviral therapy shall require extensive monitoring of all adverse effects already acknowledged during dual combination therapy.
聚乙二醇干扰素与利巴韦林联合抗病毒治疗丙型肝炎病毒慢性感染期间出现的不良反应是治疗失败和突然中断的主要原因。鉴于即将引入新的直接作用抗病毒药物，且已证明其不良反应发生率更高，我们的研究旨在评估一组感染1型基因型的罗马尼亚患者中几种不良反应的严重程度和发生率。
我们前瞻性纳入了总共150名患者（45名男性），年龄在25至64岁之间，他们接受聚乙二醇干扰素与利巴韦林联合抗病毒治疗慢性丙型肝炎。其中，145名患者在开始治疗前还进行了肝活检。我们记录了他们的病毒载量、血红蛋白值和血小板计数，以及在治疗12剂后、治疗8个月和12个月时出现的任何皮肤、精神或全身性不良反应，并在治疗完成后3个月和6个月进行了两次随访检查。
治疗12剂后病毒载量显著下降，最终共有6名患者（2名男性和4名女性）被宣布为无应答者。治疗期间血红蛋白值和血小板计数显著下降（p<0.0001），随访期间其值恢复到治疗前水平。我们在治疗期间的12剂、8个月和12个月值之间未发现显著差异（p>0.05）。我们记录了43例（11名男性和32名女性）出现皮疹、药疹和红斑的病例。我们仅遇到1级和2级皮肤不良反应。34例（10名男性和24名女性，占该组的22.6%）出现精神症状，表现为轻度抑郁，无需特殊药物治疗或调整抗病毒药物剂量。患者还出现头痛（80.6%）、疲劳（71.3%）、恶心（47.3%）、关节痛（35.3%）和发热（30%）。
我们未遇到需要调整利巴韦林剂量的严重血液学不良反应。相当数量的患者也出现了皮肤和精神不良反应；然而，其严重程度并未影响抗病毒治疗的连续性或结果。其他全身性症状也存在，但对治疗过程无直接影响。未来用于抗病毒治疗的药物需要对双重联合治疗期间已确认的所有不良反应进行广泛监测。
