Schacker T, Hu H L, Koelle D M, Zeh J, Saltzman R, Boon R, Shaughnessy M, Barnum G, Corey L
University of Washington, Seattle, USA.
Ann Intern Med. 1998 Jan 1;128(1):21-8. doi: 10.7326/0003-4819-128-1-199801010-00004.
Herpes simplex virus (HSV) infection is one of the most common opportunistic infections in HIV-infected persons. However, most documentation of the effectiveness of antiviral therapy in reducing HSV reactivation is anecdotal.
To evaluate the quantitative effect of antiviral therapy on the frequency of HSV reactivation in HIV-infected persons.
Double-blind, placebo-controlled, crossover trial.
Research clinic at a university hospital.
48 persons (45 men and 3 women) who were HIV positive and HSV seropositive.
Patients were randomly assigned to receive famciclovir, 500 mg orally twice daily, or placebo for 8 weeks. They then crossed over to receive the other regimen after a 1-week washout period.
Patients obtained daily cultures of their perirectal, urethral, oral, and genital areas and kept dairy records of signs and symptoms of genital and oral-labial herpes.
The median CD4 cell count at study entry was 384 cells/mm3. In the intention-to-treat analysis of the first study period, HSV was isolated on 122 of 1114 (11%) placebo days compared with 9 of 1071 (1%) famciclovir days (relative risk, 0.15; P < 0.001). For patients who completed the crossover, the median difference in days with symptoms between placebo and famciclovir was 13.8% of days and the median difference in days on which HSV was isolated was 5.4% of days (P < 0.001 for both). Percentage of days with HSV-2 shedding was reduced from 9.7% to 1.3%. Breakthrough reactivations that occurred while patients were receiving famciclovir were infrequent, short, and often asymptomatic, HSV-2 isolates from these reactivations were susceptible to penciclovir in vitro.
Antiviral chemotherapy with famciclovir results in clinically and statistically significant reductions in the symptoms associated with HSV infection and the symptomatic and asymptomatic shedding of HSV among HIV-positive persons.
单纯疱疹病毒（HSV）感染是HIV感染者中最常见的机会性感染之一。然而，关于抗病毒治疗降低HSV再激活有效性的大多数记录都是传闻。
评估抗病毒治疗对HIV感染者HSV再激活频率的定量影响。
双盲、安慰剂对照、交叉试验。
大学医院的研究诊所。
48名HIV阳性且HSV血清学阳性者（45名男性和3名女性）。
患者被随机分配接受泛昔洛韦，口服500mg，每日两次，或安慰剂，为期8周。在1周的洗脱期后，他们交叉接受另一种治疗方案。
患者每天对直肠周围、尿道、口腔和生殖器区域进行培养，并记录生殖器和口腔唇疱疹的体征和症状。
研究开始时的CD4细胞计数中位数为384个细胞/mm³。在第一个研究期的意向性分析中，安慰剂组1114天中有122天（占11%）分离出HSV，而泛昔洛韦组1071天中有9天（占1%）分离出HSV（相对风险为0.15；P<0.001）。对于完成交叉治疗的患者，安慰剂组和泛昔洛韦组有症状天数的中位数差异为天数的13.8%，分离出HSV天数的中位数差异为天数的5.4%（两者P均<0.001）。HSV-2脱落天数的百分比从9.7%降至1.3%。患者接受泛昔洛韦治疗时发生的突破性再激活很少见，持续时间短，且通常无症状，这些再激活中分离出的HSV-2在体外对喷昔洛韦敏感。
泛昔洛韦抗病毒化疗可使HIV阳性者中与HSV感染相关的症状以及HSV的有症状和无症状脱落出现临床上和统计学上的显著减少。
