PubMed · 16199589
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Paul Lewis, Carol A Glaser. 2005. Encephalitis.. https://doi.org/10.1542/pir.26-10-353
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OBJECTIVES: We conducted this study to compare episodic and suppressive therapy for genital herpes about disease characteristics, disease burden, and psychologic impact. STUDY DESIGN: The authors conducted a randomized, open-label, 1-year treatment trial. RESULTS: Forty subjects were randomized to episodic therapy with valacyclovir (500 mg twice daily for 5 days) and 40 to suppressive therapy (500 mg daily). Subjects in the episodic arm experienced more outbreaks (7.87 +/- 4.65) than those in the suppressive arm (1.59 +/- 1.93) (P <0.001). Subjects in the episodic arm also had significantly more days with pain and lesions (6.5 +/- 7.3) than those in the suppressive arm (1.1 +/- 3.3) (P < 0.001), and other quantitative measures of disease burden also favored the suppressive arm. Both treatment groups had significant improvements in their recurrent genital herpes quality-of-life scores from baseline that persisted throughout the study; however, there was no significant difference between the treatment arms in these scores. CONCLUSIONS: Suppressive therapy of recurrent genital herpes with valacyclovir has a greater impact on measures of disease frequency and burden than episodic therapy. However, both treatment strategies lead to significant improvements in recurrent genital herpes quality-of-life scores. Both treatment strategies benefit patients with recurrent genital herpes.
BACKGROUND: Suppressive therapy has not been studied during the first year after acquisition of genital herpes, the time of maximum frequency of reactivation, potential for transmission, and impact on quality of life. OBJECTIVE: The objective of this study was to evaluate the effectiveness of suppressive therapy with valacyclovir initiated within 3 months of infection. STUDY DESIGN: The authors conducted a double-blind, randomized, controlled trial of 1.0 g valacyclovir daily versus placebo for 6 months in 119 patients. RESULTS: Herpes simplex virus (HSV) type 2 and HSV-1 were documented in 75 and 22 patients, respectively. In intention-to-treat analysis, annualized rates of symptomatic recurrences for valacyclovir and placebo, respectively, were 1.7 +/- 2.7 (mean +/- standard deviation) and 3.4 +/- 4.0 outbreaks per year (P = 0.012). Time to first recurrence was 80 +/- 47 days for valacyclovir and 54 +/- 49 days for placebo (P = 0.001). The differences in favor of valacyclovir were greatest in patients with confirmed HSV-2 infection. The Recurrent Genital Herpes Quality of Life score in HSV-2 infected patients rose 11.9 +/- 11.1 points for valacyclovir and 5.9 +/- 9.1 points for placebo (P = 0.040). CONCLUSIONS: Early suppressive therapy with valacyclovir reduces symptomatic recurrent outbreaks, especially in patients with HSV-2 infection. Valacyclovir therapy was associated with improved herpes-related quality of life.
OBJECTIVE: To demonstrate a causal relationship between herpes simplex virus 2 (HSV-2) and increased genital HIV-1-RNA shedding in women on HAART. DESIGN: A randomized, double-blind, placebo-controlled trial of herpes-suppressive therapy (valacyclovir 500 mg twice a day) in HIV-1/HSV-2-infected women taking HAART in Burkina Faso. METHODS: Participants were followed for a total of 12 biweekly visits before and after randomization. The presence and frequency of genital and plasma HIV-1 RNA, and of genital HSV-2 were assessed using summary measures, adjusting for baseline values. Random effect linear regression models were used to assess the impact of treatment on genital and plasma viral loads among visits with detectable virus. RESULTS: Sixty women were enrolled into the trial. Their median CD4 lymphocyte count was 228 cells/mul, and 83% had undetectable plasma HIV-1 RNA at baseline. Valacyclovir reduced the proportion of visits with detectable genital HSV-2 DNA [odds ratio (OR) 0.37, 95% confidence interval (CI) 0.13, 1.05], but had no significant impact on the frequency (OR 0.90, 95% CI 0.31, 2.62) or quantity (reduction of 0.33 log copies/ml, 95% CI -0.81, 0.16) of genital HIV-1 RNA. However, according to pre-defined secondary analyses restricted to women who shed HIV-1 at least once in the baseline phase, valacyclovir reduced both the proportion of visits with detectable HIV-1 shedding (OR 0.27, 95% CI 0.07, 0.99) and the quantity of genital HIV-1 RNA during these visits (-0.71 log10 copies/ml, 95% CI -1.27, -0.14). CONCLUSION: HSV-2 facilitates residual genital HIV-1 replication among dually infected women taking HAART despite HIV-1 suppression at the systemic level.