CORRESPONDENCE • CID 2009:49 (15 September) • 991 Effect of Treatment of Asymptomatic Bacterial Vaginosis on HIV-1 Shedding in the Genital Tract among Women on Antiretroviral Therapy: A Pilot Study To the Editor—Bacterial vaginosis (BV) is a common and recurrent condition of- ten characterized by an asymptomatic dis- turbance of the vaginal flora. Studies have shown that BV is relatively common among women infected with human im- munodeficiency virus (HIV) [1] and is a risk factor for both HIV acquisition and HIV shedding in the genital tract [2, 3]. Current recommendations do not advo- cate treatment of asymptomatic BV [4]. This pilot study investigated whether treatment of asymptomatic BV would also have an impact on HIV-1 shedding in the genital tract of women who were already receiving highly active antiretroviral ther- apy (HAART). The study comprised 30 women who were receiving HAART and who had plasma viral load !75 copies/mL during the 3 months before enrollment. Asymp- tomatic BV was defined by the presence of 3 of 4 Amsel criteria or a Nugent score 17 and by the absence of gynecologic symptoms. These 30 women were ran- domly assigned (by a nonblinded person) in a 1:1 ratio to the treatment arm or the observation arm. The treatment arm re- ceived metronidazole (500 mg twice a day for 7 days) at the initial visit, and the ob- servation arm received no treatment. Par- ticipants returned 1 month later for fol- low-up. At enrollment and follow-up visits, the women were tested for HIV plasma viral load, genital tract HIV-RNA (Nuclisens, bioMe´rieux), sexually trans- mitted infections, and BV (Nugent score, Gram stain, and Amsel criteria). Women in the treatment and observa- tion groups had similar age (median, 42.5 years), race (of 30 women, 16 [53%] were white and 6 [20%] were black), and base- line plasma viral load distributions (27% detectable). At enrollment, all women met the Amsel criteria for BV, 24 women had a Nugent score 17, and 4 women (13%) had HIV genital tract shedding. None of the women had other sexually transmitted infections, including asymptomatic herpes simplex virus shedding. Although statistically insignificant, at the follow-up visit more women in the treatment arm (9 [60%] of 15 women) than in the observation arm (5 [33%] of 15 women) were negative for BV by Amsel criteria ( ). Women in the treat- P p .27 ment arm had a median change in Nugent score of 6 (range, 10 to 2; for P ! .002 no change; Wilcoxon rank-sum test), and women in the observation arm had a me- dian change in Nugent score of 1 (range, 4 to 4; ). The Wilcoxon rank-sum P 1 .05 test that compared the mean changes was statistically significant ( ). Treat- P ! .001 ment also increased the probability of hav- ing a Nugent score !7 at the follow-up visit, compared with no treatment (87% vs 27%; ). Although statistically in- P ! .01 significant, the large effect size observed (log odds ratio [OR], 2.17; standard er- ror [SE], 1.3; ) supports the con- P p .10 clusion that treatment of BV may be as- sociated with a decrease in the odds of genital tract shedding (logistic regression, adjusting for detectable plasma viral load at follow-up). Of the 4 women (3 in the observation arm and 1 in the treatment arm) who had genital tract shedding at enrollment, 1 woman in the observation arm did not have genital tract shedding on follow-up. The logistic regression anal- ysis showed that detectable plasma viral load positively correlated with genital tract shedding (log OR, 3.58; SE, 1.4; ). P ! .05 The current study demonstrates that the prevalence of HIV genital tract shedding is low among women who are receiving HAART and who have a diagnosis of asymptomatic BV. Treatment with met- ronidazole decreases the rate of asymp- tomatic BV among these women. Our finding is consistent with the few related studies that assessed the impact of sexually transmitted infection treatment on HIV-1 plasma viral load. Wang et al [5] found that neither the shedding of HIV-1 RNA nor the prevalence of DNA changed after treatment of BV among HIV-infected women. Wolday et al [6] noticed a modest reduction in shedding of HIV-1 that was related to overall syndromic treatment of sexually transmitted infection and a re- duction in cervical HIV plasma viral load among those women with clinical im- provement. The high prevalence of asymptomatic BV and the evidence that BV facilitates HIV shedding make BV an area in which interventions could have sig- nificant implications for HIV prevention. However, on the basis of the results of our intention-to-treat analysis of this pilot study, future studies will need to be pow- ered with larger sample sizes (∼500 par- ticipants per arm) and will need to screen an even larger number of women to detect cases of asymptomatic BV (6–8 women were screened to detect each case in the present study), because rates of detected genital tract HIV shedding among women on HAART are low. Acknowledgments Financial support. National Institutes of Health (RO1 AI40350 to S.C.-U. and C.M. and K24 AI066884 to S.C.-U.); Lifespan/Tufts/Brown Center for AIDS Research (P30AI42853); and Emory Center for AIDS Research (P30 AI050409 to A.M.C. and J.I.). Potential conflicts of interest. All authors: no conflicts. Carla Moreira, 1 Kartik K. Venkatesh, 2 Allison DeLong, 3 Tao Liu, 3 Jaclyn Kurpewski, 4 Jessica Ingersoll, 5 Angela M. Caliendo, 5,6 and Susan Cu-Uvin 4 1 Departments of Surgery and 2 Community Health, Alpert Medical School, and 3 Center for Statistical Sciences and 4 Division of Infectious Diseases, Departments of Medicine and Obstetrics and Gynecology, Miriam Hospital/Alpert Medical School, Brown University, Providence, Rhode Island; and 5 Department of Pathology and Laboratory Medicine, Emory University School of Medicine, and 6 Emory Center for AIDS Research, Emory University, Atlanta, Georgia References 1. Cu-Uvin S, Hogan JW, Warren D, et al. Prev- alence of lower genital tract infections among human immunodeficiency virus (HIV)–sero- positive and high-risk HIV-seronegative wom- en. HIV Epidemiology Research Study Group. Clin Infect Dis 1999; 29:1145–50. 2. Atashili J, Poole C, Ndumbe PM, Adimora AA, Downloaded from https://academic.oup.com/cid/article-abstract/49/6/991/336994 by guest on 18 June 2020