Tenofovir Gel for Prevention of Herpes Simplex Virus Type 2 Acquisition: Findings From the VOICE Trial.

Background: Genital infection with herpes simplex virus type 2 (HSV-2) is common and increases risk of human immunodeficiency virus (HIV) transmission and acquisition. Pericoital use of tenofovir (TFV) gel provided protection from HSV-2 acquisition in the CAPRISA 004 study.

Methods: We measured estimate of effect of vaginal TFV 1% gel in preventing HSV-2 acquisition among women in VOICE, randomized, double-blinded, placebo-controlled trial assessing daily use of oral and vaginal TFV for HIV-1 preexposure prophylaxis.

Prospective Characterization of the Risk Factors for Transmission and Symptoms of Primary Human Herpesvirus Infections Among Ugandan Infants.

Background: Human herpesvirus (HHV) infections are common during infancy. Primary infections are frequently asymptomatic and best studied prospectively by using direct viral detection.

Methods: Oropharyngeal swab specimens were collected weekly from Ugandan newborn infants, their mothers, and other children in the household.

Precision of the Kalon Herpes Simplex Virus Type 2 IgG ELISA: an international inter-laboratory assessment.

Background: The commercial Kalon HSV-2 IgG ELISA is currently recommended for research use in sub-Saharan Africa because of its superior accuracy compared to other serologic assays. However, there are no data on key precision parameters of Kalon such as inter-operator variation, repeatability, and reproducibility, thus contributing to a barrier for its acceptance and use in clinical trials in sub-Saharan Africa. We evaluated the analytical and field precision of the Kalon HSV-2 IgG ELISA.

Comparative performance of the Uni-Gold™ HSV-2 Rapid: a point-of-care HSV-2 diagnostic test in unselected sera from a reference laboratory.

Background: HSV-2 diagnosis is typically by viral culture, viral DNA amplification of lesion material or by serology in cases of subclinical presentation. These methods can be time consuming and expensive. The Uni-Gold™ HSV-2 Rapid is a fast, point-of-care diagnostic test that can be performed outside a full service laboratory.

Daily acyclovir to decrease herpes simplex virus type 2 (HSV-2) transmission from HSV-2/HIV-1 coinfected persons: a randomized controlled trial.

Background: Daily suppressive therapy with valacyclovir reduces risk of sexual transmission of herpes simplex virus type 2 (HSV-2) in HSV-2-serodiscordant heterosexual couples by 48%. Whether suppressive therapy reduces HSV-2 transmission from persons coinfected with HSV-2 and human immunodeficiency virus type 1 (HIV-1) is unknown.

Methods: Within a randomized trial of daily acyclovir 400 mg twice daily in African HIV-1 serodiscordant couples, in which the HIV-1-infected partner was HSV-2 seropositive, we identified partnerships in which HIV-1-susceptible partners were HSV-2 seronegative to estimate the effect of acyclovir on risk of HSV-2 transmission.

Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries.

Objective: To compare the performance of the Focus HerpeSelect-2 enzyme immunoassay (EIA) with the gold standard herpes simplex virus (HSV) type 2 western blot, among HIV-1-uninfected men and women in east and southern Africa.

Methods: 3399 HIV-1-uninfected women and men from seven countries in east and southern Africa were tested for HSV-2 antibody using the Focus HerpeSelect-2 EIA. The performance of the HerpesSelect-2 EIA was compared with the gold standard HSV-2-specific western blot.

Performance of commercial herpes simplex virus type-2 antibody tests using serum samples from Sub-Saharan Africa: a systematic review and meta-analysis.

Background: Several commercial type-specific serologic tests are available for herpes simplex virus type 2 (HSV-2). Poor specificity of some tests has been reported on samples from sub-Saharan Africa.

Methods: To summarize the performance of the tests using samples from sub-Saharan Africa, we conducted a systematic review of publications reporting performance of commercially available HSV-2 tests against a gold standard (Western Blot or monoclonal antibody-blocking EIA).

Performance of HSV-2 type specific serological tests in men in Kenya.

This study compared five serological tests with Western blot from University of Washington to determine the most accurate method for detecting antibodies to herpes simplex virus type 2 (HSV-2) in a male population in Kisumu, Kenya. A random sample of 250 fishermen from 18 beaches along Lake Victoria underwent serological testing by two generations of the HerpeSelect HSV-2 ELISA ("Focus Gen 1" and "Focus Gen 2"), Kalon HSV-2 ELISA ("Kalon"), Biokit HSV-2 Rapid Test ("Biokit"), and HerpeSelect Express Rapid HSV-2 ("Express") against the Western blot test ("WB") as the "gold standard". Sensitivity and specificity of tests in this population with a high prevalence of HSV-2 (58% by WB) were: Focus Gen 1: 98.

Comparison of focus HerpesSelect and Kalon HSV-2 gG2 ELISA serological assays to detect herpes simplex virus type 2 antibodies in a South African population.

Introduction: Sero-epidemiological studies of herpes simplex virus (HSV) type 2 infection in Africa remain difficult to interpret as a result of the high rate of false-positive results observed when using the new recombinant gG2 HSV-2 ELISA tests. The performance of two widely used gG2 ELISA was compared to derive an appropriate testing algorithm for use in South Africa.

Methods: Sera from 210 women attending family planning clinics in Johannesburg were tested using HerpeSelect and Kalon HSV-2 gG2 assays.

Herpes simplex virus type-2 seropositivity among ever married women in South and north Vietnam: a population-based study.

Objective: To investigate herpes simplex virus type-2 (HSV-2) seropositivity and associated risk factors in Vietnamese women.

Methods: Cross-sectional study with personal interviews and gynecological examinations among population-based samples of ever married women, aged 15 to 69 years, living in Ho Chi Minh City (HCMC) and Hanoi in 1997. Type-specific IgG antibodies against HSV-2 were detected using HerpeSelect ELISA (Focus Diagnostics).

Comparison of three commercial immunoassays for detection of herpes simplex virus type 2 antibodies in commercial sex workers in Yunnan Province, China.

Five hundred commercial sex workers in China were tested for herpes simplex virus type 2 by three immunoassays and Western blotting. Sensitivities for the Focus, Kalon, and Biokit assays were 86.7%, 82.

Improved performance of enzyme-linked immunosorbent assays and the effect of human immunodeficiency virus coinfection on the serologic detection of herpes simplex virus type 2 in Rakai, Uganda.

Ugandan subjects (820) were tested by Focus HerpeSelect enzyme-linked immunosorbent assay (ELISA), Kalon herpes simplex virus type 2 ELISA, and BioKit rapid test, and the results were compared to those of Western blotting. Higher-than-standard-index cutoff values gave optimal sensitivity and specificity. Kalon ELISA was the optimal assay when an index value of 1.

Use of commercial enzyme immunoassays to detect antibodies to the herpes simplex virus type 2 glycoprotein G in a low-risk population in Hanoi, Vietnam.

Sera from 1,238 Vietnamese women in Hanoi were tested for herpes simplex virus type 2 (HSV-2). HSV-2 prevalence was 2.0%.

Effect of sexually transmitted disease (STD) coinfections on performance of three commercially available immunosorbent assays used for detection of herpes simplex virus type 2-specific antibody in men attending Baltimore, Maryland, STD clinics.

Two hundred seventy-nine serum samples from men attending sexually transmitted disease (STD) clinics in Baltimore, Maryland, were tested for herpes simplex virus type 2 (HSV-2)-specific antibody by three immunosorbent glycoprotein G-2-based assays (the Kalon, Focus, and Biokit assays). The results for all samples with positive results were confirmed by Western blotting (91/279; 32.6% HSV-2 seroprevalence).

Herpes simplex virus type 2 and risk of intrapartum human immunodeficiency virus transmission.

Objective: To determine whether herpes simplex virus type 2 (HSV-2) infection was associated with risk of intrapartum human immunodeficiency virus type 1 (HIV-1) transmission and to define correlates of HSV-2 infection among HIV-1-seropositive pregnant women.

Methods: We performed a nested case control study within a perinatal cohort in Nairobi, Kenya. Herpes simplex virus type 2 serostatus and the presence of genital ulcers were ascertained at 32 weeks of gestation.

Prevalence of herpes simplex virus types 1 and 2 among children and adolescents attending a sexual abuse clinic.

Background: Children and adolescents with a history of sexual abuse are at risk for acquiring herpes simplex virus (HSV) type 2. We evaluated the prevalence of HSV-1 and HSV-2 and the usefulness for this population of 2 commercially available tests.

Methods: Sera from 150 children seen in a sexual abuse clinic were analyzed for type-specific HSV antibodies using Focus HerpeSelect HSV-2 ELISA (Focus), Biokit HSV-2 Rapid Test (Biokit), and by Western blot (WB).

Human herpesvirus 8 infection among adolescents in the REACH cohort.

Objective: Human herpesvirus 8 (HHV-8) infection is common among children in areas where Kaposi sarcoma is endemic. Human herpesvirus 8 is uncommon in children but prevalent in adults at risk for human immunodeficiency virus (HIV) infection in the United States, including men who have sex with men (MSM) and women who engage in high-risk sexual behavior. We examined the prevalence and predictors of HHV-8 infection among adolescents with or at high risk for acquiring HIV infection.

Knowledge of partners' genital herpes protects against herpes simplex virus type 2 acquisition.

Background: Prospective studies of herpes simplex virus type 2 (HSV-2) infection in discordant couples have shown a low rate of transmission. However, unlike partners with genital herpes in prospectively monitored couples, most persons who transmit genital herpes are not aware of having the infection.

Methods: Because HSV has a short incubation period and most persons who acquire genital herpes can identify the transmitting partner, a time-to-event design was used to assess risks of HSV acquisition among patients with newly acquired genital herpes.

Clinical correlates of index values in the focus HerpeSelect ELISA for antibodies to herpes simplex virus type 2 (HSV-2).

Background: Clinical correlates of HerpeSelect ELISA index values are poorly understood.

Objectives: This study was designed to determine the effects of time of infection, test variability, and antibody avidity on index values.

Study Design: Sera (N=313) from 81 patients with new HSV-2 infections and 236 sera from 32 patients with long-standing (median 11.

Herpes simplex virus infection in women in the WIHS: epidemiology and effect of antiretroviral therapy on clinical manifestations.

Objective: To determine the prevalence of infection with herpes simplex virus types 1 (HSV-1) and 2 (HSV-2) among women with and at high risk for HIV infection, and to evaluate the effect of HAART on the recurrence of genital lesions.

Methods: We evaluated the epidemiology and clinical manifestations associated with HSV-1 and HSV-2 among 1796 HIV-infected and 476 HIV-uninfected women enrolled in a multisite cohort study. Serum antibodies to HSV-1 and HSV-2 at baseline and self-reported history of genital herpes, reports of recent genital sores and presence of genital ulcers on examination, and use of HAART regimen at each study visit were analyzed.

Incidence and prevalence of herpes simplex virus infections in adolescent women.

Objectives: We conducted this study to examine the incidence, prevalence, and risk factors for herpes simplex virus (HSV) 1 and HSV 2 infection in a cohort of young women who were closely followed for acquisition of sexually transmitted infections.

Study Design: Women between the ages of 14 and 18 years had blood and genital specimens obtained quarterly to test for incident sexually transmitted infections. Subjects also had 2 12-week periods each year when they kept a detailed behavioral diary and performed weekly vaginal swabs.

Risk factors for herpes simplex virus transmission to pregnant women: a couples study.

Objective: This study was undertaken to determine risk factors for herpes simplex virus (HSV) acquisition among at risk pregnant women.

Study Design: Women in a prospective study of HSV acquisition in pregnancy invited their sexual partners for HSV type-specific serologic testing. Risk factors for HSV susceptibility, exposure, and acquisition were examined.

Herpes simplex virus type 2 (HSV-2) Western blot confirmatory testing among men testing positive for HSV-2 using the focus enzyme-linked immunosorbent assay in a sexually transmitted disease clinic.

Objective: The objective of this study was to define the positive predictive value (PPV) of the Focus herpes simplex virus type 2 (HSV-2) enzyme-linked immunosorbent assay (ELISA) in a low HSV-2 prevalence population and to develop a new test interpretation algorithm.

Methods: HSV-2 Western blots were performed on sera from male sexually transmitted disease clinic patients testing HSV-2 ELISA-positive and used to define a new class of indeterminate HSV-2 ELISA result. HSV-2 Western blots were then prospectively performed on sequential sera with indeterminate HSV-2 ELISAs.

The relationship between condom use and herpes simplex virus acquisition.

Background: Few studies have evaluated the relationship between condom use and herpes simplex virus type 2 (HSV-2) and HSV type 1 (HSV-1) acquisition.

Objective: To assess the relationship between condom use and acquisition of HSV-2 and HSV-1 among men and women.

Design: Analysis of data collected as part of a clinical trial of an ineffective candidate vaccine for HSV-2.