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Treatment with antiviral therapy and counseling were provided as recommended elsewhere [ 8 ], and blood was drawn at 3 months for the detection of seroconversion to HSV [ 9 ]. The University of Washington institutional review board approved the protocol, and all participants signed a consent form Newly acquired genital HSV infection was defined as clinically diagnosed genital herpes with laboratory documentation of new HSV-1 or HSV-2 infection.
Inclusion or exclusion of partnerships from analysis was based on a definition of transmitting partners that was specified before analysis. Sex partners were defined as transmitting partners if they were the only sex partner during the 4 weeks preceding the development of genital herpes. In that case, the single partner who was not evaluated was identified as the transmitting partner Laboratory methodsHSV Western blot was used to identify type-specific antibodies to HSV-1 and HSV-2 [ 10 ].
Seroconversion was identified as the acquisition of antibodies in paired serum samples. The outcome—the time to acquisition of genital herpes—was defined as the number of days from the beginning of the sexual relationship with the transmitting partner until acquisition [ 15 ].
The main predictor—whether the source told the participant that he or she had genital herpes—was modeled as telling versus not telling.
Kaplan-Meier curves, log-rank tests, and proportional-hazards models were used to assess relationships between the main predictor, as well as other patient characteristics, and the time to acquisition of genital herpes. Because of the study design, the main predictor was ascertained at the time of the outcome.
To allow for appropriate survival modeling, we assumed that this covariate information was indicative of the baseline status, defined at the beginning of the relationship. However, we also performed a sensitivity analysis for this variable in which we reclassified subjects by their true baseline status.
Among the remaining patients, had a first recognized recurrence of genital herpes, as documented by the presence of fully developed antibodies on the Western blot at first evaluation; 43 had alternative diagnoses; and 52 provided information insufficient to document the acquisition of infection figure 1 Figure 1 Study profile.
Thus, the analyses were conducted for 65 participants with genital HSV-1 infection and participants with HSV-2 infection. However, viral shedding persists at high rates and copy numbers years after infection, and therefore may pose continued risk of HSV-2 transmission to sexual partners.
Herpes simplex virus 2 HSV-2 is the major cause of genital herpes and one of the most frequent sexually transmitted diseases STDs worldwide.
Nearly half of these days represent subclinical shedding, occurring on the days without genital lesions [ 6 ]. Clinical recurrences are also common, with a median rate of 4 recurrences in the first year of infection [ 7 ]. The patterns of HSV-2 mucosal shedding after the initial years of infection are less clear. Clinical recurrences among patients followed for several years decreased over time in one study.
HSV-2 shedding may also decrease over time, as 2 studies demonstrated that subclinical shedding rates declined by approximately half after the first year of infection [ 68 ]. Despite these observations, detailed data on genital HSV-2 shedding many years after herpes acquisition are limited. Because the long-term natural history of genital herpes affects the risk of transmission, and consequently has psychosocial, clinical management, and public health implications, we sought to describe patterns of genital HSV-2 shedding and recurrences in years remote from the first genital herpes episode.
Participants were included in our analysis if they had a known date of their first genital herpes episode, were HSV-2 seropositive, and had at least 30 consecutive days of anogenital swab samples analyzed for HSV by polymerase chain reaction PCR.
No participants were known to be HIV-infected; participants were offered HIV testing if they reported high-risk sexual behavior or requested testing.
All participants provided written informed consent, and institutional review boards approved all study protocols. Procedures Demographic and clinical data were collected on standardized forms. An experienced research clinician reviewed the clinical signs and symptoms of genital herpes with participants and taught them to keep a diary of genital lesions and symptoms.
Antiviral therapy was not used during the sampling session and at least 7 days prior to study entry. Participants were also taught to obtain genital swab specimens for HSV detection as described elsewhere [ 69 ]. Depending on the time when they participated in the studies, women were instructed to collect separate genital swabs from the cervix, vulva, and perianal region or a mixed swab of the entire anogenital area [ 10 ]. Men collected separate genital swabs from penile skin and perianal area or a mixed swab of the entire anogenital region [ 10 ].
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If a lesion was present, participants collected a separate lesion swab. The reliability of patient sampling methods for detecting HSV DNA from mucosal and skin surfaces has been previously established and has been determined to be comparable or superior to clinician sampling [ 56 ].
Definitions Time from the first genital herpes episode was defined as the interval between a participant's first reported genital herpes episode and the study sampling session.