ArticleThe Journal of infectious diseases2018
Herpes Simplex Virus Shedding Rate: Surrogate Outcome for Genital Herpes Recurrence Frequency and Lesion Rates, and Phase 2 Clinical Trials End Point for Evaluating Efficacy of Antivirals.
Article in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 36 citations in OpenAlex.
- Can earlier biomarker measurements explain a treatment effect on diabetes incidence? A robust comparison of five surrogate markers.BMJ open diabetes research & care · 2023Trial
- Trial
- Clinical trial simulation of antiviral drugs.Journal of virology · 2026Review
- Orolabial and Genital Herpes Clinical Trials: A Meta-analysis of Endpoints.Open forum infectious diseases · 2026Review
- Article
- Surrogate Marker Evaluation: A Tutorial Using R.Statistics in medicine · 2025Article
- Viral Genomic Variation and the Severity of Genital Herpes Simplex Virus-2 Infection as Quantified by Shedding Rate: A Viral Genome-Wide Association Study.The Journal of infectious diseases · 2024Article
- Assessing heterogeneity in surrogacy using censored data.Statistics in medicine · 2024Article
- Robust approach to combining multiple markers to improve surrogacy.Biometrics · 2023Article
- Selective retention of virus-specific tissue-resident T cells in healed skin after recovery from herpes zoster.Nature communications · 2022Article
- Article
- Reliability of Self-Sampling for Accurate Assessment of Respiratory Virus Viral and Immunologic Kinetics.The Journal of infectious diseases · 2022Article
- Inhibitory activity and mechanism of silver nanoparticles against herpes simplex virus type 1.Archives of virology · 2022Article
- Estimation of the proportion of treatment effect explained by a high-dimensional surrogate.Statistics in medicine · 2022Article
- Robust methods to correct for measurement error when evaluating a surrogate marker.Biometrics · 2022Article
- HSV-2-Specific Human Female Reproductive Tract Tissue Resident Memory T Cells Recognize Diverse HSV Antigens.Frontiers in immunology · 2022Article
- Drug Combinations as a First Line of Defense against Coronaviruses and Other Emerging Viruses.mBio · 2021Review
- Development and immunobiological evaluation of nanoparticles containing an immunodominant epitope of herpes simplex virus.IET nanobiotechnology · 2021Article
- Subclinical Genital Herpes Shedding in HIV/Herpes Simplex Virus 2-Coinfected Women during Antiretroviral Therapy Is Associated with an Increase in HIV Tissue Reservoirs and Potentially Promotes HIV Evolution.Journal of virology · 2020Article
- An Early Test-and-Treat Strategy for Severe Acute Respiratory Syndrome Coronavirus 2.Open forum infectious diseases · 2020Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
Abstract
Background: We tested whether genital herpes simplex virus (HSV) shedding is an appropriate surrogate outcome for the clinical outcome of genital herpes lesions in studies of HSV-2 antiviral interventions. Methods: We analyzed prospective data from natural history studies and clinical trials of antiviral agents for HSV-2 in which HSV-2-seropositive participants provided self-collected anogenital swab specimens daily over ≥25 days for HSV DNA quantitation by polymerase chain reaction (PCR). Genital recurrences were self-reported. Results: Among 674 participants, genital HSV shedding was detected on 17% of days, and genital lesions were reported on 10% of days. Within the same session, HSV shedding rates were strongly correlated with lesion rates (ρ = 0.61, P < .0001). The relative reduction in the recurrence rate was 72% (P = .041) for recipients of the antiviral agent pritelivir as compared to recipients of placebo, but it decreased to 21% (P = .75) after adjustment for HSV shedding rate. When evaluating valacyclovir and acyclovir, adjustment for the HSV shedding rate also led to a reduced association of these antivirals with the recurrence rate. Overall, 40%-82% of the antiviral effect on recurrences was explained by its effect on HSV shedding. Conclusion: HSV genital shedding measured by PCR analysis in swab specimens self-collected daily is an appropriate surrogate outcome for genital herpes lesions because it is in the causal pathway to recurrences.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.