One dose versus three weekly doses of benzathine penicillin G for patients co-infected with HIV and early syphilis: a multicenter, prospective observational study.
Open accessAbstract
BACKGROUND: One dose of benzathine penicillin G (BPG) has been recommended for HIV-infected patients with early syphilis (primary, secondary, and early latent syphilis) in the sexually transmitted diseases treatment guidelines, but clinical data to support such a recommendation are limited. METHODS: We prospectively observed the serological response to 1 or 3 weekly doses of BPG in HIV-infected adults who sought treatment of early syphilis at 8 hospitals around Taiwan. Rapid plasma reagin (RPR) titers were followed every 3-6 months after treatment. The serological response was defined as a 4-fold or greater decline in RPR titers at 12 months of treatment. The missing values were treated by following the last-observed-carried-forward principle. We hypothesized that 1 dose was non-inferior to 3 weekly doses of BPG with the non-inferiority margin for the difference of serological response set to 10%. RESULTS: Between 2007 and 2012, 573 patients completed at least 12 months of follow-up: 295 (51.5%) receiving 1 dose of BPG (1-dose group) and 278 (48.5%) 3 doses (3-dose group). Overall, 198 patients (67.1%; 95% confidence interval [CI], 61.4-72.5%) in the 1-dose group achieved serological response at 12 months, as did 208 patients (74.8%; 95% CI, 69.3-79.8%) in the 3-dose group (one-sided 95% CI of the difference, 15.1%). In the multivariate analysis, secondary syphilis (adjusted odds ratio [AOR], 1.90; 95% CI 1.17-3.09), RPR titer ≥32 (AOR, 1.93; 95% CI, 1.38-2.69), and 3 doses of BPG (AOR, 1.68; 95% CI, 1.20-2.36) were independently associated with a serological response. The time to the first episode of treatment failure was 1184 (standard deviation [SD], 70.5) and 1436 (SD, 80.0) days for 1- and 3-dose group, respectively. CONCLUSIONS: Single-dose BPG resulted in a higher serological failure rate and shorter time to treatment failure than 3 weekly doses of BPG in the treatment of early syphilis in HIV-infected patients.
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Available data demonstrate that use of additional doses of benzathine penicillin G, amoxicillin, or other antibiotics do not enhance efficacy of the recommended regimen when used to treat primary and secondary syphilis, regardless of HIV status.
“Available data demonstrate that use of additional doses of benzathine penicillin G, amoxicillin, or other antibiotics do not enhance efficacy of this recommended regimen when used to treat primary and secondary syphilis, regardless of HIV status (591–593).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [592]
The Discussion (page unavailable) explicitly says that, among HIV-infected patients with early syphilis, one dose of benzathine penicillin G was inferior to three weekly doses for serological response at 12 months—the opposite of the claim about additional doses. The study excluded patients who received other antibiotics, so it does not establish whether adding amoxicillin or other antibiotics helps; it also does not establish the claim regardless of HIV status. (LLM, conf=0.90)
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Experimental — accuracy not yet measuredAdditional doses of benzathine penicillin G, amoxicillin, or other antibiotics in primary and secondary syphilis among persons with HIV infection do not result in enhanced efficacy.
“Available data demonstrate that additional doses of benzathine penicillin G, amoxicillin, or other antibiotics in primary and secondary syphilis among persons with HIV infection do not result in enhanced efficacy (592,593,609).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [592]
The Results report that three weekly doses of benzathine penicillin G were independently associated with a higher serological response than one dose in HIV-infected patients with early syphilis. The Discussion says the subgroup results generally favored three doses, except among patients presenting with primary syphilis; the study did not test additional amoxicillin or other antibiotics. These findings contradict the cited sentence’s blanket claim of no enhanced efficacy. (LLM, conf=0.88)
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Experimental — accuracy not yet measuredAdditional doses of benzathine penicillin G, amoxicillin, or other antibiotics in early latent syphilis do not enhance efficacy, regardless of HIV status.
“Available data demonstrate that additional doses of benzathine penicillin G, amoxicillin, or other antibiotics in early latent syphilis do not enhance efficacy, regardless of HIV status (592,593,609).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [592]
The Results report that three weekly doses of benzathine penicillin G were associated with a higher serological response than one dose in patients with HIV and early syphilis; the Discussion explicitly calls the one-dose regimen inferior at 12 months. This contradicts the claim that additional doses do not enhance efficacy. The study did not test additional amoxicillin or other antibiotics, or patients without HIV. (LLM, conf=0.90)
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- Authors
- Yang, C.-J., Lee, N.-Y., Chen, T.-C., Lin, Y.-H., Liang, S.-H., Lu, P.-L., Huang, W.-C., Tang, H.-J., Lee, C.-H., Lin, H.-H., Chen, Y.-H., Ko, W.-C., & Hung, C.-C.
- Affiliations
- Far Eastern Memorial Hospital (TW)
- National Cheng Kung University Hospital (TW)
- Kaohsiung Medical University (TW)
- Taichung Veterans General Hospital (TW)
- E-Da Hospital (TW)
- Chang Gung University (TW)
- Chi Mei Medical Center (TW)
- National Taiwan University (TW)
- Corresponding author
- Ko, Wen-Chien
- Hung, Chien-Ching
- ORCID
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2014-10-06
- Volume
- 9
- Issue
- 10
- Pages
- e109667
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC4186862
- OpenAlex
- W2048945322
- Cited by
- 51
- References
- 26
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 2 · 2023: 3 · 2022: 10 · 2021: 3 · 2020: 7 · 2019: 2 · 2018: 3 · 2017: 3 · 2016: 3 · 2015: 9
- FWCI
- 3.32
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Figshare (submittedVersion, cc-by)
- Funders
- University of Pittsburgh
- Centers for Disease Control and Prevention (DOH102-DC-1401)
- Topics
- Health Sciences › Medicine › Physiology › Syphilis Diagnosis and Treatment
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Historical Medical Research and Treatments
- Life Sciences › Immunology and Microbiology › Parasitology › Vector-borne infectious diseases
- Keywords
- benzathine penicillin G, early syphilis, HIV coinfection, serological response, treatment failure, secondary syphilis, non-inferiority, sexually transmitted infections, Taiwan
- MeSH terms
- Adult, Drug Administration Schedule, Female, Humans, Male, Penicillin G Benzathine, Prospective Studies, Syphilis, HIV Infections, Kaplan-Meier Estimate, Coinfection
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