title: One dose versus three weekly doses of benzathine penicillin G for patients co-infected with HIV and early syphilis: a multicenter, prospective observational study.
abstract: 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.
authors.affiliation: Department of Internal Medicine, Far East Memorial Hospital, New Taipei City, Taiwan.
authors.forename: Chia-Jui
authors.initials: CJ
authors.lastname: Yang
authors.affiliation: Department of Internal Medicine, National Cheng Kung University College of Medicine and Hospital, Tainan, Taiwan.
authors.forename: Nan-Yao
authors.initials: NY
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Kaohsiung Medical University Hospital and College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Internal Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
authors.forename: Tun-Chieh
authors.initials: TC
authors.lastname: Chen
authors.affiliation: Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.
authors.forename: Yu-Hui
authors.initials: YH
authors.lastname: Lin
authors.affiliation: Department of Internal Medicine, E-Da Hospital/I-Shou University, Kaohsiung, Taiwan.
authors.forename: Shiou-Haur
authors.initials: SH
authors.lastname: Liang
authors.affiliation: Department of Internal Medicine, Kaohsiung Medical University Hospital and College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
authors.forename: Po-Liang
authors.initials: PL
authors.lastname: Lu
authors.affiliation: Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.
authors.forename: Wen-Chi
authors.initials: WC
authors.lastname: Huang
authors.affiliation: Department of Internal Medicine, Chi-Mei Medical Center, Tainan, Taiwan.
authors.forename: Hung-Jen
authors.initials: HJ
authors.lastname: Tang
authors.affiliation: Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.
authors.forename: Chen-Hsiang
authors.initials: CH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, E-Da Hospital/I-Shou University, Kaohsiung, Taiwan.
authors.forename: Hsi-Hsun
authors.initials: HH
authors.lastname: Lin
authors.affiliation: Department of Internal Medicine, Kaohsiung Medical University Hospital and College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
authors.forename: Yen-Hsu
authors.initials: YH
authors.lastname: Chen
authors.affiliation: Department of Internal Medicine, National Cheng Kung University College of Medicine and Hospital, Tainan, Taiwan.
authors.forename: Wen-Chien
authors.initials: WC
authors.lastname: Ko
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; Department of Medical Research, China Medical University Hospital, Taichung, Taiwan; China Medical University, Taichung, Taiwan.
authors.forename: Chien-Ching
authors.initials: CC
authors.lastname: Hung
mesh_terms: D000328:Adult; D060085:Coinfection; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D010401:Penicillin G Benzathine / Q000008:administration & dosage* / Q000627:therapeutic use*; D011446:Prospective Studies; D013587:Syphilis / Q000097:blood / Q000150:complications* / Q000188:drug therapy*
chemical_list: D010401:Penicillin G Benzathine