Objective 
To estimate the risk of serious adverse reactions to benzathine penicillin in pregnant women for preventing congenital syphilis.


Methods 
We searched for clinical trials or cohorts that assessed the incidence of serious adverse reactions to benzathine penicillin in pregnant women and the general population (indirect evidence). MEDLINE, EMBASE, Scopus and other databases were searched up to December 2012. The GRADE approach was used to assess quality of evidence. Absolute risks of each study were calculated along with their 95% confidence intervals (95% CI). We employed the DerSimonian and Laird random effects model in the meta-analyses.


Results 
From 2,765 retrieved studies we included 13, representing 3,466,780 patients. The studies that included pregnant women were conducted to demonstrate the effectiveness of benzathine penicillin: no serious adverse reactions were reported among the 1,244 pregnant women included. In the general population, among 2,028,982 patients treated, 4 died from an adverse reaction. The pooled risk of death was virtually zero. Fifty-four cases of anaphylaxis were reported (pooled absolute risk = 0.002%; 95% CI: 0%–0.003% I2 = 12%). From that estimate, penicillin treatment would be expected to result in an incidence of 0 to 3 cases of anaphylaxis per 100,000 treated. Any adverse reactions were reported in 6,377 patients among 3,465,322 treated with penicillin (pooled absolute risk = 0.169%; 95% CI: 0.073%–0.265% I2 = 97%). The quality of evidence was very low.


Conclusion 
Studies that assessed the risk of serious adverse events due to benzathine penicillin treatment in pregnant women were scarce, but no reports of adverse reactions were found. The incidence of severe adverse outcomes was very low in the general population. The risk of treating pregnant women with benzathine penicillin to prevent congenital syphilis appears very low and does not outweigh its benefits. Further research is needed to improve the quality of evidence.

/pdf/safety-of-benzathine-penicillin-for-preventing-congenital-zf9tajvixj.pdf

Safety of benzathine penicillin for preventing congenital syphilis: a systematic review.

Objectives: To determine the sensitivity and specificity of the Architect Syphilis Chemiluminescence Assay (CLIA): a new highly automated screening test for syphilis.

Methods: To establish the sensitivity of the Architect Syphilis assay we tested 129 stored sera from serologically characterised cases of untreated syphilis. The sera were selected to contain a disproportionately high number of primary infections. There were 79 primary infections, 29 secondary infections, 9 early latent infections and 12 latent syphilis of unknown duration. To establish the specificity of the assay we tested 1107 sera that had been submitted for routine syphilis serology.

Results: The Architect CLIA and the Treponema pallidum particle agglutination test (TPPA) were in total agreement for all untreated infection with sensitivity of 98.4%. This was significantly higher than the sensitivity of the Murex immune capture enzyme (ICE) immunoassay (86%, p<0.001), the IgM enzyme immunoassay (EIA) (86.8%, p<0.001) and the Venereal Disease Research Laboratory test (VDRL) (83.7%, p<0.001). The difference in the sensitivity of the Architect and ICE assays was entirely due to primary stage syphilis (97.5% vs 77.2%, p<0.001). Although the specificity of Architect CLIA was very high (99.1%, 1049/1059) it was significantly lower (p = 0.016) than that of the Murex ICE assay (99.9%).

Conclusions: The Architect CLIA is significantly more sensitive than the Murex ICE screening assay in detecting primary syphilis but it is significantly less specific. Given the relatively high levels of early syphilis, we consider a small increase in the number of confirmatory tests required to exclude false-positive results is worthwhile to increase the detection of primary syphilis by 20%.

The Architect Syphilis assay for antibodies to Treponema pallidum: an automated screening assay with high sensitivity in primary syphilis

Background:Syphilis rates are rising in California, but the impact of HIV infection on syphilis infection remains uncertain. We describe differences between HIV-infected and HIV-uninfected patients diagnosed with syphilis within Kaiser Permanente Northern California.Methods:We performed retrospectiv

Syphilis epidemiology and clinical outcomes in HIV-infected and HIV-uninfected patients in Kaiser Permanente Northern California.

Women living with HIV (WLWH) are at increased risk of invasive cervical cancer (ICC). International HIV guidelines suggest cervical screening twice the first year after HIV diagnosis and thereafter annually. Adherence to the HIV cervical screening program in Denmark is unknown. We studied women from a population-based, nationwide HIV cohort in Denmark and a cohort of age-matched females from the general population. Screening behaviour was assessed from 1999–2010. Adjusted odds ratios (OR’s) for screening attendance in the two cohorts and potential predictors of attendance to guidelines were estimated. Pathology specimens were identified from The Danish Pathology Data Bank. We followed 1143 WLWH and 17,145 controls with no prior history of ICC for 9,509 and 157,362 person-years. The first year after HIV diagnosis 2.6% of WLWH obtained the recommended two cervical cytologies. During the different calendar intervals throughout the study period between 29-46% of WLWH followed the HIV cervical screening guidelines. Adjusted OR’s of attendance to the general population screening program for WLWH aged 30, 40 and 50 years, compared to controls, were 0.69 (95% CI: 0.56-0.87), 0.67 (0.55-0.80) and 0.84 (0.61-1.15). Predictors of attendance to the HIV cervical screening program were a CD4 count > 350 cells/μL and HIV RNA < 500 copies/mL. Calendar period after 2002 and HIV RNA < 500 copies/mL predicted attendance to the general population cervical screening program. The majority of WLWH do not follow the HIV guidelines for cervical screening. We support the idea of cytology as part of an annual review and integration of HIV care and cervical screening in a single clinic setting.

/pdf/adherence-to-the-cervical-cancer-screening-program-in-women-4ire5j7u9a.pdf

Adherence to the cervical cancer screening program in women living with HIV in Denmark: comparison with the general population

BACKGROUND There are limited data on adherence to HIV treatment guidelines. We assessed adherence to US Department of Health and Human Services guidelines with Australian Commentary for adults initiating antiretroviral therapy (ART). METHODS Data were recorded regarding "when to start", "what to start" and pre-ART comorbid disease assessment for consecutive adults initiating ART at primary care and hospital clinics in Sydney and Melbourne from 2004 through 2008. Independent predictors of adherence to guidelines were calculated by stepwise logistic regression. RESULTS For the 500 subjects (95.9% male, mean 40.2 years, median CD4 count 270 cells/μL) "when to start" adherence was 87.6%, and was less likely with initiation in a clinical trial [0.25 (95% CI: 0.13 to 0.49); P < 0.0001] and previous, short-term nontherapeutic antiretroviral exposure [0.08 (0.03 to 0.25); P < 0.0001]. "What to start" adherence was 69.0% for guideline-"preferred" regimens (85.8% for guideline-"preferred" or "alternative" regimens) and more likely with ART initiated in 2008 versus pre-2008 [OR: 2.69 (1.64 to 4.61); P = 0.0001]. Median comorbid disease assessment adherence was 56.8%, ranging from 25.6% for urinalysis to 99.2% for white blood cell count, and was more likely in patients with AIDS, and initiating ART in hospital or in a clinical trial. Hospital clinics were more likely to perform antiretroviral resistance testing (71.2% vs. 46.4%, P < 0.0001), to use "preferred" ART regimens (76.8% vs. 62.2%, P = 0.0002) but less likely to promote healthy diet and lifestyle (63.4% vs. 36.4%, P < 0.0001). CONCLUSIONS "When to start" and "what to start" guidelines have been largely adhered to in Australia, but pre-ART comorbid disease assessment requires greater attention.

Adherence to HIV treatment guidelines for comorbid disease assessment and initiation of antiretroviral therapy.

The case-notes of 3210 patients with HIV infection were audited. A sexual history was documented within four weeks before or after initial HIV diagnosis in 69% of cases (regional range 45-84%), and in the six months before attendance during the audit interval in 34% (12-53%). An offer of tests for sexually transmitted infections was documented within four weeks before or after HIV diagnosis in 58% (30-83%), and in the prior six months in 28% (14-47%). Syphilis serology was offered in the previous three months to 45% (14-100%) of cases resident in syphilis outbreak areas and to 25% (7-62%) of other cases. Hepatitis B testing was performed for 98% (95-100%) of cases and for hepatitis C, for 91% (79-100%). Cervical cytology results in the past year were documented for 73% (43-94%) of eligible women. Considerable inter-regional variation in performance exists. Interventions are needed to improve the sexual health care of people with HIV infection.

UK national audit of sexual health care for people with HIV infection: case-notes audit.

A national audit of 781 early syphilis cases presenting during 2002-03 in UK genitourinary medicine clinics was conducted in late 2004, organized through the Regional Audit Groups. Data were aggregated by region and National Health Service trust, allowing practice to be compared between regions, between trusts within regions, as well as to national averages and the UK National Guidelines. An enzyme immunoassay was used to diagnose 695 (89%) cases (regional range 18-100%). Use of a non-treponemal test was not recorded for 44 (6%) cases. Dark ground microscopy was used in the diagnosis of only 80 (29%) primary cases. Uptake of HIV testing was 77% (range 69-94%). Nationally, 527 (67%) treatments were parenteral, with almost equal use of benzathine penicillin G for 262 (50%, range 0-97%) cases and procaine penicillin G (PPG) for 260 cases (49%, range 3-100%). There were 14 (5%) treatments with less than the recommended 750 mg dose of PPG. One hundred and five (40%) PPG treatments were with greater than 750 mg and/or for longer than 10 days of which 76 (72%) were for early latent syphilis and/or cases with HIV infection. One hundred and ninety two (86%, range 0-100%) of all oral treatments were with doxycycline. The recommended regimen of 100 mg doxycycline twice daily for 14 days was used for 104 (53%) cases; the other 91 (47%) treatments were with a variety of regimens, mainly treatments with larger doses and/or longer treatment intervals and some combination treatments. Fourteen (2%) cases were not treated; treatment was not reported for seven (0.9%) and not known for 10 (1.3%) cases, who were treated at other centres.

/pdf/uk-national-audit-of-early-syphilis-management-case-notes-1sxscdwyrh.pdf

UK National Audit of Early Syphilis Management. Case notes audit: diagnosis and treatment.

Contact tracing was provided for 683/781 (87%, regional range 57-97%) cases, and identified 997 traceable contacts of whom 511 (51%) were seen, short of the recommended standard of 60%. However, the performance range for this standard was 26-70%, with seven regions achieving 60% or more. Of 511, 215 (42%, range 3-73%) contacts had syphilis. Treatment completion was recorded for 691 (88%, range 71-100%) cases, and resolution of lesions for 348/469 (74%, range 40-96%) cases. Nationally, 419/764 (55%, range 37-70%) cases were recorded as having a two dilution (four-fold) or greater decrease in non-treponemal test titre within 3-6 months after treatment; not achieving this titre decrease was mainly attributable to non-attendance for follow-up and failure of titre levels to fall. Follow-up of infectious syphilis in UK genitourinary medicine clinics is poor and falls far short of that recommended by National Guidelines. Only 16 (2%) cases had follow-up at intervals approximating to 1, 2, 3, 6 and 12 months, and only 312 (40%, range 5-61%) cases attended at least two follow-up visits. Only 17 (7%) of all 236 oral treatments (including switches to oral treatment), and 33 (27%) of 123 cases with HIV infection were recorded as designated annual follow-up. Further work is needed to determine factors that account for the wide variation between regions in contact tracing and follow-up performance.

/pdf/uk-national-audit-of-early-syphilis-management-case-notes-34kqvz5c7z.pdf

UK National Audit of Early Syphilis Management. Case-notes audit: contact tracing, information giving, follow-up and outcomes.

Data were provided by 131 clinics, and 56% of cases were managed in clinics in the London regions in 2003. Three clinics (2%) do not routinely screen new patients for syphilis, and 28 clinics (21%) do not routinely screen 'rebook' patients who have had a new partner. More than 80% of clinics routinely conduct cardiovascular and neurological examinations, although chest radiography is only performed by 50% of clinics and lumbar puncture by 13%. Only 19 (14%) clinics indicated not routinely using the recommended procaine penicillin G (PPG) regimen or one- or two-dose benzathine penicillin G (BPG) regimens for early syphilis, with 57% providing two doses of BPG 2.4 g, 40% providing PPG 750 mg for 10 days, and 15% providing one dose of BPG 2.4 g. Only seven clinics (5%) indicated that they provided treatment for early syphilis with PPG that is inferior to that recommended in the national guidelines. Only 18 clinics specified using the recommended dose and duration (or in excess of this) of PPG for neurosyphilis for cases with HIV infection. Provision for management of severe penicillin reaction is good, although few patients are desensitized. All clinics report that contact tracing for early syphilis is provided, and is mainly the responsibility of health advisers. Compared with auditing outcomes, audit of management policies overestimated performance in contact tracing and provision of dark ground microscopy.

/pdf/uk-national-audit-of-early-syphilis-management-clinics-audit-57alfu96e1.pdf

UK National Audit of Early Syphilis Management. Clinics audit: screening for and management of early syphilis

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UK national audit of sexual health care for people with HIV infection: case-notes audit.

UK National Audit of Early Syphilis Management. Case notes audit: diagnosis and treatment.

UK National Audit of Early Syphilis Management. Case-notes audit: contact tracing, information giving, follow-up and outcomes.

UK National Audit of Early Syphilis Management. Clinics audit: screening for and management of early syphilis