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Successful prevention of syphilis infection with azithromycin in both
HIV-negative and HIV-positive individuals, San Francisco, 1999-2003.
J. D. Klausner,1,2 K. Steiner,1 R. Kohn1
1San Francisco Dept Public Health, San Francisco, CA 2University of California, San Francisco, San Francisco, CA.
Background: Syphilis trends in San Francisco
EARLY LATENTPRIMARY & SECONDARY
Rep
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d ca
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Background: Current syphilis epidemic in San Francisco
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1999
Q1
1999
Q2
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Q3
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Q4
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Q4
Quarter
Cases
GAY/BI MALE + TG
MALE UNK
HETERO MALE
FEMALE
Background:Previous studies on azithromycin and syphilis
• Hook EW, Stephens J, Ennis DM, Ann Intern Med, 1999– randomized trial of 1 gram azithromycin vs. 2.4 mu
benzathine penicillin for incubating disease– no reactive FTA-ABS at 3 months in either group
• Hook EW et al., Sex Trans Dis, 2001– RCT of azithromycin vs. benzathine penicillin for
syphilis cases– 2 grams of azithromycin as effective as benzathine
penicillin for treating disease
Background:Syphilis treatment in San Francisco
• Contacts: new cases versus “epi treatment”– 2.4 mu benzathine penicillin G I.M. (“bicillin”) – 100 mg doxycycline P.O. BID for 14 days– 1 gram azithromycin P.O.
• Field-delivered therapy with Azithromycin began March, 1999
Objective
• Compare observed success in treating incubating syphilis using azithromycin to success with other treatments in order to justify continued use of azithromycin
Methods:San Francisco STD Registry
• STD clinic medical record data
• Reported morbidity and reactive STS
• Interview data and field activity
• Screening data
Methods: Sample
• Data from 1999 through 2003
• Non-reactive RPR or VDRL with any syphilis treatment (n=3812)
• Follow-up titer between 30 and 90 days after initial titer (n=151)
Methods: Measurements
• Outcome: any reactive titer defines treatment failure
• Biological false positives excluded from analysis
• HIV status measured from multiple sources, including self-reported status
Results:All patients
confidence limitsTreated Failures Percent lower upper
TreatmentArithromycin 1G 0.5% 6.8%Doxycycline 5 0 0.0% 0.0% 52.2%Bicillin 18 1 5.6% 0.1% 27.3%(Multiple) 2 0 0.0% 0.0% 84.2%All 151 4 2.6% 0.7% 6.6%
Treatment outcome
126 3 2.4%
Results: By HIV Status
Treated Failures Percent Treated Failures PercentTreatmentArithromycin 1GDoxycycline 4 0 0.0% none none noneBicillin 11 1 9.1% 6 0 0.0%(Multiple) 2 0 0.0% none none noneAll 103 3 2.9% 22 0 0.0%
HIV-negative HIV-positive
0 0.0%86 2 2.3% 16
Conclusions
• Failure rate for azithromycin was not significantly greater than rate for bicillin
• Since no resistance to bicillin has been documented, apparent treatment failures likely indicate re-exposure
• Success in treatment did not vary between HIV-negative and HIV-positive clients
Limitations
• No way to distinguish treatment failure from re-exposure
• Not all exposed will develop disease• No randomization
– penicillin allergies– field versus clinic
• Small number of follow-up titers• Wide confidence limits for negative results
Limitations
• No power to assess temporal trends– Azithromycin epi-treatment failures:
• November 2002
• April 2003
• July 2003
– Bicillin epi-treatment failure:• April 1999
Further research
• Another randomized trial of azithromycin vs. bicillin– HIV-positive clients only– San Francisco & Los Angeles– Five years later than 1999 study by Hook
Thank you ...
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