Transcript Golden et al. NEJM 2005

Evidence Summary and CDC Guidance
for Expedited Partner Therapy
2006 National STD Prevention Conference
Jacksonville, Florida
May 9, 2006
H. Hunter Handsfield, M.D.
Battelle Centers for Public Health Research and
Evaluation
Center for AIDS and STD
University of Washington
Partner Management for GC and CT in the
United States: Summary




Provider referral by public health generally isn’t
available, especially outside public clinics
- Few providers contact their patients’ partners
Almost all providers advise their patients to
inform and refer partners (patient referral)
- Many pts notify some (most?) of their ptrs
Through these methods, probably ~50% of
partners at risk get treated
- How timely? What effect on overall incidence?
General consensus of inadequacy
EPT Terminology
• Expedited partner therapy:
•
Bypassing obligatory
clinical evaluation and professional counseling
Several possible approaches
- Patient-delivered partner therapy (PDPT): Delivery
of medication or prescription to partner(s) by
index patients
- Pharmacy arrangements
- Field delivery of drug to partners by public health
personnel
- Drug pick-up by partners from providers’ offices
- Other
Use of EPT by Health Care Providers
for Gonorrhea and Chlamydia
• Five surveys
N
- National
2,538
Hogben et al, Sex Transm Dis 2005
- King Co, WA 150 Golden et al, Sex Transm Dis 2004
- RI and CT
111
Niccolai et al, Sex Transm Dis 2005
- California 1,513 Packal et al, NSTDPM 2004; ms in prep
- NYC
~350
Rogers et al, ISSTDR 2005
• Consistent results across all most surveys
- Never use
45-50%
- Sometimes
45-50%
- Usually or always
10-15% (NYC 27%, CA 50%)
RCT of PDPT for CT in Women
Schillinger J et al Sex Transm Dis 2003;30:49-56
•
•
•
•
Women age 14-34 with uncomplicated CT in 6 metropolitan areas
PDPT (azithromycin) versus patient referral
Outcome: recurrent/persistent infection at 1 mo & 3-6 mo
Follow-up: 90% at 1 month, 55% at 3-6 months; urine NAAT
PDPT
Control
890
905
CT 1 month
37 (5.1%)
54 (7.4%)
CT 3-6 mo
50 (11%)
54 (12%)
Cumulative total
87 (12%)
108 (15%)
N
OR (95% CI)
0.80 (0.62-1.05)
RCT of EPT for Men and Women with GC or CT, Seattle
Golden MR, et al. N Engl J Med 2005;352:676-85
• N = 2751, M & F, GC or CT; 42% public, 58% private care
• EPT (mostly PDPT) vs patient- or provider-referral
• Azithromycin + cefixime
• Follow-up 3-19 weeks; urine NAAT
16
Standard care
14
Percent
10
P=0.17
Expedited care
12
13.2
13
10.8
10.6
8
6
P=0.04
9.9
P=0.02
4
2
3.4
0
Gonorrhea
N=358
Chlam ydia
N=1595
GC or CT
N=1860
Multivariate Analysis
Reduced rate of infection at follow-up remained
independently associated with EPT (OR 0.75,
95% CI 0.57 - 0.97) after adjustment for:
 Age
 Sex
 Diagnosis (GC, CT, both)
 Source (STD, FP, pvt, etc)
 Race/ethnicity
 No. sex partners 60 days
Golden et al. NEJM 2005;352:676-85
 Sex since Rx
 New partner since Rx
 No. partners sex w/o condom
 Sex w/ ptr who had other ptrs
 Sex with untreated partner
 All partners treated
Summary of Results
STD
 GC or CT
- Male
- Female
 Gonorrhea
- Male
- Female
 Chlamydia
- Male
- Female
EPT
Standard
92/929 (10) 121/931 (13)
13/194 (7) 24/202 (12)
79/735 (11) 97/729 (13)
RR (95% CI)
0.76 (0.59-0.98)
0.56 (0.30-1.08)
0.81 (0.61-1.07)
6/179 (3)
3/72 (4)
3/107 (3)
19/179 (11)
8/85 (9)
11/94 (12)
0.32 (0.13-0.77)
0.44 (0.12-1.61)
0.25 (0.07-0.83)
86/797 (11)
10/132 (8)
76/665 (11)
105/798 (13)
17/135 (13)
88/663 (13)
0.82 (0.62-1.07)
0.60 (0.29-1.27)
0.86 (0.65-1.15)
Golden et al. NEJM 2005;352:676-85
Recurrent or Persistent Chlamydial Infection in
Two Trials
Number
Completing
PDPT
study
Patient
referral
OR 95% CI
108 (15)
0.80 (0.62-1.05)
Schillinger
1454
87 (12)
Golden
1595
85 (10.8)
105 (13.2) 0.82 (0.62-1.07)
Total
3049
172 (11.2)
213 (14.0) 0.81 (0.67-0.97)
Differential persistence: Infection at Follow-up
among Women Who Any Sex Since Treatment
Percent
16
14
Gonorrhea
12
Chlamydia
CT Rx Failure 8.6% (95% CI 5-12%)
10.2
P=0.34
10
7.6
8
6
4
2
0
15/147
7
11/156
1/17
2.6
0/21
1/38
0
Expedited
22/289
5.9
Standard
Study Arm
Total
RCT of PDPT for Urethritis in Men
Kissinger P, et al Clin Infect Dis (in press)
•
•
•
977 men with urethritis: 54% GC, 15% CT, 6% both, 25% neither
PDPT (AZM + cefixime/cipro) vs pt referral vs enhanced pt ref
Follow-up: Interview 720 (79%), urine NAAT 289 (38%)
Study Arm
•
•
•
Infected at FU (%)
Pt referral
Enhanced pt referral
PDPT
- Gonorrhea
- Chlamydia
35/82 (43)
16/112 (14)
20/87 (23)
Odds ratio (95% CI)
Referent
0.22 (0.11 - 0.44)
0.38 (0.19 - 0.74)
0.34 (0.13 - 0.86)
0.46 (0.13 - 0.87)
Behavioral Outcomes
• Partner notification
• Partner treatment
• Sexual behavior
Behavioral Outcomes
100
Standard
Percent
80
Expedited
78
60
77
P<0.001
P<0.001
64
40
52
61
49
P = 0.001
20
12
6
0
Talked to partner
Partner "very
about STD
likely" treated
Golden et al NEJM 2005;352:676-85
All partners
treated
Sex untreated
partner
EPT: Guidance Development
 Systematic evidence review
 Expert consultation
- Scientific evidence
- Elements of guidance
 Secondary evidence review
 Programmatic consultation
- Program, stakeholders
- Implementation issues
 Dear Colleague Letter
- General support
- Start to address barriers
 DSTDP deliberations etc
 Guidance released, posted
Autumn 2004
Oct 28-29, 2004
Nov ’04 – Feb ‘05
Mar 2-3, 2005
May, 2005
Mar ’05 – Feb ‘06
Feb ‘06
EPT: CDC Guidance
 Overview
- EPT is as least equivalent to patient referral in preventing

persistent/recurrent infection in het M&F with GC or CT,
and in several desirable behavioral outcomes
- EPT should be available as an option
- EPT does not supplant other strategies
GC and CT in heterosexual men and women
- Effective in preventing persistent/recurrent infection and
in several desirable behavioral outcomes
- Recommended as an option
- Routinely recommend personal evaluation
• Especially for women; advise re PID symptoms
• Men with symptoms
• Warn about adverse effects
EPT: CDC Guidance
 GC and CT in MSM
- No data
- High likelihood of co-morbidity, especially HIV
- Use selectively and with caution, only when standard


PN impractical or unsuccessful
Trichomoniasis in women
- Despite historic use, a single RCT showed no benefit
vs standard management
- High STD co-morbidity in partners (10-15% GC or CT)
- Metronidazole adverse effects
- Not recommended for routine use
- “Permission” to use if partner treatment is otherwise
impractical or unsuccessful
Infectious syphilis
- Not recommended for routine use