OR, IF NOT AN OPTION Cefixime
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Transcript OR, IF NOT AN OPTION Cefixime
Montana STD Update
Webinar – August 20, 2012
Kees Rietmeijer, MD, PhD
Medical Director, Denver STD/HIV Prevention Training Center
A Man with a Faint Rash
The 5-Minute STI Clinical Case Study
Case History
• 30 year-old gay man complaining of a faint, nonitching rash for >4 weeks
• Took left-over amoxicillin for sore throat about 1
month ago – however, pt. does not have a prior
history of penicillin allergy
• No neurological symptoms or other physical
complaints
Case History -Continued
• Sexual and STI History
– 2 partners in past 6 months:
• One steady partner
• One occasional partner (about 3 months ago)
– Protected receptive and insertive anal sex with steady
partner only
– Unprotected oral sex with steady and occasional
partners
– No history of genital/rectal sores
– Rectal gonorrhea and chlamydia > 1 year ago
– History of primary syphilis – treated 4 years ago with
2.4 MU LAB
– Most recent RPR: NR (14 months ago; this clinic
– HIV: negative (14 months ago; this clinic)
Physical Exam
• Faint erythematous macular rash trunk
and extremities
• Soles of feet involved, but palms of hands
are not
• No excoriations or scratch marks noted
• No penile or anal lesions observed
• Neurological exam: normal
Question 1
What laboratory test would be the least
useful in this case?
a)
b)
c)
d)
e)
Qualitative (stat) RPR
Quantitative RPR
Treponemal test (TPPA or FTA-abs)
HIV rapid test
HIV viral load
Stat Lab Results
• Qualitative RPR reactive: ++++
• HIV Rapid Test: Positive
Question 2
Based on our knowledge so far, what is the
most likely diagnosis?
a)
b)
c)
d)
Acute HIV Infection
Drug rash
Secondary syphilis
Scabies
Question 3
You decide to treat the patient for secondary
syphilis – what do the CDC treatment
guidelines recommend:
a) LAB 2.4 MU i.m. now and refer to HIV care
b) LAB 2.4 MU i.m. now and once a week for 2
subsequent weeks + refer to HIV care
c) Patient should undergo LP before treatment is
initiated
d) Refer to HIV care as treatment will depend on
HIV viral load and CD4 count
Question 4
Regarding the patient’s follow up – which is
a CDC recommendation?
a) Patient should return for follow-up at 1 and 2
weeks for additional treatment
b) Serological follow-up should be more
frequent than in HIV negative patients
c) Follow-up should include a neurological
work-up and LP to exclude neurosyphilis
Gonorrhea
The Continuing Saga
Uncomplicated Gonococcal Infections
of the Cervix, Urethra, and Rectum
Ceftriaxone 250 mg IM in a single dose
OR, IF NOT AN OPTION
Cefixime 400 mg orally in a single dose or 400 mg
by suspension (200 mg/5ml)
PLUS
Azithromycin 1g orally in a single dose
Or
Doxycycline 100 mg twice a day for 7 days
CDC 2010 STD Treatment Guidelines
Uncomplicated Gonococcal
Infections of the Pharynx
Recommended Regimens
Ceftriaxone 250 mg IM in a single dose
PLUS
Azithromycin 1g orally in a single dose
Or
Doxycycline 100 mg twice a day for 7 days
CDC 2010 STD Treatment Guidelines
Alternative Regimens
• Alternative regimens for uncomplicated
gonorrhea
– Cefpodoxime 400 mg – poor cure rates for
pharyngeal infections
– Cefuroxime 1 g orally – poor cure rates for
pharyngeal infections
– Spectinomycin: no longer available in U.S.
– Azithromycin 2 g orally – concerns about macrolide
resistance
CDC 2010 STD Treatment Guidelines
Gonorrhea Isolates with Cefixime MICS >0.25μg/mL
Northeast/Sout
West
Midwest
h
Total
#
#
#
#
No. % Tested No. % Tested No. % Tested No. % Tested
2000
0
0
1,910
3
0.2 1,565
7 0.4 1,986
10 0.2 5,461
2001
4
0
2,066
1
0.2 1,561
7 0.4 1,845
12 0.2 5,472
2002
0 0.2
2,163
1
0.1 1,273
8 0.4 1,931
9 0.2 5,367
2003
1
0
2,558
0
0.1 1,628
3 0.1 2,366
4 0.1 6,552
2004
2
0
2,540
2
0 1,673
2 0.1 2,109
6 0.1 6,322
2005
5 0.2
2,551
0
0.1 1,409
1
0 2,239
6 0.1 6,199
2006
4 0.2
2,489
0
0 1,420
1
0 2,180
5 0.1 6,089
2009 37 1.9
1,924
7
0.5 1,398
1
0 2,308
45 0.8 5,630
2010 68 3.3
2,072
6
0.5 1,146
3 0.1 2,475
77 1.4 5,693
2007
2008
2011
3.2
0.6
0.3
MMWR 2011;60:873-877 and MMWR 2012;61:590-594
1
Percentage of urethral Neisseria gonorrhoeae isolates with elevated cefixime MICs (≥0.25 µg/mL),
by U.S. Census region and gender of sex partner — Gonococcal Isolate Surveillance Project,
United States, 2006–August 2011
2006
2009
2010
2011*
Region
%
(95% CI)
%
(95% CI)
%
(95% CI)
%
(95% CI)
West (total)
0.2
(0.1–0.4)
1.9
(1.4–2.6)
3.3
(2.6–4.0)
3.2
(2.3–4.2)
MSM
0.1
(0.0–0.6)
2.6
(1.7–3.8)
5.0
(3.8–6.5)
4.5
(3.1–6.3)
MSW
0.2
(0.0–0.6)
1.4
(0.7–2.3)
1.3
(0.7–2.2)
1.8
(0.9–3.1)
Midwest (total)
0.0
(0.0–0.3)
0.5
(0.2–1.0)
0.5
(0.2–1.1)
0.6
(0.2–1.5)
MSM
0.0
(0.0–2.8)
2.3
(0.6–5.7)
3.4
(1.1–7.7)
4.9
(1.4–12.2)
MSW
0.0
(0.0–0.3)
0.3
(0.1–0.7)
0.1
(0.0–0.6)
0.0
(0.0–0.6)
Northeast and
South (total)
0.1
(0.0–0.3)
0.0
(0.0–0.2)
0.1
(0.0–0.4)
0.3
(0.1–0.8)
MSM
0.6
(0.0–3.0)
0.3
(0.0–1.9)
0.9
(0.2–2.5)
1.5
(0.4–3.9)
MSW
0.0
(0.0–0.2)
0.0
(0.0–0.2)
0.0
(0.0–0.2)
0.1
(0.0–0.4)
MMWR 2012;61:590-594
CDC Recommendations for Gonorrhea
Treatment - February 2012
• Treat with most effective regimen
– Ceftriaxone 250 mg + Azithromycin 1 g
• Closely monitor treatment failure
– Persistent symptoms:
• Test by culture
• Submit isolate for resistance testing
– MSM:
• Consider test of cure after 1 week (by culture or NAAT)
especially if treated with cefixime
• Report suspected treatment failure
Dear Colleague Letter, Dr. Gail Bolan, February 12, 2012
MMWR August 10, 2012
• “CDC no longer recommends cefixime at
any dose as a first-line regimen for
treatment of gonococcal infections.”
• “If Cefixime is used as an alternative
agent, then the patient should return in 1
week for a test-of-cure at the site of
infection.”
MMWR August 10, 2012
• Recommended regimen
– Ceftriaxone 250 mg in a single i.m. dose
PLUS
– Azithromycin 1 g orally in a single dose or
– Doxycycline 100 mg orally twice a day for 7 days
MMWR August 10, 2012
• Alternative regimen (if ceftriaxone is not available)
– Cefixime 400 mg in a single dose
PLUS
– Azithromycin 1 g orally in a single dose or
– Doxycycline 100 mg orally twice a day for 7 days
• Alternative regimen (severe cephalosporin allergy)
– Azithromycin 2 g in a single oral dose
PLUS with both of the above:
• Test-of-cure in 1 week
– NAAT
– Culture ( preferred if failure is suspected)
Expedited Partner Therapy
Expedited Partner Therapy
• Approach whereby partners are treated
without an intervening clinical assessment
– Patients delivering medications to partners
– Patients delivering prescriptions to partners
– Field treatment by DIS or outreach workers (with or
without testing)
EPT Studies
•
Schillinger et al. Sex Transm Dis 2003;30:49-56
– 20% reduction in CT re-infection of 20% among
women (P = 0.102)
•
Golden et al. New Engl J Med 2005;352:676-85
– 73% reduction in GC re-infection among men and
women (P < 0.01)
– 17% reduction in CT re-infection (P = 0.17)
•
Kissinger et al. Clin Infect Dis 2005; 41:623-9
– 46% reduction in GC and/or CT infection among men
with urethritis (P<0.001)
EPT and the STD Treatment
Guidelines
• “….patient delivered therapy (i.e., via
•
•
medications or prescriptions) can prevent
re-infection of index case and has been
associated with a higher likelihood of
partner notification, compared with
unassisted patient referral of partners”
EPT recommendations are limited to GC
and CT contacts only
EPT is not recommended for MSM
CDC 2010 STD Treatment Guidelines
EPT Medications
• Contact to gonorrhea
– Cefixime 400 mg PO x 1
– Azithromycin 1 g PO x 1
• Contact to chlamydia
– Azithromycin 1 g PO x 1
Partner Pack
Chlamydia
Legal Status of EPT
EPT Acceptance DMHC
2006 - 2009
Rate of EPT Acceptance
60%
EMR
Prompt
Initiated
50%
40%
Pilot Pha se
30%
Pha rma cy
R e vie w
20%
10%
Month/Year
Mickiewicz et al. Sex Transm Dis 2012; In Press
8/
09
6/
09
4/
09
2/
09
10
/0
8
12
/0
8
8/
08
6/
08
4/
08
2/
08
10
/0
7
12
/0
7
8/
07
6/
07
4/
07
2/
07
12
/0
6
0%
In the context of decreasing
cefixime susceptibility, is it still
safe to provide EPT for
gonorrhea?
What is the Future for EPT for
Gonorrhea?
• No recommendations have been made thus far (August
•
•
•
•
2012 MMWR does not address EPT)
While cefixime susceptibility appears to be decreasing,
frank resistance has not (yet) been reported in the U.S.
There are important differences in cefixime susceptibility
by region and by sexual preference
Probably safe to continue EPT for gonorrhea among
heterosexuals while monitoring susceptibility and
resistance regionally
Convey message to patients with gonorrhea that the
best option for their partners is to see a health care
provider
Gonorrhea
The Continuing Saga is…..
…well…. Continuing……
Stay Tuned!!!