Transcript Introductions

New Directions in STD Testing
and Treatment
Stephanie Cohen, MD, MPH
Medical Director, San Francisco City Clinic
San Francisco Department of Public Health
Ina Park, MD, MS
Chief, Office of Medical and Scientific Affairs
CA Dept of Public Health – STD Control Branch
Development of CDC STD Treatment Guidelines
Answer the “Key
Questions”
Enlistment of
Subject Matter
Experts
Key
Questions
Systematic
Review of
Evidence
Guidelines
Meeting,
April 2013
Background papers
Tables of evidence
Online: www.cdc.gov/std/treatment
Rate the quality
of the evidence
Identify critical gaps
in knowledge
(research agenda)
Write the
Guidelines
document
CDC STD Treatment Guidelines





Authoritative, evidence-based
source for STD clinical
management
Recommended regimens
preferred over alternative
regimens
Alphabetized unless there is a
priority of choice
Available at www.cdc.gov/std
Wall charts, pocket guides, app
STD Screening for Women
Sexually Active adolescents & up to age 25
Routine chlamydia and gonorrhea screening
Others STDs and HIV based on risk
Women over 25 years of age
STD/HIV testing based on risk
Pregnant women
Chlamydia
Gonorrhea (≤ 25 years of age or at-risk)
HIV
Syphilis serology
HepB sAg
Hep C (if high risk)
CDC 2010 STD Tx Guidelines www.cdc.gov/std/treatment
STD Screening for MSM*
Screen at least annually, q 3-6 mos if high risk*
HIV
Syphilis
Urethral GC and CT
Rectal GC and CT (if anal sex)
Pharyngeal GC (if oral sex)
Also screen for:
Hepatitis B (repeat as indicated by risk)
Proposed: HIV+ MSM & anal cancer: Annual digital rectal exam
may be useful, some centers perform anal Pap and HRA for
ASC-US or worse.
* High risk: multiple and/or anonymous partners, drug use, or
high risk partners
CDC 2010 STD Tx Guidelines www.cdc.gov/std/treatment
Hepatitis C screening for HIV+
Proposed : [In HIV-infected men and women] “HCV
antibody tests should be serially monitored, at least yearly
and more frequently depending on local circumstances
(HCV prevalence, incidence, resources, and other factors),
to detect conversion from HCV-antibody-negative to
positive).”
Chlamydia
Chlamydia Treatment
Adolescents and Adults
• New incidence estimates:
▪
2.8 million cases in US annually
• Diagnostic issues:
▪
▪
Self collected rectal swabs for MSM appear as sensitive as clinician
collected swabs
Highly acceptable to patients
• Pharyngeal screening:
▪
▪
Not routinely recommended
If detected, treat with routine CT tx regimens
• Hetero male screening:
▪
Consider in certain venues only (corrections, STD clinics, etc)
Satterwhite et al. STD 2013
Chlamydia Treatment
Adolescents and Adults
Recommended regimens
(non-pregnant):
 Azithromycin 1 g orally in a single
dose
 Doxycycline 100 mg orally twice
daily for 7 days
Recommended regimens
(pregnant*):
Proposed Changes:
Add Doxycycline delayedrelease 200 mg tablet daily x
7 days
 Equally efficacious to generic
doxycycline 100mg BID x 7 days
 Less GI side effect
 More expensive
Azithromycin 1 g orally in a
single dose
Concerns over amoxicillin
use in pregnancy due to
chlamydia persistence in vitro
* Test of cure at 3-4 weeks in pregnancy
 Use only as an “alternative
regimen”
Robert
• 38 yo HIV positive MSM at primary care visit.
• Doing well on atripla, with an undetectable VL
and a CD4 450. No STD symptoms.
• Routine STD screen: Rectal CT NAAT is
positive, treated with Azithromycin 1 g PO x1.
• At his next follow-up visit 3 months later, his
rectal CT NAAT is again positive and he
reports that he has not had any receptive anal
sex since his last visit.
Chlamydia Treatment:
Areas of Clinical Uncertainty
 Observational data suggest azithromycin may be less
effective than doxycycline for anorectal Chlamydia
infection
 Four published studies, 2 abstracts
 Not randomized
 Most single arm or historical cohort as comparator
 Varying times to test of cure
 Low rates of follow-up
Treatment of asymptomatic rectal CT
Author/
Site
Study
% of rectal
population Chlamydia
infections
that were
asx
Regimen
Steedman
2009
Edinburgh
Men and
women
with rectal
CT
MSM with
rectal CT;
London
92/101
(91%)
Azithro 1 g Not
reported
68/78
(87%)
87%
“Apparent”
efficacy
(excluding
possible
repeat
infections)
99%
487/766
(64%)
Doxy 100
BID x 7d
165/487
(34%)
99%
99%
116/125
(93%)
Azithro 1 g 78 days
85/116
(73%)
87%
94%
Elgalib
2011
London
Drummond MSM with
2011
rectal CT;
Sydney
Sydney
Median
Time to
TOC
45 days
% who
Overall
returned efficacy
for TOC
Steedman NM, Int J STD AIDS 2009; Elgalib A, Int J STD AIDS 2011; Drummond F, Int J STD AIDS 2011
Treatment of asymptomatic rectal CT
Author
Study
% of
population infections
that were
asx
Regimen
Median
Time to
TOC
% who
returned
for TOC
Overall
efficacy
Hathorn 2012
Men and
women
with rectal
CT
260/265
(98%)
Cohort 1:
Azithro
(N=89)
Cohort 2:
Doxy
(N=78)
Not
reported
Cohort 1:
47%
Cohort 2:
51%
Azithro: 74% Azihtro
79%
Doxy: 95%
Doxy: 95%
MSM with
rectal CT
83%
Azithro or
Doxy (not
randomized)
14-180 d.
33%
Azithro
38%
Doxy
Azithro: 78% Not
assessed
Doxy: 92%
Men with
rectal CT
Not
reported
Azithro or
Doxy (not
randomized)
180 d.
88%
Azithro
92% Doxy
For rectal CT: Not
Azithro: 84% assessed
Birmingham,
UK
Khosropour
Seattle
Khosropour
(AWARE)
Multiple sites
(US)
Hathorn E, STI 2012; Khosropour CM, Abstract 2013; Khosropour CM, Abstract 2013.
Doxy: 90%
“Apparent
efficacy “
Rectal Chlamydia
• No changes to guidelines proposed
based on these data
• Need RCT
• Some sites using doxycycline as 1st line
treatment for rectal CT
Greg
• 38 yo HIV positive MSM, doing well on atripla,
with an undetectable VL and a CD4 450.
• Presents with rectal discharge and pain with
sex
• Presumptively treated with Ceftriaxone 250 mg
IM x1 and Doxycycline 100 mg PO BID x 7
days for proctitis
• Rectal CT NAAT positive
Proctitis
Recommended:
Consider LGV:
Ceftriaxone 250 mg IM once
PLUS
Doxycycline 100 mg orally
BID x 7 days
5-30% symptomatic
rectal CT (aka CT
proctitis) is LGV
If LGV suspected
Doxycycline 100 mg orally
BID x 3 weeks
Presumptive treatment of LGV for MSM
with proctitis and anorectal chlamydia,
particularly if the patient is HIV-infected
or any of the following symptoms or
signs are present: bloody discharge,
perianal ulcers or mucosal ulcers
Elgalib A, Int J STD AIDS 2011; Hathorn E, STI 2012, Hill Int J STD AIDS 2010, de Vrieze STI 2013.
Non-Gonoccocal Urethritis
(NGU)
Issues discussed:
• >1 WBCs per hpf on urethral gram stain/methylene blue
stain may be sufficient for diagnosis
• M. genitalium is a cause of 15-25% of NGU, no
commercial test yet FDA approved
• Regional differences exist in T. vaginalis prevalence
(testing could be considered in high-prevalence areas)
NGU Treatment
Recommended
• Azithromycin 1 gm PO x
1 dose
OR
• Doxycycline 100 mg PO
BID x 7 days
Alternative
• Erythromycin base 500
mg PO QID x 7 days
• Erythromycin
ethylsuccinate 800 mg
QID x 7 days
• Levofloxacin 500 mg QD
x 7 days
• Ofloxacin 300 mg PO BID
x 7 days
Persistent NGU Treatment
If azithromycin NOT given for 1st episode:
Azithromycin 1 g orally in a single dose
PLUS
Metronidazole 2 g orally in a single dose OR
Tinidazole 2 g orally in a single dose
If azithromycin given for 1st episode:
 Moxifloxacin 400 mg orally qd x 7d
PLUS
Metronidazole 2 g orally in a single dose OR
Tinidazole 2 g orally in a single dose
Mycoplasma Genitalium
• Good evidence for role in urethritis
– 13-41% of men with persistent or recurrent
urethritis have M. gent
• May play role in PID
• No commercially-available test
• Azithromycin appears more effective than doxycycline
for M. genitalium, but efficacy of AZ for M. gent may
be declining (Manhart, CID 2013)
• Ongoing debate about whether it gets its own section
Gonorrhea
Gonorrhea
• New incidence estimates: 820,000 cases in US
annually
• Diagnostic issues:
– Self collected pharyngeal swabs: data look
favorable but not enough data to recommend (less
data than rectal)
– Self collected rectal swabs (language similar to CT)
Satterwhite et al. STD 2013
Evolution of Criteria for GC Treatment
Recommendations

Antimicrobial resistance surveillance has guided treatment
decisions (GISP, GASP)
 Change in antimicrobial if resistance prevalence >5%

(MMWR 1987)
GC treatment efficacy
 >95% and 95% CI lower bound 95% (Moran, 1995)

Pharmacokinetic/pharmacodynamic factors
 Serum concentration at least 4x MIC90 x 10 hr after peak
(Jaffe1987)
 At least twice the minimum efficacious dose

Other factors
 Mechanism of action
 Side effects and safety
 Cost
Alternative Treatment Approaches Until
Newer Agents Available




Increase dose or duration of cephalosporin
Antimicrobial susceptibility profile directed
therapy
Antibiotic cycling
Dual therapy
CDC Treatment Recommendations for
Gonococcal Infections 2012
• Ceftriaxone 250 mg IM x 1
PLUS
• Azithromycin 1 g po x 1 OR
• Doxycycline 100 mg po BID x 7 days
Alternatives
• If ceftriaxone not available or for expedited
partner therapy (EPT): Dual therapy with cefixime
(cefixime PLUS azithro or doxy)
• If cephalosporin allergy: Azithromycin 2 g po x 1
PLUS Test of cure if alternative regimen used
CDC Treatment Recommendations for
Gonococcal Infections
(under consideration)
• Ceftriaxone 250 mg IM x 1
PLUS
• Azithromycin 1 g po x 1 OR
• Doxycycline 100 mg po BID x 7 days
Alternatives
2014
• If ceftriaxone not available or for expedited partner
therapy (EPT): Dual therapy with cefixime (cefixime PLUS
azithro) or doxy
• If cephalosporin allergy: Azithromycin 2 g po x 1
• Gentamicin (240mg IM or 5 mg/kg IM) /azithro 2 g PO or
gemifloxacin 320 mg PO /azithro 2 g PO
TOC if alternative regimen used for pharyngeal GC at ~14 days
GC Treatment:
Areas of Clinical Uncertainty
No clinical data to support
increasing dose of either
ceftriaxone or azithromycin
• Higher ceftriaxone and/or
azithromycin doses
recommended outside U.S. (UK,
Japan, etc.)
• Ceftriaxone in vitro susceptibility
(MIC50 and MIC90) and clinical
efficacy data in U.S. stable
• Ceftriaxone Rx failures rare, all
outside U.S.
• Azithromycin 1g
effectiveness meets lower
CI >95% threshold
• Azithromycin resistance
remains low, but can
develop quickly
• When to get a TOC and
optimal time to TOC still
unclear
GC Dual Treatment Study
• Randomized, open-label, non-comparative trial
• 401 men and women 15 – 60 years with uncomplicated
urogenital gonorrhea (culture-positive)
• Treatment with either:
Regimen
Efficacy
Gentamicin 240 mg IM + azithromycin 2 g
100% (lower 95%CI: 98.5%)
Gemifloxacin 320 mg PO + azithromycin 2 g
99.5% (lower 95%CI: 97.6%)
• Both combinations were highly effective for treatment of
urogenital GC
CT/GC Partner
Treatment
CT/GC Partner Management Options
 Partner notification
• Patient directly notifies partner
• 3rd party (provider or health department)
• Internet-based anonymous notification
 Partner treatment
• Have patient bring partner to clinic for concurrent
treatment (CPPT)
• Expedited Partner Treatment (EPT)
• Patient-delivered partner treatment (PDPT)
• Health department field-delivered treatment
• Pharmacy-based
Percent of Partners Treated
Percent of Partners Treated by Partner Management
Strategy, California FP Clinics, 2005-2006
100
79
80
60
77
53
40
40
12
20
0
Overall
CPPT
(n=131)
PDPT
(n=193)
Yu Y-Y, STD 2011
Patient
Referral
(n=521)
None (n=93)
The Effectiveness of Expedited Partner
Treatment on Re-Infection Rates
20%
GONORRHEA
CHLAMYDIA
P=.02
P=.17
15%
10%
5%
13%
11%
11%
3%
0%
Usual Care
EPT
Usual Care
EPT
Golden M, et al. N Engl J Med 2005 Feb 17;352(7):676-85.
Partner Management: Key Points
• Clinical evaluation first-line option
• Concurrent patient-partner therapy is feasible and
effective for many clients
• PDPT is still a second-line option
– Safe and effective at reducing reinfection for GC
– Dual therapy (cefixime 400 mg + azithromycin 1 g) is
crucial if PDPT is offered
Proposed: CPPT may be added as recommended strategy
Offer PDPT routinely to heterosexual pts with
CT/GC if partner cannot be promptly treated
Partner Management:
Areas of Clinical Uncertainty
• PDPT for gonorrhea in current era
– Cefixime plus azithro still recommended
• PDPT for MSM – remains an area of
controversy
– Harm reduction approach
– Risks:
• Missed opportunities for HIV and syphilis
screening
• Undiagnosed pharyngeal GC
Re-testing for Repeat Infection
• Repeat infections are extremely common
• Dangerous – exponential increase in PID risk
• All patients with CT, GC or syphilis should be
retested ~ 3 months after initial treatment
• Retesting should occur whenever patient
returns to clinic (regardless of reason for visit),
anytime within 1-12 months post treatment
Syphilis
New incidence estimates: 55,000 cases annually
Areas of Clinical Uncertainty
 Role of reverse screening algorithm (starting with EIA
instead of RPR)
 Unclear if EIAs are more sensitive for early syphilis
than RPR
 Serologic response after treatment
 17-21% patients with early syphilis with not achieve
a four-fold decline in nontrep titer at 6-12 months
 Neurosyphilis case definition
Screening with Treponemal
Immunoassay
Negative
EIA or
CIA
Positive
Non-trep test (RPR)
Not
Syphilis
Positive
Negative
2nd Trep Test
Negative
1) Unconfirmed EIA
Unlikely syphilis; if pt at risk
retest in 1 month
Syphilis
(past or present)
Positive
1) Past Syphilis
2) Early Syphilis
APHL-CDC Consultation Report, 1/2009
MMWR 2011/Vol 60 (5)
Syphilis Treatment
Primary, Secondary & Early Latent:
Benzathine penicillin G 2.4 million units IM in a single
dose
Late Latent and Unknown Duration:
Benzathine Penicillin G 7.2 million units total, given as
3 doses of 2.4 million units each at 1 week intervals
Neurosyphilis:
Aqueous Crystalline Penicillin G 18-24 million units IV
daily administered as 3-4 million IV q 4 hr for 10 -14 d
Only one dose of PCN Is recommended for early syphilis in
HIV-infected persons, extra doses not needed
Syphilis Treatment
Primary, Secondary & Early Latent
Alternatives (non-pregnant penicillin-allergic adults):
Doxycycline 100 mg po bid x 2 weeks
Tetracycline 500 mg po qid x 2 weeks
Ceftriaxone 1 g IV (or IM) qd x 10-14 d
If penicillin or doxycycline not feasible, consider:
Azithromycin 2 g po in a single dose*
* Do NOT use azithromycin in MSM or pregnant women
In pregnancy, benzathine penicillin is the only
recommended therapy. No alternatives
Jeremy
• 26 yr old HIV-positive MSM, on stable cART
regimen for 2 years, VL ND
• Regularly screened for syphilis and other
STDs q 6 months, all neg x 2 yrs
– 6/2008- EIA +, RPR-, TP-PA – No symptoms and signs of syphilis
– MD recommends retesting in a month
Jeremy..continued
•
•
•
•
•
•
Returned 6 months later
EIA +, RPR +, titer 1:16
No current symptoms or signs of syphilis
Denies interim symptoms/signs
Dx with Early Latent Syphilis
PCN-allergic (rash), treated with doxycycline
Jeremy’s Serologic Titers
• 12/1/08 titer: 1:16
• 3/25/09 titer: 1:8
• 6/5/09 titer: 1:8
Treatment
Six-month F/u
Jeremy: Elevated Titers
• What option would you choose for this
patient
– LP to rule out neurosyphilis as reason for
lack in 4-fold decline in titer
– Repeat treatment with benzathine penicillin
G x 3 weekly doses, consider LP in 6
months if titer still unchanged
– Continue to follow serologic titers
**Talk to him and assess risk of reinfection**
Jeremy: Subsequent Follow-up
•
•
•
•
12/1/08 titer: 1:16
3/09 titer: 1:8
6/09 titer: 1:8
12/09 titer: NR
Treatment
One-year F/u
Genital Herpes
• New prevalence and incidence estimates:
– 48.5 million currently infected
– 776,000 new infections per year
• Diagnosis: Currently culture and serology
• Proposed: NAATS are most sensitive and increasingly
available
• Treatment: No changes proposed
• Prevention: Suppressive anti HSV therapy in
HIV/HSV-2 co-infected patients does not reduce risk of
HIV transmission
This is genital herpes…
This is not: Primary Syphilis and HIV+
Presentation mimicking HSV, multiple ulcers
San Francisco City Clinic
Photos courtesy of Joe Engelman, MD, SF City Clinic
HSV-1 and Genital Herpes
• Among MSM <28 yrs of age in Australia, 76% of cases
of first episode anogenital herpes in 2004-2006 were
due to HSV-1 (up from 17% in 1992-94)
• Among MSM in Paris, receptive anilingus was
associated with 6 fold increased odds of anogenital
HSV-1
• University setting; 78% of cases first episode genital
herpes due to HSV-1
• Whether genital HSV-1 is associated with same
increased risk of HIV acquisition as HSV-2 is unknown
Ryder et al STI 2009; 85 (416)
Janier et al Int J STD AIDS 2006; 17
Roberts et al STD 2003; 30 (10)
HSV Acquisition among Women Aged 18-30 in
the Control Arm of the Herpevac trial
Included subjects
n=3438
No disease suspected
Suspected Disease
N=3196
n=242
Not infected
n=3075
HSV-1
n=92
HSV-2
n=29
Not infected
n=180
HSV-1
n=35
HSV-2
n=27
HSV-1 infection rate > 2x the HSV-2 infection rate
(2.5 vs 1.1 per 100 person-years)
Bernstein, Clin Infect Dis 2013:56
HSV NAATs more sensitive than culture
• N=508 participants with anogenital lesions at STD and
family planning clinics
– 260 HSV-2 and 73 HSV-1 infections identified
• Tested with HSV NAAT (BD ProbeTec Qx) culture,
PCR (quantitative viral load)
Method
Culture
HSV Qx
PCR
Sensitivity
79.7 ±1.9
100.0
100.0
Specificity
98.9 ±1.9
98.3 ± 0.6
97.0 ±0.8
Van der Pol, B JCM 2012: 55
Genital Herpes Treatment, HIV+
Initial or Recurrent lesions
(5-14 days)
Acyclovir
400 mg po TID
Suppression
400 po BID
Famciclovir 500 mg po BID
500 mg po BID
Valacyclovir
500 mg po BID
1 g po BID
Famciclovir less effective for suppression of shedding
Suppression can continue indefinitely without regard to CD4
improvement
CDC/IDSA/HIVMA/NIH Adult Opportunistic Infection Guidelines, 2012
More potent antivirals needed to
completely suppress HSV shedding
• N=90 HSV+, HIV-negative participants,
Swabs of genitals for PCR 4 times a day to look for
shedding
Regimens compared:
• No meds vs Acyclovir 400mg BID
• Valacyclovir 500 mg Daily vs Acyclovir 800mg TID
• Valacyclovir 500 mg Daily vs Valacyclovir 1 gm TID
Outcome: Short bursts of subclinical HSV detected even during
high-dose anti-herpes RX
Johnston C et al. Lancet 2012
Human Papillomavirus
New prevalence and incidence estimates:
79 million people currently infected
14 million new infections annually
Genital Wart Management
Podophyllin resin 10-25% moved to “alternative therapy” for
genital warts
Case reports of adverse effects with misuse
Case reports of inflammatory responses to imiquimod
Worsened inflammatory or autoimmune skin disease such
as psoriasis, vitiligo, and lichenoid dermatoses
Additional FDA approved formulation of imiquimod
3.75 % cream applied daily
Satterwhite STD 2013
Sharon
• 38 yr old G2P1
• Presents to early care HIV-clinic for intake visit, was
diagnosed 2 months ago
• Not currently taking antiretroviral medications
• No history of HPV-related disease, no prior abnormal Paps
Cervical Cancer Screening Guidelines,
Average Risk Women (not HIV infected)
Age Group
Screening Recommendation
< 21
21-29
DO NOT SCREEN
Cytology q 3 years*
DO NOT USE HPV co-testing
30-65
Cytology q 3 years* OR
Cytology + HPV cotest q 5 years*
> 65
Discontinue if adequate prior screening
& not at high risk
Hysterectomy for Do not screen
benign reasons
* Screening intervals reduced with h/o high grade disease, DES
exposure, immunosuppression/HIV
USPSTF March 2012
ACS/ASCCP/ACIP March 2012
Screening in Special Populations-HIV+,
immunocompromised
• Consider starting 1 year after sexual debut, regardless
of age
• Cytology alone q 6 months for the first year
• If cytology negative, continue annual screening for life
• If cytology abnormal-follow ASCCP guidelines
.
– EXCEPTION: Do not use HPV tests to follow-up abnormal
cytology in HIV-infected women
– High prevalence of oncogenic HPV among HIV-positive
women limits utility of HPV testing
CDC/NIH/HIVMA/IDSA 2012 Guidelines for Prevention & Treatment of Opportunistic Infections
*NEW* Cervical Abnormalities
Management Algorithms -- ONLINE
www.asccp.org
ACIP HPV Vaccine Recommendations*
Population
Gender
Recommendation
Age
All Females
11-26
(as young
as 9)
Routine vaccination with either
HPV4 or HPV2
All Males
11-21
(as young
as 9)
Routine vaccination with HPV4
22-26
Permissive recommendation HPV 4
22-26
Routine vaccination with HPV 4
MSM and
HIV+ Males
* Irrespective of history of abnormal Pap, HPV, genital warts
MMWR, May 28 2010; 59(20):626-629 , 630-632
MMWR , December 23 2011; 60(50);1705-1708
Trichomonas
• Incidence estimates: 1 million new infections
• Prevalence: 3% nationwide, 10% African American
women, 20-30% among incarcerated women
Proposed:
• Retesting recommended 3 months after treatment
• Consider screening those at high risk for infection or
negative sequelae (receiving care in corrections or STD
clinic settings)
Management of TV with HIV coinfection
HIV-infected women should receive periodic
screening for TV including at entry to care and
annually
HIV-infected, pregnant women should be screened
for TV, ? at mid-gestation
HIV-infected women diagnosed with TV should
receive metronidazole 500mg BID for 7 days to
improve cure rates
HIV-infected women with TV randomized to
7 days of metronidazole 500mg BID (vs. 2g
once) had less TV at TOC and at 3 months
RR 0.46,
CI:0.21–0.98
(Kissinger,
2010)
HIV/STD Prevention
Slides courtesy of Susan Philip, MD, MPH
Advances in HIV Prevention
HPTN 052
• Among
serodiscordant
couples, treating HIV
positive partner
decreases
transmission risk by
96%
PrEP
• iPrEX, Partners
PrEP, TDF-2, Thai
IDU Study
Proposed: Antiretroviral treatment should be
offered to HIV-infected persons not only to
provide benefit to individual health but also to
reduce transmission to sex partners.
Proposed: HIV Pre-Exposure Prophylaxis
should be available to sexually active MSM and
to adults at high risk of HIV infection per the
current CDC recommendations. All clients
requesting PrEP should be counseled that high
levels of adherence are needed for the best
efficacy.
Post-Exposure Prophylaxis of STDs, HIV
and Unintended Pregnancy
Emergency Contraception
– Plan B One Step – 1.50mg levonorgestrel as a single
dose approved for sale OTC with no age restrictions
– Next Choice – 2 tablets of 0.75mg levonorgestrel taken
12 hours apart
– Ella (FDA approved 2010) – 30mg ulipristal acetate as
a single dose after two clinical trials demonstrated it
was safe and effective (Glasier 2010)(Fine 2010)
• A recent Cochrane review concluded that the copper IUD
was the most effective emergency contraceptive and only
one that provides ongoing contraception (Cheng 2012)
STD/HIV Prevention Counseling
Project AWARE
• RCT of 5012 clients in STD clinics in the US
• Brief client-centered HIV risk-reduction counseling
vs. information only
• Outcome: STIs and HIV positivity at 6 mo f/u
• No difference in STI incidence by study arm
(aRR = 1.12; 95% CI 0.95-1.33).
• In MSM, 99/529 (18.7%) incident STI in
counseling arm vs. 68/545 (12.5%) in info only
arm (aRR = 1.48, 95% CI 1.04, 2.10).
(Metsch, JAMA in press
HIV Seroadaptation
• Community originated strategy for HIV prevention
• Predicated on knowledge of self and partner HIV-infection
status.
• Serosorting:
– Choosing sex partners of the same HIV-infection status
– Choosing to selectively use condoms only with HIV
serodiscordant partners
– Viral load serosorting
• Seropositioning: HIV-infected individual is the receptive
partner for anal intercourse.
HIV Seroadaptation and HIV risk
• In most studies, serosorting assoc with
decreased HIV risk c/w no seroadaptive
behavior (OR 0.26-0.88)
• In one study, serosorting NOT assoc with
decreased HIV risk for AA MSM
• No data to support seropositioning for
HIV risk reduction
Phillip 2010, Vallabhaneni 2012, Golden 2012
HIV Seroadaptation and STD risk
• Observational study in MSM: Serosorting associated with
early syphilis and urogenital or rectal gonorrhea or
chlamydia (aPR 2.51; 95% CI 1.79-3.51) (Hotton 2012).
• Heath in Men cohort of HIV-uninfected MSM in Australia:
– Seroconcordant UAI vs. no UAI:
Increased risk of urethral (aHR 1.97; 95% CI 1.432.72) and anal Chlamydia (aHR 1.62; 95% CI 1.112.36)
– Seroconcordant UAI vs. Serodiscordant UAI:
Reduced risk of syphilis (aHR 0.21; 95% CI 0.05-0.81)
and urethral gonorrhea (aHR 0.61; 95% CI 0.39-0.96).
(Jin 2012)
HIV Seroadaptation
Discussed:
Providers should counsel HIV-uninfected MSM
patients that seroadaptive strategies, including
serosorting and seropositioning have shown some
efficacy as an HIV risk reduction strategy but are not fully
protective. However, these strategies do increase the risk
of STD transmission and therefore are not a best practice
to maintain overall sexual health.
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Parking lot
What is the maximum time allowed
between Bicillin doses?
• Clinical experience suggests 10-14 days ok for nonpregnant adults
• <9 days is best based on limited pharmacologic
data
• In pregnancy, must adhere to strict 7 days between
doses
• 40% of pregnant women are below treponemicidal
levels after 9 days
• If a dose is missed, the entire series must be
restarted