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December
2007: VOLUME
1, NUMBER 6
Clinical Topics in Sexually Transmitted Infections
In this Issue...
Sexually transmitted infections (STIs) continue to cause major morbidity throughout the world, including increased acquisition and transmission of the human immunodeficiency virus (HIV). Since 2006, when the Centers for Disease Control and Prevention (CDC) last updated their STI guidelines, there have been several new developments.
In this issue, we highlight current reports on major advances in the field: a vaccine against the most common human papilloma virus (HPV) strains that cause anogenital cancer and warts, the troubling loss of the fluoroquinolone class as first line agents for the treatment of gonorrhea, the resurgence of lymphogranuloma venereum (LGV) among men who have sex with men (MSM), and the continued misuse of diagnostic testing for herpes simplex virus (HSV). |
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Course
Directors
John
G. Bartlett, MD
Professor of Medicine
Department of Medicine
The Johns Hopkins University
School of Medicine
Baltimore, MD
Paul
G. Auwaerter, MD
Associate Professor of Medicine
Clinical Director
Division of Infectious Diseases
The Johns Hopkins University
School of Medicine
Baltimore, MD
Sara
E. Cosgrove, MD, MS
Assistant Professor of Medicine
Division of Infectious Diseases
Director
Antibiotic Management Program
Associate Hospital Epidemiologist
The Johns Hopkins University
School of Medicine
Baltimore, MD |
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GUEST
AUTHOR OF THE MONTH |
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Commentary
& Reviews: |
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Khalil Ghanem, MD
Assistant Professor of Medicine
Associate Fellowship Program Director
Division of Infectious Diseases
Johns Hopkins University School of Medicine
Baltimore, MD |
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Guest
Faculty Disclosures
Khalil Ghanem, MD has disclosed that he serves on the Speakers' Bureau for Merck & Co.
Unlabeled/Unapproved Uses
The author has indicated that his discussion will
include reference to unlabeled / unapproved uses
of pharmaceutical agents or devices.
Program
Directors' Disclosures |
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At
the conclusion of this activity, participants should
be able to:
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Describe
the utility of the quadrivalent HPV vaccine and
identify its target population |
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Discuss
the rise of fluoroquinolone-resistant Neisseria
gonorrhoeae and its therapeutic implications |
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Describe
the clinical characteristics of lymphogranuloma
venereum |
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Identify
the appropriate testing strategy for HSV |
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COMPLETE
THE
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Complete the post-test and course evaluation.
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Print out your certificate.
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Worldwide, HPV is the most prevalent STI and is responsible for genital warts and anogenital cancers. HPV types 6 and 11 cause 90% of genital warts, and types 16 and 18 cause 70% of cervical cancers. In 2006, the FDA approved a quadrivalent HPV vaccine (HPV types 6, 11, 16, and 18) for use in women aged 9 to 26 years for the prevention of genital warts and anogenital cancers caused by these four types. The vaccine contains non-infectious virus-like particles which induce a robust humoral immune response. The papers by the FUTURE II investigators and by Joura et al (reviewed herein) summarize the efficacy of this vaccine in preventing high-grade cervical, vaginal, and vulvar lesions caused by HPV types 16 and 18. The vaccine appears to prevent nearly 100% of high grade lesions due to these types. It has also been shown to prevent 99% of genital warts.1 This vaccine, however, has no therapeutic benefits: a woman infected with HPV 16 prior to vaccination will have the same risk of developing HPV-16 related dysplasia as an unvaccinated woman. She will, however, be protected from infection with HPV types 6, 11, and 18 if she were not previously exposed. A bivalent vaccine only containing types 16 and 18 has shown similar efficacy, and is currently under FDA review for licensure. The use of either vaccine will not replace the need for routine screening using the Papanicolaou (Pap) smear.
There are approximately 350,000 cases of gonorrhea reported annually in the U.S. The treatment and control of gonorrhea has been hindered by the ability of the organism to develop drug resistance. Penicillin resistance developed shortly after its introduction, and tetracycline resistance soon followed. Fluoroquinolones have been used as a mainstay of gonorrhea therapy since the early 1990s, but resistance to fluoroquinolones appeared shortly thereafter, and rates of resistance increased significantly in the Far East, the Middle East, and parts of Africa.2
The CDC updated their sexually transmitted diseases treatment guidelines in 2006.3 In the US at that time, fluoroquinolones were still considered first-line agents for the treatment of gonorrhea - except for infections acquired in California and Hawaii, and infections diagnosed in men who have sex with men (MSM). In 2005, >30% of gonorrhea infections were treated with fluoroquinolones. As described in the review of the Wang paper, rates of fluoroquinolone resistance have been steadily increasing since 1999. Significant increases in fluoroquinolone-resistant strains were detected in 2005 and 2006, which led the CDC to update their 2006 treatment guidelines. The new recommendation is that fluoroquinolones should no longer be used for the treatment of gonorrhea in the US. Currently, the only first-line agents recommended by CDC are the cephalosporins (for uncomplicated gonorrhea, a single 125 mg dose of intramuscular ceftriaxone or a single oral 400mg dose of cefixime are recommended). For penicillin-allergic patients, the treatment of gonorrhea has become much more complicated, given that the only alternate agent recommended by the CDC, spectinomycin, is difficult to obtain after the US manufacturer ceased production of the drug. A single 2g dose of oral azithromycin has excellent activity against uncomplicated gonorrhea and may be used, but the fear of increasing resistance and its gastrointestinal side effects precluded the CDC from listing it as a second-line agent.
Lymphogranuloma venereum (LGV) is a STI caused by Chlamydia
trachomatis serovars L1-L3. It is endemic in tropical
regions and usually presents as a urogenital syndrome
consisting of an ulcer and painful regional lymphadenopathy.
The LGV serovars are more invasive than the C. trachomatis
D-K serovars that are commonly encountered in the US.
Around 2002, an outbreak of LGV occurred in the Netherlands
among MSM4,
with cases spreading to other European countries and
to North America. The largest case series is summarized
in the Ward paper (reviewed herein), which highlights
the clinical manifestations of a recent LGV outbreak
in the United Kingdom. Unlike the classical urogenital
manifestations, the majority of patients in this outbreak
have been HIV-infected MSM presenting with proctitis.
Symptoms included rectal discharge, pain, bleeding,
tenesmus, and constipation. Given that the treatment
of LGV requires at least 21 days of doxycycline for
LGV (compared to a usual 7 day course for non-LGV C.
trachomatis D-K infections), it is imperative that
clinicians not miss this diagnosis.
HSV-2 infects about 25% of the US population. In many
cases it is asymptomatic, and although antivirals are
available, there is no known definitive cure since herpesviruses
establish lifelong latent infection. Culture has been
used to diagnose HSV-2, but sensitivity is very low,
especially when lesions are absent. Serological testing
has been used to diagnose HSV-1 and HSV-2 infections.
Initially, crude antigen-based tests were used, but
as described in the Morrow paper, significant cross-reaction
between HSV-1 and HSV-2 occurs. More recently, glycoprotein-G
based tests have been shown to be more specific in differentiating
HSV-1 from HSV-2 antibodies. These tests are commercially
available (HerpeSelect™ ELISA 1 and 2; HerpeSelect™
Immunoblot 1 and 2; Biokit HSV-2™ or SureVue HSV-2™),
but many clinicians are unaware of their existence,
and many laboratories continue to perform crude antigen-based
tests despite their limitations. Currently, the recommendation
is that only glycoprotein-G based tests should be used
for the serodiagnosis of HSV-1 and 2. Despite this advancement
in serological HSV testing, the study by Mark and colleagues
(reviewed herein) highlights an important limitation
of the glycoprotein-G based tests: in low prevalence
settings the number of false-positive test increases.
Both the limitations and the cost of serological testing
have made the question of who to test a controversial
one. There are no formal recommendations, despite the
attempts by different groups to produce a consensus
statement.5
Clinicians are reminded that the interpretation of any
serological test for HSV depends on the type of test
that is used, and should take into account the pre-test
probability of infection.
References
| 1. |
Barr
E, Tamms G. Quadrivalent
human papillomavirus vaccine. Clin Infect
Dis. 2007; 45(5):609-7. |
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| 2. |
Ghanem
KG, Giles JA, Zenilman JM. Fluoroquinolone-resistant
Neisseria gonorrhoeae: the inevitable
epidemic. Infect Dis Clin North Am.
2005;19(2):351-65. |
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| 3. |
Centers
for Disease Control and Prevention. Sexually
Transmitted Diseases Treatment Guidelines, 2006.
MMWR Morb Mortal Wkly Rep. 2006; 55 (RR#11). |
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| 4. |
Van
der Bij AK, Spaargaren J, Morre SA, et al. Diagnostic
and clinical implications of anorectal lymphogranuloma
venereum in men who have sex with men: a retrospective
case control study. Clin Infect Dis.
2006; 42:186-94. |
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| 5. |
Guerry
SL, Bauer HM, Klausner JD, et al. Recommendations
for the selective use of herpes simplex virus
type 2 serological tests. Clin Infect
Dis. 2005; 40:38-45. |
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A NEW QUADRIVALENT HPV VACCINE FOR THE PREVENTION OF ANOGENITAL LESIONS IN WOMEN |
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Females
United to Unilaterally Reduce Endo/Ectocervical
Disease (FUTURE) II Study Group. Quadrivalent
vaccine against human papillomavirus to
prevent high-grade cervical lesions.
N Engl J Med. 2007; 356(19):1915-27.
(For non-journal subscribers, an additional
fee may apply for full text articles.)
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Joura
EA, Leodolter S, Hernandez-Avila M, et al.
Efficacy of a quadrivalent prophylactic
human papillomavirus (types 6, 11, 16, and
18) L1 virus-like-particle vaccine against
high-grade vulval and vaginal lesions: a
combined analysis of three randomized clinical
trials. Lancet. 2007;
369(9574):1693-702.
(For non-journal subscribers, an additional
fee may apply for full text articles.)
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The
study by the FUTURE II investigators describes
one of the two large, multicenter, randomized
controlled trials evaluating the efficacy of the
quadrivalent (HPV types 16, 18, 6, and 11) HPV
vaccine against high grade cervical lesions. This
impressive study recruited women (N=12,167) between
the ages of 15 and 26 years who had four or fewer
lifetime sexual partners; participants were randomized
to receive 3 doses of the quadrivalent vaccine
at 0, 2, and 6 months, or placebo. The primary
endpoints were the development of cervical intraepithelial
neoplasia (CIN) 2 or 3, adenocarcinoma in-situ,
or invasive cancer related to HPV types 16 and
18. The primary analysis was restricted to the
women who received all three doses of the vaccine
and who did not have virologic evidence of past
or current infection with HPV 16 or 18 (N=10,565)
through month 7 (i.e. one month following the
third dose).
After a mean follow-up time of 3 years, overall
vaccine efficacy based on the primary analysis
was 98%. Over 99% of a subset of women included
in an immunogenicity subgroup analysis seroconverted
following the third dose of the vaccine. After
two years of follow-up, most women (>95%) had
detectable antibody levels to three types of HPV
found in the vaccine. A lower percentage of women
(32%) had undetectable levels to type 18, but
all of these women were still protected against
disease caused by type 18. The investigators also
conducted a population efficacy analysis that
included all women who were randomized and who
received at least 1 dose of the vaccine irrespective
of their baseline HPV status (this analysis provides
short-term information on how efficacious this
vaccine will be in a 'real' population, where
some women may have already been infected with
HPV). The population efficacy against HPV 16-
and 18-related lesions after 4 years of follow-up
was 44%. Vaccine side-effects included fever (10%),
pain (83%), swelling (25%), and erythema (25%)
at the injection site. The vaccine did not appear
to have any therapeutic benefit in women who were
previously infected with the four types contained
in the vaccine. To date, no serious side effects
have been definitively linked to the vaccine.
As this is a relatively new vaccine, long-term
monitoring for side effects is ongoing.
Joura et al analyzed data from the FUTURE II as
well as two other large clinical trials1,2 to
determine the efficacy of the vaccine against
vulvar and vaginal intraepithelial neoplasia grades
2 and 3 associated with HPV 16 and 18 in 18,174
women. The methods were identical to the ones
described above. For the primary analysis, the
vaccine was 100% effective at preventing vaginal
and vulvar lesions. In the intention-to-treat
analysis, it was 71% effective. The intention
to treat analysis is similar to the population
efficacy analysis described above; it includes
women who may have been previously infected with
HPV prior to vaccination as well as women who
may not have completed all three doses of the
vaccine. This analysis provides a better estimate
of how this vaccine will perform in a 'real-life'
setting.
These studies indicate that this vaccine is highly
effective at preventing cervical, vaginal, and
vulvar high-grade lesions associated with HPV-types
16 and 18 as well as low grade lesions and warts
caused by types 6, 11, 16, and 18. They also highlight
the importance of trying to vaccinate women before
their first sexual exposure to maximize vaccine
efficacy. Finally, given the lower population
efficacy, it is important to continue routine
Papanicolaou (Pap) smear testing in all women
irrespective of their vaccination status.
Currently, the quadrivalent vaccine is approved
for use in girls/women ages 9 to 26 years. The
vaccine requires refrigeration. The three doses
are given intramuscularly at 0, 2, and 6 months.
Ideally, it is preferable to try and give all
doses within one year, but if a patient presents
at a later time, the recommendation is to pick
up where you left off, i.e. the whole vaccine
series need not be reinitiated. The vaccine is
labeled category B in pregnancy; it is not recommended
that the vaccine be given to pregnant women because
the relative immunosuppression associated with
pregnancy may limit the efficacy of the vaccine.
Duration of protection is unknown, but after four
years of follow-up, the vaccine-type antibody
levels are still high. There are ongoing studies
to evaluate the efficacy of the vaccine in mid-adult
women (up to the age of 45 years), HIV-infected
women, and men.
References
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THE RISE OF FLUOROQUINOLONE-RESISTANT GONORRHEA AND THE LOSS OF A FIRST-LINE THERAPEUTIC CLASS |
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Wang
SA, Harvey AB, Conner SM, et al. Antimicrobial
resistance for Neisseria gonorrhoeae
in the United States, 1988 to 2003: the spread
of fluoroquinolone resistance. Ann
Intern Med. 2007; 147(2):81-8.
(For non-journal subscribers, an additional
fee may apply for full text articles.) |
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Centers for Disease Control and Prevention. Update to CDC's sexually transmitted diseases treatment guidelines, 2006: fluoroquinolones no longer recommended for treatment of gonococcal infections. MMWR Morb Mortal Wkly Rep. 2007; 13; 56(14):332-6.
(For non-journal subscribers, an additional
fee may apply for full text articles.) |
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Wang
et al recently conducted a 15-year retrospective review
of the Gonococcal Isolate Surveillance Project (GISP)
database and reported on the antimicrobial resistance
trends of Neisseria gonorrhoeae in the United
States. GISP was established in 1986; this network of
25-30 US-based STD clinics collects the first 25 male
gonococcal isolates each month and submits these to
a regional laboratory for antimicrobial susceptibility
testing. The CDC relies on this information to make
therapeutic recommendations.
In this report, based on 82,064 isolates collected from 37 US cities, the investigators found the following trends:
- Ciprofloxacin resistance increased from 0% in
1990 to 4.1% in 2003
- Only 3 isolates had decreased susceptibility to
ceftriaxone
- Azithromycin resistance was low: 0% in 1992, 0.7%
in 1996, and 0.4% in 2003
- Only 5 spectinomycin resistant isolates were identified,
all pre-1995
By 2006, approximately 13% of all GISP isolates were resistant to fluoroquinolones. Based on these data, the CDC issued an update to the 2006 STD Treatment Guidelines. In this update, they no longer recommend the use of fluoroquinolones for the treatment of gonorrhea (and related diseases such as pelvic inflammatory disease). The only remaining first-line treatment options are cephalosporins: intramuscular ceftriaxone and oral cefixime. Alternate agents include other cephalosporins (ceftizoxime, cefoxitin + probenicid, or cefotaxime). For penicillin-allergic patients, the only recommended alternate regimen is intramuscular spectinomycin. Clinicians should note, however, that spectinomycin has reduced activity against oropharyngeal gonorrhea, and is difficult to find in the US, since the manufacturer has discontinued production of the drug. The report mentions that a single 2g dose of azithromycin, although not recommended due to fears of increasing resistance and gastrointestinal intolerance, is effective and may be considered in penicillin-allergic patients.
These studies highlight the emergence and rapid spread
of fluoroquinolone-resistant N. gonorrhoeae,
as well as the ensuing difficulty in treating this infection.
Single-dose fluoroquinolones have been the mainstay
of therapy since 1993. Their therapeutic loss has limited
the options to essentially a single class of antibiotics:
the cephalosporins. Penicillin-allergic patients are
left with very limited CDC-recommended options. |
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THE RESURGENCE OF LYMPHOGRANULOMA VENEREUM AMONG GAY MEN |
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Ward H, Martin I, Macdonald N, et al. Lymphogranuloma venereum in the United Kingdom. Clin Infect Dis. 2007 Jan 1; 44(1):26-32.
(For non-journal subscribers, an additional
fee may apply for full text articles.) |
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Ward
and colleagues report on the largest case series of
LGV, which, since 2005, has emerged as a significant
cause of proctitis among MSM in the United Kingdom.
Similar outbreaks had been reported in the Netherlands
and North America. LGV is caused by C. trachomatis
serogroups L1, L2, and L3. In 2004, an enhanced surveillance
system for LGV was set up which consisted of a reference
laboratory diagnostic service and reporting system.
Clinicians were encouraged to test all MSM who presented
with an inguinal syndrome or proctitis. If the presence
of C. trachomatis was confirmed by the local
laboratory, specimens were forwarded to a reference
laboratory for genotyping.
Several patients were mistakenly treated for inflammatory
bowel disease. The majority of infections were thought
to have been acquired in the United Kingdom.
Until recently, LGV had only been thought of as a "tropical
disease", rarely occurring outside of the developing
world. Unlike the classically described manifestations
that are urogenitally-based (primary ulcers followed
by painful lymphadenopathy, also known as buboes), the
majority of cases reported in the recent outbreak have
been associated with predominantly anorectal symptoms
among MSM who are also likely to be HIV infected. Diagnosis
is based on clinical suspicion and the exclusion of
other etiologies of proctitis, along with C. trachomatis
testing (if available). Lymph node specimen aspirates
may also be tested for C. trachomatis by culture
(not always available), direct immunofluorescence, or
nucleic acid detection. (Clinicians should note that
nucleic acid amplification tests for C. trachomatis
are not FDA-cleared for testing rectal specimens.) Additional
procedures (e.g. genotyping) are required for differentiating
LGV from non-LGV C. trachomatis strains, but
these are not widely available. In the absence of specific
LGV diagnostic testing, if a patient presents with the
typical syndrome, it is appropriate to treat for LGV.
The primary CDC-recommended treatment regimen is oral
doxycycline 100mg twice a day for 21 days. |
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HSV SEROLOGICAL TESTING: ITS USE AND MISUSE |
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Morrow RA, Brown ZA. Common use of inaccurate antibody assays to identify infection status with herpes simplex virus type 2. Am J Obstet Gynecol. 2005 Aug; 193(2):361-2.
(For non-journal subscribers, an additional
fee may apply for full text articles.) |
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Mark HD, Nanda JP, Roberts J, Rompalo A, Melendez JH, Zenilman J. Performance of focus ELISA tests for HSV-1 and HSV-2 antibodies among university students with no history of genital herpes. Sex Transm Dis. 2007 Sep; 34(9):681-5.
(For non-journal subscribers, an additional
fee may apply for full text articles.) |
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Morrow
reports the results of HSV-type specific testing at
172 laboratories that participate in the College of
American Pathologists' test proficiency program. In
this study, each lab received a serum sample known to
be positive for HSV-1 IgG and negative for HSV-2 IgG
antibodies.
Nearly all the laboratories (98%) detected the HSV-1
antibodies, while more than half the laboratories erroneously
detected the presence of HSV-2 antibodies. Ninety-four
laboratories reported the type of test used to detect
HSV-2. Among the laboratories that used a glycoprotein-G
based test, 100% accurately reported the lack of HSV-2
antibodies; when earlier generation HSV serological
tests that contained crude antigen mixtures were used,
up to 84% detected the presence of HSV-2 antibodies.
The poor performance in this survey is thought to be
due to the cross-reactivity of HSV-1 and HSV-2 antigens
when non-glycoprotein-G based tests are used.
Mark and colleagues report the results of a study that
used glycoprotein-G based testing to determine the HSV-1
and HSV-2 serostatus of 100 university students (64%
female; mean age 24.5 years) who reported no history
of genital herpes. The overall seroprevalence of HSV-2
was 3.4% by Western Blot. The sensitivity of the glycoprotein-G
based ELISA was 100%, the specificity was 94.1%, and
the positive predictive value was 37.5%. Low positive
predictive value results reflect frequent false positive
results.
The study by Morrow highlights the fact that serological
testing for HSV-1 and HSV-2 should only be performed
using the more specific glycoprotein-G based tests,
and that crude-antigen based testing should no longer
be performed. The study by Mark indicates a high rate
of false positive test results when glycoprotein-G based
serological testing is performed in a population where
the prevalence of HSV-2 is low. The more specific Western
Blot test is not commercially available: in the US,
a single laboratory in Seattle, Washington performs
this test. If the pre-test probability for HSV-2 infection
is low (e.g., patient asymptomatic, low-risk), it is
probably best not to test. Interpretation of HSV serologies
should take into account both the type of test used
and the pre-test probability of infection.
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At
the conclusion of this activity, participants
should be able to:
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|
Describe
the utility of the quadrivalent HPV vaccine
and identify its target population |
|
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|
Discuss
the rise of fluoroquinolone-resistant Neisseria
gonorrhoeae and its therapeutic implications |
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Describe
the clinical characteristics of lymphogranuloma
venereum |
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Identify
the appropriate testing strategy for HSV |
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The
Office of Continuing Medical Education (CME) at
The Johns Hopkins University School of Medicine
is committed to protect the privacy of its members
and customers. The Johns Hopkins University SOM
CME maintains its Internet site as an information
resource and service for physicians, other health
professionals and the public.
Continuing Medical Education at The Johns Hopkins
University School of Medicine will keep your personal
and credit information confidential when you participate
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will never be given to anyone outside of The Johns
Hopkins University School of Medicine's CME program.
CME collects only the information necessary to
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As
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policy of The Johns Hopkins University School
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relationship a faculty member or a provider has
with the manufacturer(s) of any commercial product(s)
discussed in an educational presentation. The
Program Directors reported the following:
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John
G. Bartlett, MD has disclosed that
he has served on the HIV Advisory Board
for GlaxoSmithKline, Abbott, Bristol-Myers
Squibb, Pfizer and Tibotec. He is also on
the Policy Board for Johnson & Johnson.
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Paul
G. Auwaerter, MD has disclosed
that he has served as a consultant for Novartis,
Pfizer, Ortho-McNeil, Schering-Plough, and
Genzyme. He is on the Speakers' Bureau for
Schering-Plough and has also disclosed that
he is a Stock Shareholder for Johnson &
Johnson. |
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Sara
E. Cosgrove, MD, MS has disclosed
that she has received grants or research
support from Merck and served on the Advisory
Boards for Ortho-McNeil, Cadence Pharmaceuticals,
and Theravance/Astellas. |
Guest
Author Disclosures |
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review the complete prescribing information of
specific drugs or combination of drugs, including
indications, contraindications, warnings and adverse
effects before administering pharmacologic therapy
to patients. |
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2007 JHUSOM and eInfections Review
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