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Volume No.
XI Issue
No.2 February,
2003
HIV/AIDS Volunteer Enrichment Network
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Volume No.
XI Issue
No.2 February,
2003
HIV/AIDS Volunteer Enrichment Network
|
HIV Report Jan 2003: 2001
Syphilis Rates Show Increase: Does This Portend a New Wave of HIV Infection?
By Emily Erbelding, M.D., M.P.H.
The Centers for Disease Control and Prevention released
their final surveillance summary for 2001 syphilis rates in the U.S. in
November of this year: Primary and secondary syphilis rates rose for the first
time since 1990. Though the overall increase was slight (2.2 cases per 100,000
up from 2.1 per 100,000 in 2000), the increase occurs in the context of a
very aggressive national
syphilis elimination campaign launched in 1999. The national goal of syphilis
elimination is to improve local capacity t respond to every syphilis case so
there is no evidence of sustained transmission after an infectious case is
detected (i.e., no transmission after 90 days of the report of an imported
index case). This goal is numerically comparable to a reduction in the overall
number of primary/secondary syphilis cases to less than 1000 by the year 2005.
There were 6103 total cases of primary/secondary syphilis in 2001.
Historical Summary of U.S. Syphilis
Trends
Syphilis rates in the U.S. are high compared to the rest of
the developed world and have shown cyclical rises and falls over the past
several decades (Figure 1): Syphilis rates were very high in the late 1970s and
early 1980s among gay men – rates declined rapidly in this group during the
early-to-mid 1980s, which was explained by the changes in sexual practices in
this group related to the looming threat of AIDS. In the late1980s there was a
sharp rise in heterosexual transmission of syphilis in cities, associated with
the introduction of crack cocaine and the anonymous exchange of sex for drugs
or money that was a common feature in networks composed of crack users. Since
the early 1990s rates have been steadily declining in the U.S., leading to
optimism that syphilis elimination goals could be met if community-based
prevention activities were intensified through federal funding dedicated to
syphilis elimination.
Analysis of Current Trends
In 2001, rates of syphilis increased 15% among men and
decreased 18% among women; the male: female ratio of syphilis cases increased
50% (from 1.4 to 2.1). Public health surveillance data do not traditionally
include behavioral variables, such as same-sex contact among the men who
are represented among reported syphilis
cases. However, this rising M:F trend,coupled with the explosive outbreaks of
syphilis among men who have sex with other men (MSM) reported in several large
U.S. cities [MMWR 2001; 50:117; MMWR 2002; 51:853] indicates that the rise in
U.S. syphilis rates for 2001 is due to new epidemics of syphilis among MSM.
What Might the Current Situation Mean for
HIV Transmission?
Biologic and epidemiologic data support the concept that untreated syphilis biologically enhances HIV transmission. Data from cities reporting new epidemics of syphilis in the MSM community suggest that an increasing proportion of persons with syphilis are also HIV-infected compared to those diagnosed with syphilis in prior years. Thus, rising rates of syphilis among MSM may be a marker of changes in sexual practices among both
HIV-infected and -uninfected
individuals in this era of HAART and treatment optimism. This may well indicate
increasing HIV transmission in many MSM communities.
What Does This Mean for HIV Treatment
Providers?
The CDC surveillance summary underscores the importance of
maintaining a high level of suspicion
for syphilis. This remains true for all clinicians, but most importantly for
clinicians who treat HIV infected patients. Clinicians should be aware that the
growing connectivity of this information age allows for diverse opportunities
for their patients to meet sex partners
in distant cities or on distant continents: Epidemics of syphilis have been
described among individuals who met in Internet-based chat rooms or through
website postings, so that syphilis epidemics can be
rapidly introduced tomorrow into jurisdictions reporting low
syphilis morbidity today. Providers should also be aware that the clinical manifestations of syphilis may be atypical:
Because oral sex is recognized to be a lower risk activity than other acts with
respect to HIV transmission, clinical presentations such as oral chancres
(appearing first at the site of T. pallidum inoculation) should always trigger
a discussion of sexual risk behavior and serologic testing for syphilis. A
request by a patient for HIV testing should prompt syphilis testing as well,
and conversely, HIV testing should be recommended for any person treated for
syphilis.
Summary
In past decades, rising rates of syphilis have preceded
rising rates of HIV among specific populations. Though intensification of
syphilis control and prevention efforts have markedly reduced syphilis rates in
groups most impacted by syphilis in the past decade, these gains have been
offset by rising rates among MSM. Developing
effective new strategies for education, screening, and risk reduction in the
MSM population will be necessary to meet syphilis elimination goals in the U.S.
Copyright © 1997-2003 The
Johns Hopkins University on behalf of its Division of Infectious Diseases and
AIDS Service. Permission to use and reproduce portions of this newsletter is
hereby granted, provided that author and publication are fully credited and
both the copyright and permission notice appear. All other rights reserved.
Smallpox
Vaccination and HIV Infection
By John G. Bartlett, M.D.
The details of national plans for smallpox vaccination are
somewhat unclear, but are evolving rapidly. It now appears definite that this
vaccine will be given to about 500,000 in the military, and it will probably
also be given to about 500,000 hospital-based health care professionals, who
will comprise a “Smallpox Response Team.” Additional vaccinations will be given
only when the risk is judged to be sufficiently great.The following is a review
of these recommendations as they apply to the patient with HIV infection.
The Vaccine
Smallpox vaccine is vaccinia, a related poxvirus that
has been used for three centuries to prevent smallpox. It is a live virus
vaccine that is 95% effective in preventing smallpox even when given 3-4 days
post-exposure [N Engl J Med 2002;346:1300].
It is the most toxic vaccine used routinely
in the 20th century, due to side effects
that are local (98%), systemic (20-30%),
and potentially lethal (1/million). The normal reaction following vaccination
is development of a pustule at day 3 or 4, formation of a vesicle with intense
surrounding erythema at day 5 or 6, development of a pustule at day 8 or 9,
scab formation at day 12+, and detachment of the scab on day 17 to 21, leaving
a scar. When this sequence of events does not occur, immunity is unlikely to
occur, and revaccination is required. Systemic symptoms occur after about one
week and include fever, malaise, myalgias, local pain, and regional adenopathy.
In the recent trial of 680 previously unvaccinated healthy adults given diluted
and undiluted Dryvax, the currently available product, local reactions
indicating development of immunity occurred in 97-99%, fever in 9%, muscleaches
in 21%, and severe fatigue in 20%. Reactions caused 30% to miss school or work
[N Engl J Med 2002;346:1265].
Severe Reactions
The major severe reactions (Table 1) to smallpox vaccination
are well described in classic studies from the 1960s, when smallpox vaccination
was routine in the U.S. [N Engl J Med 1969;281:1201; J Infect Dis 1970;122:303;
Am J Epidemiol 1971;93:238]. Smallpox vaccination was abandoned in the U.S. in
1972, and the WHO recommended global discontinuation in 1980. Thus, there is
limited experience with this vaccine in the era of HIV, organ transplantation,
and immunosuppressive therapy. Major risks for severe complications identified
in the earlier experience included congenital and acquired immuno-deficiencies,
especially in those with
defective cell-mediated immunity, pregnancy, and skin lesions, especially
eczema. A second issue is “contact vaccinia,” which represents secondary spread
of vaccinia from the site of inoculation of a vaccine recipient to close
contacts. For HIV-infected patients, concerns would include the risk of
progressive vaccinia following vaccination, and the risk of contact vaccinia
with possible progressive disease after close contact with a vaccine recipient,
both of which are discussed below.
Current CDC Recommendations
Definitive plans are speculative, but it appears that the
military will vaccinate 500,000 recruits and hospitals will preemptively
vaccinate health care workers to allow formation of a “smallpox response team,”
which will provide smallpox care for the first 7-10 days of a bioterrorism
attack. Vaccination will be voluntary, and selection of candidates will be at
the discretion of individual hospitals based on perceived need for a
hospital-based “first response team.” There may be preference for those over 30
years of age, since prior vaccination reduces the risk of vaccine reactions.
The total for the U.S. is an estimated 500,000 or an average of about
100/hospital. It should be emphasized that the recommendation is for voluntary vaccination if there are no contraindications,
which includes HIV infection (see below). It is estimated that 23,000 health
care workers have HIV infection [JAMA 2002;288:1901].“Ring vaccination”: This
plan will be executed if there is a need, which would probably be based on
contact with a smallpox case.Contact is
defined as being 6-8 feet from
a person with smallpox during the period of fever (which precedes the rash by
2-3 days) to the scab dislodgement stage. Also included will be close
(household) contacts of case contacts. Here the recommendation is for voluntary
vaccination, even with
contraindications. Justification for this recommendation is based on the
effectiveness of smallpox vaccination (>95%), the vulnerability of the U.S.
population based on absence of routine vaccine for 30 years, the 30% mortality
in immunocompetent persons with smallpox, and the assumption that there would
be a much higher mortality among individuals with compromised cell-mediated
immunity.
CDC-defined Contraindications for
Vaccinees
Persons with the following conditions or with household contacts
with the following conditions should not be vaccinated: Immunodeficiency,
including HIV infection regardless of CD4 count. This category is estimated to
total about 900,000 people in the U.S., including about 300,000 who are unaware
of HIV infection.
HIV Serologic Screening
The CDC is not recommending HIV serologic testing as a
contingency for smallpox vaccination. Instead, the recommendation is to make
all vaccinations voluntary, so that those with HIV infection can simply refuse
vaccination or accept the acknowledged risk. Serologic testing should be made available for those with unknown HIV
status who wish to be tested prior to vaccination. For “Smallpox Response
Teams,” testing could presumably be performed using routine serology, and vaccination
could be offered when the screening EIA test is negative. In more emergent
settings, a rapid test such as SUDS or OraQuick may be preferred to permit
results potentially within 20 minutes. It should be noted that CLIA regulations
require the rapid tests to be interpreted by a CLIA-certified lab technician,
so unnecessary delays may be inevitable.
Progressive Vaccinia
The major risk of smallpox vaccination is “progressive
vaccinia” or “vaccinia necrosum.” The
risk applies to any person with defective cell-mediated immunity, which could
include the estimated 900,000 persons
with HIV infection in the U.S. This complication is characterized by
uncontrolled growth of vaccinia at the site of inoculation, viremia, and generalized infection involving organs and
skin. The skin lesions resemble the primary inoculation site, with continued
circumferential expansion and necrosis. The major risk factor is deficient
cell-mediated immunity, but humoral immunity also plays a role. This
complication should be suspected if the inoculation site fails to show signs of
involution at 2-3 weeks in an immunologically deficient host. Progressive
vaccinia is usually fatal; at autopsy the virus can be recovered from skin
lesions and most organs. This complication can be treated with VIG (vaccinia
immune globulin), which is most useful in patients with less severe immunologic
defects [Am J Med 1972;52:411; Cancer 1977;40:226; Pediatrics 1960;26:176; N
Engl J Med 1969;281:1201]. However, the experience with VIG for treatment of
progressive vaccinia in persons with AIDS is limited to one reported case that
occurred in 1984 [N Engl J Med 1987;316:673], and VIG supplies are currently
limited to a total of 600 doses for the U.S.
The Risk of Progressive Vaccinia With HIV
Infection
There is one case report of progressive vaccinia in a
19-year-old military recruit who received smallpox vaccination in 1984, before HIV serology was available [N Engl J
Med 1987;316:673]. In the review of this experience, it was later estimated
that about 350 other HIV-infected military recruit had received smallpox
vaccination without known complications. Zagury also reported experience with cell immunotherapy using recombinant
vaccinia that resulted in “wide necrosis” at the site of inoculation in 3 of 8
patients; all 3 had CD4 counts <50 cells/mm3 [Lancet 1991;338:695]. The
extensive experience with smallpox vaccination in other compromised host
populations shows that both cellular and humoral immune response contribute to
control of vaccinia, but cellular immunity is more important, and the degree of
impairment dictates risk. Despite sparse experience, these data support what
every HIV provider knows: The risk of this OI is largely dependent on the CD4
cell count. The CDC recommendation is to avoid vaccination in anyone with HIV
infection, due to the limited experience in this population, but the risk is
presumably greatest in patients with a CD4 count <50 cells/mm3 and may be
minimal in those with CD4 counts >200 cells/mm3, though there are obviously
no data to support this supposition.
Contact Vaccinia
Transmission of vaccinia virus to close contacts occurs
during the period of viral shedding from the pustule stage until the scab falls
off. The risk is greatest in “exceptionally close contacts,” which are almost
always household and rarely hospital contacts. The reported rate based on
extensive prior studies was 20-60 per million vaccine recipients [JAMA
2002;288:1901]. Of greatest
concern are patients with active eczema or a history of eczema, since they
account for 15% of the population. Published experience shows that these
patients accounted for the great majority of serious contact vaccinia cases in
the 1960s. No cases of progressive vaccinia were reported as complications of contact
vaccinia in the 1960s, but this preceded the era of HIV, extensive organ
transplantation and aggressive cancer chemotherapy. The risk is greater with
primary vaccination vs revaccination due to the larger amount of shed virus.
The period of shedding has been measured at up to 19 days or until the scab
dislodges [Lancet 1991;337:567]. Based on this experience, the options are to
consider preemptive vaccination to be contraindicated in those with the defects
noted above and in those with close
(household) contacts with these risks. The alternative is separation for three
weeks, which is judged as unrealistic for policy purposes. Eczema is a major
concern
because of the numbers of
people affected, but HIV-infected individuals will also be included in this
category, regardless of CD4 count. For vaccinated health care workers, the
hospital will be given the responsibility of determining policies for
protecting vulnerable patients, using three options: 1) Furlough workers until
the lesions heal. 2) Reassign those who work with vulnerable patients,
including personnel on
AIDS wards. 3) Business as
usual. Most recommend the third strategy, business as usual, although it is
expected that many vaccine recipients will miss about one day of work due to
systemic reactions, and one authority suggests vaccinating around a holiday so the employee would not be working
at the time of maximum viral shedding [JAMA 2002;288:1901].
Conclusions
The anticipated plan is that all smallpox vaccinations in non-military personnel will be voluntary, even after a smallpox attack. The greatest vaccine-related risk for HIV-infected individuals is progressive vaccinia, which is usually lethal.
Copyright © 1997-2003 The Johns Hopkins University on
behalf of its Division of Infectious Diseases and AIDS Service. Permission to
use and reproduce portions of this newsletter is hereby granted, provided that
author and publication are fully credited and both the copyright and permission
notice appear. All other rights reserved.
Bristol-Myers Squibb Submits New Drug Application for Investigational
Protease Inhibitior Atazanavir For Treatment Of HIV Infection
PRINCETON, NEW JERSEY
(December 20, 2002) -- Bristol-Myers Squibb Company (NYSE: BMY) today announced
the submission of a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for atazanavir, an investigational protease inhibitor
under development for the treatment of
HIV/AIDS in combination with other antiretroviral agents.
Atazanavir, currently in Phase III clinical development, is an
azapeptide viral protease inhibitor of HIV-1. It is the first protease
inhibitor to be submitted with pharmacokinetic data supporting the potential
for once-daily administration. The NDA includes data from more than 2,400
patients enrolled in clinical trials comparing atazanavir to widely prescribed
drugs for HIV infection.
"Bristol-Myers Squibb is committed to bringing new treatments to patients
with HIV/AIDS," said Peter R. Dolan, chairman and CEO, Bristol-Myers
Squibb. "Should atazanavir gain FDA approval, the company will be the
first to provide once-daily HIV medications in all three drug classes -- a
testament to Bristol-Myers Squibb's leadership in the development of therapies
that provide a range of treatment options for people in need."
In
the United States, Bristol-Myers Squibb is currently enrolling patients in an
Early Access Program (EAP) to provide
atazanavir to eligible patients infected with HIV. An EAP provides medicines to
patients in need of alternative therapy prior to the medicine's approval. HIV-infected patients who have experienced
treatment failure with other available antiretroviral agents and who require an
alternative antiretroviral agent in order to construct a new treatment regimen
may be eligible to participate in the
EAP. Reasons for treatment failure include a sufficient degree of
antiretroviral resistance, intolerance
or adherence problems. Physicians must use atazanavir in combination with two
or more new or recycled antiretroviral agents. In addition, patients must meet
other protocol-specified eligibility criteria.
Patients may be enrolled in the EAP through physicians only. Physicians may call 1-877-7BMSEAP (1-877-726-7327) or visit http://www.ATVEAP.com for more information about the program.
Need Help With Your SSI Application?
Need help with your SSI application, please call the
Health Department at (410) 244-7108.
Buddy Services
If you are a Buddy
and need to chat, always feel free to call Vance Larson at (410) 672-7571, or
page him at (410) 863-8500.
Anne Arundel County Community Warmline
410 768-5522
Clip this out and carry it with
you in your wallet or purse. Share it
with those who need it. If you have a
friend who says he fears hurting himself or others give him the number. When
it seems like you are at the
end
of your rope, don't
be afraid to ask for help and call the number yourself.
Consumer Advisory Board's meeting
\FEB 11 6-8pm At HAVEN OFFICE
Retreat Dates
QUALITY OF LIFE RETREATS:
Feb 3rd – 6th
at Washington, D.C. Retreat House
May 16th –18 at
Camp Manidokan,
Knoxville, MD.
SAMARITAN MINISTRIES
Feb. 6-9 CoEd
April 13-16 CoEd
June 26- 29 CoEd
August 21-24 CoEd
October 16-19 WOMEN ONLY
November 10-13 MEN ONLY
December 11-14 CoEd
Please apply for a retreat only if you are sincerely
interested in going. Samaritan
Ministries Retreat Director Michael Boteler held 7 places for HAVEN clients at
the last retreat, and none showed up.
If this happens again, he said he will be forced to stop accepting applications
from HAVEN clients.
h.A.v.e.n.
Telephone Numbers
H.A.V.E.N.
P.O. BOX 514
Arnold, Maryland 21012
Office: (410) 224-AIDS [2437]
Fax: (410) 571-9328
Interim President Board of Directors
Steve Migdal
(410) 263-8855
Executive Director
Diane Goforth
(410) 544-2244
Director of Volunteer & Client Services
Tony Teano
(410) 224-2437
Housing Director
Merrell-Ayana Waters
(443) 802-7726
Buddy Program Director
Vance Larson
(410) 672-7571
Anne Arundel County
Health Department
(410) 222-7108
HERO Legal Service
(410) 685-1180
Legal Aid
(410) 263-8330
CDC National AIDS Hotline:
1-800-342-AIDS (342-2437)
Spanish: 1-800-342-SIDA
1-800-342-7432
Deaf TTD: 1-800-AIDS-TTY
1-800-243-7889
National STD (Sexually Transmitted Diseases)
Hotline
1-800-227-8922
National Lesbian & Gay Crisis Line:
1-800-SOS-GAYS
1-800-767-4497
National Runaway Switchboard:
1-800-344-7432
Teens & AIDS Hotline:
1-800-234-TEEN
1-800-8336
Questions About Treatment for HIV Disease?
Call the
HIV/AIDS Treatment Information Service for
federally approved treatment information.
Call:
1-800-HIV-0440
1-800-448-0440
TDD/Deaf Access:
1-800-243-7012
Monday - Friday
9:00 a.m. to 7:00 p.m. EST
All calls are completely
confidential.
Write:
P.O. Box 6063
Rockville, MD 20849-6303
Fax: 1-301-738-6616
Sponsored by the U.S. Public
Health Service
Free Testing
For free, anonymous HIV/AIDS
testing and counseling, call the Anne Arundel County Health Department at:
222-7493
- Annapolis (Riva Road)
222-6633 -
Glen Burnie Health Center
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