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Post-Exposure Prevention (PEP); What to Do If the Condom Breaks?
by John S. James
When healthcare workers have serious exposure to HIV (through
a needlestick, for example), they are likely to be started on
a two- or three-drug regimen within hours (within two hours
if possible), and continue taking the drugs for four weeks.
The U.S. Centers for Disease Control and Prevention (CDC) has
published guidelines recommending this preventive care, since
observational studies had suggested (although not proved)
that use of AZT alone reduced the risk of HIV infection by
about four fifths.
But the guidelines say nothing about preventing HIV infection
after exposure through sexual contact, or through needle
sharing by injection drug users, even though the risk is
biologically similar. Programs are now beginning in a few
areas (including San Francisco) to provide such treatment,
together with counseling and other services which may be
needed (for example, hepatitis B and C testing, and hepatitis
B vaccination). In other areas where there are no programs,
the same drugs can be prescribed by any doctor, since they
are FDA approved and commercially available; however, at this
time few doctors know about preventive treatment after sexual
exposure.
Treatment must start as soon as possible after the incident.
Many experts believe that after 72 hours it is too late,
since the virus will already be integrated into human cells.
In practice it is difficult to get into treatment within 72
hours after an accidental exposure -- especially if those
exposed, and friends or associates they turn to for advice,
do not know ahead of time that such treatment is available,
and do not know how to contact a program or doctor who can
provide it.
Fortunately this preventive treatment lasts only for four
weeks and then the drugs are stopped. Therefore it does not
involve a commitment to long-term antiretroviral use. The PEP
programs include counseling to help people reduce the risk of
further exposures.
In San Francisco alone, it is estimated that 600 to 800
people become HIV-positive each year. Hopefully, post-exposure prevention can be one part of the efforts to prevent
these infections.
In or Near San Francisco
In the San Francisco area (if you live close enough that you
can come in for repeated visits), you can join a local
research program for non-occupational exposure; it pays for
the drugs, tests, and other expenses, and provides counseling
and certain other services as needed. You will be encouraged
to give your real name, but if that is a problem, the staff
will accept whatever name you give. There is no placebo, and
you can stay in this program to benefit from the testing,
etc., even if you choose not to take the drugs. The drugs are
used for four weeks, and then there are occasional visits for
followup blood tests. The entire program lasts one year, and
includes nine visits to the research clinic.
If you live in or near San Francisco and have been
accidentally exposed to HIV, call the research program
hotline number, 415-514-4PEP, 24 hours a day (the previous
number, 415-502-5PEP, will also work; the new one may be
easier to remember). You may need to leave a phone number for
a return call, which you will probably receive within half an
hour. Or you can drop in at the PEP site, during certain
hours, at either of two locations: San Francisco General
Hospital Ward 4C, or the City Clinic on 7th Street between
Harrison and Folsom. No appointment is needed, but call the
number above to check when the clinics are open. Do not wait
for open hours; use the telephone hotline so that if you are
found to need treatment, it can be started immediately.
Other Locations
If exposed to HIV, you need to locate either a PEP program,
or a PEP-knowledgeable physician. Unfortunately there is no
national list of programs. A local AIDS service organization
may be able to help; you can find one in your area by calling
the National AIDS Hotline, 800-342-AIDS, 24 hours a day. (For
a Spanish-speaking operator, call 800-344-SIDA, 8 a.m. to 2
a.m. Eastern time; for TTY, call 800-243-7889, 10 a.m. to 10
p.m. Monday through Friday Eastern time.)
Who Is Likely to Need Treatment?
Here are some of the guidelines used by the PEP program in
San Francisco to decide who may benefit from drug treatment.
Other PEP programs, or private physicians experienced with
PEP, are likely to use similar criteria.
There must be a "significant" sexual or injection drug use
exposure. "A significant sexual exposure is when a person has
receptive or penetrative anal intercourse, receptive or
penetrative vaginal intercourse or receptive oral intercourse
with ejaculation. Significant sexual exposures are always
without a condom (or when the condom breaks) and with someone
who is HIV infected. Since it is not always possible to know
if the person you are having sex with is HIV infected, PEP
should be offered to anyone who has had a significant sexual
exposure with a 'high risk' partner. High risk partners are
men who have had sex with men, anyone with a history of
injection drug use, sex workers, and anonymous partners."
(Quoted from Twenty Top Questions and Answers About PEP; to
obtain this document, see "For More Information," below.)
What Treatment Is Used?
Most people are treated with AZT plus 3TC for four weeks. The
drugs are combined into a single tablet (called
Combivir™); the adult dose is one tablet, taken twice a
day.
The San Francisco program also offers an alternative of ddI
and d4T, for those who do not want to take AZT, or when the
alternative is indicated by the partner's treatment history.
If it is suspected from clinical history that the patient's
partner may have drug-resistant HIV, then a third
antiretroviral may be added -- the protease inhibitor
nelfinavir.
Besides the antiretrovirals, the program includes counseling
on risk reduction, testing for sexually-transmitted diseases
and treatment if necessary, hepatitis B and C screening and
hepatitis B vaccination or referral, and pregnancy testing.
(Pregnant women are allowed to enter the program and use the
antiretroviral drugs.)
What Has Been Learned So Far?
At this time about 150 people have been treated; no one has
become HIV positive. Since the risk from a single exposure is
fairly small, this could have happened by chance.
There has been no serious toxicity of the medications, and
over 80% of the volunteers have completed the full four weeks
of treatment.
One of the concerns of the program -- that people would take
more risks because of it -- is too early to evaluate with the
short follow-up so far.
Several documents about post-exposure prevention, and the San
Francisco program in particular, are available on the Web.
The most important are:
"Twenty Top Questions and Answers about PEP." At
http://hivinsite.ucsf.edu/topics, select "Post Exposure
Prevention" in the list of topics, then select "PEP: The San
Francisco Feasibility Study," then select "Top Twenty
Questions..." Many other documents about PEP, and the San
Francisco study of non-occupational exposure, are also
available on this site.
"San Francisco PEP Update: What Happens," by Bill Snow and
Larry Hanbrook, ACT UP/Golden Gate Writers' Pool, published
in Bay Area Reporter, April 2, 1998. Go to
http://www.actupgg.org, select "Writers' Pool articles,"
select "1998," then select the article, in the list which is
sorted by date. (Note: The organization of this site, and the
other sites also, may change in the future.)
Background on PEP for occupational exposure to HIV and
other blood-borne illnesses can be found at http://epi-center.ucsf.edu.
The government guidelines for occupational exposure (Public
Health Service Guidelines for the Management of Health-Care
Worker Exposures to HIV and Recommendations for Postexposure
Prophylaxsis) can be found at many Web sites; the document has
been translated into convenient Web format (to avoid a
separate download step) at http://www.healthcg.com/hiv
(select "Guidelines"). As of this writing, the current
version was published May 15, 1998.
New Drug Pricing Consensus Letter, Sign-Ons Requested
Treatment activists are circulating a letter on new-drug
pricing -- especially regarding abacavir (Ziagen™) and
efavirenz (Sustiva™), which are likely to be approved
soon. This consensus statement, to be signed by organizations
and individuals, addresses concerns that the new drugs may be
priced significantly higher than others in the same class
(nucleoside analogs, and non-nucleoside reverse transcriptase
inhibitors, respectively).
The statement notes:
The longer survival of patients today allows manufacturers
to charge lower prices and still have a healthy profit and
incentive for further research;
Abacavir and efavirenz will be used by both treatment naive
and treatment experienced patients, making the potential
market very large;
Both the development and production costs of these drugs
appear to be much lower than for the protease inhibitors;
Because patients are using more drugs today, the overall
decrease in the cost of HIV therapy could be reversed if
prices are set too high;
State ADAP drug-assistance programs often face bankruptcy
before the end of their fiscal year and must stop providing
vital drugs; both ADAP and Medicaid programs are under close
scrutiny to cut costs; and HMOs are also starting to restrict
drugs because of the expense.
Exploitative pricing will trigger widespread hostility,
contentious debate, and closer scrutiny of industry practices
in general.
This consensus letter is sponsored by the Fair Price Working
Group, which currently includes Martin Delaney of Project
Inform, Bill Bahlman of ACT UP/New York, Ron Baker of San
Francisco AIDS Foundation, Dave Gilden of GMHC Treatment
Issues, Linda Grinberg of the Foundation for AIDS and Immune
Research, and John S. James of AIDS Treatment News. To obtain
the full statement, or to sign for your organization or as an
individual, contact Linda Grinberg by email at
linda_grinberg@prodigy.com, by fax at 310-471-4565, or by voicemail at 310-471-4108.
Hepatitis C: New Treatment Overview
by Jeffery Stoia
Hepatitis C -- called the silent epidemic -- affects 4 million
Americans and as many as 40% of persons with HIV disease. It
is the number one reason for liver transplants in the U.S.
Only one out of four people with the disease know they have
it.
Until June of this year, only one drug, ineffective and
expensive, had been approved by the FDA to treat hepatitis C
(HCV). That was alpha interferon. At best it was said to
produce a long-term remission rate of 5% in relapsed
hepatitis C patients. Side effects included fatigue, joint
pains, fever, anxiety, and severe depression. According to
the HCV Global Foundation, interferon was considered for
people with HCV and HIV co-infection only if their HIV was
well controlled.
On June 3, 1998 the picture changed when the FDA approved a
second therapy. This was Schering-Plough Corporation's
REBETRON™, which combines in a single "bundled" package
alpha interferon for injection, and oral doses of ribavirin.
Ribavirin, a synthetic nucleoside, has been approved
throughout the world as a broad-spectrum antiviral but has
been stalled in the U.S. because of questions concerning its
potential usefulness in treating HIV. Its chief side effect
is anemia. (Ribavirin is now also called REBETOL®, which is
a brand name of Schering-Plough, which recently acquired
worldwide rights to the drug from its developer, ICN
Pharmaceuticals.)
In approving the new combination therapy, the FDA labeled it
as indicated only for patients who had "relapsed" following
interferon alone. (This may change soon; Schering-Plough has
submitted a supplemental new drug application to the FDA for
the treatment of naive patients, and the new application is
currently under priority review.) For relapsed patients, the
cure rate climbed sharply with the combination ("cure"
defined as undetectable HCV virus, even after therapy has
ended). In two major clinical studies, patients given
interferon plus placebo had a cure rate of 5%, while those
given interferon plus ribavirin achieved a rate of 46%. The
usual length of the two-drug treatment is six months.
Meanwhile, Schering-Plough, which markets the bundled drugs,
was sharply criticized from several quarters. Some saw
Amgen's brand of interferon as more effective than
Schering's, but hard to prescribe because of the way the two
drugs were packaged and sold together. Some pointed to the
unfair monopolistic advantage Schering-Plough had received
with the FDA decision. Others objected to patient
restrictions and to drug "bundling" in a single package which
sells for as much as $1440 a month, nearly double the cost of
interferon treatment alone. One protester wrote, "This is as
absurd as the notion that aspirin would need separate
approvals when used in conjunction with each possible kind of
antibiotic on the market."
Robert Consalvo, on behalf of the drug company, pointed out
that in controlled clinical studies, the combination of
INTRON® A (Schering-Plough's alpha interferon) and
ribavirin demonstrated a significant improvement over
standard monotherapy -- and that Schering is supplying the
product free to many research volunteers. "Both alpha
interferon and ribavirin have known side effects," he added,
"but no synergistic toxicity was seen in clinical studies
with REBETRON."
HCV is a blood-borne virus. Testing is all-important, and
patients usually need to take the initiative to be tested.
The virus tends to progress slowly and insidiously over 20 to
30 years, so that until they reach an advanced, chronic
stage, as many as 75% of infected people are totally
asymptomatic. People at risk of acquiring HCV include drug
users, hemodialysis patients, those with tattoos, those with
multiple sex partners, and anyone who had a blood transfusion
before 1990. Some people may contract the virus through
unprotected sex. People with HIV and other immunodeficiencies
are considered a major risk group.
AmFAR (the American Foundation for AIDS Research) is
conducting the first study of ribavirin plus alpha interferon
for treating hepatitis C in persons who also have HIV. Two
hundred volunteers will be enrolled in 14 U.S. cities. (For
more information about this study, see AIDS Treatment News #295, May 15, 1998.)
[Jeffery Stoia is a medical writer and editor who also
volunteers for AIDS service organizations in San Francisco.]
For More Information
At this time the most current and in-depth medical
information on the use of the newly approved combination
treatment is the transcript of the discussion of the FDA's
Antiviral Drugs Advisory Committee meeting of May 4, 1998.
This transcript, about 90 pages single spaced, is available
on the FDA's Web site, http://www.fda.gov. Select "Dockets,"
then "FDA Advisory Committees Menu," then "Center for Drug
Evaluation and Research (CDER)," then "Antiviral Drugs
Advisory Committee
." The hearings are listed by date, and can
be downloaded in either pdf or rtf file format. (The rtf -- rich
text format -- is much more compact and downloads faster, but
you may need to turn off automatic line numbers in your word
processor, to prevent overprinting.)
A major article on the controversy about the bundling of
the two drugs -- forcing patients to pay for Schering-Plough's
interferon in order to buy ribavirin in the U.S. -- is scheduled
to be published in the San Francisco Bay Times, September 3,
1998. You can obtain a copy by sending a self-addressed
stamped envelope to: San Francisco Bay Times, 525 Bryant St.,
San Francisco, 94107; request the hepatitis C article by
Bruce Mirken.
"HIV & Hepatitis: Complexities of Co-infection," a continuing
medical education program primarily for physicians, will be
presented Saturday September 12 from 8:30 a.m. to 12:30 p.m.,
at the California Pacific Medical Center Davies Campus
(auditorium, level B). There is no charge to attend, but
advance registration is requested.
The learning objectives are: "Describe the prevalence of co-infection with HIV and hepatitis; Describe the natural
history of co-infection with HIV and hepatitis; Describe
currently available data on treatment options for hepatitis B
and C; Describe the impact of co-existing hepatitis on
response to highly active antiretroviral therapy."
This program, which includes four lectures and a panel
discussion, is presented by the Community Consortium and the
California Pacific Medical Center, with unrestricted
educational grants from Glaxo Wellcome Company and Roche
Laboratories, Inc. To register, or for more information,
contact the Community Consortium, fax 415-476-6948, phone
415-502-0657.
IHV 1998 Annual Meeting ("Gallo Lab Meeting")
Program, Many Talks on Web
by John S. James
Many of the world's leading researchers in the virology and
immunology of HIV disease present new information at the
annual meeting of the Institute for Human Virology; the 1998
meeting occurred August 23-29 in Baltimore. The complete list
of speakers and their topics -- about 200 scientific
presentations -- is available at http://www.ihv.org. About 1,000
people attended.
Many of the talks will be available through audio and slides
at http://www.helix.com, an educational site for health care
professionals developed by Glaxo Wellcome; there will be a
link from the IHV site. Unfortunately some presentations
could not be included, because researchers are concerned that
certain medical journals will not publish new data if it is
released first on the Web.
Abstracts of the talks are not on the Web, but will be
published in the next Journal of Human Virology, which should
be available in late September.
Fomivirsen Approved for CMV Retinitis: First Antisense Drug
On August 27 the U.S. Food and Drug Administration approved
the first drug using antisense technology -- fomivirsen
(Vitravene™) for patients "who are intolerant of or have a
contraindication to other treatments for CMV retinitis or who
were insufficiently responsive to previous treatments for CMV
retinitis." This drug is injected directly into the eye, and
is given monthly, except that the first two doses are two
weeks apart. The drug was developed by Isis Pharmaceuticals,
in cooperation with CIBA Vision, a unit of Novartis AG.
Antisense drugs work by blocking a specific gene from
producing the protein it codes for. This kind of drug has
great potential importance because it can be targeted against
only a single gene -- either in a virus or other disease-causing
organism, or an abnormal human gene. This highly specific
action should improve efficacy and reduce side effects. The
development of antisense drugs has been slower than some had
expected, however, because of technological difficulties such
as designing compounds which can readily enter cells.
Fomivirsen was considered on July 22 by an FDA advisory
committee (the Ophthalmic Drugs Subcommittee of the
Dermatologic and Ophthalmic Drugs Advisory Committee). The
subcommittee voted 5-2 for approval, with all the clinicians
voting to approve the drug; but there was much concern about
the small number of patients in the trials, especially the
pivotal study for "first line" use, which compared 18
patients randomly assigned to immediate treatment vs. 10
assigned to deferred treatment. The reason for these small
numbers is that the availability of protease inhibitors
greatly reduced the incidence of new CMV retinitis, making it
very difficult to enroll volunteers into the trial. This
small number of patients is probably the reason that the FDA
did not grant the additional "first line" approval (for
patients previously untreated for CMV retinitis) that the
company had requested. There were more volunteers in the
studies of fomivirsen for patients who had failed previous
treatment for CMV retinitis.
An application to market fomivirsen in Europe is currently
being reviewed.
A major national conference on prison issues (medical and
other), including over 150 workshops on varied topics, will
take place September 25-27 at the University of California at
Berkeley. "Critical Resistance: Beyond the Prison Industrial
Complex," is sponsored by many prison, academic, and legal
organizations, including California Coalition for Women
Prisoners, California Prison Focus, and the Prison Activist
Resource Center.
Major topics include prison as industry, law and policy,
research and activism, alternatives for addressing problems
such as drugs and homelessness, human rights and conditions
of confinement, education in prison and otherwise, and media
representations & popular culture. HIV and healthcare
workshops include disabled prisoners, women's health,
medical neglect in prison, alternatives to incarceration for
the disabled, terminally ill and elderly, responding to the
infectious disease epidemic within the prison industrial
complex, and health and human rights in prison. For more
information, contact Critical Resistance, P.O. Box 339,
Berkeley, CA 94701, 510-643-2094, email critresist@aol.com,
Web http://www.prisonactivist.org/critical/index.html.
Prison-related Web sites include:
http://www.prisonactivist.org, Prison Activist Resource
Center, includes prison issues, prison news, a current list
of over 150 prison issues and reform organizations, and
almost 50 prison-related Web links.
http://www.igc.org/justice, JusticeWeb, includes about 180
articles on medical care in prisons, and about 50 on HIV, as
of our search on September 1. Click "Search," then enter
'HIV', 'medical', or other keyword you are searching for
(without the single quotes), and click "Search."
http://www.wco.com/~aerick/link.htm#hlt, Prison Law Links,
includes over 200 Web links on: Health and Well-Being, Prison
Information and Resources, Activism, Corrections,
Correctional Officers, Education, International, Journals and
Magazines, Law and Prisons, and poetry, art, and other
prison-related sites.
[California note: The Caravan for Prisoners' Human Rights, a
protest by many organizations on October 17, will carpool
from San Francisco and other cities to Chowchilla women's
prison for a noon rally, and then from there to Corcoran
prison for a 2:30 p.m. rally. Major focus will include
substandard medical care, worsening conditions for California
prisoners, and denial of access to news media. For carpool
and other information, call the HIV in Prison Committee of
California Prison Focus, 510-533-2590.]
Help Wanted: Executive Director, Project Inform
Project Inform, the largest U.S. AIDS treatment information
and advocacy organization, is seeking an executive director.
This position will be available on January 1, 1999, and is
located in San Francisco. The current executive director,
Annette Brands, is leaving on February 28, 1999.
Qualifications are "three to five years of successful
management experience in either the not-for-profit or for-profit environment. Excellent personnel management/people
skills, organizational management, fund development, and
leadership skills. Demonstrated success in program
development and public relations. Effective team building and
innovative management skills. Possess exceptional
communication skills and external relations capabilities.
Previous experience working effectively with a board of
directors.
"Knowledge of HIV/AIDS issues and experience either
personally, professionally, or through volunteer activities.
A commitment to the mission of Project Inform and to fight to
end the AIDS epidemic."
For more information, obtain the four-page Executive Search
Announcement from www.projinf.org.
ISSN # 1052-4207
Copyright 1998 by John S. James. Permission granted for noncommercial reproduction, provided that our address
and phone number are included if more than short quotations are used.
