Post-Exposure HIV Chemoprophylaxis (PEP) - A Discussion Paper

Prepared by Lauren Lindsay, Social Work Student
for The AIDS Committee of Toronto
August 1997

Should people exposed to HIV/AIDS outside the health care setting have access to PEP therapy?

The use of PEP medication (AZT and 3TC, plus or minus indinavir) after accidental exposure to HIV/AIDS has raised numerous questions and concerns. The issues to be discussed affect health care workers, survivors of sexual assault and persons exposed to HIV/AIDS through needle use or during sex.

CATIE will be providing information on the risks and effectiveness of PEP therapy.


1) PEP Therapy, Will it Reduce Safer Sex Practices?

AIDS service organizations are concerned that the extended provision of PEP therapy in cases of accidental sexual exposure may reduce safer sex practices. Persons may view the PEP therapy as a ‘morning after pill’ with the ability to halt the transmission of HIV in all instances.

    [][]Gorman, Christine. If the Condom Breaks: A morning-after treatment for exposure to HIV might protect you from AIDS. But don’t count on it. Time. June 23, 1997;26.
    [0]Immen, Wallace. AIDS experts issue drug warnings: ‘Morning-after’ treatments could encourage resistance to medication, M.D.s warned. The Globe and Mail June 12, 1997.
    [0]Katz, Mitchell and Julie Louise Gerberding. Postexposure Treatment of People Exposed to the Human Immunodeficiency Virus Through Sexual Contact or Injection-Drug Use. The New England Journal of Medicine 1997;336(15):1098.
    [0]King, Edward. ‘Morning After’ Drugs: Can anti-HIV drugs reduce the chance of infection through sex? AIDS Treatment Update. 1997;52:9,10.
    [0]Okie, Susan. Should preventative HIV treatment be expanded? The Washington Post February 4, 1997;Z13.
    [0]Sabin, Russel. Tantalizing HIV Study to Probe Prospect of ‘Morning-After’ Pill. San Francisco Chronicle March 4, 1997:1,2.
    [0]Zuger, Abigail. ‘Morning-After’ Treatment for AIDS. The New York Times June 10 1997;B12.

There are public health departments and AIDS service organizations that believe that in order to combat the possible decrease in safer sex practices, public health campaigns and/or educational materials will have to incorporate information on PEP therapies. Slogans and other educational material will have to be carefully worded so as to relay the correct information and minimize misconceptions. Individual counselling can also assist in relaying correct information.
    [][]Katz, Mitchell and Julie Louise Gerberding. p.1098.
    [0]King, Edward. p.9,10.
    [0]Okie, Susan. p.213
    Examples:

    Russel Armstrong, executive director of the Canadian AIDS Society, states, “I worry the message is going to get out that it’s okay not to have safer sex. A lot of people are looking for excuses...”.
      [][]Immen, Wallace.

    “Barr of the Gay Men’s Health Crisis said that he worried that offering preventative drug treatment might relay mixed ‘messages messages,’ making people think they could engage in unsafe sex and worry about the consequences later.”
      [][]Okie, Susan. p.213.

    “AIDS providers in San Francisco...plan to offer the preventative treatment as part of a public health campaign that would also include counselling, HIV testing and other services...”
      [][]Okie, Susan. p.213.

    “We (Mitchell H. Katz, M.D. San Francisco Department of Public Health, Julie Louise Gerberding M.D., M.P.H. University of California, San Francisco) believe that the answer lies in public health messages that place prophylaxis in the context of an overall program of health promotion. People who have an exposure to HIV are by definition at increased risk for infection, and giving them preventative services should be a priority”.
      [][]Katz, Mitchell and Julie Louise Gerberding. p.1098.

    Questions and concerns:

    1) Should educational campaigns that incorporate information on PEP therapy only target certain population groups, for example, mixed status couples?

    2) Or, should educational campaigns in Canada even promote PEP therapy as a preventative strategy?


2) Lack of Completion of PEP Therapies:

Reports of persons not finishing the full course of the prescribed PEP therapy are numerous. Reasons cited for not finishing include the inability to tolerate side effects (for example, diarrhoea, headaches, fatigue, sleep disturbances)
    [][] Gostin, Lawrence, Zita Bazzarini, Diane Alexander, Alan Brandt, Kenneth Mayer and Daniel Silverman. HIV Testing, Counselling, and Prophylaxis After Sexual Assault. Journal of the American Medical Association. 1994; 271(18):1438,1439.
    [0]Katz, Mitchell and Julie Louise Gerberding. p.1097.
    [0]Gorman, Christine. p.26.
and/or a personal risk assessment that decreases the decision to complete the medical regimen.
    [][]Coutts, Jane. Hospitals keep drug packs in case of AIDS accidents. Globe and Mail October 17, 1996.

    Examples:

    Dr. Mc Leod, chairman of the committee on accidental exposure for the British Columbia Centre for Excellence in HIV/AIDS stated that “only about twenty five percent of people given the five day starter packs go on to finish the month-long treatment”.
      [][]Couts, Jane.

    In Time magazine, the article, “If the Condom Breaks”, states, “In the past year, eight of the twenty patients treated at the Fenway Center couldn’t finish the full six-week regimen because the side effects were so painful”.
      [][]Gorman, Christine. p.26.

    At the B.C Women’s Sexual Assault Service, only two women out of thirty, finished the month long PEP therapy (as of June 1997).
      [][]First AIDS Kit: Rape clinic offers anti-HIV prophylaxis. POZ. July 1997;36.

    Questions and concerns:

    a) Are people not finishing the PEP therapy for other reasons? For example, the side effects from the drug may make it difficult for a person to atttend work, therefore, the person may terminate the medication in order to return to work. He/she may be unable to financially afford to take time off from work and telling his/her employee of the incident may not be an option.

    In British Columbia, the provincial government covers the cost of the PEP therapy for anyone accidentally exposed/possibly exposed to HIV/AIDS.
      [][]Coutts, Jane.
    Financial coverage is however not available when the incident is due to a “lifestyle choice”, for example, in the case of injection drug use or failure to wear a condom. The therapy can be accessed from most hospital emergency units or in more remote communities, from the Red Cross.
      [][]B.C. Centre for Excellence in HIV/AIDS, Conversation August 5, 1997.

    In Ontario, Women’s College Hospital Sexual Assault Care Centre has only provided the PEP therapy to two sexual assault survivors. Financial coverage of the therapy is of concern (Conversation June 1997).
      [][]Conversation with Sheila McDonald, Women’s College Hospital, June 1997.

    In the United States, “Private health insurers do not pay for the therapy because it has not been shown to be medically necessary”.
      [][]CDC Considers ‘Morning After’ Therapy for Sexual Exposure. AIDS Policy and Law. 1997;4.

    b) Does more research need to be conducted as to why some people “choose” not to complete the PEP therapy?


3) Drug Resistance:

Lack of completion of the PEP therapy may “encourage the evolution of drug resistance HIV strains”.
    [][]King, Edward. p.8.
As well, repeated use of the therapy may promote drug resistance and increase short and long-term side effects.
    [][]Okie, Susan. p.3.
Attempts to curb repeated use of PEP therapy have been addressed by some health care centres.
    [][]British Columbia Centre for Excellence in HIV/AIDS. Management of Accidental exposure to HIV. St. Paul's Hospital, The University of British Columbia and The Ministry of Health, British Columbia, Canada. February 1997;.2.
    [0]Okie, Susan. p.3.
    Examples:

    The British Columbia Centre for Excellence in HIV/AIDS explicitly states, “It is not the intention of this program to provide antiretroviral therapy in the event of exposure occurring as a part of an individual’s personal behaviour, e.g. unsafe sex or sharing injection equipment”.[][]British Columbia Centre for excellence in HIV/AIDS. p.2

    Questions and Concerns:

    a) Are there additonal measures (besides the risk assessments that are currently being conducted in hospitals and rape crisis centres) that can be adopted to reduce the development of drug resistant HIV strains?

    b) Because the chance of drug resistant HIV strains increases the more times one is given the medications, should there be a limit on how many times someone can access the PEP therapy?
    If there is a limit, is enforceability possible?

    c) What are the medical implications for someone who takes the PEP therapy for one month, goes off it and then seroconverts?

    It seems that going off the PEP therapy is not terribly dangerous, but one should go off it all at once to reduce resistance. If a person seroconverts, s/he would probably have to continue with the same medication that was taken during that one month.
      [][]Discussion on post-exposure HIV prophylaxis for community groups held by CATIE and ACT. August 5, 1997.

4) Financial Cost:

The cost of PEP therapy, plus laboratory and physician visits, is approximately (U.S.) $1200.00 for one month
    [][]Coutts, Jane.
Differences in cost are dependent on the type of drug combinations taken (approximately $300 for AZT and 3TC and an extra $300.00 for indinavir) and laboratory tests and physician visits needed (approximately $100.00-$200.00).
    [][]Bartnof, Harvey. Treatments for HIV: Postexposure Prophylaxis. BETA. June 1997;47-48.
    [0] CDC Considers ‘Morning After’ Therapy for Sexual Exposure. p. 4.
    [0]Sabin, Russel. p.3,4.

Providing PEP therapy in all cases of sexual exposure is not viewed as cost-effective. Although the cost of PEP therapy for one person cannot be compared to the lifetime medical care costs (approximately $119,000)
    [][]Katz, Michael and Julie Louise Gerberding. p.1098.
for a person living with HIV/AIDS, the provision of PEP therapy to all persons who demand it, with no or little consideration of risk exposure, would not be cost effective.
    As Edward King in the article, “Can anti-HIV drugs reduce the chance of infection through sex?” states,
    On average, about one out of every three hundred people who have unsafe sex
    with an HIV-positive person becomes infected as a result. So if all 300 come
    forward for PEP after their risk exposure, 299 would be treated unnecessarily,
    because they would not have become infected regardless of whether or not they
    had received PEP...In blunt financial terms, this no longer compares so favourably
    with the lifetime costs of medical care”.[][]p.8,9

    This article and the “AIDS Reference Manual”, ed. Keith Alcorn, suggests that cost effectiveness could be increased if the therapy was only provided under certain circumstances, i.e. high risk exposures, for example, if the sexual exposure is with a person who is known to have HIV/AIDS. Another option would be to use all three drug combinations for high risk exposures, and use fewer drug combinations when the risk is less severe.
      [][]Alcorn, Keith ed. AIDS Reference Manual. London: National AIDS Manual Publications. 1997;258,259.
      [0]King, Edward. p.8.9.

    Questions and concerns:

    a) Could funds designated to assist persons living with HIV/AIDS be diverted to pay for PEP therapies? If funds are not diverted, who will pay for these drugs (excluding health care workers)? If large numbers of people (excluding health care workers) request these drugs, how will health centres/hospitals be financially able to provide PEP therapies?
      [][]Alcorn, Keith. p.259.

    b) At times, deciding who should receive PEP therapies and who should not, is a difficult decision to make, especially in cases of sexual assault where the HIV status of the person is unknown.
      [][]Zuger, Abigail. p.B12.
    The victims level of risk is in most cases unknown. Do health professionals have the right to deny PEP therapies to certain patients? And, what are the possible legal ramifications of denying people access to PEP therapies?

    c) As well, if people know PEP therapy is only available for high risk exposures, there is nothing to prevent them from telling a health care worker that they had a high risk exposure. How stringently can the line be drawn between high and low risk activity for PEP therapy intervention?

5) Policy and Procedure Development:

The Centre for Disease Control and Prevention in the United states has established guidelines for management of health care workers after exposure/possible exposure to the HIV virus and the Division of HIV Epidemiology Research,
    [][]Rowe, Paul. New Guidelines set for occupational HIV exposure. Science and Medicine. July 6, 1996;348:48.
the Division of Nosocomial and Occupational Infections and the Division of Bloodborne Pathogens of LCDC has developed a protocol that applies to workers in occupational health settings.
    [][]Archibald, Chris. HIV transmission at work: Guidelines for management of exposure. Canadian AIDS News. 1997; ix.4:19,
Various hospitals in Canada and the United States have also developed policies on the management of health care workers after accidental exposure to HIV/AIDS.
    [][]The Wellesley Central Hospital. Occupational Health Manual.
Wellesley Hospital, for example, has developed a policy in this area which is aimed at health care workers;
    [][]The Wellesley Central Hospital. Occupational Health Manual.
the British Columbia Centre for Excellence in HIV/AIDS has established guidelines for health care workers exposed to blood and/or body fluids in the workplace or community settings;
    [][]British Columbia Centre for Excellence in HIV/AIDS.
and the British Columbia Women’s Sexual Assault Services has developed “a protocol for managing HIV exposure in sexual assault victims”.
    [][]British Columbia Centre for Excellence in HIV/AIDS p.1.
    If a person is exposed to fluids containing HIV/AIDS or is suspected of having contact with fluids containing HIV/AIDS, a risk assessment is conducted. The type of exposure will determine whether PEP therapy is recommended, offered or not offered to the health worker/sexual assault victim. Each health care setting has a slightly different policy, however, differences in suggested treatment (medical and psychosocial) are slight. Certain articles discuss the kind of information that should be discussed in a counselling session with someone exposed/possibly exposed to fluids containing HIV/AIDS; while some hospitals, sexual assault centres and provinces (i.e. British Columbia) have specific guidelines.
      [][]Alcorn, Keith. p.258.
      [0]Bartlett, John. Occupational Exposure to HIV: Revised Hopkins Report. The Hopkins HIV Report. July 1996;
      [0]8(2):14-16.
      [0]British Columbia Centre for Excellence in HIV/AIDS.
      [0]DeNoon, Daniel. CDC Updates Guidelines on Post-HIV Exposure Prophylaxis. AIDS Weekly Plus. July 15,1996.
      [0]Gostin, Lawrence, Zita Bazzarini p.143.
      [0]The Wellesley Central Hospital. Occupational Health Manual.

    Drawing on material from different sources, the following discusses the types of information that should be provided in a counselling session. Certain information will however be dependent on whether the person decides to have an HIV test and/or PEP therapy.

    Counselling should include discussions on:

    1) The risk of contracting the HIV virus, dependent on the type of exposure
      [][]British Columbia Centre for Excellence in HIV/AIDS p.17.
      [0]Gostin, Lawrence, Zita Bazzarini p.1437.
      [0]The Wellesley Central Hospital. Occupational Health Manual. p.5.

    2) The disadvantages and advantages of taking the HIV antibody test, the window period and the meaning of results
      [][]British Columbia Centre for Excellence in HIV/AIDS. p.22.
      [0]Gostin, Lawrence, Zita Bazzarini. p.1437.
      [0]Jurgen, Ralf and Michael Palles. HIV Testing and Confidentiality: A Discussion Paper. Montreal: Canadian HIV/AIDS Legal Network. March 1997;76.
      [0]The Wellesley Central Hospital. Occupational Health Manual. p. 5.

    3) Confidentiality of test results and the advantages of anonymous testing. Persons should be given the choice to have their test conducted anonymously or confidentially
      [][]British Columbia for Excellence in HIV/AIDS. p.17.
      [0]Jurgens, Ralf and Michael Palles. p.76.
      [0]The Wellesley Central Hospital. Occupational Manual. p. 5.
    The “British Columbia Centre for Excellence in HIV/AIDS”, in its guidelines for management of accidental exposure to HIV, states, “Confidentiality of test results is often a major concern for persons tested for HIV. Provide assurance that all test results will be treated in a strictly confidential manner, and will be sent to the person's physician if requested. If requested, their sample may be sent to the laboratory without personal identifying information, thus, only the exposed person and his/her physician will have access to the test results”.
      [][]Jurgens, Ralf and Michael Palles. p.76.

    4) The avoidance of certain activities/behaviours, and precautions in others in order to reduce the risk of transmitting the HIV virus
      [][]British Columbia Centre for Excellence in HIV/AIDS.
      [0]Canadian Association of Nurses in AIDS Care. Accidental Exposure to HIV: Self Care.
      [0]The Wellesley Central Hospital. p.5.

    5) Information on PEP therapy. This should include a discussion on the short term side effects of the therapy. The discussion should also include information on PEP studies and its results, the limited knowledge on the efficacy of PEP therapy (only AZT and its affect on seroconversion rates has been studied in humans)
      [][]DeNoon, Daniel.
      [0]Gostin, Lawrence and Zita Bazzarini. p. 1437. , the functions of the different medications (AZT, 3TC and indinavir) and its unknown long term side effects.[][]British Columbia Centre for Excellence in HIV/AIDS. p. 18-22. The reasons for recommending or suggesting the PEP therapy should be discussed.[][]British Columbia Centre for Excellence in HIV/AIDS. p. 5-7,17.
      [0]CDC Updates Guidelines on Post-HIV Exposure Prophylaxis.
      [0]The Wellesley Central Hospital. Occupational Health Manual. p.5,8,9.

    6) The stress that may occur while waiting for test results, as well as the possible reactions to learning the results
      [][]Jurgens, Ralph and Michael Palles. p.76.
      [0]The Wellesley Central Hospital. Occupational Health Manual. p.12.

    It is imperative that the final decision to be tested and/or to take the PEP therapy be made by the client/patient and the right to refuse treatment is respected.
      [][]Gostin, Lawrence and Zita Bazzarini. p.1438.
      [0]Jurgens, Ralph and Michael Palles. HIV Testing and Confidentiality. p.160. If a person decides to take the PEP therapy informed consent must be sought.[][]Bartlett, John. p.16.
      [0]Gostin, Lawrence, Zita Bazzarini. p.1438.
      [0]Katz, Mitchell and Julie Louise Gerberding. p.1098.
      [0]The Wellesley Central Hospital. p.16

    Questions and concerns:

    1) How do we ensure that certain individuals or populations are not denied access to the PEP therapy because of a physician's opinion that lack of compliance of the medical regimen is likely to occur? Some physicians have already denied protease inhibitors to injection drug using patients.

    2) As well, how do we ensure that certain individuals or populations are not denied access to the PEP therapy because of either their own or the physicians lack of knowledge on the issue. Women, for example, continue to be diagnosed for HIV at a later point than men because many physicians do not think they are at risk. As well, women tend to be less educated on HIV/AIDS than some other populations and therefore seek medical attention at a later stage in the illness.
      [][]Department of Health and Welfare. Women and AIDS. Minister of Supply and Services Canada. 1990;22.

    3) A number of psychosocial issues have not been included in policy guidelines and expansion of these issues is a possibility. Three examples have been provided below.
      a) Waiting for test results is stressful and coping mechanisms for testing
        [][]Jurgens, Ralf and Michael Palles. HIV Testing and Confidentiality. p.76.
        [0]The Wellesley Central Hospital. Occupational Health Manual. p.5.
      and PEP therapy should be discussed. PEP therapy has physical side effects which increase emotional stress and it is therefore important that counsellors discuss the possible emotional reactions that may occur as a result of taking these medications.
        [][]The Wellesley Central Hospital. Occupational Health Manual. p.9.

      b) Health care workers/sexual assault victims waiting for test results and/or taking PEP therapy should be given the name and telephone numbers of AIDS organizations and hot lines so that they can access assistance if needed.
        [][]Jurgens, Ralf and Michael Palles. HIV Testing and Confidentiality. p.76.

      c) A person who chooses to take PEP therapy should be made aware that if seroconversion occurs, early medical intervention is available; and that early intervention has assisted persons with HIV to live longer and healthier lives.

6) Prevention for Health Care Workers:

Needles with safety sheaths and blunt tips reduce health care workers’ risks of being pricked.
    [][]Nurses crusade for safer needles in hospitals. AIDS Alert. October 1996.
“One study, conducted by the U.S. Centers for Disease Control and Prevention at six hospitals...between 1993 and 1995, concluded that workers reduced their risk of being pricked by up to 76 percent...”.
    [][]Needles With Covers and Dull Tips Can Reduce Sticks. AIDS Weekly Plus. February 3, 1997;21.
Some hospitals in the United States are however reluctant to introduce these needles as the cost for them is 25 cents compared to 8 cents for a regular hypodermic needle.
    [][]Needles With Covers and Dull Tips Can Reduce Sticks. p.21.
A number of hospitals in Ontario do use safer needles but the cost of these needles is a concern.
    [][]Conversation with John Flannery, Casey House, August 5 1997.
    Although these needles are more expensive than the regular hypodermic needles, wider use of them would be a proactive approach to the problem of accidental exposures to HIV. Introduction of these needles would have major psychosocial benefits for individuals, reduce their need to take medication with uncomfortable short term side effects and unknown long term effects, and avoid potential HIV infection.


7) AIDS Service Organizations (A.S.O.s) and their Role in the Post Exposure HIV Chemoprophylaxis Debate:

Questions and concerns:

1) Do A.S.Os have a responsibility to advocate for the coverage of PEP therapy in for example, specific sexual assault cases or where an HIV negative partner in a mixed status relationship has been accidentally exposed?

2) Do A.S.O.s have an advocacy role to play in seeing that the availability of PEP therapy is extended to population groups that currently do not have access to this therapy?

3) What role could A.S.O.s play in supporting people who are taking PEP therapies and/or hospitals and sexual assault centres?

4) What should A.S.O.s counselling and referral methods be with regards to PEP therapy?

5) Should A.S.O.s be playing some role in supporting health care workers to obtain safety sheath and/or blunt tip needles either on all wards or on some wards?
Notes


References

Alcorn, Keith, ed. AIDS Reference Manual. London: National AIDS Manual Publications. 1997.

Archibald, Chris. HIV transmission at work: Guidelines for management of exposure. Canadian AIDS News. 1997;ix.4:19.

Bartlett, John. Occupational Exposure to HIV: Revised Hopkins Report. The Hopkins HIV Report. July 1996; 8(2):14,16.

Bartnoff, Harvey. Treatments for HIV: Postexposure Prophylaxis. BETA. June 1997;46-48.

British Columbia Centre for Excellence in HIV/AIDS. Management of Accidental Exposure to HIV. St Paul’s Hospital, The University of British Columbia and The Ministry of Health, British Columbia, Canada. February 1997;1-25.

Canadian Association of Nurses in AIDS Care. Accidental Exposure to HIV: Self Care.

CDC Considers ‘Morning After’ Therapy for Sexual Exposure. AIDS Policy and Law. 1997;4

Coutts, Jane. Hospitals keep drug packs in case of AIDS accidents. Globe and Mail. October 17, 1996.

DeNoon, Daniel. CDC Updates Guidelines on Post-exposure Prophylaxis. AIDS Weekly Plus. July 15, 1996.

Department of Health and Welfare Canada. Women and AIDS. Minister of Supply and Services. 1990.

First AIDS Kit: Rape clinic offers anti-HIV prophylaxis. POZ July. 1997;36.

Gorman, Christine, If the Condom Breaks: A morning-after treatment for exposure to HIV might protect you from AIDS. But don’t count on it. Time. June 23, 1997;26.

Gostin, Lawrence, Zita Bazzarini, Diane Alexander, Alan Brandt, Kenneth Mayer and Daniel Silverman. HIV Testing, Counselling and Prophyalxis After Sexual Assault. Journal of the American Medical Association. 1994; 271(18):1436-,1444.

Immen, Wallace. AIDS experts issue drug warnings: ‘Morning-after’ treatments could encourage resistance to medication, M.D.s warned. The Globe and Mail. June 12, 1997.

Jurgen, Ralf and Michael Palles. HIV Testing and Confidentiality: A Discussion Paper. Montreal: Canadian HIV/AIDS Legal Network. March 1997;76.

Katz, Mitchell and Julie Louise Gerberding. Postexposure Treatment of People Exposed to the Human Immunodeficiency Virus through Sexual Contact of Injection-Drug Use. The New England Journal of Medicine 336(15):1097-1100,1997.

King, Edward. ‘Morning After’ Drugs: Can anti-HIV drugs reduce the chance of infection through sex? AIDS Treatment Update. 1997;52:7-11.

Needles With Covers and Dull Tips Can Reduce Sticks. AIDS Weekly Plus. February 3, 1997;21.

Nurses crusade for safer needles in hospital. AIDS Alert. October 1996.

Okie, Susan. Should preventative HIV treatment be expanded? The Washington Post. February 4,1997;Z13.

Rowe, Paul. New Guidelines set for occupational HIV exposure. Science and Medicine. July 6, 1996;348:48, .

Sabin, Russel. Tantalizing HIV Study to Probe Prospect of ‘Morning-After Pill. San Francisco Chronicle. March 4 1997;1-4

The Wellesley Central Hospital. Occupational Health Manual. December 1996;1-25.

Zuger, Abigail. ‘Morning-After’ Treatment for AIDS. The New York Times June 10, 1997;:B12.

B.C. Centre for Excellence in HIV/AIDS. Conversation August 5, 1997.

Conversation with John Flannery, Casey House. August 5, 1997.

Conversation with Sheila McDonald, Women’s College Hospital. June 1997.

Discussion on post-exposure HIV prophylaxis for community groups held by CATIE and ACT, August 5, 1997.