The Bay Area Reporter - March 27, 1998
Bill Snow and Larry Hanbrook, ACT UP/Golden Gate Writers Pool

The idea of offering antiviral medication to HIV-negative people who may have been exposed to the virus, in hopes of aborting an infection, is not new. For the past 10 years, health workers have been given AZT or other, more potent antivirals if they had some potential exposure to HIV. In a healthcare setting, even AZT monotherapy very soon after exposure may decrease one's chances of becoming infected by as much as 81 percent. This statistic is from a widely reported Centers for Disease Control study, but not everyone agrees about its validity, even for healthcare workers, since it was done after the fact and with no controls.

Of course, accidental needle sticks and other occupational exposures are not the most common means of HIV transmission. So it was only a matter of time - too much time in our book - before antivirals were considered as a potential form of HIV prevention for exposures through sex or injection drug use.

One major problem is that nobody knows if this would work for sexual exposures as well as it appears to work for blood-to-blood exposure, the typical health worker situation. And while it's reasonable to assume that PEP could be effective, there really is no data to support or refute either the efficacy or the public health benefit, especially if the availability of PEP also causes some people to change their behavior.

It seems obvious that studies should be done as soon as possible to determine if PEP is effective in preventing HIV infection through sexual transmission. Unfortunately, that is much easier said than done; at least, easier than done in an ethical and scientifically sound way. An efficacy study of PEP would require a large number of participants - thousands - all of whom would be HIV-negative but at high risk. And ideally the group would be randomized, so that an equal number received treatment and the rest were given a placebo. Clearly, such a study would not be ethical or practical. In fact, that's largely why the original healthcare study isn't definitive.

San Francisco will soon be home to two studies of PEP. The first is already open and is the focus of this article. It is a collaborative effort between the San Francisco Department of Public Health (DPH) and UCSF, and has been in operation for several months. The second study, which hasn't begun yet, will be part of a multi-city study sponsored by the National Institutes of Health HIVNET program of prevention and vaccine preparedness research. In San Francisco, it will also be based at the Department of Health in San Francisco, in its Research Branch. Because of the ethical problems mentioned, neither of these studies will be able to give scientifically significant data about the actual efficacy of PEP, though each will answer important and different access, behavioral, and logistical questions about using PEP in a public health setting.

In addition, private doctors are free to prescribe PEP with approved drugs at any time, and a good case can be made for insurance companies or HMOs to pay for the appointments, tests, and medications. In many cities the only access to PEP is privately.

Call 502-5-PEP

The usual method of accessing PEP in the DPH/UCSF study begins with a call to the hotline (502-5PEP). This means that the person who calls must know or hear about the study and call soon after exposure. On the hotline call, an interviewer/counselor discusses the type and time of the potential exposure with the caller and sets up an appointment if the individual qualifies.

Entry is based on the exposure type and what is known about the caller's partner. Unprotected insertive or receptive intercourse, either anal or vaginal, with or without ejaculation, or receptive oral sex with ejaculation may meet the entry criteria if the partner is either a man who has sex with men, an injection drug user, a sex worker, anonymous, or is otherwise possibly at risk of HIV infection.

If the caller meets the exposure criteria, and the potential exposure occurred within the previous 72 hours, he or she is urged to come in as quickly as possible, since the health workers in the previous study accessed PEP within a few hours of exposure. This study is being run from three sites: City Clinic on 7th and Folsom; San Francisco General Hospital; and Tom Waddell Health Center, near Polk Street. The caller can choose which site to go to.

The initial intake can take up to three hours. It begins with a brief orientation by an interviewer. This first part of the process is mostly paperwork and in some ways the most difficult for someone who may be very upset about exposure, so the interviewer spends some time with the participant to see if he or she needs immediate counseling. If not and the participant gives informed consent to continue, the intake process begins in earnest. The interviewer gathers study information on the person's background, sexual or drug use history, mental state, and factors that might interfere with taking the medications, as well as contact information.

After this interview, the participant usually sees a counselor, who will be the main contact person for the study. One's time with the counselor is very different from the interview, where the interviewer merely records the person's answers to questions. The counselor may go over some of the same information, but as part of an interactive process. The goals of the counseling session are to support and help the participant through a very frightening process, to identify any risk behavior and help the participant explore the actual event that brought them in to get PEP with the hope of preventing future exposure.

Blood is then drawn and the participant sees a clinician, who discusses the pros and cons of taking PEP, and gives medications if the participant wants them. Then there is a final discussion with the counselor, this time to discuss methods of remembering to take the medication as prescribed and to find out if the person can get the sex or needle sharing partner to come to the clinic. If the partner is not HIV-infected, the participant can stop taking PEP; if the partner is infected, then his or her participation can be useful to determine what medications are best to use and what the exposure may have been.

A year's follow-up

The PEP treatment regimen lasts 28 days, with almost weekly visits for the first five weeks. Blood is drawn during the first visit and again at the end of 28 days, when it is tested for HIV antibody, viral load, hepatitis B, hepatitis C, syphilis, and liver enzymes. During the first five weeks, participants meet with their counselor weekly, and also are asked to report any adherence problems or side effects. Participants are encouraged to return for an optional visit after twelve weeks for additional antibody testing, to ensure that no infection has occurred, as well as to check in with their counselor.

The next scheduled study visit is at week 26, when information is collected on sexual and drug use behavior; viral load and antibody tests are run again, as well as an STD check; and the participant meets with the counselor for more risk reduction counseling. The results of the tests are given the next week. After that, the next visit is at week 52, when information is again collected on sexual and drug use behavior, another battery of blood tests are run, and more risk reduction counseling. Again, results are given one week later.

As the study and program continue, and information is accumulated, its investigators will be able to report to the scientific community and to us on: the frequency of PEP use, who accesses PEP and why, and what the effects are on taking the medications, behavior, and future use. We will describe the second, HIVNET study, which will occur in five cities, and provide different complementary information when its enrollment begins.

ACTion UPdate:

Put some PEP in your life

The Department of Public Health PEP Project has a Community Advisory Board (CAB), which meets on the third Wednesday of the month. If you are interested in the study, you are encouraged to participate in the CAB. For information on the time and place, call Jay Unick at the Center for AIDS Prevention Studies at (415) 597-9266.

For significant exposures, the PEP Hotline number is (415) 502-5PEP (502-5737).
980327
BR980304

Copyright ©1990, 2000. ÆGIS. All materials appearing on ÆGIS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of ÆGIS, or the party credited as the provider of the content. Feedback/Contact Us.