Lack of state policy puts those exposed to HIV at greater risk

It was a mistake, Trevor Hoppe admits. He made a poor choice in a sexual encounter in Philadelphia in October which may have exposed him to HIV, the virus that causes AIDS.

Are antiretroviral medications used to treat HIV infections, the newest weapon in the fight against HIV/AIDS? Photo (Michigan Messenger photo illustration)

But being a candidate for a masters degree in public health and for a Ph.D in women’s studies at the University of Michigan, Hoppe knew that if he were prescribed a 28-day course of the medicines used to treat HIV for those infected, that could actually prevent him from contracting the virus. The treatment is called nonoccupational postexposure prophylaxis (nPEP) by the U.S. Centers for Disease Control and Prevention, and is modeled on more than 15 years of similar prevention methods for health care workers.

However, getting access to the medications, he said in an interview, led to a confrontation with a nurse practitioner with U-M’s University Health Service, where he was denied access to the medications not once, but twice. Not only did the staff continue to refer to the antiretroviral medications as “antibiotics,” he says the nurse practitioner was more concerned about judging his behavior than in treating his medical situation.

“She told me, at this point, she said ‘Well you had your chance to protect to yourself and you didn’t, so …’ and she sort trailed off,” Hoppe said.

Hoppe’s experience may not be uncommon in Michigan hospitals, health clinics and health departments, a Michigan Messenger investigation has found, and some of that confusion might rest in the state’s failure to have any written policies, procedures or protocols relating to the use of antiretroviral medications in preventing HIV infections.

Use of postexposure prophylaxis in health care

PEP was first put into a policy and guideline form following the release of protease inhibitors and other classes of antiretroviral medications. The combination is called Highly Active Antiretroviral Treatment, or HAART. This was a natural outgrowth of the move in the late 1980s and early ’90s to prescribe health care workers the drug AZT following exposure to infected body fluids in medical settings. Almost exclusively such exposures involved the health care worker sticking themselves with a needle which had infected blood in it.

Those guidelines were released in a June, 1996 memo from CDC that said “postexposure prophylaxis (PEP) may reduce the risk for HIV transmission after occupational exposure to HIV-infected blood” and noted a 79 percent decrease in the risk of HIV infection after its use.

Later that year, the U.S. Food and Drug Administration approved new medications to add to medical treatment of HIV. Those new classes of drugs were added to CDC recommendations for PEP in May 1998, with the following message:

“Recommendations for PEP have been modified to include a basic 4-week regimen of two drugs (zidovudine and lamivudine) for most HIV exposures and an expanded regimen that includes the addition of a protease inhibitor (indinavir or nelfinavir) for HIV exposures that pose an increased risk for transmission or where resistance to one or more of the antiretroviral agents recommended for PEP is known or suspected.”

Postexposure Prophylaxis medications Kaletra, the yellow pills, and Truvada, the blue pills. (Michigan Messenger photo illustration)

In June 2001, the CDC again updated its recommendations for PEP, and expanding the medications recommended for use in prevention of infection not only with HIV, but with Hepatitis B or C. The new guidelines also addressed the possibility of viral resistance to a variety of medications in the PEP protocol.

“Recommendations for HIV PEP include a basic 4-week regimen of two drugs (zidovudine [ZDV] and lamivudine [3TC]; 3TC and stavudine [d4T]; or didanosine [ddI] and d4T) for most HIV exposures and an expanded regimen that includes the addition of a third drug for HIV exposures that pose an increased risk for transmission. When the source person’s virus is known or suspected to be resistant to one or more of the drugs considered for the PEP regimen, the selection of drugs to which the source person’s virus is unlikely to be resistant is recommended.”

What’s good for the goose is good for the gander

While most medical professionals, and the state of Michigan’s HIV/AIDS Prevention and Intervention Section (HAPIS), are aware of the occupational exposure PEP guidelines, the growing body of literature featuring the effectiveness of nonoccupational postexposure prophylaxis (nPEP) has gone largely unnoticed. A nonoccupational exposure includes sexual assault, unprotected sexual behavior and the use of unclean needles in drug use.

The body of literature includes January 21, 2005, CDC guidelines which highlighted the effectiveness of nPEP. That document outlines the case for, as well as some reservations about, nPEP. But it specifically notes:

“In addition, certain clinicians and exposed patients are unaware of the availability of nPEP or unconvinced of its efficacy and safety. Finally, access to knowledgeable clinicians or a means of paying for nPEP might constrain its use … Surveys of clinicians and facilities indicate a need for more widespread implementation of guidelines and protocols for nPEP use (61). In a survey of Massachusetts emergency department directors, 52% of facilities had received nPEP requests during the preceding year, but only 15% had written nPEP protocols (62). Similarly, in a survey of Massachusetts clinicians, approximately 20% had a written nPEP protocol (63). Among pediatric emergency medicine specialists surveyed throughout the United States and Canada, approximately 20% had a written policy about nPEP use, but 33% had prescribed it for children and adolescents; different prescribing practices were reported (64). In a survey of 27 European Union countries, 23 had guidelines for occupational PEP use, but only six had guidelines for nPEP use (65).”

The study cites the potential side effects of the medicines — which in extreme cases can include liver failure — as well the cost of the medications, which can run as high as $3,000 for a 28-day supply, as additional reasons that clinicians might be avoiding the nPEP guidelines altogether.

In addition to the CDC guidelines, the World Health Organization in 2007 (PDF) released a protocol which outlines the use of PEP and nPEP.

Hoppe’s Philadelphia hope

It was 1 a.m. and Hoppe was in a city far from Ann Arbor, but he knew he needed access to postexposure prophylaxis.

U of M grad student Trevor Hoppe laughs with incoming Detroit City Council President Charles Pugh at a meeting about HIV in Ferndale last month. Photo: Todd A. Heywood/Michigan Messenger

He called the Mazzoni Center in Philadelphia. The lesbian, gay, bisexual and transgender health center provided him a reference to a local doctor who concurred with Hoppe’s assessment of his situation. He needed to start PEP, and the sooner the better. But the doctor was uncomfortable writing a prescription for the medication for Hoppe, because he was not an area resident and not a patient of Mazzoni, which would make the necessary follow up and monitoring of PEP adherence and possible side effects impossible. The doctor, Hoppe said, recommended he call the University of Michigan to see if doctors there would prescribe the medications.

So he called the University Health Service’s hotline, designed to help patients triage health events which do not have an immediate need to be treated in a hospital emergency department.

He was greeted by a nurse practitioner, he said, and promptly explained his situation and his need for access to PEP. For the medication to work in preventing an infection, it has to be started no later than 72 hours after exposure, with better outcomes the sooner the protocol is started.

“She didn’t understand what I was talking about when I talked about postexposure prophylaxis, that was the first issue. I had to explain to her what these drugs were; what these antiretrovirals were, that she had never heard of which was my initial frustration of having to explain what I needed from a health care provider,” Hoppe said. “She referred to them these antiretrovirals at one point as antibiotics, which signaled to me she didn’t know what I was talking about. She recommended I go to the emergency room. I explained it was an unnecessary and wasteful step.”

The exchange with the nurse practitioner continued.

“She told me at this point, she said, ‘Well you had your chance to protect to yourself and you didn’t, so…’ and she sort trailed off. At that point and I sort of interrupted her and said ‘Excuse me it’s not your job to moralize this situation, tell me that I have some sort of price to pay for the situation I am in. There are drugs available that can lessen my chances of seroconverting from this potential exposure to HIV and that’s the end of the story as far as you’re concerned.’”

The nurse backed off at this point, Hoppe said, and agreed to consult with the doctor on duty. She promised she would call back.

In the meantime, Hoppe spoke again with the Mazzoni Center doctor and told her the tale of trying to get local doctors in Michigan to write a prescription. The doctor, Hoppe said, saw similar responses from health care providers all the time. She then assisted Hoppe in gaining access to the medications, including hunting down a 24-hour pharmacy in Philadelphia which had both medications in stock.

As he was preparing to get the medications, the nurse practitioner from Michigan called back.

“She said the doctor on duty didn’t know about these drugs and she said she was sorry, [UHS] was not going to help me with this matter,” he said. “I was sort of on my own.”

Rick Fitzgerald, a spokesman for the University of Michigan, declined to comment on Hoppe’s case, saying he was “unfamiliar with the situation.”

He said, however, that the health service typically refers weekend callers with concerns about HIV exposure to the emergency room, and that doctors “typically don’t prescribe medication over the phone.”

Location could be the difference between access to medications or not

A review of county health clinics and hospitals in Michigan found wildly varying adherence to the January 2005 CDC memo and guidelines for nPEP.

In Kent County, officials refer patients with exposures to HIV through nonoccupational events to the area infectious disease specialist, said Denise Bryan, STD and HIV supervisor for the county’s health department.

“We don’t have specific guidelines,” Bryan said. “It’s outside the scope of what we do. It would have to be a referral [to an infectious disease specialist]. It would not be good medicine to just write a script [prescription].”

Bryan pointed to potential toxicities and noted that many people put on PEP from occupational exposures do not complete the course of medications because of side effects.

She also said the clinic has not had any clients seeking the treatment.

But in Ingham County, the health department does provide the medication and support for nPEP, said Marcus Cheatham, a department spokesman.

“We do offer the medications, and we stock them here,” Cheatham said.

The difference between Kent and Ingham counties could be the fact that Ingham has an infectious disease clinic specializing in HIV care embedded in its adult health clinic. This puts those knowledgeable about HIV, infection, HIV medications and other issues related to nPEP together under one roof. In Kent, to get that amount of expertise, one has to leave the health department to find it from private care providers.

Erica Phillipich, from the Michigan State University Olin Health Center’s Center for Sexual Health Promotion, said doctors at the clinic located on the East Lansing campus are encouraged to discuss HIV exposure concerns with patients. In an e-mail, Phillipich wrote:

“If a student presents with concerns about HIV exposure, they have the opportunity to meet with a provider to discuss what option would be best for them. The provider would refer to the CDC’s PEP recommendation and help the student decide what course of action to take.”

The CDC PEP recommendations she’s referring to are those contained in the January 2005 memo. She said Olin does not have a written policy on implementing the nPEP recommendations.

Fitzgerald, said U-M’s Univeristy Health Service staff directs patients to the emergency room for evaluation.

“Health Services is not open on weekends,” Fitzgerald said. “So referring people to the emergency room is the best way to get them help quickly.”

Even the actions of hospital emergency rooms vary.

At the University of Michigan Health Systems, an emergency room physician confronted with an HIV exposure case will call in an infectious disease specialist to consult. If one is not available, the doctor will write a two-week prescription of the nPEP drugs, and arrange an appointment with the patient to follow up with a specialist, according to a health system representative.

At Detroit Receiving Hospital, Rose Fernadez, the director of the emergency department, said the hospital utilizes the CDC’s nPEP protocols.

Failure of state policies

Part of the explanation for such a range of disparate policies by health care providers may lie in the fact that the Michigan Department of Community Health has no written policies, procedures, recommendations or memos relating to the nPEP.

MDCH spokesman James McCurtis said the absence of such written documents does not mean the department is not discussing nPEP with providers across the state.

“It’s not mandated, we provide referrals,” McCurtis said. Those referrals are to the CDC’s PEP hotline — which is really designed for doctors, not patients — or local health departments, which may or may not provide the medication.

When asked if MDCH had any written protocols or policies, McCurtis responded. “No. I don’t believe there is a solid, written-in-stone policy that talks about nonoccupational post exposure prophylaxis,” McCurtis said. “But just because there isn’t a policy, doesn’t mean we’re not talking about it.”

Asked to clarify how many times nPEP had been mentioned in MDCH memos to health departments, outlining specific strategy, McCurtis said he did not know, adding that it would be unfair to say that the lack of a set policy is a sign of departmental neglect.

Also on the phone with McCurtis was Robert Berri, a public health consultant in quality assurance for the MDCH HIV/AIDS Prevention and Intervention Section which coordinates all HIV response for the state.

“There is a policy. We really push the prevention,” Berri said. “We ask people [health care workers] to take precautions, universal precautions, or to use condoms. We have great prevention programs.”

Those programs are run under the mandate of the state’s three-year prevention strategy, which is developed with stakeholders such as HIV-positive people, doctors, prevention workers and public health officials. That document is shared with the CDC for granting purposes. But both Berri and McCurtis acknowledge nPEP is not included in the strategy, which is currently being rewritten for the new three-year cycle which begins in January.

Berri said increased news coverage of nPEP was important, adding that a link to the CDC nPEP guidelines on MDCH’s website would be “a really great idea.” MDCH’s website currently has a link to the occupational PEP protocols, as well as the the national PEP hotline.

In addition, Berri said nPEP was not that big of an issue, if he were to judge by phone calls. He said he has had three calls in five years from people seeking information about PEP. He was uncertain if those were people seeking information because of an occupation exposure or from a nonoccupational exposure. All were referred to the national PEP hotline.

Prevention vs. treatment

Concerns about the effects of post-exposure treatment on the psychology of prevention were mentioned in the CDC’s January, 2005 memo, which addressed the “possible decrease in risk-reduction behaviors resulting from a perception that postexposure treatment is available,” but the document refers to several studies that minimized that risk.

While Hoppe himself has taken nPEP, he is not a fan of pushing it loudly as a prevention measure.

“Well, to suggest that PEP is a strategy we should sort of rev up to the level of condom use is not an ideal goal,” said Hoppe. “It should be something we keep in mind, it shouldn’t be something you intentionally take time and time again.”

Regardless of whether the use of nPEP is promoted to patients, Hoppe said health care providers need to be educated on the subject and every doctor who deals with patients facing non-occupational exposure must be ready and willing to follow the CDC guidelines and prescribe the appropriate medications.

“I certainly think there needs to be more awareness that these drugs exist,” he said. “They need to be made readily available to anyone who needs them.”