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HIV postexposure prophylaxis guidelines revised

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Monitor carefully for side effects

Exposed health care workers and those managing their exposures will now have more PEP options to consider. This offers the benefit of being able to individualize therapy to the individual; however, for providers with less experience in managing HIV exposures, having these options may be more confusing or intimidating. For that reason, expert resources like the HIV PEPline (888-448-4911) will be increasingly important.

These regimens will be more expensive. There aren’t any data to suggest that these three-drug regimens will be more effective in PEP. Here’s why the guideline authors said they made the change:


Dr. C. Bradley Hare

"The recommendation for consistent use of three-drug HIV PEP regimens reflects (1) studies demonstrating superior effectiveness of three drugs in reducing viral burden in HIV-infected persons compared with two agents; (2) concerns about source patient drug resistance to agents commonly used for PEP; (3) the safety and tolerability of new HIV drugs, and (4) the potential for improved PEP regimen adherence due to newer medications that are likely to have fewer side effects. Clinicians facing challenges such as antiretroviral medication availability, potential adherence and toxicity issues, and others associated with a three-drug PEP regimen might still consider a two-drug PEP regimen in consultation with an expert."

Any time you use more drugs, there is an opportunity for side effects. While the medications recommended here are generally safe and well tolerated, careful monitoring for side effects will be important for individuals receiving PEP.

In addition their improved tolerability, I think the other rationale for recommending these exact regimens is based on these regimens being less likely to have resistance.

Dr. C. Bradley Hare is medical director of the HIV/AIDS Clinic at San Francisco General Hospital. He has been a consultant or speaker for the following companies that make HIV medications: Gilead, Bristol-Myers Squibb, Janssen Pharmaceuticals, Merck, and AbbVie Pharmaceuticals.


 

FROM INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY

Revised federal guidelines for managing health care workers who are exposed to HIV recommend using at least three drugs for prophylaxis in all cases instead of assessing a person’s risk to decide on the number of drugs, among other updates to the guidelines.

Changes in the recommended drugs in preferred postexposure prophylaxis (PEP) regimens should make them easier to tolerate than earlier regimens and may increase the proportion of health care workers who are able to complete the 28-day treatment, Dr. David T. Kuhar and his associates said in the new document from the U.S. Public Health Service.

Dr. Ronald Goldschmidt

Another change is that follow-up HIV testing in health care workers on PEP can be shortened to 4 months instead of 6 months if a newer fourth-generation combination HIV p24 antigen/HIV antibody test is used, the guidelines state. The document, which updates 2005 guidelines, was published online in the journal Infection Control and Hospital Epidemiology (2013 Aug. 7 [doi: 10.1086/672271]).

The updates are based on expert opinion in a working group comprised of representatives from the Centers for Disease Control and Prevention (CDC), the National Institutes of Health, the Food and Drug Administration, and the Health Resources and Services Administration, in consultation with a panel of experts, wrote Dr. Kuhar of the CDC and his associates.

The principles of PEP remain the same: Occupational exposures to HIV in health care workers should be considered urgent medical concerns, and should be reported and managed promptly under your institution’s procedures. Determine the HIV status of the patient whose blood or other bodily fluids potentially exposed the health care worker to HIV, if possible, to guide the need for PEP. Start PEP as soon as possible (within hours) after the exposure if PEP is indicated. Expert consultation is recommended, but PEP initiation should not be delayed while waiting for a consult. Close follow-up should start within 72 hours of HIV exposure and include counseling, baseline and follow-up HIV testing, and monitoring for drug toxicity, according to the guidelines.

Clinicians can consult experts locally or can call the National Clinicians’ Post-Exposure Prophylaxis Hotline (PEPline) at 888-448-4911.

The PEPline received approximately 10,000 calls in 2012 from clinicians about potential occupational exposures to HIV, said Dr. Ronald Goldschmidt of the department of family and community medicine at the University of California, San Francisco. He is director of the university’s National HIV/AIDS Clinicians’ Consultation Center, which includes the PEPline. Dr. Goldschmidt was a member of the panel of experts that consulted on the guidelines update.

Several new antiretroviral agents have been approved since the last update to the guidelines in 2005, and more information has become available about the use and side effects of the PEP medications. Clinicians had struggled with the 2005 version’s recommendations to assess the level of risk of HIV transmission in individual exposure incidents, creating problems in deciding whether to use two or three or more drugs in PEP regiments.

The new guidelines’ preferred HIV PEP regimen is oral raltegravir (Isentress) 400 mg twice daily and once-daily Truvada (a fixed-dose combination tablet containing 300 mg of tenofovir and 200 mg of emtricitabine). "Preparation of this PEP regimen in single-dose ‘starter packets,’ which are kept on hand at sites expected to manage occupational exposures to HIV, may facilitate timely initiation of PEP," the guidelines state.

Dr. Goldschmidt cautioned that Truvada should not be used before checking for preexisting renal problems. If there’s a history of renal problems, consult an HIV expert or consider a different regimen, he said.

An appendix to the document lists recommended and contraindicated alternatives.

Although there are no new definitive data showing greater efficacy with three-drug regimens for PEP compared with two-drug regimens for occupational HIV exposures, the new recommendation to use at least three drugs rests on studies showing greater reduction of viral burden in HIV-infected patients on three antiretroviral drugs instead of two, concerns about drug resistance in source patients of occupational exposures, and better safety and tolerability with some of the newer medications. The guidelines add a caveat that two-drug PEP regimens might be considered in consultation with an expert if antiretrovirals aren’t easily available or because of adherence or toxicity issues.

None of the antiretroviral agents have been approved by the Food and Drug Administration for use as PEP.

The previous complicated recommendations to assess a health care worker’s level of risk after a potential exposure to HIV were enshrined in a 2001 version of the guidelines, Dr. Goldschmidt said. The 2005 revision updated the recommended drugs but didn’t simplify the risk assessment. The current update makes decision-making less confusing by recommending at least a three-drug regimen for all occupational PEP cases and using better-tolerated drugs.

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