COMMENTARY

Update to NYSDOH AIDS Institute Guidelines on HIV Post-exposure Prophylaxis

Samuel T. Merrick, MD

Disclosures

June 17, 2015

Recently the Medical Care Criteria Committee of the New York State Department of Health AIDS Institute updated all three guidelines addressing the vital topic of HIV post-exposure prophylaxis (PEP) for exposures that result from sexual assault,[1] nonoccupational exposure (nPEP),[2] and occupational exposure (oPEP).[3]

In 2012, among other important changes, the preferred regimen was changed to recommend tenofovir (Viread®) plus emtricitabine (Emtriva®) (or lamivudine [Epivir®]) plus raltegravir (Isentress®), in part based on improved tolerability and higher completion rates of the 28-day recommended course for both nPEP and oPEP. With the most recent update in October 2014, dolutegravir (Tivicay®) became an additional choice for the third drug, so the preferred regimen is now tenofovir plus emtricitabine (or lamivudine) plus either raltegravir or dolutegravir.

Historically, adherence to the full 28-day course of PEP had been unacceptably low, with one large meta-analysis showing an overall completion rate of only 56.6%, varying by exposure category from 65.6% in nPEP to as low as 40.2% in cases of sexual assault.[4] Rates of completion for regimens including raltegravir have been reported to be higher relative to previously recommended regimens: 76.3% in one study[5] and 92% in a second study.[6] A substitution of dolutegravir for raltegravir should have identical or greater success given the similar side-effect profile and once-daily dosing, as well as extensive clinical experience showing excellent tolerability of this widely prescribed medication. Nevertheless, education and support throughout the course of treatment is essential, regardless of the regimen, as side effects and discontinuations have been reported even with this better-tolerated combination.[7] Interventions such as adherence counseling and psychological support throughout treatment have been shown to increase completion rates.[8]

Dolutegravir, approved in the United States in August 2013, is, like raltegravir, an integrase strand transfer inhibitor. It has a favorable side-effect profile and has the advantage over raltegravir of once-daily dosing when not used with other potent inhibitors of UGT1A/CYP3A. Raltegravir and dolutegravir are probably equally efficacious when combined with the nucleoside backbone, so the final decision on PEP regimen may depend on factors such as availability and cost. Neither of these drugs has food restrictions, but, importantly, both may be affected by concurrent administration of polyvalent cations such as calcium, aluminum, magnesium, or iron, the first three of which are common ingredients found in over-the-counter antacids. Dosing of antacids should be separated by at least 2 hours before taking the integrase inhibitors and, preferably, up to 6 hours after. There are no contraindications to using proton pump inhibitors with these regimens.[9,10]

The October 2014 update also highlights the need to make every effort to test the source patient when possible, and emphasizes the importance of considering plasma HIV RNA testing of the source patient if the initial HIV screening test is negative but the possibility of HIV exposure exists within 6 weeks prior to presentation. HIV RNA testing should also be performed if the source patient has a positive antibody or antigen test but the confirmatory antibody differentiation test is indeterminate. If possible, a newer fourth-generation antibody/antigen HIV test should be used in accordance with the current recommended algorithm for testing.[11] Plasma HIV RNA testing can shorten the time to diagnosis of acute HIV infection, during which individuals are at high risk for transmission.

Other important recommendations remain the same:

  • All exposures require urgent medical evaluation. The guideline committee further emphasizes that PEP should be initiated as soon as possible, ideally within 2 hours of exposure. A first dose of PEP should be offered while evaluation is underway. Initiation of PEP should not be delayed while awaiting information about the source patient or results of the exposed individual's baseline HIV test.

  • Baseline HIV testing of the exposed individual should always be obtained after an exposure, even if the exposed individual declines PEP.

  • Regardless of whether the exposed individual accepts or declines PEP, if the post-exposure evaluation determines that PEP is indicated, repeat HIV testing at 4 weeks and 12 weeks should be obtained. A negative HIV test result at 12 weeks post-exposure reasonably excludes HIV infection related to the exposure; routine testing at 6 months post-exposure is no longer recommended.

  • In cases of nonoccupational exposures, in individuals presenting for repeated courses of nPEP in the setting of ongoing high-risk sexual behavior, pre-exposure prophylaxis (PrEP) should be discussed and offered where appropriate.[12]

On April 19, 2015, the governor of New York announced the Blueprint to End the AIDS Epidemic, which details a plan to reduce new HIV infections in New York State to below epidemic levels by the year 2020. While this will require renewed focus, new investments, regulatory changes, and reorganization or expansion of existing care delivery networks, it is an exciting and achievable goal. Post-exposure and pre-exposure prophylaxis are featured in several of the recommendations. Awareness of the availability of methods to prevent infection after exposure, among both the at-risk population[13] and medical care providers,[14] remains far lower than it ought to be, given that PEP has been an integral part of medical care since the advent of zidovudine (Retrovir®) in the 1980s.[15] Both the New York City and New York State Departments of Health (NYSDOH) have launched campaigns aimed at increasing awareness of PEP and PrEP among medical providers and the general public. As part of its PrEP & PEP: New Ways to Prevent HIV campaign, the city distributed an action kit to clinical practices citywide; the NYSDOH's letter to medical care providers statewide detailed available resources.

It is incumbent upon all providers, particularly those on the front line in primary care, to have the knowledge and confidence to implement this safe, effective measure to reduce ongoing forward transmission of HIV, and all of us must redouble efforts to educate the populations who can benefit most.

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