PEP Clock Ticking After Sharps Injury
‘These medications can be taken in pregnancy.’
Infection preventionists involved in post-exposure prophylaxis (PEP) for potential human immunodeficiency virus (HIV) needlesticks should know the clock is ticking after injury follow-up begins. Such needlesticks certainly are a rare event, but the risk of seroconversion is not zero. A call to the National Clinician Consultation Center (NCCC) PEP line could be in order.
“If PEP is going to be started, it has to be started within 72 hours,” says Erin Lutes, MS, RN, PHN, CNS, a clinical nurse specialist at the NCCC at UC-San Francisco. “However, it should be started ASAP after an exposure because it’s clear from animal exposure studies the efficacy of the medication decreases from the time of the exposure.”
Testing of the healthcare worker and source patient is a first step to start assessing the risk factors. “The rationale of testing the exposed person at baseline is to rule out preexisting infection of HIV, hepatitis B or C,” Lutes says. “It will not tell us [with certainty] whether someone has [seroconverted] already from the exposure that they’ve just sustained. If the source person is known to be a person living with HIV, we also want a quantitative HIV viral load. This is really important because we know that a higher HIV viral load constitutes a higher risk of transmission of HIV.”
Lutes spoke at a recent webinar along with NCCC colleague Rebecca Martinez, MS, RN, FNP-C.
The exposed worker and patient also should be tested for hepatitis C virus (HCV) antibodies, and, if positive, follow-up with HCV ribonucleic acid testing. There is no vaccine for HCV, but it is now treatable.
“We have a cure for hepatitis C, and unlike HIV, which is a chronic, lifelong condition, once we assess that somebody has either acute or chronic hep C, we can refer them to treatment immediately,” Martinez says.
There is, of course, a vaccine for hepatitis B and PEP regimens for hepatitis B virus (HBV). The HBV immunization and titer history of the exposed should be determined. In addition to HIV, HBV, and HCV testing should be done on the source patient. If they come back negative, investigation of the HBV and HCV status of the exposed worker can stop.
As this information is accumulated, a shared decision may be reached to administer HIV PEP, which standardly is given in a three-drug regimen with some variation possible on the medication.
“I get a fair amount of calls from providers who are under the impression that these medications are extremely toxic,” Lutes says. “It’s not to say that there aren’t any toxicities. That wouldn’t be accurate. There’s a small, real risk of renal and liver toxicities, but patients are monitored while they’re on these medications. They are on these medications for a very short amount of time, 28 days.
“I’ve also gotten calls where folks think PEP is either six months or a year — or even three days. Others think these medications are completely contraindicated in pregnancy, which is not accurate. These medications can be taken in pregnancy.”
Again, PEP consists of a total of three medications, with one pill containing two of them.
“The first two come in one pill, and that’s tenofovir plus emtricitabine,” Lutes says. “It would be those two medications in one pill, one tablet daily for 28 days. Plus, either raltegravir, at 400 milligrams twice a day for 28 days; or you could do dolutegravir, at 50 milligrams, one tablet daily for 28 days.”
In general, these PEP drugs inhibit HIV viral pathways, cell penetration, and circulating virus overall.
“Most folks tolerate these medications okay,” she said. “The most common side effects are gastrointestinal upset like nausea, very rarely vomiting, diarrhea, headache, insomnia, fatigue, bloating.”
The medications can be taken with or without food, but antacids containing magnesium or aluminum generally should be avoided while on these medications.
The Open Window
A common question is what if a source patient is in the so-called HIV “window period,” which means detectable HIV antibodies have not formed but the patient still could be infectious. “To date, no such instances of occupational transmission have been detected in the United States, hence investigation of whether or not a source person might be in the window period is unnecessary for determining whether HIV PEP is indicated unless acute retroviral syndrome is clinically suspected,” Lutes said.
Acute retroviral syndrome refers to flu-like symptoms that can occur two to four weeks after HIV infection.
There is good news on another common question regarding the risk of getting a bloodborne virus from a used needle in a sharps box.
“One statistic that I find very reassuring is that HIV cannot replicate outside of the human host, therefore infectivity is greatly reduced every hour outside of the body,” she said. “In fact, every nine hours outside of the human body infectivity is reduced by an entire 90%. We get a lot of calls about found needles and sharps containers, trash cans, etc. And there’s actually zero documented cases of HIV transmission from found needles outside of the healthcare setting and only two cases of HIV transmission from found needles within the healthcare setting ever documented.”
Lutes went through a little myth busting, noting that even after decades, there still is a lot of misunderstanding about bloodborne pathogen exposures.
“The first criteria is that there needs to be a body fluid that is considered potentially infectious, and that would include blood; vaginal, seminal or rectal fluids; cerebrospinal fluid; synovial plural, peritoneal, pericardial, amniotic fluid; pus; and breast milk, with the caveat that breast milk is only considered potentially infectious for hepatitis B and C if it is visibly bloody,” she said. “The following body fluids are only considered infectious if they are visibly bloody, and that would be saliva, sputum, urine, feces, sweat, tears, [and] nasal secretions.”
For an exposure to occur, one of these potentially infectious fluids must get into someone’s body through a “portal of entry.” Portals of entry include a percutaneous injury such as a needle stick; a mucosal exposure, such as a splash to the eyes or nose; a cutaneous exposure, which would be a splash to an open wound or break in the skin. A splash of blood on intact skin is not considered an exposure. However, if the area of skin exposed is chapped, abraded, or has eczema, an evaluation should be conducted, she said.
“Bloodborne pathogens are not spread through sharing utensils or cups, kissing, holding hands, hugging, sweat, non-visibly bloody tears, coughing, sneezing, or sharing a toilet,” Lutes said.
Exposure or Not?
With so many variables and conditions to consider, a call to the PEP line can require some detective work. For example, the speakers described a call from a dental office that asked about administering HIV PEP.
A dental assistant felt “pressure” on a middle finger from a dental burr. The patient was a 56-year-old woman who said she was in a monogamous relationship and denied any history of injecting drugs.
The first thing to determine is whether an exposure occurred, which raised these questions for the hotline consultants.
• Was there a break in the glove?
• Was there a break in the skin?
• Was there visible blood in the patient's mouth at any point in the procedure?
“If you determine that there was no exposure then there’s nothing to do from a bloodborne pathogen perspective,” Lutes said. “There’s no HIV, hepatitis B, PEP. There’s no baseline, no follow-up testing. The case is closed. However, for this case, it does seem like we need a little bit more information about whether or not this was an exposure.”
The dental burr was not visibly bloody at the time of the injury, so it’s not entirely clear from the initial information provided that there was an exposure.
“Was there a portal of entry?” Lutes said. “We asked the clinician to clarify was there a break in the glove, was there a break in the skin? There was no break in the glove — she actually filled it with water to check. They also used a magnifier to examine her finger and no wound was observed. Because there was no portal of entry, this cannot be an exposure, so this case is closed.”
Hypothetically, if there had been a break in the dental worker’s skin, the next question would have been, “Was there any visible blood in the mouth of the patient at any time during the procedure?”
“This is really important for dental procedures specifically,” Lutes said. “If they said ‘no,’ then we would close the case for HIV, as non-visibly bloody saliva does not transmit HIV.”
However, the risk of hepatitis B and C transmission from non-visibly bloody saliva is considered negligible but possible.
Had there been an exposure to the dental worker, the question of HBV and HCV transmission would have to be figured out in the absence of clear data. The Centers for Disease Control and Prevention makes no specific recommendations regarding follow-up.
“The PEP line does not routinely recommend follow-up testing in these scenarios, but we don’t take the position that such testing should not occur,” Lutes said. “The advantages of follow-up testing include that it could provide reassurance for the exposed person. We’re not legal experts of course, but it would be documentation of lack of transmission for liability.”
The disadvantages of follow-up testing in this hypothetical case include that some confusion and stress likely would spring from no clearly established path to resolution. “This has a very negligible risk, yet there’s going to be months of follow-up testing, addressing potential false-positive results, possibly increasing work-related stress, creating a period of modified sexual practices or interactions in family planning in certain instances, and increasing overall healthcare cost and time away from work,” Lutes said.
Editor’s note: The NCCC occupational PEP consultation phone number is 1-888-448-4911. Hours of operation are 11 a.m.-8 p.m. ET seven days a week. Information on PEP outside of these times is available in the NCCC’s PEP Quick Guide: https://nccc.ucsf.edu/clinical-resources/pep-resources/pep-quick-guide-for-occupational-exposures/
Infection preventionists involved in post-exposure prophylaxis (PEP) for potential human immunodeficiency virus needlesticks should know the clock is ticking after injury follow-up begins. Such needlesticks certainly are a rare event, but the risk of seroconversion is not zero. A call to the National Clinician Consultation Center PEP line could be in order.
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