Pam Harrison

July 07, 2015

Offering a postexposure prophylaxis (PEP) "starter kit" to patients attending a sexually transmitted infection clinic is feasible and appears to be almost uniformly accepted by clientele who are concerned about HIV infection after high-risk sexual exposure to the virus, new research shows.

"PEP is time sensitive — the sooner you get the medication on board, the better the chance you have of preventing infection," said Emily Westheimer, from the New York City Department of Health and Mental Hygiene.

"But there are only a few places that give PEP for free to someone who does not have health insurance, and I absolutely think that by offering these starter kits, we filled an unmet need," she told Medscape Medical News in an email.

The findings were presented at the 10th International Conference on HIV Treatment and Prevention Adherence in Miami.

The New York City Department of Health and Mental Hygiene's sexually transmitted infection clinics began offering PEP starter kits in 2014.

Patients reporting select high-risk exposures in the previous 36 hours were eligible to receive a free 3-day three-drug regimen kit. Staff at the clinics also helped patients obtain the remainder of the standard 28-day course of PEP medication.

In addition, eligible patients were referred for further medical and laboratory evaluation. Referral facilities were responsible for follow-up HIV testing.

Of the 209 patients offered the starter kit from April to December 2014, 202 (97%) accepted it. When contacted by clinic staff 2 days after receiving the kit, 98% of patients reported taking the medication.

Clinic staff also called kit recipients 30 days after PEP was initiated. Although they were only able to reach 63% of starter kit recipients, 95% reported that they had completed the regimen.

In addition, referral facilities reported that 84% of patients attended at least their first referral appointment.

"Many of our patients are motivated to do whatever they can to stay HIV-negative. They were worried enough to come to the clinic and seek out PEP, so it wouldn't be a surprise that many would finish the full course," Westheimer explained.

Patients also received counseling at the referral center, where the importance of completing the regimen was stressed.

However, "patient-reported adherence needs to be taken with a grain of salt," Westheimer cautioned. "We had a relatively low response rate to the 30-day call, so we really don't know what the actual PEP completion rate is."

It is also difficult to assess just how effective PEP is at preventing HIV infection.

But, as Westheimer noted, one study that tried to quantify the effectiveness of PEP in the context of occupational exposure found that PEP reduced the risk for HIV infection by about 80%, and this was with a very early PEP regimen that included only zidovudine (AZT) (multiple brands).

And because "AZT caused major side effects in the majority of those who took it, adherence was suboptimal," Westheimer observed. "Nowadays, we offer a three-drug PEP regimen that causes few to no side effects, so presumably PEP adherence and effectiveness should be much higher."

PEP is only one type of biomedical HIV preventive measure available to people at high risk for HIV infection.

When a person has ongoing exposure to HIV — such as an HIV-negative partner of someone who is HIV-positive — pre-exposure prophylaxis (PrEP) can be prescribed. "I sometimes use the analogy that PrEP is like birth control and PEP is like the morning after pill," Westheimer said.

"Our hope is that by connecting patients to referral facilities that are sensitive to the unique needs of high-risk populations, patients will be more likely to find a place where they can get all of their medical needs met in one place," she explained.

Gap in Care Cascade

HIV prevention suffers from a very significant gap in the care cascade, and many who might benefit from biomedical interventions such as PEP and PrEP fail to receive care, said Benjamin Young, MD, from the International Association of Providers of AIDS Care, in Washington, DC.

"Even if care is engaged, structural, behavioral, or financial barriers limit the ability of at-risk individuals to successfully complete treatments," he told Medscape Medical News in an email.

Because treatment is only effective if it is started within 72 hours of HIV exposure, "timely initiation of PEP can be seen as a medical emergency," Dr Young explained.

"This can be particularly problematic if the patient presents for care in the evening or on the weekend, and perhaps even moreso if the exposure occurs in the context of sexual assault," he said.

Jury Out on Starter Packs

Starter packs have been one strategy to deal with access to PEP. The starter kits are an acknowledgement of the "challenges of health system navigation, which are key issues in the HIV prevention care cascade," said Dr Young.

"The positive results from the New York City Department of Health are innovative and encouraging."

However, a recent systematic review by the World Health Organization (WHO) revealed that 28% of people provided with a PEP starter pack failed to return for their subsequent appointment and therefore did not receive their full course of PEP (Clin Infect Dis. 2015;60 Suppl 3:S182-S186).

Although the quality of the evidence reviewed was rated as very low, the WHO researchers nevertheless concluded that their findings suggest that starter packs do not improve adherence to PEP and could result in lower adherence and completion rates.

Emily Westheimer and Dr Young have disclosed no relevant financial relationships.

10th International Conference on HIV Treatment and Prevention Adherence: Abstract 10. Presented June 29, 2015.

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