HIV PEP in Amsterdam: paper suggests policy since 2000 a success

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Only one individual who received HIV post exposure prophylaxis (PEP) in Amsterdam between 2000 – 2003 subsequently tested HIV-positive, according to a paper published in the April 9th edition of the British Medical Journal, and this individual reported unprotected sex after finishing his course of PEP. The paper also reports that making PEP available to individuals reporting unsafe sexual contacts did not lead to either a “tremendous increase in demand” or unsafe sex.

Since 1997 PEP has been made available to hospital staff in the Netherlands reporting possible occupational exposure to HIV. New guidelines relating to the non-occupational use of PEP were issued in 1999. Between 1997 and 2000 provision of PEP, source tracing, testing and follow-up for hepatitis B and C virus, were divided between hospitals and municipal health authorities. In early 2000 a new protocol of introduced which essentially made municipal health authorities responsible for the routine administration of PEP, with hospitals providing back-up in exceptional cases and for the treatment of severe side-effects.

PEP from 2000

All individuals presenting with a possible HIV exposure risk received counselling which fully explained HIV transmission risks. If an individual was thought to have a high risk of HIV, PEP was recommended. However, PEP was discouraged for individuals who were thought to have been placed at a low risk of HIV infection.

An immediate 200mg dose of nevirapine was provided to individuals taking PEP, along with a three day “starter pack” consisting of twice-daily Combivir and twice-daily nelfinavir. A follow-up appointment was made three days later when an additional 25 days treatment was provided. Patients also had their kidney and liver functions assessed after two and four weeks of PEP and were tested for HIV after three months and again after six months.

Glossary

post-exposure prophylaxis (PEP)

A month-long course of antiretroviral medicines taken after exposure or possible exposure to HIV, to reduce the risk of acquiring HIV.

protocol

A detailed research plan that describes the aims and objectives of a clinical trial and how it will be conducted.

diarrhoea

Abnormal bowel movements, characterised by loose, watery or frequent stools, three or more times a day.

occupational exposure

Exposure to HIV as a result of work (job) activities. Exposure may include accidental exposure to HIV-infected blood following a needlestick injury or cut from a surgical instrument

loss to follow up

In a research study, participants who drop out before the end of the study. In routine clinical care, patients who do not attend medical appointments and who cannot be contacted.

The total number of exposures was 1381, increasing from 322 in 2000 to 377 in 2003. Most of the reported exposures were occupational. A total of 172 possible sexual exposures to HIV were reported. Six gay men requested a second course of PEP after possible sexual exposure to HIV.

A total of 225 individuals were provided with PEP. This included 151 people who were provided with PEP after a possible non-occupational exposure.

No infections

Nobody seroconverted for hepatitis B or C virus. In addition, all the individuals possibly exposed to HIV tested HIV-negative after three months.

All but one of these individuals also tested HIV-negative after six months. The exception concerned a gay man who admitted unsafe sexual contacts after completing his course of PEP.

PEP was started within 24 hours by 189 of the 225 (84%) individuals who received it. Of the 53 individuals who were provided with it for possible sexual exposure, the investigators note that only 46% (54/116) started PEP within twelve hours of their possible exposure to HIV.

Side-effects common

Diarrhoea was the most frequently reported side-effect (48%), and fatigue (31%) and nausea (29%) were also common. Three patients were advised to discontinue their PEP because of side-effects: one developed a rash; one had elevated liver enzymes; and the third had extreme diarrhoea and tiredness.

A total of 65 patients stopped taking PEP after it was established that the possible source did not have HIV. Of the 169 remaining individuals, 121 (72%) completed their course of treatment, the remaining patients being lost to follow-up.

PEP after risky sex

A high proportion of the sexual contacts of individuals receiving PEP were identified as HIV-positive (30/42, 71%). The investigators note “people exposed through sexual contact seem to seek HIV prophylaxis when the perceived risk of HIV infection is high.” They also write that the Amsterdam experience of providing PEP for sexual exposure to HIV “did not confirm [concerns] that prophylaxis after unsafe sex leads to tremendous increase in demand and unsafe sex.”

All hospitals in Amsterdam are now participating in the PEP protocol, which the investigators conclude has been a success both for healthcare providers and individuals requiring PEP. To improve adherence and reduce side-effects, the PEP regimen changed with nelfinavir replaced with atazanavir for all possible exposures outside a hospital setting.

References

Sonder GJB et al. Prophylaxis and follow-up after possible exposure to HIV, hepatitis B virus, and hepatitis C virus outside hospital: evaluation of policy 2000 – 2003. BMJ 330: 825 – 829, 2005.