UK health workers should have antiretrovirals off-label
This article was originally published in Scrip
Post-exposure prophylaxis (PEP) with antiretrovirals prescribed off-label is recommended for UK healthcare workers who may have come in contact with HIV in an occupational setting.
In updated guidance from the department of health, healthcare workers should be offered a course of at least 28 days of three antiretrovirals within 72 hours of significant occupational exposure to blood or another high-risk body fluid from a patient or other source known to be HIV infected or considered to be at high risk of HIV infection but where test results have not been or cannot be obtained.
The UK chief medical officer's expert advisory group on AIDS has issued guidance that echoes recommendations for prophylaxis dispensed in local sexual health services following non-occupational exposure. Harmonisation of the recommended regimens for both types of exposure is meant to simplify access arrangements.
The new guidance says Gilead Sciences' Truvada (200mg emtricitabine plus 300mg tenofovir disoproxil fumarate) once daily and two tablets of Abbott's Kaletra (200mg lopinavir plus 50mg ritonavir) twice daily should be available in starter packs for healthcare workers' PEP. GlaxoSmithKline's Combivir (lamivudine plus zidovudine) can be used in place of Truvada if there is difficulty in obtaining starter packs containing Truvada, the guidance notes.
US guidelines recommend two-drug PEP regimens, the guidance notes, although the main arguments in their favour – fewer side-effects and better adherence – are being addressed through better-tolerated agents and lower pill burdens.
An earlier version of the guidance issued in 2004 recommended zidovudine on its own as the nucleoside/nucleotide analogue reverse transcriptase inhibiting component in PEP. The guidance notes that zidovudine is the only drug which has been studied and for which there is evidence of a reduction in risk of HIV transmission following occupational exposure. It adds that no antiretroviral has been licensed for PEP, so they can only be prescribed off-label.
The inclusion of a non-nucleoside reverse transcriptase inhibitor – Boehringer Ingelheim's Viramune (nevirapine) or Bristol-Myers Squibb's Sustiva (efavirenz) – is not recommended because each is associated with short-term toxicity, the guidance says.
Newer classes of drugs, including entry inhibitors and integrase inhibitors, may have a place in PEP in cases of resistant source virus, but there is currently no evidence for their use in this situation, the guidance adds.
The guidance encourages local health administrators to keep abreast of research and to ensure that PEP policies and protocols reflect current best practice.