Expert Advisory Group on AIDS
Providing expert scientific advice on HIV
Change to recommended regimen for post-exposure prophylaxis (PEP)
EAGA was asked to review its recommended regimen for occupational post-exposure prophylaxis (PEP) in light of new evidence. When the PEP regimen was last changed, it was agreed that consistency should be maintained with the recommended regimen for PEP following sexual exposure (PEPSE).
- some PEP starter packs include domperidone1 as an anti-emetic to counteract side effects associated with the protease inhibitor (Kaletra) component of PEP;
- domperidone is now contra-indicated for use with boosted protease inhibitors (such as Kaletra) because of the risk of cardiac adverse events due to QT interval prolongation ;
- the integrase inhibitor, raltegravir, can be stored at ambient temperature and is better tolerated when used as PEP than combinations including a ritonavir-boosted protease inhibitor , while having equal efficacy in suppressing viral replication in infected individuals [3,4].
EAGA recommends that
- PEP starter packs that include domperidone should have domperidone removed before being issued. Prescribers need to be aware of the interactions between domperidone and Kaletra and prescribe appropriate alternative anti-emetics if continuing to use Truvada/Kaletra e.g. while using up existing stocks of PEP starter packs.
- Until such time as the PEP/PEPSE guidelines have been systematically reviewed and updated, the preferred first-line regimen for PEP (for occupational and non-occupational use) is Raltegravir/Truvada for 28 days.
One Truvada tablet (245mg tenofovir disoproxil (as fumarate) and 200mg emtricitabine (FTC)) once a day
One Raltegravir tablet (400mg) twice a day
The reasons for this choice include
- No significant safety issues with this combination from extensive testing in HIV-infected patients .
- Raltegravir is better tolerated than Kaletra, so switching is likely to improve adherence, and hence efficacy, of PEP.
- There are fewer drug interactions with integrase inhibitors than with other classes of antiretroviral agent.
- Raltegravir is stable for at least 1 year at room temperature2,
- MHRA. Domperidone: risks of cardiac side effects – indication restricted to nausea and vomiting, new contraindications, and reduced dose and duration of use. Drug Safety Update volume 7 issue 10, May 2014: A1.
- Mayer KH et al. Raltegravir, tenofovir DF, and emtricitabine for postexposure prophylaxis to prevent the sexual transmission of HIV: safety, tolerability, and adherence. J Acquir Immune Defic Syndr 2012; 59: 354-9.
- Ridler SA et al. Class-sparing regimens for initial treatment of HIV-1 infection. N Engl J Med 2008; 358: 2095-106.
- Gotuzzo E et al. Sustained efficacy and safety of raltegravir after 5 years of combination antiretroviral therapy as initial treatment of HIV-1 infection: final results of a randomized, controlled, phase II study (Protocol 004). J Acquir Immune Defic Syndr 2012; 61: 73-7.