PEP Guidelines

Prescribing PEP

Important note for medical and nurse practitioners who have not previously prescribed HIV PEP

The availability of generic formulations of tenofovir disoproxil 300 mg /emtricitabine 200 mg, (TD/FTC) used for PrEP, now make it possible for any prescriber to provide a private prescription for TD/FTC as two-drug PEP at a reasonable cost (at the time of publication: approximately $40-50 for a one-month course). Traditionally the medication used for two-drug PEP (TD/FTC) has only been available at emergency departments, sexual health clinics, HIV specialists or other accredited HIV s100 prescribers, however, due to widespread uptake of PrEP, TD/FTC is now also available in many community pharmacies. The medications used are not Therapeutic Goods Administration (TGA) approved, or PBS listed for PEP, therefore, a private prescription for TD/FTC with no repeats needs to be written.

Please follow the guidelines outlined in this document to assess if your patient fits the recommendation for two-drug PEP and, if unsure, contact your local PEP telephone support line. If two-drug PEP is indicated and the individual is considering starting PrEP, as there are likely to be ongoing HIV exposures, a 3-month prescription for PrEP (TD/FTC 30 tabs with 2 repeats) can be offered, as PrEP and two-drug PEP are the same medication. Alternatively, write a private prescription for PEP (TD/FTC 30 tablets, no repeats) and arrange follow-up.

As PEP medication comes in 30-day supplies, prescriptions can be written for 30 days. Advise the individual to take 28 days and keep the remaining 2 tablets to allow immediate commencement of PEP should they have a future exposure.

As generic formulations are not currently available for dolutegravir, the current recommended third drug used for PEP, if the individual requires three-drug PEP, please consult your local PEP phone line for advice on where to access dolutegravir.

Local telephone support is available here for PEP prescribing in each Australian jurisdiction.

Provide the full course at first presentation

Previously, anecdotal reports suggested potential benefits of starter packs, including clinical review within the first week to ensure completed baseline pathology and to allow modification of inappropriate or poorly tolerated PEP regimens. However, a systematic review and meta-analysis of outcomes of PEP initiation using starter packs (versus dispensing the full 28-day course) suggested that starter packs do not improve acceptance and may negatively affect completion of PEP, with almost 30% of those provided with a starter pack not returning for follow-up.29,59 PEP starter packs of 5-7 days remain an option for emergency department presentations, especially presentations in rural and remote and low PEP presentation settings, where timely specialist advice may not be available. In some settings, starter packs may contain all three drugs, with patients receiving either two or three drugs depending on the exposure.

If a three-drug PEP regimen is recommended and the third drug is not available, a two-drug regimen may be initially prescribed. Contact the PEP phoneline in your state or the closest PEP providing site for advice on where to obtain the third drug.

What to prescribe

The current recommended first-line two-drug regimen is co-formulated tenofovir disoproxil 300mg and emtricitabine 200mg (TD/FTC) taken once daily. This regimen is ideal for PEP because it is well tolerated with good anogenital tissue penetration.60 In addition, TD/FTC is now available in affordable, generic forms.

Where a third drug is required, dolutegravir is recommended.

2-drug regimen

Tenofovir disoproxil* 300mg /emtricitabine 200mg (daily)

3-drug regimen

Tenofovir disoproxil* 300mg /emtricitabine 200mg (daily)

PLUS

Dolutegravir 50mg (daily)

If dolutegravir is unsuitable due to drug interactions use raltegravir 1200 mg daily (see Table 5)

Legend

* There are four salts of tenofovir disoproxil available with slightly different dosages, which are considered bioequivalent: maleate, phosphate, fumarate and succinate
In general, tenofovir disoproxil and emtricitabine with dolutegravir is well tolerated when taken as PEP.21,28,29,31,32,61,62

If a patient reports intolerable or serious side effects from a previous PEP course or has an e-GFR < 60mL/min:

  • An alternative PEP regimen should ideally be prescribed (discuss with specialist or PEP phone line)
  • In emergency (out-of-hours) situations (unless previously reported side-effects were serious), the available PEP regimen should be prescribed with urgent specialist follow-up arranged to monitor the PEP regimen.

Medications and cautions

Table 5: Specific medications and cautions

MedicationComments and cautions
Tenofovir disoproxil
  • Use with caution or avoid in renal disease (eGFR <60), consult specialist for alternative (tenofovir alafenamide) if eGFR <60

  • Avoid high doses of NSAIDS

  • Where tenofovir is directly contraindicated seek expert advice.
Dolutegravir
  • Phenytoin, phenobarbital, rifampicin, St John's Wort, carbamazepine all reduce dolutegravir levels. If unable to cease above medications, use raltegravir 1200 mg daily

  • Antacids containing polyvalent cations e.g. Mg or Al - use at least 2 hours before or 6 hours after the dolutegravir dose

  • Products containing calcium or iron - use at least 2 hours before or 6 hours after the dolutegravir dose OR dose concomitantly with food

  • Metformin - increase monitoring of glycaemic control, adjustment in metformin dose may be required.
Raltegravir
  • Small risk of rhabdomyolysis - inform patients about the potential for myalgia and the need to re-present if myalgia occurs. Caution patients who engage in heavy gym work about the increased risk of rhabdomyolysis, especially when anabolic steroids are used.

  • Check CK, renal function and urinary myoglobin in patients who report myalgia on raltegravir

  • Advise against the use of statins while on PEP containing raltegravir.

Adverse Events

Proximal renal tubular dysfunction (including Fanconi syndrome) has been reported among people with HIV on tenofovir disoproxil-containing therapy,63 but has not been reported among patients prescribed a 28-day PEP course.

Myopathy or severe rhabdomyolysis has been reported, albeit rarely, with use of dolutegravir and raltegravir.64-67 It is advised that:

Patients on PEP should be monitored for symptoms

Caution should be taken among those with a history of myopathy, or co-administration with medications such as statins,68 which may also cause myopathy

Creatine kinase (CK), renal function and urinary myoglobin should be checked in patients who report significant myalgia.

Potential Drug-Drug interactions can be checked using the Liverpool HIV Drug interaction checker.

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