Victoria’s expanded PrEP study (PrEPX) has been approved by Alfred Health — a key milestone in the initiative’s development. Now that PrEPX has been given the green light, the process to import a generic PrEP drug has begun.
More approvals have to be obtained from Customs in order to import the drug; it’s anticipated the drug — a bio-equivalent to Truvada —will be ready for dispensation to study participants mid-to-late July. More than 1,400 people have so far registered for PrEPX (2,600 places are available in total).
Within the next six-to-eight weeks, all those registered will be assessed for eligibility. All gay, bisexual, transgender, heterosexual people, and people who inject drugs are eligible if they are at risk of contracting HIV. To be screened for the PrEPX study, participants must first sign a consent form, answer a number of questions about sexual history, and have some blood tests carried out — including an HIV test. PrEPX participants must have a Medicare card, be over 18 years of age, have documentation of an HIV-negative test, and a kidney function blood test result.
Truvada has now been approved by the Therapeutic Drugs Administration for use as PrEP. The Pharmaceutical Benefits Advisory Committee (PBAC) is meeting in July for subsidisation approval. If PBAC approved, Truvada then has to be signed off on by the Federal Government — meaning PrEP is unlikely to be available on the Pharmaceutical Benefits Scheme until 2017. The PrEPX study is therefore an important bridge for people at risk of HIV.
There are similar PrEP studies being implemented in NSW and Queensland.
For more information about PrEPX email PrEPX@alfred.org.au or call 0429 4737 318.