Milestone: Medsafe Approves Truvada For Use As PrEP
The New Zealand Medicines and Medical Devices Safety Authority has approved the use of Truvada as PrEP - confirming the drug is a safe and effective way of preventing HIV transmission through sex.
PrEP is a preventative drug for HIV - taken daily by those at high risk of acquiring the virus, it has been shown in many international studies to stop HIV from taking hold and spreading in the body. If PrEP isn't taken daily, there may not be enough medicine in the bloodstream to block acquisition. Click here for more info.
There's still a lot of work to do before PrEP becomes funded in New Zealand, but this is a big step in the right direction.
What Else Is Happening In The PrEP Space In New Zealand?
- The NZPrEP study is due to commence this month. This two-year study will make PrEP available to 150 gay and bisexual men in Auckland who are at high risk of acquiring HIV, and seeks to show PrEP's acceptability in New Zealand.
- Even with Medsafe's approval, the cost of the drug is very prohibitive - around $1000 a month. PHARMAC and drug manufacturer Gilead need to negotiate terms for public funding to make PrEP affordable for those who need it.
“Without PHARMAC funding, it will be difficult to maximise the potential benefit of PrEP. We call on both PHARMAC and Gilead Sciences, to agree on terms for public funding so that this ground-breaking tool is affordable for New Zealanders at highest risk of HIV. Making this tool available would be a giant leap forward towards our ambitious goal of ending new HIV transmissions in New Zealand by 2025,” says Jason Myers, Executive Director of NZAF.
- It appears the two key patents on Gilead's Truvada expire in July 2017. When this happens, PHARMAC should be in a good position to negotiate a very affordable price for the public health system.
- Work is underway to improve access to generic versions of PrEP from overseas. This could be a cost-effective way of providing access to the drug, but NZAF is currently working through two key issues that are preventing progress:
- There aren't many doctors in NZ with good knowledge of PrEP - it's more than just a prescription, it's part of a comprehensive sexual health programme that includes regular monitoring of HIV status, other STIs and kidney function. It’s important that doctors have good training in order to maximise patient safety and PrEP effectiveness.
- There is no way of knowing the quality of the imported generic PrEP, and Medsafe claims that the risk regarding this falls on the doctor who prescribed it, rather than the person ordering it. This means that many doctors are uncomfortable prescribing generic PrEP for importation, for fear of being held liable in the event that it turns out to be of poor quality.