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Wednesday 09 November 2016


Truvada and Pharmac

Posted in: Health & HIV
By Craig Young - 4th June 2016

In this second article, I'll be dealing with Truvada's progress through the New Zealand pharmaceutical regulatory system.

Even given that Truvada/PrEP is not currently funded through the New Zealand pharmaceutical subsidy regulator Pharmac, the New Zealand pharmaceutical and medical device safety regulator MedSafe does provide manufacturer application for potential use in New Zealand, preliminary clinical advice for medical practitioners and users who might be able to access the currently unsubsidised medication. It also carries information about the pharmacological properties of Truvada. On the Pharmac side, Truvada has been listed as an (unsubsidised) medication for prophylaxis against HIV/AIDS since 2012. However, its cumulative information about the medication only goes as far as 2013.

So, what about the PROUD and Ipergay clinical studies? What did they have to say about the effectiveness of Truvada? PROUD released its results first and its findings were written up in aLancetjournal article in September 2015 as well as presented at the Conference on Retroviruses and Opportunistic Infections in February 2015. One slightly worrying aspect of the trial was that some men dispensed with the use of condoms if they were taking Truvada, which is not recommended. Moreover, there was no difference in transmission of other STIs if one went on Truvada in the context of the PROUD clinical trial, given that condoms remain the optimal way of avoiding transmission in the latter context. In the PROUD study, 544 men were enrolled at thirteen sexual health centres. 275 were to take it immediately, while 269 were asked to wait for a year.

In December 2015, Ipergay's results were released. These results were published in theNew England Journal of Medicine(1 December 2015), designed to coincide with World AIDS Day 2015. The Ipergay results were more modest than those of PROUD- it encompassed only 400 participants and evalusated them for nine months thereafter. Although these limit the applicability of the results, one key finding was that intermittent use of PrEP was as effective in prophylaxis against HIV as regular daily use. A placebo was also used in this trial, although its use was controversial. The trial participants were from Paris, Lyons, Nice, Tourcoing and Nantes in France and Montreal, Canada. They had high levels of alcohol and recreational drug use. There were no serious pharmaceutical cross-reactions, but participants did report nausea, vomiting, abdominal pain and diarrhoea as side-effects.


What might be delaying Pharmac's response? In a factsheet on decisionmaking processes, it is explained what processes are involved in deciding to fund specific pharmaceuticals. They include evaluation of current health needs, the financial costs and benefits of alternative medications, as well as their clinical risks and benefits, budgetary impact and priorities related to government expenditure, direct costs to health service users, and 'other criteria.' When it comes to clinical criteria, Pharmac assesses and compares existing treatments and alternatives, effectiveness of the proposed medication, reliability and duration of submitted clinical trial evidence, availability or otherwise of data, side effects and scale of the population to be treated. Economics are also evaluated in this context. Pharmac assesses scarcity, choices and foreclosed alternative opportunity costs if a particular treatment is funded. Also assessed are effects and improvement of the quality of life, short and long term effects, effects on the costs of other pharmaceutical treatment and other medical costs and the risks and uncertainties of existing evidence. Finally, appropriate consultation is carried out. One or all of these processes may be ongoing in the context of Truvada, related to other existing and proposed HIV treatments.

As yet, there has been no final, definitive Pharmac or Ministry of Health decision about funding subsidised New Zealand PrEP treatments that involve Truvada. Tentative permission seems to exist for local clinical trials if necessary, as does clinical and potential consumer information. However, unsubsidised, the drug will cost $NZ 1200 per month. It is unclear how the recent NHS England refusal to subsidise the treatment option may impact on the New Zealand outcome, if at all.



Recommended:

Medsafe: Truvada:http://www.medsafe. govt.nz/consumers/cmi/t/ truvada.pdf

Medsafe: Truvada: Chemical Composition:http://www. medsafe.govt.nz/profs/ datasheet/t/truvadatab.pdf

Medsafe Product Detail: Truvada:http://www.medsafe. govt.nz/regulatory/ ProductDetail.asp?ID=11880

Gus Cairns: "HIV and AIDS Information: PROUD PrEP Study Results Released"National AIDS Manual:15.09.2015:http://www. aidsmap.com/PROUD-PrEP-study- results-published/page/ 2998033/

Gus Cairns: "HIV and AIDS Information: Ipergay Study Results Released":National AIDS Manual:02.12.2015:http://www. aidsmap.com/Ipergay-PrEP- study-results-published/page/ 3018781/

04: "Funding Decisions": Pharmac Factsheet: 16.09.2011:http://www. pharmac.govt.nz/2011/09/16/ 04FUNDING_DECISIONS.pdf


Molina J-M et al.On-demand preexposure prophylaxis in man at high risk for HIV-1 infection.NEJM early online publication, DOI: 10.1056/NEJMoa1506273. 2015


Craig Young - 4th June 2016

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