Published on October 24, 2014
1. Pre‐exposure Prophylaxis: the state of the nation Dean Murphy 17 October 2014
2. Overview Knowledge and use Willingness and motivation to use PrEP Who takes up PrEP? PrEP projects in Australia Post-study access Regulatory approval and funding (TGA and PBS) Importing drugs for personal use
3. PrEP knowledge and use Knowledge of PrEP: 62% unaware of any research evidence regarding PrEP efficacy (Zablotska, IAS 2013) Additional 14% believed effectiveness had not been shown for either MSM or heterosexual populations Use of PrEP by gay men: Low levels of ‘informal’ or non-prescribed use of ARVs as PrEP (≤2.5%) Some overlapping of PrEP and N-PEP?
4. Willingness and motivation to use PrEP National survey of gay men in 2013 found 23% of all HIV-negative men were willing and motivated to use PrEP (Holt, 2014) Decreased from 28% in 2011 (Holt, 2014) Men most interested in PrEP were more likely to: have an HIV-positive or untested regular partner have casual sex partners perceive themselves as more likely to become HIV positive have fewer concerns about PrEP have previously had post-exposure prophylaxis PrEP eligible men were significantly more likely to report willingness to use PrEP (36% vs 19%) 9% of all gay and bisexual men In San Francisco, overall uptake of 49% among potentially eligible clients
5. Who takes up PrEP? In iPrEx OLE: higher uptake among those who reported recent non-condom receptive anal intercourse Concern about side-effects and stigma associated with not starting PrEP PrEP uptake not associated with age, education, alcohol or substance use Demo Project (San Francisco): Reasons for declining: time commitment (28%), side effect concerns (25%), no perceived HIV risk (8%) Uptake higher with prior knowledge of PrEP and higher risk Retention is high; only 8% of participants have discontinued PrEP
6. Who takes up PrEP? PROUD Study (UK): Mean age 35.5 years Median of 10 anal sex partners in the last 3 months (50% without condoms) HIV status of sex partners: 23% unknown HIV status 44% known or assumed to be HIV negative 33% known to be HIV positive (81% on ARV therapy) 40% had used post-exposure prophylaxis (PEP) in the last year; and 21% had used it more than once
7. PrEP Projects in Australia Victoria (June 2014) NSW (November 2014?) Qld
8. Aims of demonstration projects To determine uptake of PrEP among eligible participants To describe the duration and pattern of PrEP use To determine the acceptability of PrEP To monitor the safety of PrEP To identify any changes in behaviour among people taking PrEP To measure the incidence of HIV and STIs (and factors associated with incidence) To determine the feasibility of providing a PrEP service in Victoria
9. Participants in VicPrEP (N = 80) Age 38.7 years (median 36.5) No. sex partners last 3 months Median 9 Current regular partner 50% (52.5% HIV-positive partner) Casual partners last 3 months 90% (median = 12 acts) HIV status of casual partners HIV negative 60.5% HIV positive 17.3% Unknown / untested 20.8% Condom use with casual partners Mean 3.04 (range 1–5); i.e. about half the time IDU 17.5% (13.9% in last 12 months) Heard of PrEP previously 93.75% Previous use of ARVs as PrEP 28.75% Previous post-exposure prophylaxis (PEP) 55.7%
10. Post-study access Manufacturer has indicated willingness to provide drug on an ongoing basis for study participants Linked to ongoing data collection Study participants in VicPrEP have indicated anxiety about discontinuation of the drug
11. Regulatory approval FDA (in United States) approved Truvada as PrEP (July 2012) for MSM at high risk of getting infected with HIV through sex, and heterosexual couples where one partner has HIV and the other does not. Gilead considering filing application to TGA for use of Truvada as PrEP Letters of support provided by AFAO and others Previous reluctance to pursue licensing in Aust. because anticipated low uptake Considerations for seeking regulatory approval Likelihood of positive outcome Likelihood that country will make the drug available Could application be expanded from ‘PrEP’ to ‘prevention of HIV infection’? Include use of ARVs as both PrEP and PEP Pharmaceutical Benefits Scheme (PBS) Cost effectiveness case needs to be made
12. Importing for personal use Small numbers already import ARVS for PrEP Cost approx. $105 per bottle (i.e. 30 pills) TGA ‘Personal importation scheme’ may import a 3 month supply (at the maximum dose recommended by the manufacturer) of unapproved therapeutic goods into Australia without any approval required by the TGA provided that: the goods are for your own treatment or the treatment of your immediate family; and you do not supply (sell or give) the medicine to any other person; and the goods are not restricted under Australian Customs controls or quarantine rules To bring more than 3 months supply into Australia, an Australian-registered doctor will first need to apply to the TGA for Special Access Scheme approval. To purchase or import a prescription medicine in Australia, you must have a valid Australian-issued prescription. Needs to be done in conjunction with clinician for purpose of screening, ensuring HIV-negative status, monitoring.
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