Submission to PBAC re Consideration of Truvada as PrEP

Updated: 11 January 2017 [NB For original submission, see below]

Unfortunately, although perhaps not unexpectedly (because most first-time major submissions are rejected or at least deferred), the PBAC decided not to support the application for Truvada as PrEP to be added to the Pharmaceutical Benefits Scheme (PBS).

In its decision the PBAC stated that it “did not recommend the listing of Truvada for HIV pre-exposure prophylaxis (PrEP) on the basis of unacceptable and uncertain cost effectiveness in the proposed population and at the proposed price.”

The PBAC also included comments questioning the expected adherence of people taking PrEP: “the efficacy of Truvada was highly dependent on adherence, and that it is not clear if subjects at high risk of contracting HIV due to self-reported low adherence to safer sex practices would also have lower adherence to medication.”

This last point was strongly rejected by HIV activists and organisations when the PBAC decision was released. From the Star Observer:

“This statement is insulting, unfair, and paternalistic. It is a given that for medications to work properly, they must be taken as directed,” Nic Holas, co-founder, the Institute of Many (TIM) – a peer-run community of people living with HIV – said.

“The reasons why a person may have a ‘low adherence to safer sex practices’ are complex and varied, and should not be the basis for withholding PrEP as a necessary addition to the prevention toolkit.”

VAC’s Simon Ruth added: “Drawing a comparison between risk behaviour and adherence to medication is illogical. It is wrong and offensive to assume that gay men would not be taking every measure to protect themselves when it comes to HIV, and we view PrEP as the most powerful tool for doing that.

“PrEP demonstration projects have shown that gay men’s adherence to PrEP is extremely high, and comments like this are unhelpful, stigmatising and homophobic.”

Interestingly, and perhaps somewhat disappointingly, a new application for Truvada as PrEP is not on the agenda for the March 2017 meeting of the PBAC meaning it cannot be considered again until July 2017 at the earliest.

Even if that application is successful, however, it would still be another 3-6 (or even potentially 9 months) from that meeting until it is finally included on the PBS – or likely sometime in the first half of 2018.

In the meantime, most Australian states and territories have commenced large-scale trials of PrEP, especially in populations at higher risk of acquiring HIV (including gay men). This includes:

  • In NSW, the EPIC trial
  • In Victoria, VICPrEP (although noting that this website states the trial is now closed to participants) and
  • In Queensland, QPrEPd

In other jurisdictions, please check with your local AIDS Council (or equivalent) for more.

Original Submission

In July 2016, the Pharmaceutical Benefits Advisory Committee (PBAC) will consider whether to recommend that Truvada (tenofovir + emtricitabine) should be added to the Pharmaceutical Benefits Scheme (PBS) for the purposes of PrEP (or Pre-Exposure Prophylaxis) for HIV.

As part of this process, the PBAC accepts submissions from relevant organisations, and from members of the community who would either be personally affected by, or who are interested in, this decision. Further details on the submission process can be found here (including the main questions that a community submission should address).

The following is my personal submission calling for the approval of PrEP as a vital HIV prevention measure to help achieve the goal of the virtual elimination of HIV transmission by 2020.

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Consumer input: Please indicate whether you are a person with this medical condition, a friend or family member, a prescriber, a representative of an organisation or other interested person:

I am an ‘other interested person’, by which I mean I am a member of the lesbian, gay, bisexual, transgender and intersex (LGBTI) community. Specifically, I am a 37 year old gay man, and therefore a member of a community that has been disproportionately affected by HIV for essentially my entire life, and continues to be disproportionately affected to this day.

That also means I am a member of a community that would particularly benefit from the availability of a proven, highly-effective HIV-prevention measure such as the use of Truvada (tenofovir + emtricitabine) for Pre-Exposure Prophylaxis (PrEP).

Therefore, while based on my personal circumstances I will likely not be a candidate for PrEP, I passionately believe it should be made available through the PBS so that other members of my community can engage in the HIV-prevention actions that would be most effective for them, and not be prevented from doing so based on factors such as geography or cost.

What comments would you like the PBAC to take into account when it considers this submission?

It was 35 years ago this week that the first medical report of a mysterious illness affecting homosexual men in New York and California was published. Within a few years the entire world knew about AIDS, and the virus that could cause it – HIV could be transmitted sexually and via other means involving blood-to-blood contact, it was potentially deadly, and there was neither a vaccine nor a cure.

Fortunately, in the decades since there have been some significant advances, not least of which was the treatment revolution from 1996 onwards which transformed HIV from a (far-too-often) lethal virus to a chronic manageable condition (at least for those who had access to these life-changing medicines).

However, at the other end of the spectrum, prevention, there has been far less progress. There is still no vaccine – and it doesn’t seem like there will be one in the short-to-medium-term either.

There have been some advances involving ‘treatment as prevention’, where HIV treatment resulting in Undetectable Viral Load dramatically lowers the risk of transmission, which is especially beneficial for people in sero-discordant relationships.

But the effectiveness of treatment as prevention on a population-wide level also relies on extremely high levels of HIV testing among priority populations (levels which, despite increases in some well-served areas, haven’t been achieved in all locations and harder to reach populations).

Which means the primary prevention method for people in communities that are at disproportionate risk of HIV transmission within Australia, including gay men, remains exactly the same as it was in the mid-1980s – the consistent use of condoms. While that is obviously effective for a significant number of people, and will continue to remain so for many, it has clearly never been effective for everyone.

The proof of that is in the number of new HIV diagnoses reported each year. The Kirby Institute’s 2015 Annual Surveillance Report on HIV, viral hepatitis and sexually transmissible infections found that “[t]he number of HIV infections newly diagnosed in Australia has remained stable for the past three years, with 1,081 cases in 2014, 1,028 in 2013 and 1,064 in 2012” (p11), with sexual contact between men continuing to be the main route of transmission, accounting for approximately 70% of those notifications.

However, while ‘stable’ might sound vaguely positive, the Report further notes that “[t]he number of new HIV diagnoses has gradually increased by 13% over the past 10 years, from 953 diagnoses in 2005” (p32). In fact, the longer-term trend has been one of a gradual increase, from 1999 onwards, which is obviously a concern.

The biggest concern is that, more than three decades into this epidemic, more than 1,000 people are still being diagnosed with HIV in Australia each year. That is a figure I doubt anyone would find ‘acceptable’.

Indeed, recent HIV Strategies at both Commonwealth and NSW levels have made prevention a greater focus to help address this issue. The Seventh National HIV Strategy 2014-2017 lists as its first goal to “work towards achieving the virtual elimination of HIV transmission in Australia by 2020”.

The NSW HIV Strategy 2016-2020 also aims to “virtually eliminate HIV transmission in NSW by 2020”. This is part of the overall ‘Ending HIV’ agenda pursued by the NSW Government in partnership with community organisations such as ACON.

But neither the NSW nor Commonwealth Government Strategies will be able to meet their goals without the introduction of new methods to improve HIV prevention.

One such method is the use of Truvada (tenofovir + emtricitabine) for Pre-Exposure Prophylaxis (PrEP). As has been demonstrated in multiple international studies[i], PrEP is highly (although not 100%) effective in preventing HIV transmission in sex between men.

For people at high risk of acquiring HIV, including gay men and other men who have sex with men who intend or are likely to have condomless anal sex with casual partners, or with HIV-positive partners with detectable HIV viral load, PrEP has the potential to be a ‘game-changer’.

Fortunately, for many it already is – or soon will be. This includes gay men who are accessing PrEP through direct personal importation schemes. It also covers those men who have already been or will shortly be enrolled in the PrEP trials being run by various State Governments, including NSW, Victoria and Queensland.

However, while these trials are obviously welcome, and, in the absence of PBS listing accessing PrEP online is an entirely rational personal decision to make, there are problems with the current situation – including that access to PrEP is dependent on geographical location and/or financial circumstance, and that some of the people purchasing PrEP online may not be seeing their GP regularly for appropriate monitoring and sexual health check-ups.

This is clearly not a sustainable position. And, because not all those people who would benefit from PrEP are currently able to access it, nor will they be able to at least in the short-term, the current ad hoc approach means Australia will not achieve the full HIV transmission reductions that could be possible.

The only way to make the most out of the new ‘technology’ that is Truvada as PrEP is to ensure that it is made available through the PBS to people at high risk of HIV transmission.

This would then allow gay men – members of my community – to be able to engage in the HIV-prevention measures that are most effective for them, with the potential to take PrEP for those periods in their life when their risk of acquiring HIV is higher.

I genuinely believe that, only by adding Truvada as PrEP to the overall HIV prevention mix, alongside other measures such as condoms, increased testing and treatment to support treatment as prevention, and better and more appropriate sexual health education, do the Commonwealth and NSW Governments stand any chance of achieving their goals of virtually eliminating HIV transmission by 2020. And, with notifications stubbornly remaining above 1,000 each and every year, those are goals that I hope everyone, including the members of the PBAC, will support.

How did you learn about this consumer submission process to be able to submit your comments today? Are there any other comments you would like to make about the process for submitting consumer input to the PBAC?

I learnt about the consumer submission process regarding Truvada for PrEP through my involvement in the blood borne virus sector (including viral hepatitis as well as HIV) and specifically via the advocacy for HIV prevention, including access to PrEP, by organisations such as ACON and AFAO.

truvada1

The little blue pill that will make a huge impact on HIV prevention.

[i] Including McCormack S et al. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. The Lancet, early online publication. DOI: http://dx.doi.org/10.1016/S0140-6736(15)00056-2. 2015.

Submission on Redrafted National Health & Physical Education Curriculum

The Australian Curriculum, Assessment and Reporting Authority (ACARA) released a slightly redrafted version of the national Health & Physical Education curriculum for limited public consultation over the past 2 weeks. While there were some modest improvements from the original draft released in December 2012, there are still significant problems with what is proposed, especially as it fails to ensure that content is relevant for LGBTI students, and that every classroom is genuinely LGBTI inclusive.

This afternoon I provided my personal submission to the process, which included attachments covering my previous petition to the Commonwealth Education Minister, the Hon Peter Garrett MP, and the comments which people made on that (although not reproduced here because both are too large). Anyway, here is my submission (I understand that a range of groups, including the NSW Gay & Lesbian Rights Lobby and others, will be making submissions too, so hopefully there is more change before the final document is released later this year):

Submission on Redrafted National Health & Physical Education Curriculum

I am writing to provide a personal submission in response to the redrafted national Health & Physical Education (HPE) curriculum, as published on the Australian Curriculum, Assessment and Reporting Authority (ACARA) website in July 2013.

I also provided a submission in April 2013 in response to the original draft HPE curriculum as released by ACARA in December 2012. Please find a copy of that submission at Attachment A. In it, I outlined a range of substantive concerns with the draft curriculum, and in particular in relation to how it related to (or, more accurately, ignored) the needs of lesbian, gay, bisexual, transgender and intersex students.

These concerns included that:

  • The draft curriculum did not explicitly include LGBTI students by name, nor did it ensure that every classroom in every school included content that was relevant to LGBTI student needs
  • The draft curriculum also concentrated on ‘reproductive health’ meaning that it effectively excluded the sexual health needs of LGBTI students and
  • The draft curriculum did not even include the term HIV, let alone ensure that groups at higher risk of contracting HIV (including gay and bisexual men) receive appropriate education to help prevent new transmissions.

Following the lodgement of my submission, I also initiated a national petition to the Commonwealth Education Minister at the time, the Hon Peter Garrett MP, and his state and territory counterparts. I have since sent this petition to the new Commonwealth Education Minister, the Hon Bill Shorten MP, and the NSW Education Minister, the Hon Adrian Piccoli MP.

This petition, which called for the three issues listed above to be remedied as a matter of urgency, received an incredible level of community support, garnering more than 6,000 signatures in less than four weeks.

However, just as important as the number of signatures, the comments which people provided demonstrate the breadth and depth of community concern about the failure of the original HPE curriculum to address the issues of LGBTI inclusion, sexual health education and HIV.

These comments show that this is an issue which matters not just to LGBTI people themselves, but also to their family members and friends, as well as a broad cross-section of the community who understand that everyone has a right to inclusive, appropriate health education, irrespective of sexual orientation, gender identity or intersex status. I would strongly encourage you to read these comments, as many of them are far more articulate and passionate about why LGBTI students must be included than I could ever hope to be.

Having examined the redrafted HPE curriculum released on the ACARA website earlier this month, I would like to acknowledge that there have been some improvements made from the December 2012 version, including an attempt to include reproductive health and sexual health, rather than just reproductive health.

However, it is also disappointing to note that many of the significant problems which existed in the original draft have not been resolved.  I will use the remainder of this submission to identify those areas which still require amendment in order to meet the needs of LGBTI students, including specific recommendations to make these much needed improvements.

Recommendation 1:  The national HPE curriculum must directly and explicitly include lesbian, gay and bisexual students, and content which is relevant to their needs

As with the original draft submission, I believe that it is irresponsible for a national HPE curriculum not to even include the words lesbian, gay or bisexual. These are the most common forms of sexual orientation for people who are not heterosexual. To deliberately exclude these terms from the curriculum contributes to the marginalisation of students who may grow up to identify with any one of these terms.

By excluding these terms/sexual orientations, I believe that the curriculum would inevitably lead to some schools ignoring the health needs of these students, and ultimately contribute to higher level of mental health issues across the lesbian, gay and bisexual communities, including higher rates of depression and youth suicide.

I must also highlight that including the term same-sex attracted (in the ‘aspirational’ paragraph on page 18 – more on that at recommendation 3, below – and in the Glossary) is insufficient in and of itself to ensure that lesbian, gay and bisexual students are included in both classrooms and content. While I acknowledge that it is an inclusive term, I do not understand how referring to the term ‘same-sex attracted’ twice (and only once in the body of the document, and even then not in the content description for any year), without providing more information, will help ensure that all students learn what being lesbian, gay and bisexual mean, in the same way that they would learn what being heterosexual means.

In fact, I find it impossible to see how excluding the words lesbian, gay and bisexual does anything other than ensure that students who happen to be lesbian, gay or bisexual are denied their right to an equal and fair health education, irrespective of which school they might attend.

Recommendation 2: The national HPE curriculum must directly and explicitly include transgender and intersex students, and content which is relevant to their needs, whilst noting that gender identity and intersex status are different things meaning that education about these issues must make this distinction

I acknowledge that the terms transgender and intersex are at least included in the redrafted national HPE curriculum. However, they are only included in the glossary on page 45, and unfortunately the curriculum incorrectly includes both as part of the definition of gender-diverse. Transgender may fall within this term, but intersex is a distinct characteristic as a biological sex status.

I am not an expert in this field, and expect that submissions from the National LGBTI Health Alliance as well as Organisation Intersex International (OII) Australia will provide recommendations to improve the curriculum in terms of transgender and intersex inclusion. I would encourage you to give full consideration to their suggestions in these areas.

Recommendation 3: The statement about LGBTI inclusion must explicitly refer to lesbian, gay, bisexual, transgender and intersex students, and ensure that all schools are inclusive of these students, irrespective of whether students have publicly identified their orientation, identity or status

I note that the ‘aspirational’ statement of inclusion on page 18 of the redrafted curriculum has been amended from the original December 2012 draft. In particular, I am concerned by the decision to omit the statement that ‘same sex attracted and gender diverse’ students exist in all schools. It is unclear why this statement of fact has been removed, given we know that people who are LGBTI have come from all school communities across the country.

This omission also presents some complications when read together with remainder of the paragraph as redrafted, which talks about “becoming increasingly visible”, “designed to allow flexibility” and “have a responsibility… to ensure teaching is inclusive and relevant to the lived experiences or all students”. One reading of this paragraph is that schools now only have a responsibility to be inclusive where they are aware that students are LGBT or I (ie where schools are aware of the lived experience of their students).

If this is the case, it is not acceptable. All students have a right to be included, and to have their health and physical education needs met, and most importantly should not have the onus placed on themselves to disclose their orientation, identity or status in order to receive this education (especially when such disclosure can risk discrimination from other students, teachers and sometimes from the school itself).

I strongly recommend that this paragraph be amended so that it:

  • Explicitly names LGBTI students (for example, same-sex attracted students, including lesbian, gay and bisexual students, and transgender and intersex students) and
  • States that all school communities must provide content and classrooms which are inclusive of LGBTI students, irrespective of whether they disclose their orientation, identity or status.

Recommendation 4: The statement about LGBTI inclusion must be supported by explicit references to LGBTI content in the year descriptions

While an ‘aspirational’ statement on page 18 is welcome, in order to be most effective it should be backed up by explicit references to issues of concern to LGBTI students at relevant points throughout the curriculum.

For example, the terms transgender and intersex should be introduced and explained from Foundation/Years 1-2, given these identities and statuses can be present from early childhood and/or birth.

Ideally, the orientations lesbian, gay and bisexual should be introduced and explained in Years 3-4, so that students who experience same-sex attraction in puberty (which can commence for some in these years) are aware that these attractions are normal. At the latest, all students should be aware of the concepts of heterosexuality, as well as homosexuality and bisexuality, by the end of Year 6.

This would then leave room from comprehensive and inclusive sexual health education (and not just reproductive health) in Years 5-6 (more on this at recommendation 5, below), or Years 7-8 at the absolute latest.

I note with particular concern the sub-strand Being healthy, safe and active, on page 27 of the redrafted curriculum, which includes the following points under Years 7-8:

  • Examining the impact of physical changes on gender, cultural and sexual identities and
  • Exploring sexual identities and investigating how changing feelings and attractions are part of getting older.

This is both far too old (covering students who are turning 13 and 14 across most states, beyond the age which many people have first realised that they are same-sex attracted, including myself) and far too vague, to be genuinely inclusive of LGBTI students and their needs.

LGBTI issues should also be explicitly mentioned in the outline of the Relationships and sexuality learning area on page 9 of the document, which is reproduced in the Glossary on pages 47 and 48. For example, the dot point “changing identities and the factors that influence them” could be redrafted to include “developing sexual orientations, include heterosexual, lesbian, gay and bisexual, and the factors that influence them” while transgender and intersex should be included in in this Area of learning in Foundation to Year 2 (as indicated above).

Recommendation 5: The term sexual health should be preferred to reproductive health throughout

I welcome the amendment from the original draft of the HPE curriculum, with the addition of sexual health to the redrafted curriculum. However, I am confused by the inclusion of both reproductive health and sexual health, and the definitions of both which are provided in the Glossary on pages 48 and 49 respectively.

In particular, the definition of reproductive health seems to try to ‘cover the field’ for the physical aspects of sexual health, even though for many people their sexual anatomy/systems are not primarily related to ‘reproduction’. This is especially apparent when considering the definition of sexual health, which uses the shorter World Health Organisation definition of sexual health, but not the 2006 longer and more inclusive definition which begins:  “…a state of physical, emotional, mental and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity” [emphasis added].

This longer definition makes it clear that sexual health includes the physical health aspects of sex education. As a result, I believe that the much more inclusive term sexual health should be used throughout the document, and if explicit references to reproduction are considered necessary, then the term should be ‘sexual health, including reproductive health’. This would help to ensure that the needs of all students are considered and not just those of heterosexual students.

Recommendation 6: The topic of sexual health should include more detailed information on safer sex, including condom usage, and Sexually Transmitted Infections (STIs)

While it is welcome that sexual health has been added as a term to the redrafted HPE curriculum, it is unclear where it is intended that detailed sexual health education, including STI information and prevention, is included in the content for specific years.

As indicated above, I believe that comprehensive sexual health education should be included in Years 5-6 (and by 7-8 at the absolutely latest). In order to meet the needs of all students, whether LGBTI or otherwise, it must include specific references to safer sex, and condom usage, as well as ensuring that students learn about STIs and how they can best be prevented (and where relevant treated). I cannot locate this information in the redrafted document.

I believe it would be irresponsible for a HPE curriculum not to ensure that students learn this information prior to the age at which they become sexually active.

Recommendation 7: The national HPE must include Blood Borne Viruses, and in particular HIV

Building on the inclusion of sexual health, and comprehensive sexual health education, including STIs (recommendations 5 and 6 respectively), I believe that it is vital for the national HPE curriculum to explicitly refer to Blood Borne Viruses, including HIV.

As a gay man who has just turned 35, I find it almost incomprehensible that HIV, including information about how it can be prevented, has been omitted from the HPE curriculum, both in the original draft and in the redraft. While HIV is no longer a ‘death sentence’, diagnoses with HIV is still a serious thing, and we should be maintaining our efforts to minimise new transmissions. This is particularly important for younger gay and bisexual men, with male same-sex intercourse remaining the primary means of HIV transmission within Australia.

The importance of this message is reinforced by recent figures which show that the number of HIV notifications in NSW rose by 24% in 2012, including 19% among men who have sex with men. The HIV epidemic is not over, and it is essential that a national Health & Physical Education curriculum provides relevant information for young people to help them avoid future HIV transmissions.

Recommendation 8: The national HPE curriculum should ensure that all students learn about homophobia, bi-phobia, trans-phobia and anti-intersex prejudice, and the damage caused by each

One of the pleasing aspects of the original HPE curriculum, released in December 2012, was that it explicitly named ‘homophobia’ as something that students should be taught about (and implicit in this, was the assumption that students would learn the damage caused by discrimination on the basis of sexual orientation). In my original submission, I argued that this should be amended to include bi-phobia, trans-phobia and anti-intersex prejudice as well, as these encompass similarly destructive beliefs and behaviours.

Unfortunately, it appears that the reference to homophobia has now been deleted, and replaced by a much more generic statement on page 34: “examining values and beliefs about cultural and social issues, such as gender, race, sexuality and disability” and “researching how stereotypes and prejudice are challenged in local, national and global contexts.”

To me, these statements do not ensure that students learn that homophobia, bi-phobia, trans-phobia and anti-intersex prejudice are entirely negative phenomena, which can cause immense hurt amongst members of these groups (indeed, the first statement makes no value judgment at all about different ‘values and beliefs’ in relation to sexuality, and leaves it open to some schools teaching that discrimination on the basis of sexual orientation, gender identity and intersex status is acceptable behaviour).

I would strongly urge you to reconsider the drafting of these dot points, and to include homophobia, bi-phobia, trans-phobia and anti-intersex prejudice as subjects about which students should learn, including being taught about the damage caused by these types of discrimination.

Conclusion

Thank you for reading my detailed submission, and attachments. I acknowledge that much of what I have written is strongly worded, but it is only done so out of genuine concern that, if the redrafted national HPE curriculum was implemented without further amendment, it would fail to meet the needs of our LGBTI students, and fail to provide them with the sexual health and HIV prevention education that they have a right to.

Research has shown that younger LGBTI people are amongst the most disadvantaged students across the country, with high rates of bullying and harassment, and consequently of mental health issues including depression and youth suicide.

I believe that the development of a national Health & Physical Education curriculum is an ideal opportunity to remedy some of the active discrimination which exists against lesbian, gay, bisexual, transgender and intersex students, through the introduction of LGBTI-inclusive content, and hopefully leading to LGBTI students being genuinely included in classrooms across the country. I hope that the final version of the HPE curriculum will implement as many of the above recommendations as possible, to help make this a reality.

Sincerely,

Alastair Lawrie