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US PrEP guidelines (May 2014): emphasis on broad access may miss optimal use by people at highest risk

27 May 2014. Related: Guidelines.

PrEP guidelines coverSimon Collins, HIV i-Base

On 14 May 2014, the US CDC updated guidelines for using daily oral tenofovir plus FTC (Truvada) as PrEP. [1]

These recommendations for how and when to use PrEP are broadly similar to previous interim advice issued in January 2011, but the resource has been greatly expanded.

The summary of indications stresses that PrEP is an intervention for men who have sex with men (MSM), heterosexual men and women and adult injecting drug users that are “at substantial risk of HIV acquisition”.

However, the expanded definition of substantial risk for sexual transmission is:

  1. Any penetrative sex (gay or bisexual men, and heterosexual men and women) in the previous six months without a condom; or
  2. Any bacterial STI in the previous 6 months; or
  3. Having a partner who is HIV positive; or
  4. Not being in a mutually monogamous relationship with someone who recently tested HIV negative.

For people who inject drugs, this includes anyone who has “injected illicit drugs in the past 6 months and who has shared injection equipment or been in drug treatment for injecting drug use in the past 6 months”.

Another summary of the criteria for significant risk (Table 1 in the guidelines) includes having a high number of sexual partners or a history of inconsistent or no condom use. Sex work is also included as a criteria to use PrEP.

The 67-page guidelines and 43-page clinical providers’ supplement are published as PDF files. [2, 3]

The guidelines are designed as a practical guide to support healthcare workers to prescribe PrEP. They include background information on assessing risk, patient materials and an evidence review.

Comment

These guidelines are a political response to the continued US epidemic, where, similar to the UK, annual numbers of new diagnoses have remained persistently high for the last decade. They are also a response to the low use of PrEP: where less than 1800 at-risk HIV negative people started tenofovir/FTC (Truvada) in the US, eight months after it was approved for this indication. [4, 5]

The guidelines were quickly supported by a statement from 82 US-based community organisations that understandably challenged a high-profile negative campaign against PrEP. [6]

Activists who support PrEP have also responded with other campaigns including the “Truvada-whore” T-shirts in order to positively affirm this can and should be an active choice (in this case, for gay men). [7, 8]

However, even in this context, the guidelines have a few important limitations.

  1. Expanding the indication for PrEP to include virtually anyone who is sexually active, risks diluting the importance of efficacy being dependent on use in people at a significant high-risk.
  2. Confidence in PrEP is also diminished by avoiding the implications of its high efficacy. While the guidelines emphasise daily PrEP reduces the relative risk of infection by 99%, they go on to recommend PrEP should be used IN ADDITION to condoms.
    Rather than simplifying HIV prevention, the guidelines therefore create a more complicated barrier. For people at low risk who may already be leading anxious lives, fearful of HIV, this may be unhelpful. And for someone who wants to reduce their risk of HIV while having sex that DOES NOT involve condoms (and when neither pregnancy nor STIs are a concern), the data support clearly stating throughout the guidelines, that PrEP is a highly effective stand-alone option.
  3. Although a discussion on stopping PrEP is included, periodic use is not. There are many people who might choose to use PrEP during high risk periods and stop for months if their circumstances change. The iPrEX study reported that most high risk men in were only periodically high risk, for example, when between relationships. Expanding on this in future updates to the guidelines might therefore be useful. [9]
  4. Finally, the inclusion as a criteria for PrEP of having a sexual partner who is HIV positive does not include a discussion on the role of HIV viral load as a risk factor, and the dramatically reduce risk from someone on treatment.

In Europe, although Truvada has not been submitted to the European Medicines Agency for a PrEP indication, it can be prescribed if a doctor believes this is appropriate. However, funding for PrEP in the UK has been complicated by the recent decision to separate commissioning of prevention and treatment services.

This is likely to make results from the ongoing PROUD study especially important in determining whether access to PrEP is broadened in the for people at high risk of HIV. Broader NHS access should be a community demand for activists involved in HIV prevention. [10]

References:

  1. US CDC press release. New guidelines recommend daily HIV prevention pill for those at substantial risk. (14 May 2014).
    http://www.cdc.gov/nchhstp/newsroom/2014/PrEP-Guidelines-Press-Release.html
  2. US Public Health Service. Pre Exposure Prophylaxis for the prevention of HIV infection in the United States – 2014: a clinical practice guideline. (14 May 2014).
    http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf (PDF)
  3. Supplementary material to the guidelines.
    http://www.cdc.gov/hiv/pdf/guidelines/PrEPProviderSupplement2014.pdf (PDF)
  4. Rawlings K et al. Status of Truvada for HIV pre-exposure prophylaxis (PrEP) in the United States: an early drug utilization analysis. 53rd ICAAC. September 10-13, 2013. Denver. Abstract H-663a. See report by Mark Mascolini for NATAP:
    http://www.natap.org/2013/ICAAC/ICAAC_04.htm
  5. FDA approves first drug for reducing the risk of sexually acquired HIV infection. (16 July 2012).
    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm
  6. Joint community statement in support of PrEP guidelines. Leading HIV/AIDS groups endorse CDC HIV PrEP: Guidelines reiterate that PrEP is a powerful, additional tool in the AIDS response. (15 May 2014).
    http://www.prepwatch.org/wp-content/uploads/2014/05/Advocates-joint-statement-to-the-CDC-PrEP-Guidelines.May-15.pdf (PDF)
  7. Duran D. An evolved opinion on Truvada. Huffington Post. (27 March 2014).
    http://www.huffingtonpost.com/david-duran/truvadawhore-an-evolved-o_b_5030285.html
  8. Stern MJ. “I have learned not to underestimate the stigma”: Peter Staley on Truvada, condoms, and HIV prevention. Slate.com blog. (22 May 2014).
    http://www.slate.com/blogs/outward/2014/05/22/peter_staley_talks_about_truvada_hiv_and_stigma.html
  9. CROI 2013: iPrEx Update—A Q&A with Dr. Robert Grant. Beta magazine. (6 March 2013).
    http://betablog.org/iprex-update-with-robert-grant/
  10. PROUD study.
    http://www.proud.mrc.ac.uk/

Links to other websites are current at date of posting but not maintained.