US PrEP prescriptions more likely to go to Southern women

About 2000 prescriptions likely in 2013
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A US survey of the prescribing of Truvada (tenofovir/emtricitabine) to HIV-negative people as pre-exposure prophylaxis (PrEP) has found that, when participants in clinical trials and demonstration projects are excluded, PrEP recipients are more likely to live in the southern states and are more likely to be female than people receiving Truvada for HIV treatment.

It found that prescriptions for PrEP represented perhaps 1% of all Truvada prescriptions, though use has grown slowly. However, the majority of PrEP in the US is still being prescribed in the context of clinical trials: this survey represents prescribing outside trials, by individual doctors in a variety of healthcare settings.  

In addition, the survey only acquired prescription information from 55% of all US pharmacies, so the true figure for PrEP prescriptions will be somewhat higher.

Glossary

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

demonstration project

A project that tests and measures the effect of a treatment or prevention approach in a ‘real world’ setting. Usually done after clinical trials have shown that the intervention is efficacious, but while there are outstanding questions about how it can be best implemented.

post-exposure prophylaxis (PEP)

A month-long course of antiretroviral medicines taken after exposure or possible exposure to HIV, to reduce the risk of acquiring HIV.

trend

In everyday language, a general movement upwards or downwards (e.g. every year there are more HIV infections). When discussing statistics, a trend often describes an apparent difference between results that is not statistically significant. 

exclusion criteria

Defines who cannot take part in a research study. Eligibility criteria may include disease type and stage, other medical conditions, previous treatment history, age, and gender. For example, many trials exclude women who are pregnant, to avoid any possible danger to a baby, or people who are taking a drug that might interact with the treatment being studied.

The US Food and Drug Administration (FDA) approved the use of Truvada as PrEP in July 2012. Although, so far at least, its use has only grown slowly, it began to gather speed even before the FDA approval. The survey found prescriptions for PrEP made out to 150 individuals in 2011.

In 2012, Truvada PrEP was prescribed to 1274 individuals, but only slightly more than half of these (681) were prescribed after the FDA approval. In the first quarter of 2013, 350 more individuals were prescribed PrEP, implying a total of at least 2000 for the whole year. However, with Truvada being one of the most frequently prescribed antiretroviral drugs for HIV treatment, this probably only represents 1-2%, at most, of Truvada prescribing in the US.

A total of 620 healthcare professionals (37% of all those surveyed) were found to have prescribed PrEP at least once during the survey period, from January 2011 to March 2013.

The median age of PrEP recipients was 37 and there was a trend over time for PrEP recipients to be younger (3% of recipients were under 25 in 2011 compared with 14% overall).

PrEP was most likely to be prescribed by family practitioners (i.e. GPs) in the southern states, and primary care prescribing was also more common on the west coast. In areas other than the south, PrEP was most likely to be prescribed by internal medicine practitioners (i.e. generalist physicians rather than the infectious disease specialists who would normally treat HIV) and in the midwest it was often prescribed by emergency doctors too. However, all broad medical specialities prescribed some PrEP, including nurse practitioners, who prescribed about one in 10 courses.

The figures were derived by looking at all prescriptions for Truvada from the pharmacies surveyed and sequentially eliminating:

  • All prescriptions that included other antiretrovirals or hepatitis B drugs.
  • All patients diagnosed with HIV or where these was any diagnosis of an AIDS-related opportunistic infection.
  • All patients with chronic hepatitis B.
  • All prescriptions for post-exposure prophylaxis (PEP).

The remainder were all deemed to be PrEP prescriptions.

When compared to people receiving Truvada for HIV treatment, PrEP recipients were 1.8 times more likely to be women, 1.4 times more likely to be under 24 years old, 1.4 times more likely to be from the southern states and 3.8 times more likely to have Truvada prescribed by someone who was not an infectious diseases specialist.

It is important to emphasise that a high proportion of PrEP in the US is currently being prescribed in the context of a clinical trial or demonstration project. In California alone, the state HIV/AIDS research programme plans to enrol 4000 people in PrEP implementation trials. These may be more likely to be gay men attending larger sexual health centres.

References

Mera RM et al. Status of Truvada (TVD) for HIV pre-exposure prophylaxis in the United States: an early drug utilization analysis. 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Denver. Abstract H-663a. View the abstract on the ICAAC conference website.  

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