It's sound like something out of a Star Trek movie. Imagine this for a second:

You swallow a pill. Digestive juices activate a sand grain-sized sensor inside the pill. A remote signal is then sent to an adhesive patch on the surface of your skin. The patch sends a digital confirmation to your healthcare provider, who can track and record your adherence. The sensor (made of trace copper and magnesium) is then safely expelled from your body.

Believe it or not, technology like this may not be all that far away. Developers at Proteus Digital Health in Redwood City, California have just submitted the world's first ingestible microchip to the U.S. Food and Drug Administration (FDA) for approval. The FDA has already given the product its pre-market clearance, paving the way for full approval should the device pass final safety and effectiveness testing.

It is envisioned that devices such as these may not only be able to track the adherence to chronic medications such as antiretrovirals (ARVs)and TB drugs, but that they might also find use as diagnostic tools. Imagine swallowing a pill that can remotely monitor your kidney function (for patients on tenofovir-based regimens) or indicate the development of lactic acidosis, a side effect associated with certain ARVs.

Proteus believes that digital devices like these will help prevent the development of drug resistant virus due to suboptimal adherence (something  frequently seen in Africa with the proliferation of multidrug-resistant TB).

That's not to say the device doesn't stir some ethical concerns -- bringing to mind questions about medical privacy, or what other types information might be potential captured without a person's knowledge or consent.

Sci-fi speculations aside, investor response to the devise has been strong in light of the FDA's pre-market approval. Earlier this month, Proteus announced that it had raised just over $62 million in its latest round of funding.

More on HIV Adherence

• Top HIV Adherence Tips
• Understanding HIV Resistance
• Why People Don't Adhere to Their Meds

_{Photograph © Evan Sharboneau is used under a Creative Commons license  at www.flickr.com/photos/thevlue/4839060646/}

On the face of things, the strategy makes perfect sense.

With the patent expiring on one of the three drugs in Atripla (the once-daily, single-pill antiretroviral used in first-line therapy in the U.S.), why not save money by using a cheap generic version of first drug (Sustiva), replacing the second (Emtriva) with a suitable generic (Epivir), and offering the branded drug component (Viread) on its own? Drug coverage providers in the U.S. could potentially save up to $1 billion per year, said an investigative team from Harvard Medical School this past July.

While we admit that this is hardly "new" news, the expiry this month of Sustiva's composition patent does raise the specter of such an approach. And while there's little doubt that a Sustiva generic would be enthusiastically received by the public, particularly private payers and commercial insurers who would benefit the most, the study does raise a few important questions.

In their mathematical modelling, the Harvard researchers justified the approach by stating that a switch from one pill to three would result in a "modest survival loss" of 4.5 months (meaning that you would decrease your life expectancy by about 18-20 weeks). While we don't doubt the veracity of these figures, they largely conflict with what other research has shown.
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We have gotten a number of queries on our recently updated Understanding HIV Therapy, regarding the adult treatment initiation guidelines issued by the U.S. Department of Health and Human Services (DHHS) at the end of March, which state:

"The Panel has updated its recommendations on initiation of ART in treatment-naïve patients...The strength and evidence for this recommendation vary by pretreatment CD4 cell count: CD4 count <350 cells/mm³; CD4 count 350 cells/mm³ to 500 cells/mm³; CD4 count >500 cells/mm³."

Simply put, the Panel recommends that antiretroviral therapy (ART) be initiated in previously untreated ("treatment-naïve") patients when their CD4 count is either

• under 350 cells/mm³;
• between 350-500 cells/mm³, or;
• over 500 cells/mm³.

But wait a second... doesn't that just mean to start treatment whenever you want? And if so, why not say as much?

Despite the apparent ambiguity of it all, the DHHS guidelines reflect the shifting consensus among U.S. treaters, many of whom are calling for the initiation of ART at the time of diagnosis, irrespective of CD4 count. While the Panel doesn't actually go as far that, their recommendations clearly pave the way for such an approach.
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Citing evidence that the early testing of HIV results in better clinical outcomes and a lower risk of transmission, the U.S. Prevention Services Task Force (USPSTF) issued recommendations on Thursday that all people ages 15 to 65 be offered an HIV test when visiting their physician.

This is an expansion of their 2005 recommendations, which limited testing to pregnant women or those in a high-risk group (e.g. IV drug users, men who have sex with men).

The panel's recommendations arrived as the infection rate in U.S. hovers at just over 50,000 new cases per year, while nearly one in five of those infected remain wholly unaware of their status. By calling for the routine testing of all sexually mature Americans, the USPSTF hopes to meet the Obama administration's goal of reducing the annual HIV transmission rate by some 30% by the year 2015.

Despite the overwhelming support from activists and treaters alike, some policy experts believe there will be challenges in the implementing the recommendations.

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