Napo Pharmaceuticals

market

Chronic diarrhea in people living with HIV/AIDS, US and EU market (product: CRO-HIV)

At the end of 2005, according to the World Health Organization, there were approximately 900,000 HIV/AIDS patients under care in the US. The post-HAART (highly active anti-retroviral therapy) HIV/AIDS population shows prevalence or incidence of diarrhea ranging from 23-47% with 15-30% managing chronic diarrhea. 50% of these were resistant to currently available treatments for diarrhea.

It is believed that most of the diarrhea in people with HIV/AIDS is due to ARV (anti-retroviral) therapy itself, particularly protease inhibitors (where in fact there has been research demonstrating the cause of diarrhea specifically via an intestinal secretory mechanism, which is the site of action for CRO-HIV).

In 2004, there were 37,000 ARV drug switches in US HIV/AIDS patients due to diarrhea, the second most common reason for switching ARV drugs in this 2004 survey.

There are many reasons to treat diarrhea in people with HIV/AIDS, and the documented medical importance for doing so will enhance the reimbursement opportunity. Reasons include:

• intolerability of chosen course of therapy, resulting in the need to switch therapy
• adherence to drug regimen - patients skipping doses
• inappropriate absorption of ARVs
• risk of resistant strain emergence
• quality of life/ability to work – patient interviews indicate a tremendous mismatch in the perception of “managed diarrhea.” People with HIV/AIDS often define “managed” as having to wear diapers, giving up their professional life, and total control of their diet and eating at home.
• cost of managing diarrhea in people with HIV/AIDS (A 1993 Stanford study found that it costs US$10,000 more to treat HIV/AIDS patients with diarrhea than matched HIV/AIDS patients without diarrhea)
• nutritional status of patient
• personal dignity

One of the behavior patterns which emerge from failure to treat diarrhea in people with HIV/AIDS is lack of adherence, which has been shown to increase the risk of resistant viral strain emergence. This is a powerful point to support widespread reimbursement of crofelemer.

People living with HIV/AIDS typically attempt to manage their diarrhea with anti-motility medications, which can cause constipation, rebound diarrhea and are generally not indicated for chronic use. Patients with diarrhea will often take 8 pills per day in an attempt to manage their diarrhea.

In Europe, there were approximately 612,000 HIV/AIDS patients under care at the end of 2005.