Methods and compositions for treating HIV-associated diarrhea
Inventors
Forbes, William • Bortey, Enoch • King, Steven • Chaturvedi, Pravin
Assignees
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Publication Number
US-9585868-B2
Publication Date
2017-03-07
Expiration Date
Abstract
Presented herein are methods for treating diarrhea by administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. Treatment of diarrhea includes the treatment of the diarrhea as well as the pain, abdominal discomfort and other symptoms associated with diarrhea. In one embodiment, the inhibitor of chloride-ion transport is crofelemer.
Core Innovation
Crofelemer is used for ameliorating symptoms of HIV associated diarrhea or highly active antiretroviral therapy (HAART) associated diarrhea in an HIV positive subject. The method comprises administering crofelemer in an amount of about 250 mg per day or about 125 mg two times per day.
The disclosed approach addresses treatment duration and timing relationships for symptom improvement when crofelemer is administered. Symptom improvement begins on day 3 in the method, and the treatment response increases when crofelemer has been administered for longer than 4 months.
The method evaluates symptom alleviation using specific outcome measures associated with diarrhea and related symptoms. These measures include reductions in bowel movement frequency, including watery bowel movements, reduction of urgency and fecal incontinence days, improvement in daily abdominal pain or discomfort score, improvement in daily stool consistency score with a watery-to-formed transition, and a decrease in unscheduled visits for significant worsening of diarrhea.
A further disclosed application is treating or improving HIV associated diarrhea or HAART associated diarrhea in an HIV positive subject who has previously used protease inhibitors. In this context, the method comprises administering crofelemer to a subject in need thereof in an amount of about 250 mg per day or about 125 mg two times per day.
Claims Coverage
The document provides two independent claims. Both focus on administering crofelemer to an HIV positive subject with HIV associated diarrhea or HAART associated diarrhea, with dosage-based treatment of about 250 mg per day or about 125 mg two times per day, and one independent claim adds a protease-inhibitor prior-use context.
Crofelemer symptom amelioration dosing for HIV and HAART-associated diarrhea
A method of ameliorating symptoms of HIV associated diarrhea or HAART associated diarrhea in an HIV positive subject by administering crofelemer in an amount of about 250 mg per day or about 125 mg two times per day.
Crofelemer treatment for protease-inhibitor–previously used subjects with HIV or HAART-associated diarrhea
A method of treating or improving HIV associated diarrhea or HAART associated diarrhea in an HIV positive subject who has previously used protease inhibitors by administering crofelemer in an amount of about 250 mg per day or about 125 mg two times per day.
Across the independent claims, the central coverage is crofelemer administration at about 250 mg per day or about 125 mg twice daily to ameliorate, treat, or improve HIV associated diarrhea or HAART associated diarrhea, including a specifically constrained patient context of prior protease-inhibitor use in one independent claim.
Stated Advantages
Amelioration of symptoms of HIV associated diarrhea or HAART associated diarrhea.
Treatment or improvement of HIV associated diarrhea or HAART associated diarrhea in an HIV positive subject who has previously used protease inhibitors.
Symptom improvement beginning on day 3.
Increased treatment response when crofelemer is administered for longer than 4 months.
Reduction in bowel movement frequency, including watery bowel movements.
Reduction of urgency and fecal incontinence days.
Improvement in daily abdominal pain or discomfort score and daily stool consistency score, including a watery-to-formed stool transition.
Decreased unscheduled visits for significant worsening of diarrhea.
A treatment-response criterion based on a decrease in the number of watery bowel movements per day.
Documented Applications
Treating or improving HIV associated diarrhea or highly active antiretroviral therapy (HAART) associated diarrhea in an HIV positive subject.
Treating or improving HIV associated diarrhea or HAART associated diarrhea in an HIV positive subject who has previously used protease inhibitors.
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