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-8962680-B2
Publication Date
2015-02-24
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
The disclosed invention relates to methods of treating, improving, and alleviating diarrhea in an HIV positive subject using crofelemer. The methods include administering about 250 mg of crofelemer per day to an HIV positive subject to address stool consistency and watery diarrhea.
Crofelemer is characterized as a chloride-ion transport inhibitor acting in the topical gastrointestinal tract. The mechanism is described as luminal blockade of CFTR chloride channels, with low systemic bioavailability, and crofelemer is described as a proanthocyanidin polymer with formulation options including enteric coated crofelemer.
Clinical treatment response is defined using decreases in stool-related clinical measures. Treatment is described as meeting clinical response concepts based on decreases in watery bowel movement frequency and/or improvements in stool consistency from watery to formed, and may include reductions in urgency and fecal incontinence days as well as reductions in unscheduled visits for worsening diarrhea.
Claims Coverage
The document includes five independent claims. Each independent claim centers on administering crofelemer, primarily about 250 mg per day, to an HIV positive subject, with dependent claims refining the dosing regimen and the specific clinical outcome criteria used to define treatment response.
Treating stool consistency with daily crofelemer
A method of treating stool consistency in an HIV positive subject, comprising administering about 250 mg of crofelemer per day to the HIV positive subject.
Improving stool consistency with daily crofelemer
A method of improving stool consistency in an HIV positive subject, comprising administering about 250 mg of crofelemer per day to the HIV positive subject.
Alleviating watery diarrhea with daily crofelemer
A method of alleviating watery diarrhea in an HIV positive subject, comprising administering about 250 mg of crofelemer per day to the HIV positive subject.
Decreasing bowel movements per day with daily crofelemer
A method of decreasing the number of bowel movements per day in an HIV positive subject, comprising administering about 250 mg of crofelemer per day to the HIV positive subject.
Decreasing fecal incontinence days with daily crofelemer
A method of decreasing the number of days per week a subject experiences fecal incontinence associated with HIV associated diarrhea or HAART associated diarrhea, comprising administering about 250 mg of crofelemer per day to the subject experiencing fecal incontinence associated with HIV or HAART.
Across the independent claims, the core inventive coverage is crofelemer administration to an HIV positive subject to improve stool consistency and diarrhea-related outcomes. Dependent claims refine the quantitative administration regimen, including about 125 mg twice per day, and define when a subject is considered treated using specific stool, watery bowel movement, and diarrhea-associated clinical endpoint criteria.
Stated Advantages
Improved stool consistency.
Alleviation of watery diarrhea.
Decreased number of bowel movements per day.
Decreased number of days per week with fecal incontinence associated with HIV-associated diarrhea or HAART-associated diarrhea.
Decreases in urgency and fecal incontinence days.
Reduced unscheduled visits for worsening diarrhea.
Documented Applications
Treating HIV-associated diarrhea in HIV-positive subjects.
Treating HAART-associated diarrhea in HIV-positive subjects.
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