Use of 17-ketosteroid compounds, as well as derivatives, metabolites and precursors for treatment of hapatitis C type virus and other togavirus infections
A technology of toga virus and metabolites, applied in the direction of steroids, antiviral agents, medical preparations containing active ingredients, etc., can solve problems such as difficult implementation or standardization
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Embodiment 2
[0403] Example 2. BrEA formulation 2. A formulation containing 100 mg / mL of BrEA (10% w / w) in 30.4% w / w benzyl benzoate (USP), 30.7% w / w polyethylene glycol 300 (NF), approximately 28% w / w propylene glycol (USP) and 1.9% w / w benzyl alcohol (NF), this formulation, hereinafter referred to as "Formulation 2", was prepared as follows. A predetermined amount of BrEA (1.0 kg) was suspended in PEG300 (approximately 3.0 L) present in the dosing container, followed by mixing for at least 5 minutes at room temperature to form a homogeneous emulsion. Thereafter the necessary amount of propylene glycol (about 1.5 L) was added and mixing continued for at least 5 minutes to form a homogeneous suspension. Benzyl benzoate (approximately 3.0 L) was added and the contents of the vessel were mixed for approximately 5 minutes, resulting in a translucent suspension. Benzyl alcohol (about 200ml) was added and mixing continued for about 5 minutes to give a clear colorless solution. Propylene glyco...
Embodiment 3
[0404] Example 3. Human clinical trials. The clinical trial protocol includes approximately 15-20 patients. In Phase I or I / II trials, patients are moderately infected with one or more togaviruses (eg, HCV) and they are moderately symptomatic. Patients received treatment for 1, 2 or 3 weeks. In 3, 4 or 5 days of the patient's medication week, two or more dosage groups, such as 25, 50 or 100 mg / day of 16α-bromo-androsterone ( BrEA) or its esters. Dosing is on consecutive days or on an intermittent schedule, eg 2, 3 or 4 doses administered every other day. The formulation containing BrEA is a formulation as described herein, eg the formulation of example 1 or 2, preferably the formulation of example 2. During the week of treatment and 1, 2, 3, or more weeks thereafter, regular blood draws were drawn to assess infection or its symptoms, pharmacokinetics, blood cytokines (e.g., IL-2, IL-4, IL- 10, IGF1, γIFN, GM-CSF) and intracellular cytokines (eg IL-2, IL-4, IL-10, IGF1, γI...
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