Method for treating a disease, disorder or adverse effect...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai

Reexamination Certificate

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C514S365000

Reexamination Certificate

active

07320961

ABSTRACT:
The present invention is directed to a method for inducing UGT1A1 isoform expression for treatment of a disease, disorder or adverse effect caused by an elevated serum concentration of an UGT1A1 substrate comprising the step of administering to a subject an effective amount of ritonavir. In particular, the present invention is directed to a method of treating unconjugated hyperbilirubinemia by UGT1A1 induction comprising the step of administering to a subject an effective amount of ritonavir.

REFERENCES:
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patent: 2004/0192624 (2004-09-01), Kempf et al.
Agarwala et al., “Steady state pharmacokinetic (PK) interaction study of Atazanavir (ATV) with Ritonavir (RTV) in healthy subjects,” Poster presented at the 42ndInterscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, CA, Sep. 27-30th, 2002.
O'Mara et al., “Relationship between uridine diphosphate-glucuronsyl transferase (UDP-GT) 1A1 Genotype and total bilirubin elevations in healthy subjects receiving BMS-232632 and saquinavir,” Poster presented at the 40thInterscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, Ontario, Canada, Sep. 17-20, 2000.
Zucker et al., “Mechanism of indinavir-induced hyperbilirubinemia,” PNAS 98(22):12671-12676 (2001).
Ritter, Joseph K., “Expression and inducibility of the human bilirubin UDP-glucuronosyltransferase UGT1A1 in liver and cultured primary hepatocytes: Evidence for both genetic and environmental influences”, Hepatology, vol. 30, No. 2, Aug. 1999, pp. 476-484.
Sugatani, Junko, et al., “The Phenobarbital response enhancer module in the human bilirubin UDP-glucuronosyltransferase UGT1A1 gene and regulation by the nuclear HEPATOLOGY”, vol. 33, No. 5, May 2001-05, pp. 1232-1238.
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Penzak, Scott, et al., “Influence of ritonavir on olanzapine pharmacokinetics in healthy volunteers”, Journal of Clinical Psychopharmacology, vol. 22, No. 4, Aug. 2002, pp. 366-370.
Ouellet Daniele, et al, “Effect of ritonavir on the pharmacokinetics of ethinyl oestradiol in healthy female volunteers”, British Journal of Clinical Pharmacology, vol. 46, No. 2, Aug. 1998, pp. 111-116.
O'Mara E. et al., “Steady state pharmacokinetic interaction study of atazanavir (ATV) with efavirenz (EFV) and ritonavir (RTV) in healthy subjects” Programs and abstracts of the 9thConference on Retroviruses and Opportunistic Infections; Feb. 24-28, 2002, Seattle, Washington. Abstract 444.
A. Radominska-Pandya et al.,Structural and Functional Studies of UDP-Glucoronosyltransferases, Drug Metabolism Reviews 31(4):817-99 (1999).
R.H. Tukey et al.,Human UDP-Glucoronosyltransferases: Metabolism, Expression, and Disease, Ann. Rev. Pharmacol. Toxicol. 40:581-616 (2000).

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