Recombinant interferon alfa-2b conjugated to polyethylene glycol (PEG-Intron), the first "pegylated"alpha interferon, has been approved by the FDA for once-a-week monotherapy of chronic hepatitis C virus (HCV) infection in patients not previously treated with alpha interferon.

The FDA has approved recombinant interferon alfa-2a conjugated to polyethylene glycol (Pegasys - Roche) alone or with oral ribavirin (Copegus - Roche) for treatment of adults with chronic hepatitis C virus (HCV) infections not previously treated with interferon alpha. The standard of care for treatment of most patients with hepatitis C has been once-weekly injections of peginterferon alfa-2b (PEG-Intron -Schering) plus oral ribavirin (Rebetol - Schering) (Medical Letter 2001; 43:54).

Recombinant alpha interferon has been marketed in the USA for treatment of hairy-cell leukemia, genital warts, and AIDS-related Kaposi's sarcoma (Medical Letter, 28:78, 1986; 30:70, 1988). Recent reports indicate it may also be useful for treatment of chronic viral hepatitis. Recombinant alpha interferon is available as alfa-2a (Roferon-A - Roche) or alfa-2b (Intron A - Schering), which are identical except for one amino acid.

Rebetron, a combination of injected recombinant interferon alfa-2b with oral ribavirin has been approved by the FDA for treatment of chronic hepatitis C virus infection.

The FDA has approved peginterferon alfa-2b (Sylatron – Merck) for adjuvant treatment of node-positive melanoma after surgical resection. Pegylated interferon has a longer duration of action than interferon alfa-2b (Intron A), which is also FDA-approved for adjuvant treatment of malignant melanoma after surgery, and can be given once a week, compared to 3-5 times a week for standard interferon.

Adefovir dipivoxil (Hepsera - Gilead), a nucleotide analog, has been approved by the FDA for oral treatment of chronic active infection with hepatitis B virus (HBV). In 1999, because of concerns about renal toxicity, the FDA rejected a higher-dosage formulation of adefovir for treatment of HIV infection.

Pentostatin (2'-deoxycoformycin; DCF; - Parke-Davis), a purine analog, was recently approved by the US Food and Drug Administration (FDA) for treatment of hairy-cell leukemia resistant to interferon alfa (Intron A; Roferon-A). is a rare (500 cases/year in the USA) form of chronic lymphocytic leukemia. Acutely ill patients may respond rapidly to interferon, but the drug is rarely curative. Another purine analog, 2-chlorodeoxyadenosine (CdA; Leustatin - Ortho Biotech), may also be approved soon for treatment of hairy-cell leukemia (JD Piro, Blood, 79:843, 1992). Fludarabine (Fludara...

When patents expire on brand-name drugs and generic formulations become available, patients and managed care organizations may express a preference for the lower-cost generics. Are they equivalent to the brand-name product?

Older patients are especially susceptible to drug-induced cognitive impairment. They are more likely to be taking multiple drugs, to have higher blood levels of those drugs because of renal or hepatic dysfunction, and to have pre-existing cognitive problems that make it difficult to detect the role of drugs causing new symptoms or making old ones worse.

Imatinib mesylate (STI-571; Gleevec - Novartis), an oral tyrosine kinase inhibitor, has received accelerated approval from the FDA for treatment of all phases of chronic myeloid leukemia (CML) after interferon has failed.