FDA Approves New Agents for Benefit of HIV-Infected Patients

ROCKVILLE, Md--In a flurry of activity at year's end, the FDAapproved two new anti-HIV agents, as well as two liposomal productsto combat HIV-related infections and Kaposi's sarcoma.

Hoffmann-La Roche's saquinavir (Invirase) has become the firstprotease inhibitor to receive FDA approval. The drug has beenshown to temporarily halt the decline in CD4 counts and to increasecounts by 30 to 40 cells/mL.

Glaxo Wellcome's 3TC (lamivudine, Epivir), a reverse transcriptaseinhibitor, received approval for use in combination with AZT (zidovudine,Retrovir). The drug appears to decrease resistance to AZT andhas comparatively fewer side effects, the company said. HIV patientswho received the 3TC/AZT combination had a larger increase inCD4 cells than those on three other regimens: 3TC alone, AZT alone,or AZT plus ddC.

New Liposomal Agents

Sequus Pharmaceutical's Doxil (doxorubicin HCl liposome injection)was approved for the treatment of Kaposi's sarcoma (KS) in peoplewith AIDS whose KS disease has progressed on prior combinationchemotherapy or in patients who are intolerant to such therapy.

According to Sequus, Doxil has a circulating half-life of approximately50 hours, compared to about 10 minutes for free, nonliposome doxorubicin.This allows concentration of the encapsulated drug in areas ofthe body such as tumor where new blood vessels are forming.

The Liposome Company's Abelcet (amphotericin B lipid complex)received FDA clearance for the treatment of asper-gillosis inpatients who are refractory to or intolerant of conventional amphoteri-cinB therapy. Its use allows delivery of higher amphotericin B doseswith reduced nephrotoxicity, the company said.