ROCKVILLE, Md--In a flurry of activity at year's end, the FDA
approved two new anti-HIV agents, as well as two liposomal products
to combat HIV-related infections and Kaposi's sarcoma.
Hoffmann-La Roche's saquinavir (Invirase) has become the first
protease inhibitor to receive FDA approval. The drug has been
shown to temporarily halt the decline in CD4 counts and to increase
counts by 30 to 40 cells/mL.
Glaxo Wellcome's 3TC (lamivudine, Epivir), a reverse transcriptase
inhibitor, received approval for use in combination with AZT (zidovudine,
Retrovir). The drug appears to decrease resistance to AZT and
has comparatively fewer side effects, the company said. HIV patients
who received the 3TC/AZT combination had a larger increase in
CD4 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 people
with AIDS whose KS disease has progressed on prior combination
chemotherapy or in patients who are intolerant to such therapy.
According to Sequus, Doxil has a circulating half-life of approximately
50 hours, compared to about 10 minutes for free, nonliposome doxorubicin.
This allows concentration of the encapsulated drug in areas of
the 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 in
patients who are refractory to or intolerant of conventional amphoteri-cin
B therapy. Its use allows delivery of higher amphotericin B doses
with reduced nephrotoxicity, the company said.