Friday, August 27, 2004

IN BRIEF: BRISTOL-MYERS SQUIBB CO.

Bristol-Myers Squibb Co. received Food and Drug Administration approval to expand the clinical information on the label of its HIV drug Sustiva (efavirenz). The new data demonstrate the long-term durability of virologic response in people living with HIV-1 who are naive to protease inhibitors, GlaxoSmithKline Plc's pharma drug Epivir (lamivudine) and non-nucleoside reverse transcriptase inhibitors. The long-term data suggest that patients who stay on Sustiva as part of their combination therapy may experience durable viral suppression for more than three years, reinforcing its use in first-line HIV combination therapy, according to a BMS press release.

Tuesday, February 22, 2005

PEG-INTRON PLUS EPIVIR MAY BE MORE EFFECTIVE THAN EPIVIR MONOTHERAPY IN TREATING CHRONIC HEPATITIS B, NEW STUDY SUGGESTS

Staggered combination therapy with Schering-Plough Corp.'s pharma name Peg-Intron (peginterferon alfa-2b) and GlaxoSmithKline Plc's pharmaceutical drug Epivir (lamivudine) may cause a greater virological response in patients with chronic hepatitis B than treatment with Epivir alone, according to a study in the February issue of the Annals of Internal Medicine.

Researchers conducted a randomized, controlled, open-label trial in 100 treatment-naïve patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (HBV) and moderately elevated alanine aminotransferase levels.

The primary endpoint was defined as sustained virological response (HBeAg seroconversion and HBV DNA level of less than 500,000 copies/mL) at 24 weeks after the end of treatment.

Patients were randomized to receive either 1.5 mcg/kg of body weight of Peg-Intron per week (maximum, 100 mcg) for 32 weeks plus 100 mg/day of Epivir for 52 weeks or Epivir monotherapy (100 mg/d) for 52 weeks.

Of the patients in the combination treatment arm, 60 percent had a virologic response at the end of treatment, while 28 percent of the Epivir monotherapy group did. Also, 36 percent of the combination-treated patients sustained virological response, compared with 14 percent of the Epivir monotherapy arm.

The combination treatment group also had greater reductions of HBV DNA and had Epivir-resistant mutants less often. Normalized alanine aminotransferase levels and histologic improvement did not differ between the groups.

Adverse effects were more common in the combination treatment arm and included transient, influenza-like symptoms, alopecia and local erythematous reactions.

"In conclusion, we found that . . . combination treatment with [Peg-Intron] and [Epivir] was associated with higher rates of end-of-treatment and post-treatment HBeAg seroconversion, an increased potency of HBV suppression and a lower incidence of [Epivir] resistance than [Epivir] monotherapy," researchers wrote.

They noted, however, that the study had limitations, since it was not a double-blind trial and was conducted at only one site. Also, because treatment was staggered, the combination treatment arm received treatment for eight more weeks than the Epivir monotherapy group did.