Gilead公司 Hiv药物在Iii期试验中有强效，扩展研究
&nbps;&nbps;&nbps;&nbps;NEW YORK (Reuters Health) - Gilead Sciences Inc. released on Tuesday full results from a pivotal phase III trial of its antiretroviral agent tenofovir disoproxil fumarate indicating that, when used in conjunction with other antiretrovirals, the investigational HIV treatment significantly reduced viral load in patients versus those who received placebo.
&nbps;&nbps;&nbps;&nbps;Newly dubbed Viread, the drug is a reverse transcriptase inhibitor and is given to patients once daily in a single 300 mg tablet. The drug is also being evaluated in a large-scale international trial in treatment-na飗e HIV patients.
, 百拇医药
&nbps;&nbps;&nbps;&nbps;Top-line trial results at 24 weeks were first released in February.
&nbps;&nbps;&nbps;&nbps;Results from the 48-week study of 552 treatment-experienced patients, said Gilead, shows that Viread, in combination with a patient's current antiretroviral therapy, causes a significant reduction in mean HIV RNA levels over a patient's current therapy and placebo. Also, 45% of Viread-treated patients achieved HIV RNA levels below detection at 24 weeks compared with 13% in the placebo arm.
, 百拇医药
&nbps;&nbps;&nbps;&nbps;Consistent with earlier clinical data, patients infected with common mutant HIV strains resistant to a class of antivirals known as nucleoside analogue reverse transcriptase inhibitors who received Viread experienced a significant reduction in viral load versus those who received placebo.
&nbps;&nbps;&nbps;&nbps;On May 2, Gilead submitted Viread to the US Food and Drug Administration (FDA) for approval under the agency's fast-track program. Traditionally, fast-tracked drugs are reviewed within 6 months.
, 百拇医药
&nbps;&nbps;&nbps;&nbps;Two days later, the Foster City, California-based company submitted the drug to European regulators.
&nbps;&nbps;&nbps;&nbps;Dr. Eric Ende, an analyst with Banc of America Securities, told Reuters Health that while the study results at 48 weeks was as expected, "the real important thing here that is new is that [Gilead's] expanded access program is close to 5,000 patients at this point."
&nbps;&nbps;&nbps;&nbps;In January, Gilead announced an expanded access program for Viread. According to Dr. Ende, enrollment in this program has increased from 433 patients per month in July, to 514 in August, to 619 per month currently.
, 百拇医药
&nbps;&nbps;&nbps;&nbps;"This represents a rapid acceleration of patient enrollment on a monthly basis," he said. "We're believing now that the physician uptake is going to be very strong upon approval of this drug, which should happen in early November."
&nbps;&nbps;&nbps;&nbps;Dr. Ende estimated that peak sales of Viread could reach $400 million by around 2006.
&nbps;&nbps;&nbps;&nbps;In Tuesday trade on the NASDAQ, shares of Gilead closed up 3.92 at 52.38., 百拇医药
&nbps;&nbps;&nbps;&nbps;Newly dubbed Viread, the drug is a reverse transcriptase inhibitor and is given to patients once daily in a single 300 mg tablet. The drug is also being evaluated in a large-scale international trial in treatment-na飗e HIV patients.
, 百拇医药
&nbps;&nbps;&nbps;&nbps;Top-line trial results at 24 weeks were first released in February.
&nbps;&nbps;&nbps;&nbps;Results from the 48-week study of 552 treatment-experienced patients, said Gilead, shows that Viread, in combination with a patient's current antiretroviral therapy, causes a significant reduction in mean HIV RNA levels over a patient's current therapy and placebo. Also, 45% of Viread-treated patients achieved HIV RNA levels below detection at 24 weeks compared with 13% in the placebo arm.
, 百拇医药
&nbps;&nbps;&nbps;&nbps;Consistent with earlier clinical data, patients infected with common mutant HIV strains resistant to a class of antivirals known as nucleoside analogue reverse transcriptase inhibitors who received Viread experienced a significant reduction in viral load versus those who received placebo.
&nbps;&nbps;&nbps;&nbps;On May 2, Gilead submitted Viread to the US Food and Drug Administration (FDA) for approval under the agency's fast-track program. Traditionally, fast-tracked drugs are reviewed within 6 months.
, 百拇医药
&nbps;&nbps;&nbps;&nbps;Two days later, the Foster City, California-based company submitted the drug to European regulators.
&nbps;&nbps;&nbps;&nbps;Dr. Eric Ende, an analyst with Banc of America Securities, told Reuters Health that while the study results at 48 weeks was as expected, "the real important thing here that is new is that [Gilead's] expanded access program is close to 5,000 patients at this point."
&nbps;&nbps;&nbps;&nbps;In January, Gilead announced an expanded access program for Viread. According to Dr. Ende, enrollment in this program has increased from 433 patients per month in July, to 514 in August, to 619 per month currently.
, 百拇医药
&nbps;&nbps;&nbps;&nbps;"This represents a rapid acceleration of patient enrollment on a monthly basis," he said. "We're believing now that the physician uptake is going to be very strong upon approval of this drug, which should happen in early November."
&nbps;&nbps;&nbps;&nbps;Dr. Ende estimated that peak sales of Viread could reach $400 million by around 2006.
&nbps;&nbps;&nbps;&nbps;In Tuesday trade on the NASDAQ, shares of Gilead closed up 3.92 at 52.38., 百拇医药