If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  ICAAC: T-20 Containing Regimens Reduce HIV In Heavily Pre-Treated Patients SAN FRANCISCO, CA. -- September 28, 1999 -- The 16-week results from a Phase II clinical trial (T20-205) show that patients heavily pre-treated with T-20 in combination with oral antiretroviral agents had a clinically significant reduction of HIV in their blood. The results of this study were presented today, Sept. 28, at a late-breaking session of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). T-20 is a member of a new class of anti-HIV compounds known as fusion inhibitors. Unlike other anti-HIV medications, these compounds attack and block the HIV virus before it enters the host cell. In the study, 33 of 55 (60 percent) responded with a clinically significant reduction of HIV in the blood. Indeed, 20 of the 55 (36 percent) had virus levels below the level of quantification (<400 copies/mL). "There is an urgent unmet need for new treatment options that are effective in the ever-growing number of HIV-infected patients who have cycled through available drugs. The study results are exciting because the response rates exceeded what is normally observed in this advanced and heavily pre-treated patient population. We achieved these results by combining a fusion inhibitor with traditional AIDS drugs," commented lead study investigator Jay Lalezari, M.D., of Quest Clinical Research in San Francisco, CA. "This trial answered two major questions not addressed in previous trials. The first was that T-20 provides a virologic benefit through week 16 and the second was that the drug was well tolerated through week 16. No patients discontinued the trial due to T-20-related adverse events or intolerance of the twice-daily subcutaneous injection," said Sam Hopkins, senior vice president of medical affairs at Trimeris. "The results of this study now give us the confidence to continue planning for our Phase III pivotal trials. These trials, which are scheduled to begin next year, will evaluate T-20 in patients who are extensively pre-treated as well as in those with less treatment experience."
T20-205--Trial Design and Results In this Phase II clinical trial, T-20 was given in combination with oral antiretrovirals to 55 evaluable HIV-1 positive adults who had received T-20 during earlier trials. At entry, patients had previously been treated with a median of 11 antiretrovirals and 93 percent had a clinical history of triple class exposure. Ninety-three percent of patients demonstrated genotypic evidence associated with resistance to protease inhibitors (median of five mutations per patient) and 87 percent demonstrated mutations associated with resistance to reverse transcriptase inhibitors (median of four mutations per patient). In this protocol, patients received T-20 (50 mg/twice daily via subcutaneous injection) in combination with a median of four oral antiretrovirals. Combinations were individualized to each patient and were chosen based on genotypic analysis evaluating patients’ resistance to anti-HIV medications. The median baseline viral load was 79,400 copies/mL (4.9 log10 copies/mL) and median CD4+ count was 70 cells/mm3. At sixteen weeks, 33 of 55 (60 percent) heavily pre-treated patients who were given T-20 in combination with oral antiretrovirals responded with a clinically significant reduction of HIV in the blood (viral suppression of greater than 1.0 log10 from baseline or below the level of quantification of 400 copies/mL, using the Roche Amplicor Assay). Furthermore, 20 of 55 (36 percent) had virus levels below the level of quantification. The average decrease in viral load for all patients was greater than 90 percent over the 16-week period. In all clinical studies to date, the most common adverse events reported on T-20 were mild to moderate in severity. The most frequent adverse events include fever, headache, and lymph node abnormalities in addition to local irritation resulting from the sub-cutaneous injection. "Because T-20 attacks the HIV virus before it enters the cell, it works differently than currently approved anti-HIV drugs. It therefore has the potential to combat strains of the virus that have become resistant to these treatments," said Michael Saag, M.D., director of HIV outpatient care at the University of Alabama at Birmingham. "These exciting results confirm observations from prior short-term T-20 studies where a greater than 98 percent reduction was seen when T-20 was given alone. This current trial goes one step further in validating the T-20 proof of concept." This past July, Trimeris and Roche signed an agreement for the full-scale clinical testing and development of Trimeris’ two novel anti-HIV fusion inhibitors, T-20 and T-1249.
|
