Late-Stage Testing of T-20 Fusion Inhibitor Yields ‘Extremely Positive Results’
A second late-stage test of Roche AG's experimental fusion inhibitor T-20 has yielded "extremely positive results," meaning that submission to the FDA and the European Union for regulatory approval should proceed as scheduled in the second half of this year, Reuters reports (Reuters, 5/16). T-20 is part of a new class of drugs created to block the virus before it invades a cell. The drugs were specifically designed for patients who have developed a resistance or intolerance to standard antiretroviral treatment, which is a growing problem (Kaiser Daily HIV/AIDS Report, 1/31/01). Up to 50% of people with HIV have a strain of the virus that is resistant to at least one of the antiretroviral drugs currently on the market. The 24-week TORO 2 trial involved 504 such high-risk HIV patients who had already demonstrated resistance to one or more antiretroviral drugs (Reuters, 5/16). Participants received either standard antiretroviral therapy alone or therapy in conjunction with T-20. Those receiving T-20 showed a "significant additional decrease" in their viral levels compared to those receiving antiretroviral therapy alone (Roche release, 5/16). "The positive results from TORO 2 are both clinically and statistically significant. It is remarkable that both TORO studies consistently demonstrate the substantial treatment effect of T-20 across a diverse, treatment-experienced patient population from a number of countries," Dani Bolognesi, CEO of Trimeris Inc., which is developing the drug in conjunction with Roche, said (Reuters, 5/16).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.