Barcelona, Spain, July 9 – Confirmatory findings of paediatric dosage are released today which indicate that T-20, used in conjunction with other anti-retrovirals, is well tolerated by children and adolescents living with HIV. Interim results from this latest study (T20-310), have confirmed that T-20 dosed by body weight reaches children's bloodstreams at a similar rate as those observed in adults. T-20 is anticipated to be a vital component of new cocktail therapies for treatment experienced children as well as adults.

"Our large scale T-20 trials in adults have already confirmed the important role that fusion inhibitors will play in the continued fight against HIV. Today’s news will be welcomed by all those involved in helping HIV-infected children and young adults, who like their adult counterparts, have diminishing treatment options.", said Dr. Eralp Bellibas, Clinical Pharmacologist, Associate Clinical Director, Roche.

Unlike existing AIDS drugs which work once the HIV virus has entered the human cell, T-20 works in a completely new way in that it blocks HIV from entering CD4 cells of the immune system.

The addition of T-20 on top of conventional optimised therapy is expected to become a key treatment component helping physicians optimise therapy in previously treated HIV patients, as it helps the body’s immune cells (CD4 cells) from further depletion by facilitating the reduction of the amount of HIV virus in the blood that can destroy these cells.

In the study presented today, twenty patients, between the ages of 3 and 16 years, who had more than 5000 copies of HIV RNA per millilitre of blood, and had used at least two of the three currently available anti-retroviral classes for a period of three months or more, are participating in the 48 week investigation. The ongoing study includes monitoring for drug levels in the bloodstream, safety and effectiveness. In addition to optimised background therapy, the patients were prescribed two milligrams (mgs) of T-20 for every kilogram of body weight, ensuring their total dosage did not exceed 90mgs- the adult dose under investigation.

The results showed that children and adolescents had T-20 absorption rates similar to the results seen in adults and that twice-daily, subcutaneous injections of T-20 were initially well-tolerated. Local reactions of redness and/or thickening at injection site were the most commonly reported side-effect. Other related side-effects included diarrhoea, decreased appetite and tinnitus.

"We very much hope that T-20 can be used to form a nucleus around which physicians can create an optimal combination of anti-retrovirals for their treatment experienced children as well as adults" said Dr. David Reddy, Disease Area Head, HIV/AIDS, Roche. "The paediatric dosing data from this clinical trial will be included in our application for marketing approval of T-20 in Europe and the US in an effort to make T-20 available to children at the same time as adults. We will continue to work at full speed to bring T-20 to patients and physicians who are looking to strengthen their armamentarium in the constant battle against HIV".

Early Access to T-20

In November 2001, Roche and Trimeris announced the initiation of the T-20 open-label safety study