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The Pharmaceutical Journal
Vol 269 No 7209 p152
3 August 2002

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Aids 2002 (more)

Fusion inhibitor "vital component" of new cocktail therapies for HIV infection

A fusion inhibitor, T-20 (enfuvirtide), is expected to be a vital component of new cocktail therapies in children as well as adults with HIV infection, according to Roche and Trimeris, the two companies co-developing the new agent. T-20 works by stopping HIV from entering CD4 cells and fusing with host cells.

The companies report that in an ongoing study of 20 patients aged between three and 16 years, T-20 absorption rates were similar to those seen in adults. The patients had more than 5,000 copies of HIV RNA per ml of blood and had taken drugs from at least two of the available antiretroviral classes for three months or more. Subcutaneous injections were initially well tolerated with local reactions of redness and/or thickening at injections sites being the most common side effect. Other related side effects included diarrhoea, decreased appetite and tinnitus.

The companies also report that phase III results, of over 1,000 patients across 112 centres worldwide, have shown that levels of HIV in the blood are reduced when T-20 is used with individually chosen antiretroviral drug combinations. Twice as many patients achieved a reduction in their viral load below detectable levels in the study arms that contained T-20 than in the study arms that only contained currently available antiretrovirals. They add that T-20 was well tolerated and that twice-daily, subcutaneous administration of the drug was well accepted.

A survey of over 500 patients taking T-20 has shown that subcutaneous self-injections of T-20 do not disrupt patients' lives. Roche and Trimeris say that, after eight weeks of treatment, 65 per cent of patients found that T-20 was either "very easy" or "easy" to use. Most patients reported little or no impact of subcutaneous delivery of T-20 on normal activities of daily living such as familiar routines of work, recreation, sleep, social life, travel, intimacy or privacy.

Data were presented at the 14th International AIDS Conference, held in Barcelona last month.

Genetic mutations causing resistance to T-20 Researchers have identified genetic mutations in HIV that may cause resistance to T-20. Viral samples were examined from six patients who did not respond to combination therapy with four or more drugs including T-20. Mutations occurred in regions of the gene sequence that normally remain highly conserved during viral replication, according to Visible Genetics, a pharmacogenomics company, involved in the research. Data were presented at the same meeting.