The adverse event profile of abacavir during an expanded access programme was similar to that in previous trials.
Abacavir is a new carbocyclic nucleoside reverse-transcriptase inhibitor used in combination with other antiretroviral drugs in the management of HIV. Researchers from Rush Presbyterian St. Luke's Medical Centre, Chicago, centres in the United States and Puerto Rico, as well as Glaxo Wellcome, reported results from an expanded access programme that assessed abacavir in more than 13,000 adults infected with HIV-1. The patients no longer responded to commercially available regimens.
After two months treatment with regimens containing abacavir, 31.4 percent of patients showed a decrease in viral load (plasma HIV-1 RNA levels) of at least 0.5 log10. Moreover, regimens containing abacavir reduced viral load < 400 copies/mL in 5.6 percent of patients.
The expanded access programme suggested that abacavir was well tolerated. Overall, 7.7 percent of patients reported serious adverse events related to abacavir. Nausea, skin rash, diarrhoea, malaise or fatigue, and fever emerged as the commonest serious side effects. Moreover, 4.6 percent of patients developed a hypersensitivity reaction possibly related to abacavir.
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