HIV AIDS News [International Conference on AIDS (12th: 1998: Geneva, Switzerland)]

"This twice-daily protocol combining CRIXIVAN + efavirenz is one of the
most convenient of the antiretroviral treatments yet devised to fight HIV," said
Jose Gatell, MD, an HIV treatment specialist from the University of Barcelona,
Spain. "If, as we believe, this combination can demonstrate long-term efficacy, it
promises to be excellent first-line therapy for patients with HIV." Currently,
CRIXIVAN is only approved for use at 800mg q8h.
The other study, DMP 266-003, Cohort IV, examined 101 patients, 71
percent of whom had previously received treatment with nucleoside analogues
(also called nucleoside reverse transcriptase inhibitors, or nRTIs). None,
however, had previously received protease inhibitors or NNRTIs.
Patients were randomised to receive CRIXIVAN three-times-a-day
(800/1000mg q8h; n=59)), either in combination with once-daily efavirenz alone
(600mg qd) or, according to the original protocol, CRIXIVAN monotherapy
(n=42). After 16 weeks, monotherapy was terminated and patients were given
the option of adding efavirenz and stavudine (d4T) to align with current practice.
After 60 weeks of treatment, 89 percent of patients in the CRIXIVAN + efavirenz
group had undetectable levels of HIV virus in their bloodstream (viral RNA <400
copies/ml), compared to 68 percent of those in the group that also received
stavudine.
The mean reduction in the viral load of the CRIXIVAN + efavirenz group
was 2.5 log 1o(+ 0.09), while in the stavudine group it was 1.9 Iogo0 (~ 0.20).
CD4 cell counts increased by 267 cells/mm3 (~ 26) and 210 cells/mm3 (~ 36)
respectively. Adverse events were few, with only one patient being withdrawn
from the trial due to rash of mild-to-moderate intensity. No severe rashes were
reported.