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

While patients in this study had not been treated with an NNRTI or
protease inhibitor before, 71 percent had received an nRTI. At the start of the
trial, the mean CD4 count was 283 cells/mm3(+118) and the mean HIV RNA
level was 5.06 log1o copies/mL(+ 0.55). Adverse events included rash,
headache and diarrhea, but only one patient in the trial was discontinued on
treatment with efavirenz due to rash. No occurrences of severe rash were
reported.
Simplified Twice-Daily Regimens
Preliminary results from Merck Protocol 067 show that the simple and
convenient twice-daily dosage of CRIXIVAN 1200mg q12h plus efavirenz 300mg
q12h holds the prospect of being as well-tolerated and having equal efficacy to
the three-times-a-day combination.
In this study, 71 patients were randomised to the twice-daily or threetimes-a-day regimens of CRIXIVAN in addition to efavirenz. Interim analysis
after 16 weeks of therapy, showed that six out of seven patients in the
CRIXIVAN three-times-a-day arm had undetectable levels of viral load (<400
copies/ml), compared to six out of eight in the twice-daily arm. Study drugs were
generally well tolerated, with two patients in the twice-daily group and one in the
three-times-a-day group requiring discontinuation of CRIXIVAN or efavirenz due
to drug toxicity. Updated data from Protocol 067 will also be presented at the
12th World AIDS Conference in Geneva.
"Based on clinical evidence to date, CRIXIVAN + efavirenz could be an
ideal combination twice-daily: a new first-line therapy with high efficacy, durable
effect, low levels of adverse events and a high level of convenience for the
patient," said Jose Gatell, M.D., an HIV-treatment specialist and clinical
investigator from the University of Barcelona, Spain.