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

"We've been able to establish the efficacy and durability of CRIXIVAN
over two years," said Dr. Chodakewitz. "Now we are working to make CRIXIVAN
as convenient as possible for the more than 160,000 patients who are taking it
around the world, many of whom have been on this lifesaving drug for years
now."
To increase the convenience of taking CRIXIVAN, MSD has undertaken a
series of studies that have, or are, examining twice-daily dosing, a subject that
was first reported upon at the annual conference of the Infectious Diseases
Society of America (IDSA) last year. The studies that have examined twice-daily
dosing with CRIXIVAN that will be discussed in Geneva include Merck Protocols
067 and 061. Other studies examining twice-daily dosing include Merck Protocol
054, and a study being conducted by a group of international AIDS treatment
specialists called the BID Safety and Efficacy Trial (BEST).
Two of the most significant twice-daily studies are Protocol 067 and
Protocol 061. The larger study, Protocol 067, recruited 71 patients and
randomised them to either CRIXIVAN three-times-a-day (1000mg q8h) combined
with the investigational non-nucleoside reverse transcriptase inhibitor efavirenz
once-daily (600mg qd), or CRIXIVAN twice-daily (1200mg q12h) with efavirenz
twice-daily (300mg q12h).
After 16 weeks of therapy, 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: out of 71 patients enrolled, only two patients in the twice-daily
group and one in the three-times-a-day group required discontinuation of
CRIXIVAN or efavirenz due to side effects.
Protocol 061 is examining the regimen of CRIXIVAN twice-daily in
combination with nelfinavir. Twenty-four week data on 21 patients indicate that
this may be another future avenue for exploration, and an opportunity to examine
another combination therapy with CRIXIVAN as the cornerstone.