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

[12290] Sixteen week follow-up of indinavir sulfate (IDV) administered Q8 Hours (H)
versus Q12H in combination with efavirenz (EFV) (MSD protocol 067)
12th World AIDS Conference
June 28 - July 3, 998
Geneva, Switzerland
Robin Isaacs, Diane Havlir, J. Pottage, J. Kahn, C. Shikuma, D. Mehrotra, R. Isaacs,
UCSD Treatment Center San Diego CA; Rush Presbyterian St. Lukes Med. Ctr. Chicago
IL; San Francisco General Hospital San Francisco CA; HARC Honolulu; Merck Research
Laboratories West Point PA, USA
Background: Simplified dosing regimens with potent antiretroviral therapy may
improve adherence and outcome of HIV therapy. We compared the antiviral activity
and safety of a twice daily regimen (BID group: IDV 1200 mg q12H in combination
with EFV 300 mg ql2H) to that of a thrice daily regimen (TID group: IDV 1000 mg
q8H in combination with EFV 600 mg qhs). Methods: 71 HIV-1 infected patients who
were protease inhibitor- and nonnucleoside reverse transcriptase inhibitor-naive, with
baseline CD4 counts >= 100 cells/mm3 and serum vRNA >= 10,000 copies/mL were
randomized to one of the two regimens in an open-label, multicenter study (Merck
Protocol 067). Results: After up to 16 weeks of therapy, preliminary results are:
+
Proportion (%) <400 HIV RNA
copies/mL
BID Group TID Group
Week8 11/1 (58%) 7/1 (39%)
9 8
Week 12 11/1 (79%) 7/1 (58%)
4 2
Week 16 6/7 (86%) 6/8 (75%)
The median changes in CD4 cell count after 8 and 16 weeks of therapy were 160
cells/mm3 (n = 15), respectively, in the BID group, and were 120 cells/mm3 (n = 21)
and 141 cells/mm3 (n = 14), respectively, in the TID group. Study drugs were generally
well tolerated; two patients in the BID group and one in the TID group required
discontinuation of study medications attributed to drug toxicity.
Conclusions: Preliminary results suggested that the antiviral activity and safety profile
of the twice daily regimen (IDV/EFV q12H) appeared to be comparable to that of the
thrice daily regimen (IDV q8H/EFV qhs). Updated data will be presented.