PMID- 17621237
OWN - NLM
STAT- MEDLINE
DCOM- 20071119
LR  - 20200930
IS  - 1525-4135 (Print)
IS  - 1525-4135 (Linking)
VI  - 46
IP  - 1
DP  - 2007 Sep 1
TI  - Safety and efficacy of darunavir (TMC114) with low-dose ritonavir in 
      treatment-experienced patients: 24-week results of POWER 3.
PG  - 24-31
AB  - OBJECTIVE: In POWER 1 and POWER 2, darunavir (TMC114) with low-dose ritonavir 
      (darunavir/r) demonstrated greater efficacy versus control protease inhibitors 
      (PIs). To examine the efficacy and safety of the selected darunavir/r dose 
      further, additional patients were analyzed. METHODS: Treatment-experienced 
      HIV-1-infected patients received darunavir/r at a dose of 600/100 mg twice daily 
      plus an optimized background regimen. The primary intent-to-treat analysis was 
      the proportion of patients with an HIV-1 RNA reduction >or=1 log10 at week 24. 
      RESULTS: Three hundred twenty-seven patients were treated; the baseline mean 
      HIV-1 RNA was 4.6 log10 copies/mL, and the median CD4 count was 115 cells/mm3 
      (median primary PI mutations = 3, PI resistance-associated mutations = 9). Two 
      hundred forty-six patients reached week 24 by the cutoff date and were included 
      in the efficacy analysis: 65% and 40% achieved HIV-1 RNA reductions of >or=1 
      log10 and <50 copies/mL, respectively, at week 24. The mean CD4 count increase 
      was 80 cells/mm3. The most common adverse events (AEs) were diarrhea (14%), 
      nasopharyngitis (11%), and nausea (10%). Nine (3%) patients discontinued 
      treatment because of AEs or HIV-1-related events. Six treatment-unrelated deaths 
      (2%) were reported. CONCLUSIONS: These results corroborate POWER 1 and POWER 2. 
      In this larger set of treatment-experienced patients, darunavir/r at a dose of 
      600/100 mg twice daily provided substantial virologic and immunologic responses 
      and was generally safe and well tolerated.
FAU - Molina, Jean-Michel
AU  - Molina JM
AD  - Assistance Publique--Hopitaux de Paris, Department of Infectious Diseases, 
      Hopital St. Louis, Paris, France. jean-michel.molina@sls.aphp.fr
FAU - Cohen, Calvin
AU  - Cohen C
FAU - Katlama, Christine
AU  - Katlama C
FAU - Grinsztejn, Beatriz
AU  - Grinsztejn B
FAU - Timerman, Artur
AU  - Timerman A
FAU - Pedro, Rogerio de Jesus
AU  - Pedro Rde J
FAU - Vangeneugden, Tony
AU  - Vangeneugden T
FAU - Miralles, Diego
AU  - Miralles D
FAU - Meyer, Sandra De
AU  - Meyer SD
FAU - Parys, Wim
AU  - Parys W
FAU - Lefebvre, Eric
AU  - Lefebvre E
CN  - TMC114-C208 Study Group
CN  - TMC114-C215 Study Group
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
RN  - 0 (Anti-HIV Agents)
RN  - 0 (RNA, Viral)
RN  - 0 (Sulfonamides)
RN  - O3J8G9O825 (Ritonavir)
RN  - YO603Y8113 (Darunavir)
SB  - IM
MH  - Adult
MH  - Anti-HIV Agents/administration & dosage/adverse effects/therapeutic use
MH  - Darunavir
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - HIV Infections/blood/*drug therapy/virology
MH  - Humans
MH  - Male
MH  - RNA, Viral/blood
MH  - Ritonavir/*administration & dosage/adverse effects/*therapeutic use
MH  - Statistics as Topic
MH  - Sulfonamides/administration & dosage/*adverse effects/*therapeutic use
MH  - Time Factors
MH  - Viral Load
EDAT- 2007/07/11 09:00
MHDA- 2007/12/06 09:00
CRDT- 2007/07/11 09:00
PHST- 2007/07/11 09:00 [pubmed]
PHST- 2007/12/06 09:00 [medline]
PHST- 2007/07/11 09:00 [entrez]
AID - 10.1097/QAI.0b013e3181359cfb [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2007 Sep 1;46(1):24-31. doi: 
      10.1097/QAI.0b013e3181359cfb.