PMID- 17720661
OWN - NLM
STAT- MEDLINE
DCOM- 20071127
LR  - 20151119
IS  - 1528-4336 (Print)
IS  - 1528-4336 (Linking)
VI  - 8
IP  - 4
DP  - 2007 Jul-Aug
TI  - Safety, tolerability, and efficacy of darunavir (TMC114) with low-dose ritonavir 
      in treatment-experienced, hepatitis B or C co-infected patients in POWER 1 and 3.
PG  - 213-20
AB  - PURPOSE: This subanalysis examines the safety and efficacy of darunavir with 
      low-dose ritonavir (DRV/r) in hepatitis B or C virus (HBV or HCV) co-infected 
      patients in POWER 1 and 3 trials. METHOD: POWER 1 and 3 enrolled 
      treatment-experienced, HIV-infected patients with > or =1 primary protease 
      inhibitor (PI) mutation and HIV-1 RNA >1,000 copies/mL. All patients received an 
      optimized background regimen plus either control PI (almost all ritonavir 
      boosted) or one of four DRV/r doses (POWER 1) or DRV/r 600/100 mg bid (POWER 3). 
      Patients with active HBV or HCV co-infection who did not require treatment for 
      hepatitis were included. Safety parameters were evaluated. RESULTS: Of 634 DRV/r 
      and 63 control (97% ritonavir boosted) patients assessed, 13% and 16%, 
      respectively, had active co-infection. In both groups, more patients with active 
      co-infection than without co-infection had liver-related adverse events (AEs). 
      These AEs were mainly asymptomatic liver transaminase elevations, although 
      changes were slightly less in the DRV/r group (DRV/r, 13% vs. 8%; control PI, 20% 
      vs. 12%). Only two patients (one per treatment arm) discontinued therapy due to 
      grade 3 or 4 alanine and aspartate transaminase elevations. CONCLUSION: DRV/r was 
      generally well tolerated in treatment-experienced, HBV or HCV co-infected 
      patients. No differences in liver-related AEs were observed between treatment 
      groups.
FAU - Rachlis, Anita
AU  - Rachlis A
AD  - Division of Infectious Disease, Department of Medicine, Sunnybrook Health 
      Sciences Centre, University of Toronto, Toronto, Ontario, Canada. 
      a.rachlis@utoronto.ca
FAU - Clotet, Bonaventura
AU  - Clotet B
FAU - Baxter, John
AU  - Baxter J
FAU - Murphy, Robert
AU  - Murphy R
FAU - Lefebvre, Eric
AU  - Lefebvre E
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - HIV Clin Trials
JT  - HIV clinical trials
JID - 100936377
RN  - 0 (HIV Protease Inhibitors)
RN  - 0 (Sulfonamides)
RN  - O3J8G9O825 (Ritonavir)
RN  - YO603Y8113 (Darunavir)
SB  - IM
MH  - Adult
MH  - Antiretroviral Therapy, Highly Active
MH  - CD4 Lymphocyte Count
MH  - Darunavir
MH  - Female
MH  - HIV/drug effects
MH  - HIV Infections/*complications/*drug therapy/virology
MH  - HIV Protease Inhibitors/administration & dosage/adverse effects/*therapeutic use
MH  - Hepatitis B/*complications/virology
MH  - Hepatitis C/*complications/virology
MH  - Humans
MH  - Male
MH  - Ritonavir/administration & dosage/adverse effects/*therapeutic use
MH  - Sulfonamides/administration & dosage/adverse effects/*therapeutic use
MH  - Viral Load
EDAT- 2007/08/28 09:00
MHDA- 2007/12/06 09:00
CRDT- 2007/08/28 09:00
PHST- 2007/08/28 09:00 [pubmed]
PHST- 2007/12/06 09:00 [medline]
PHST- 2007/08/28 09:00 [entrez]
AID - U59011RL50787210 [pii]
AID - 10.1310/hct0804-213 [doi]
PST - ppublish
SO  - HIV Clin Trials. 2007 Jul-Aug;8(4):213-20. doi: 10.1310/hct0804-213.