PMID- 18234149
OWN - NLM
STAT- MEDLINE
DCOM- 20080613
LR  - 20151119
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 24
IP  - 3
DP  - 2008 Mar
TI  - Experience with darunavir in HIV-infected adults enrolled in a US expanded access 
      program: results from a single center.
PG  - 769-73
LID - 10.1185/030079908X261122 [doi]
AB  - OBJECTIVE: A multicenter, international, expanded access program (EAP) was 
      initiated in October 2005 for patients failing multiple antiretroviral regimens. 
      The primary objective was to provide early access to darunavir (DRV) (PREZISTA) 
      co-administered with low-dose ritonavir (DRV/r) for antiretroviral-experienced 
      patients who failed multiple regimens and had limited treatment options; the 
      secondary objective was to gather additional DRV/r safety information. METHODS: 
      Following initiation of DRV/r 600/100 mg bid, patients were evaluated at 
      baseline, Weeks 4 and 12, and every 12 weeks thereafter for changes in CD4 cell 
      counts and HIV-1 RNA levels. Safety and tolerability were also evaluated. 
      RESULTS: Results from patients treated at a single US EAP center in Houston, 
      Texas (N = 38; mean age 47 years; 92% male; 60% Caucasian, 24% Black, 16% 
      Hispanic) are presented. At time of analysis, 38 and 23 patients completed 12 and 
      24 (+/- 1) weeks of therapy, respectively. At Weeks 12 and 24, the mean change in 
      viral load (VL) from baseline was -1.96 log(10) copies/mL (n = 38) and -2.17 
      log(10) copies/mL (n = 22), and 54% and 50% of patients achieved HIV-1 RNA < 50 
      copies/mL, respectively. Mean CD4 cell count increased by 109 cells/mm(3) from 
      baseline to Week 24. DRV/r was generally safe and well tolerated. Most adverse 
      events (AEs) were mild to moderate in severity (nine events considered possibly 
      related to DRV); neither of the two serious AEs was considered related to DRV/r. 
      CONCLUSIONS: Although this study reflects results from only a small cohort of 
      patients at a single center, among this community-based population of highly 
      treatment-experienced patients, DRV/r 600/100 mg bid provided clinically 
      meaningful decreases in VL, an undetectable rate similar to that seen in the 
      POWER studies, and was well tolerated with infrequent AEs.
FAU - Gathe, Joseph
AU  - Gathe J
AD  - Therapeutic Concepts, Houston, TX 77004, USA. drgathe@josephgathe.com
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20080129
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Anti-Retroviral Agents)
RN  - 0 (HIV Protease Inhibitors)
RN  - 0 (Sulfonamides)
RN  - YO603Y8113 (Darunavir)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anti-Retroviral Agents/adverse effects/*therapeutic use
MH  - CD4 Lymphocyte Count
MH  - Darunavir
MH  - Female
MH  - HIV Infections/*drug therapy
MH  - HIV Protease Inhibitors/adverse effects/*therapeutic use
MH  - HIV-1/*drug effects
MH  - Humans
MH  - International Cooperation
MH  - Male
MH  - Middle Aged
MH  - Program Development
MH  - Sulfonamides/adverse effects/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
MH  - Viral Load
EDAT- 2008/02/01 09:00
MHDA- 2008/06/14 09:00
CRDT- 2008/02/01 09:00
PHST- 2008/02/01 09:00 [pubmed]
PHST- 2008/06/14 09:00 [medline]
PHST- 2008/02/01 09:00 [entrez]
AID - 4151 [pii]
AID - 10.1185/030079908X261122 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2008 Mar;24(3):769-73. doi: 10.1185/030079908X261122. Epub 
      2008 Jan 29.