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.
OBJECTIVE
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.


METHODS
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.


CONCLUSIONS
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.
Rachlis
Anita
A
Division of Infectious Disease, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada. a.rachlis@utoronto.ca
Clotet
Bonaventura
B
Baxter
John
J
Murphy
Robert
R
Lefebvre
Eric
E
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D000069454:Darunavir; D005260:Female; D006678:HIV / Q000187:drug effects; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy* / Q000821:virology; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006509:Hepatitis B / Q000150:complications* / Q000821:virology; D006526:Hepatitis C / Q000150:complications* / Q000821:virology; D006801:Humans; D008297:Male; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019562:Viral Load
D017320:HIV Protease Inhibitors; D013449:Sulfonamides; D019438:Ritonavir; D000069454:Darunavir