| Abstract | 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. |
| Authors | Anita Rachlis, Bonaventura Clotet, John Baxter, Robert Murphy, Eric Lefebvre
(Affiliation: Division of Infectious Disease, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada. a.rachlis at utoronto.ca)
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| Journal | HIV clinical trials
(HIV Clin Trials)
2007 Jul-Aug
Vol. 8
Issue 4
Pg. 213-20
ISSN: 1528-4336 United States |
| PMID | 17720661
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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| Chemical References |
- HIV Protease Inhibitors
- Ritonavir
- Sulfonamides
- darunavir
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| Topics |
- Adult
- Antiretroviral Therapy, Highly Active
- CD4 Lymphocyte Count
- Female
- HIV
(drug effects)
- HIV Infections
(complications, drug therapy, virology)
- HIV Protease Inhibitors
(administration & dosage, adverse effects, therapeutic use)
- Hepatitis B
(complications, virology)
- Hepatitis C
(complications, virology)
- Humans
- Male
- Ritonavir
(administration & dosage, adverse effects, therapeutic use)
- Sulfonamides
(administration & dosage, adverse effects, therapeutic use)
- Viral Load
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