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.

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
• Journal: HIV clinical trials (HIV Clin Trials) 2007 Jul-Aug Vol. 8 Issue 4 Pg. 213-20 ISSN: 1528-4336 [Print] England
• PMID: 17720661 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• HIV Protease Inhibitors
• Sulfonamides
• Ritonavir
• Darunavir

Topics

• Adult
• Antiretroviral Therapy, Highly Active
• CD4 Lymphocyte Count
• Darunavir
• 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