Week 96 Efficacy, Virology and Safety of Darunavir/r Versus Lopinavir/r in Treatment-Experienced Patients in TITAN

Title:Week 96 Efficacy, Virology and Safety of Darunavir/r Versus Lopinavir/r in Treatment-Experienced Patients in TITAN

Volume: 10 Issue: 2

Author(s): Denes Banhegyi, Christine Katlama, Clovis Arns da Cunha, Stefan Schneider, Anita Rachlis, Cassy Workman, Sandra De Meyer, Ann Vandevoorde, Tom Van De Casteele and Frank Tomaka

Affiliation:

Keywords: Darunavir, HIV, lopinavir, TITAN, treatment-experienced, efficacy, virology, safety

Abstract:

Long-term potent activity of antiretrovirals is essential for HIV-1-infected, treatment-experienced patients. TITAN (TMC114/r In Treatment-experienced pAtients Naive to lopinavir) compared Week-96 efficacy and safety of darunavir/ritonavir (DRV/r) versus lopinavir/ritonavir (LPV/r). Treatment-experienced, LPV-naïve, HIV-1-infected patients were randomised to DRV/r 600/100 mg bid or LPV/r 400/100 mg bid plus optimised background regimen (≥ 2 NRTIs/NNRTIs).

595 patients were enrolled (mean baseline HIV-1 RNA: 4.30 log10 copies/mL; median CD4 count: 232 cells/mm3). At Week 96, more DRV/r than LPV/r patients achieved HIV-1 RNA <400 copies/mL (66.8% versus 58.9% [intent-to-treat (ITT)/time-to-loss of virological response (TLOVR)], estimated difference 8.7%, 95% confidence interval [CI]: 0.7-16.7), demonstrating the primary endpoint of non-inferiority of DRV/r (p<0.001); the difference in response was statistically significant (p=0.034). For the secondary efficacy parameter (HIV-1 RNA <50 copies/mL) at Week 96, response to DRV/r was 60.4% versus 55.2% for LPV/r (ITT-TLOVR), estimated difference 5.8%, 95% CI: –2.3-13.9. Virological failure (VF; HIV-1 RNA >400 copies/mL) with DRV/r (13.8%) was nearly half that with LPV/r (25.6%). Discontinuations due to adverse events were 8.1% for both DRV/r and LPV/r. Treatment-related grade 2-4 diarrhoea was 8.1% (DRV/r) versus 15.2% (LPV/r). Increases in triglycerides and total cholesterol were less pronounced with DRV/r. At 96 weeks, noninferiority (HIV-1 RNA <400 copies/mL) of DRV/r over LPV/r was maintained; the difference in response was statistically significant. VF rate and treatment-related grade 2-4 diarrhoea were lower with DRV/r versus LPV/r.

Cite this article as:

Banhegyi Denes, Katlama Christine, Arns da Cunha Clovis, Schneider Stefan, Rachlis Anita, Workman Cassy, De Meyer Sandra, Vandevoorde Ann, Van De Casteele Tom and Tomaka Frank, Week 96 Efficacy, Virology and Safety of Darunavir/r Versus Lopinavir/r in Treatment-Experienced Patients in TITAN, Current HIV Research 2012; 10 (2) . https://dx.doi.org/10.2174/157016212799937218