Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial

@article{Madruga2007EfficacyAS,
  title={Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial},
  author={Jos{\'e} Valdez Ramalho Madruga and Daniel S Berger and M. Mcmurchie and Fredy Suter and D{\'e}nes B{\'a}nhegyi and Kiat Ruxrungtham and Dorece Norris and {\'E}ric Lefebvre and Marie-Pierre de B{\'e}thune and Frank L. Tomaka and Martine De Pauw and Tony J Vangeneugden and Sabrina Spinosa‐Guzman},
  journal={The Lancet},
  year={2007},
  volume={370},
  pages={49-58}
}
The ARTEMIS trial: once-daily darunavir/ritonavir in the management of treatment-naive, HIV-infected patients
TLDR
The 48-week primary analysis of ARTEMIS demonstrated that once-daily darunavir/ritonavir 800/100 mg was noninferior to lopinavIR/rit onavir, given either 400/100mg twice daily or 800/200 mg every day, in treatment-naive, HIV-1-infected patients.
Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week 48
TLDR
DRV/r 800/100 mg qd was non-inferior to LPV/ r 800/200 mg at 48 weeks, with a more favorable safety profile, and offers a new effective and well tolerated once-daily, first-line treatment option for treatment-naive patients.
Pharmacokinetics, Efficacy, and Safety of Darunavir/Ritonavir 800/100 mg Once-Daily in Treatment-Naïve and -Experienced Patients
TLDR
The current evidence from clinical trials of darunavir/ritonavir supports the efficacy of the 800/100 mg once-daily dose for treatment-naïve patients and further evaluation for Treatment-experienced patients with no genotypic resistance to dar unavir.
Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis
TLDR
Once-daily darunavir/ritonavir was both statistically noninferior and superior in virologic response to LPV/r, with a more favorable gastrointestinal and lipid profile, confirming DRV/ r as an effective, well tolerated, and durable option for antiretroviral-naive patients.
Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96
TLDR
Treatment with DRV/r 600/100 mg twice daily was well tolerated and led to sustained virological and immunological responses in treatment-experienced HIV-1-infected patients over 96 weeks.
Cost Effectiveness of Darunavir/Ritonavir 600/100mg bid in Treatment-Experienced, Lopinavir-Naive, Protease Inhibitor-Resistant, HIV-Infected Adults in Belgium, Italy, Sweden and the UK
TLDR
Whether DRV/r 600/100mg bid-based HAART is cost effective compared with LPV/ r-based therapy, from the perspective of Belgian, Italian, Swedish and UK reimbursement authorities, when used in treatment-experienced patients similar to TITAN patients with one or more IASUSA primary PI mutations at baseline is determined.
US Cost Effectiveness of Darunavir/Ritonavir 600/100mg bid in Treatment-Experienced, HIV-Infected Adults with Evidence of Protease Inhibitor Resistance Included in the TITAN Trial
TLDR
A highly active antiretroviral therapy (HAART) regimen containing darunavir with low-dose ritonavir 600/100mg bid is estimated to be a cost-effective therapy when compared with a HAART regimen containing LPV/r, for the management of treatment-experienced, PI-resistant, HIV-infected adults with a broad range of previous PI use/failure.
Efficacy and Safety of Darunavir/Ritonavir at 48 Weeks in Treatment-naïve, HIV-1–infected Adolescents: Results From a Phase 2 Open-label Trial (DIONE)
TLDR
Over 48 weeks, once-daily darunavir/ritonavir 800/100 mg plus NRTIs was effective and well-tolerated for treatment of HIV-1–infected, antiretroviral-naïve adolescents (≥12 to <18 years).
The POWER and TITAN trials: darunavir/ritonavir in the management of HIV-infected patients
TLDR
The highest responses were observed with the darunavir/ritonavir 600/100 mg twice daily dose (also evaluated in the POWER 3 analysis), which was selected for the subsequent Phase III TITAN study.
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References

SHOWING 1-10 OF 11 REFERENCES
Efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients: 24-week results of POWER 1
TLDR
TMC114/r demonstrated statistically higher 24-week virological response rates and CD4 cell count increases than CPI(s) and has received regulatory approval in treatment-experienced patients.
Safety and antiviral activity at 48 weeks of lopinavir/ritonavir plus nevirapine and 2 nucleoside reverse-transcriptase inhibitors in human immunodeficiency virus type 1-infected protease inhibitor-experienced patients.
The safety and antiviral activity of lopinavir (Lpv), a protease inhibitor (PI) coformulated with ritonavir (Rtv) to enhance its pharmacokinetic properties, were evaluated in 70 patients with plasma
Week 24 efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients
TLDR
TMC114/r treatment resulted in greater virological and immunological responses in ART-experienced patients compared with CPI at 24 weeks, and more patients in each TMC 114/r dose group achieved ≥ 1.0 log10 copies/ml reduction in HIV-1 RNA than in the CPI group.
Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures
TLDR
ATV boosted with RTV is as effective and well tolerated as LPV/RTV in treatment-experienced patients, with a more favorable impact on serum lipids and Pharmacokinetically enhanced ATV provides a suitable choice for therapy of treatment- Experienced HIV-infected patients.
Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America.
TLDR
The addition of enfuvirtide to an optimized antiretroviral and immunologic benefit through 24 weeks in patients who had previously received multiple antireTroviral drugs and had multidrug-resistant HIV-1 infection.
Update of the Drug Resistance Mutations in HIV-1.
The International AIDS Society-USA (IAS-USA) Drug Resistance Mutations Group reviews new data on HIV-1 drug resistance that have been published or presented at recent scientific meetings to maintain
Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society-USA panel.
TLDR
The virologic target for patients with treatment failure is now a plasma HIV-1 RNA level below 50 copies/mL, making delivery of state-of-the-art care challenging.
The relative prognostic value of plasma HIV RNA levels and CD4 lymphocyte counts in advanced HIV infection
TLDR
It appears that the HIV RNA level has a relatively weak association with risk of death in patients with advanced HIV infection and that the CD4 lymphocyte count is probably more useful in assessing prognosis.
Update of the drug resistance mutations in HIV-1: Fall 2006.
The International AIDS Society-USA (IAS-USA) Drug Resistance Mutations Group is marking 6 years as an independent volunteer panel of experts focused on identifying key HIV-1 drug resistance
...
...