for Health Care Providers
Darunavir Approved for Use with Boosted Ritonavir as Preferred PI, Pediatric Dosing
DHHS recommendations: The DHHS adult and adolescent ARV guidelines now include ritonavir-boosted darunavir, given once daily, as a "Preferred" protease inhibitor for initial treatment. This recommendation is based on results of a randomized open-label noninferiority study comparing once-daily darunavir/ritonavir with lopinavir/ritonavir (given once or twice daily), in treatment-naive patients. All patients also received tenofovir + emtricitabine. At 48 weeks, HIV RNA levels were suppressed to <50 copies/mL in 84% of darunavir recipients and 76% of lopinavir recipients. For those with baseline HIV RNA levels >100,000 copies/mL, the rate of virologic suppression was significantly higher in the darunavir arm than in the lopinavir arms (79% vs 67%; p < .05).
The recommended dosage for initial therapy is darunavir 800 mg BID + ritonavir 100 mg BID.
Pediatric approval: The FDA recently approved pediatric dosing recommendations for darunavir for children aged 6 years and older, and a new 75 mg tablet formulation. Recommended dosage is shown in the table below. Once-daily dosing of darunavir should not be used in pediatric patients.
|Age/Weight||Pediatric Darunavir Dosage|
|Age <6 years or weight <20 kg||Not FDA approved|
|Age 6 to <18 years|
|Wt ≥20 kg to <30 kg||Darunavir 375 mg BID + ritonavir 50 mg BID|
|Wt ≥30 kg to <40 kg||Darunavir 450 mg BID + ritonavir 60 mg BID|
|Wt ≥40 kg||Darunavir 600 mg BID + ritonavir 100 mg BID (adult dosage)|
- Panel on Antiretroviral Guidelines for Adult and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services; November 3, 2008.
- Ortiz R, Dejesus E, Khanlou H, et al. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week 48. AIDS. 2008 Jul 31;22(12):1389-97.
- Prezista prescribing information (December 2008).