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DHHS Guidelines Recommendations for Treatment-Naïve Patients

DHHS Guidelines Recommendations for Treatment-Naïve Patients. Select 1 NNRTI or 1 PI Plus a Dual NRTI. 1 Do not use during 1 st trimester of pregnancy or in those with high pregnancy potential. Use with caution in patients with unstable psychiatric disease.

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DHHS Guidelines Recommendations for Treatment-Naïve Patients

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  1. DHHS Guidelines Recommendations for Treatment-Naïve Patients Select 1 NNRTI or 1 PI Plus a Dual NRTI 1Do not use during 1st trimester of pregnancy or in those with high pregnancy potential. Use with caution in patients with unstable psychiatric disease. 2Do not use in patients who require high-dose (>20 mg omeprazole equivalent/day) proton-pump inhibitors (PPIs). Use with caution in patients on PIIs on any dose, H2 blockers, or antacids. 3Do not use lopinavir/r in pregnant women. 4Do not use in patients with severe hepatic impairment (Child-Pugh score B or C) and in women with CD4 cell count >250 cells/mm3 or in men with CD4 cell count >400 cells/mm3. 5Do not use in combination with tenofovir DF or didanosine/lamivudine. 6Do not use in patients who test positive for HLA-B*5701. Use with caution in patients with baseline HIV RNA >100K copies/mL and in patients at high risk for cardiovascular disease. Available at: http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Revision November 3, 2008.

  2. IAS-USA Guidelines Recommendations for Treatment-Naïve Patients Select 1 NNRTI or 1 PI Plus a Dual NRTI 1A baseline urinalysis and estimation of creatinine clearance or glomerular filtration rate for assessment of renal function are recommended. All patients receiving tenofovir should be observed for development of renal dysfunction. Lamivudine can be substituted for emtricitabine. 2Emtricitabine can be substituted for lamivudine. Hammer SM, et al. JAMA. 2008;300:555-570.

  3. ACTG 5142:Summary of 96-Week Efficacy Results ITT: missing values were ignored. *P=0.006; †P=0.041; and ‡P=0.003 versus lopinavir/ritonavir. §P=0.01 versus efavirenz. Riddler SA, et al. N Engl J Med. 2008;358:2095-2106.

  4. ARTEMIS: Darunavir + Ritonavir Versus Lopinavir/Ritonavir Week 96 Outcomes All patients received emtricitabine/tenofovir DF; virologic failure: >50 copies/mL. *P=0.0437 versus lopinavir/r. †P<0.001 for non-inferiority and P=0.012 for superiority to lopinavir/r. ‡P=0.023 versus lopinavir/ritonavir. §P<0.0001 for lopinavir/r adherent versus suboptimal adherence. Mills A, et al. 48th ICAAC. Washington, DC, 2008. Abstract H-1250c. Nelson M, et al. 16th CROI. Montreal, 2009. Abstract 575.

  5. Abacavir + lamivudine (n=398) Emtricitabine/tenofovir DF (n=399) ACTG 5202: Analysis of the Baseline HIV RNA >100K Copies/mL Stratum • DSMB requested data be combined and analyzed by NRTI arms (n=797) • Abacavir/lamivudine • Emtricitabine/tenofovir DF • Primary efficacy endpoints • Time to virologic failure • Early (week 16-24): HIV RNA >1000 copies/mL • Late (week 24 or later): HIV RNA >200 copies/mL • Time to first grade 3/4 sign, symptom, or laboratory abnormality • Time to modification of regimen Major 96-Week Outcomes HR 1.89† (95% CI 1.43, 2.50) HR 1.87† (95% CI 1.38, 2.54) 32.7% 28.6% Patients (%) HR 2.33* (95% CI 1.46, 3.72) 19.5% 17.0% 14.3% 6.5% Virologic Failure Time to First Safety Event Time to Regimen Modification *P=0.0003 and †P<0.0001 for between groups. Sax P, et al. 17th IAC. Mexico City, 2008. Abstract ThAB0303.

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