Journal of Antivirals & Antiretrovirals
Open Access

Abstract

Safety and Effectiveness of Tenofovir/Emtricitabine or Lamivudine Plus Ritonavir Boosted Atazanavir in Treatment Experienced HIV Infected Adults at Two Urban Private Medical Practices

Betty J. Dong, Douglas J. Ward, Lisa A. Chamberlain, Y. Sunila Reddy, Ramin Ebrahimi, John F. Flaherty and William F. Owen

Objectives: The efficacy and safety of once daily ritonavir-boosted atazanavir (ATV/r) plus tenofovir (TDF) and emtricitabine (FTC) or lamivudine (3TC) was evaluated in the management of treatment experienced HIV-infected patients in routine clinical practice.
Research design and methods: A retrospective analysis was performed in HIV infected patients residing at two active, urban clinical practices receiving at least one month of tenofovir, emtricitabine or lamviudine plus ritonavir boosted atazanavir following a change from another antiretroviral regimen to simplify or reduce toxicity. Parameters evaluated included the proportion of patients with HIV RNA <400 copies/mL; change in CD4 count from baseline (start of both TDF and ATV/r), adverse effects, and laboratory changes over time in estimated glomerular filtration rate (calculated creatinine clearance and MDRD) and lipids.
Main outcome measures: One hundred sixty five patients, the majority being Caucasian and male, were studied. Twenty nine (18%) discontinued therapy, including 4 for adverse events and 5 for virologic failure. At baseline, 71% of patients had HIV RNA values <400 copies/mL. At 12 months, 81/90 (90%) patients remaining on therapy had HIV RNA <400 copies/mL, including 17/25 (68%) of those with baseline HIV RNA ≥400 copies/m; 88% (35/40) achieved HIV RNA <75 c/mL. Median increase in CD4 count at 12 months was 26 cells/uL. Grade 4 hyperbilirubinemia occurred in 12% of patients. Estimated glomerular filtration rates did not change significantly by either the Cockcroft-Gault or MDRD method. At 12 months, median declines from baseline in total cholesterol, LDLcholesterol, HDL-cholesterol, and triglycerides were -14, -18, -1, and -12 mg/dL, respectively.
Conclusions: In routine clinical practice, a once-daily regimen containing ATV/r plus TDF/FTC or 3TC controlled HIV in most patients without renal toxicity and improved the lipid profile.