[NATAP] Reyataz/r + TDF: safety & efficacy

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Reyataz/r + TDF: safety & efficacy

Reported by Jules Levin

“Safety and Efficacy of Antiretroviral Treatment (ART) Regimens Containing Tenofovir DF (TDF) and Atazanavir/Ritonavir (ATV/r) in HIV-infected Adultsâ€

W Owen, L Chamberlain, D Warren, R. Ebrahimi, J Flaherty3, and B Dong2

1Private Practice, San Francisco, CA, USA; 2University of California, San Francisco, CA, USA; and 3Gilead Sciences, City, CA

poster# WePe6.3C10

IAS-Rio, July 2005

Study authors provided this background:

o Combination ART with ATV/r and TDF is an attractive option for ART-naïve and experienced patients because this offers:

- The convenience of QD dosing

- Favorable safety and resistance profiles

o When combined, TDF reduces the Cmax and AUCss of ATV by 21% and 25%, respectively; therefore, ritonavir boosting is recommended when these agents are combined

o The combination of ATV/r with TDF and another NRTI has been evaluated in BMS-045, a 48 week, Phase 3 trial conducted in treatment experienced patients; good efficacy and safety profiles were demonstrated1

AUTHOR CONCLUSIONS:

o In this study, combination antiretroviral therapy which includes TDF and ATV/r was:

- Safe and well tolerated

- Associated with positive virologic and immunologic outcomes

o Hyperbilirubinemia was common, but did not result in discontinuation of ATV/r in most cases

o Only 1 out of 82 patients discontinued TDF due to transient creatinine elevation

STUDY OBJECTIVES

o To evaluate the virologic and immunologic efficacy of TDF and ATV/r when used together as part of HAART therapy in naïve and experienced patients

o To characterize the safety profile of TDF and ATV/r when used together

METHODS

o Retrospective review of all HIV-infected patients receiving ART containing TDF and ATV/r for at least 1 month

o Data collected over the period of July 2003 through December 2004

o Records review included:

- Demographics

- HIV RNA and CD4 counts

- Laboratory tests (creatinine, total bilirubin, and lipids)

- Adverse events

- Concurrent ART and other medications

o Data Analysis:

- Data were analyzed based on availability over the 17 month collection period

- Performed at baseline*, and after 2-4 months, 5-7 months,

8-10 months and 11-13 months of combined treatment

o Endpoints:

- Proportion of patients with HIV RNA < 400 copies/mL, and change from baseline in HIV RNA

- CD4 + cell count change from baseline

- Graded laboratory values

RESULTS

TDF and ATV/r were given together for a median (range) of 10 (1-13) months

- Treatment naïve: median 5 (1-7) months

- Treatment experienced with Baseline HIV RNA:

o < 400 c/mL: median 11 (1-13) months

o >400 c/mL: median 7 (1-13) months

5 patients had treatment discontinued

- 3 patients discontinued treatment due to an AE:

o Scleral icterus (1)

o Dizziness/fatigue (1)

o Grade 3 Scr elevation (1)

- 2 patients discontinued treatment for personal reasons

Hyperbilirubinemia was observed in 38 pts (46%)

- 31 (38%) Grade 3

- 7 (8%) Grade 4

Baseline Demographics (N = 82)

Baseline HIV RNA, CD4 Counts

HIV RNA Results

HIV RNA Values in Treatment Experienced Patients

Lipid Parameters - Overall Results

CD4 Results