Program Schedule

538
A Retrospective Study to Evaluate the Safety of Switching Antiretroviral Therapy (ART) to Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine (RPV/TDF/FTC) STR in Virologically Suppressed HIV-Infected Patients

Session: Oral Abstract Session: HIV Antiretroviral Therapy
Thursday, October 9, 2014: 2:30 PM
Room: The Pennsylvania Convention Center: 107-AB
Background:

Recent clinical trials have shown that switching from PI/r or NNRTI to RPV/TDF/FTC is safe and effective in virologically suppressed HIV-infected patients.  In this study, we assessed the tolerability, metabolic profile, maintenance of virologic suppression and changes in renal function after switching to RPV/TDF/FTC in a clinical setting. 

Methods:

Retrospective chart review of HIV-infected individuals on stable ART for at least 6 months and HIV RNA levels <200 copies/mL whose ART was switched to RPV/TDF/FTC for simplicity, dyslipidemia or ARV intolerance. Wilcoxon signed rank tests and paired t tests were used to test the changes of the lab results and 10-year cardiovascular risk.

Results:

162 out of 175 subjects were analyzed at week 6±4 (n=140), 24±8 (n=137) and 48±8 (n=139). 33% were female; 32% African-American and 57% Hispanic/Latino. Baseline ARV regimen contained NNRTI in 55% and PI/r in 41% of subjects. 18 (11%) of 162 subjects discontinued RPV/TDF/FTC: 3 (2%) due to virologic failure (HIV RNA ≥200 copies/mL) and 6 (4%) grade ≥3 adverse event (2 CNS symptoms, 2 liver toxicity, 1 pancreatitis and 1 acute renal failure).  Adverse events occurred in 19 (12%) subjects: 10 reported CNS symptoms, 4 liver toxicity, 2 acute renal failures and 1 each of CV event, pancreatitis and cutaneous reaction.  7 subjects developed virologic failure; 3 subjects continued RPV/TDF/FTC achieving re-suppression.

 Median (Interquartile Range) changes from baseline in fasting lipid parameters (mg/dL)

Visit

Baseline

Week 24

Change from Baseline

P (Wilcoxon signed rank test)

Total Cholesterol

183 (163 , 212)

161 (145 , 183)

-20 (-38 , -1)

<0.0001

LDL-Cholesterol

106 (88 , 129)

99 (82 , 119)

-8 (-22 , 9)

<0.0001

HDL-Cholesterol

43 (35 , 54)

39 (33 , 47)

-4 (-10 , 2)

<0.0001

Triglycerides

147 (106 , 247)

112 (78 , 161)

-34 (-97 , -6)

0.006

There was significant improvement (mean±SD, -0.41±1.54, P=0.04) in 10-year Framingham Cardiovascular Risk score (%) from baseline (4.57±5.01) to week 24 (4.16±4.71). Mean (SD) changes from baseline in creatinine were 0.03 mg/dL (0.15) at week 24 (P=0.02). 

Conclusion:

Switching to RPV/TDF/FTC resulted in significant improvement in lipid profile leading to a decrease in 10-year Framingham Risk score at week 24. It was well tolerated with low rates of discontinuation due to adverse events.

Ana Monczor, MD, FUNCEI - Fundacion Centro de Estudios Infectologicos, Buenos Aires, Argentina, Xiaoying Yu, MD, MS, Baylor College of Medicine and Study Design and Analysis Core, Baylor-UTHouston Center for AIDS Research, Houston, TX, Karen J. Vigil, MD, The University of Texas Health Science Center at Houston, Houston, TX, Claudia Kozinetz, PhD, MPH, Department of Pediatrics, Baylor College of Medicine and Study Design and Analysis Core, Baylor-UTHouston Center for AIDS Research, Houston, TX and Roberto Arduino, MD, Infectious Diseases, The University of Texas Health Science, Houston, TX

Disclosures:

A. Monczor, None

X. Yu, None

K. J. Vigil, None

C. Kozinetz, None

R. Arduino, None

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