Discontinuation of tenofovir disoproxil fumarate for presumed renal adverse events in treatment-naïve HIV-1 patients: meta-analysis of randomized clinical studies.

BACKGROUND: Safety and efficacy of tenofovir disoproxil fumarate (TDF) as a component of antiretroviral therapy (ART) have been demonstrated in clinical trials. TDF nephrotoxicity has been reported in both HIV-infected and noninfected patients. This meta-analysis explored the frequency of discontinuation attributed to renal adverse events (AEs) in randomized, controlled clinical studies that used TDF-containing regimens for ART-naïve, HIV-infected patients. METHODS: A literature search of 4 electronic databases through October 31, 2013 was utilized. RCTs included were limited to randomized, prospective, comparative design in ART treatment-naïve adults with HIV-1 infections receiving ART. Studies included trials containing TDF treatment regimens, with or without a non-TDF control group. Study design, follow-up, size of study population, treatment group, patient demographics, number of patients exposed to TDF or non-TDF control, baseline characteristics, investigator-defined criteria for renal AEs, and number of discontinuations due to a presumed renal AEs were extracted. RESULTS: Twenty-one clinical studies met the selection criteria. Treatment duration ranged from 48 to 288 weeks. Renal AEs led to study drug discontinuation in 44 of 10,129 patients exposed to TDF (0.43%; 95% CI, 0.32%-0.58%) and 2 of 2,013 patients exposed to non-TDF-containing regimens (0.10%; 95% CI, 0.01%-0.36%). In 5 randomized, controlled studies that included a non-TDF comparator, the estimated risk difference between the treatment groups (TDF vs non-TDF) was 0.50% (95% CI, 0.13%-0.86%; P = .007). CONCLUSIONS: In clinical studies using TDF-containing regimens, the rate of discontinuations due to renal AEs was low, but was slightly higher than in studies using non-TDF comparators.

Validation of the Special Projects of National Significance adherence tool in HIV/AIDS patients.

BACKGROUND: Adherence to highly active antiretroviral therapy (HAART) is crucial for success. Therefore, having validated tools to help assess adherence is necessary. The Health Resources and Services Administration assessed adherence as a Special Project of National Significance (SPNS). As a result of their study, a 3-question survey was developed as a simple tool to assess adherence in patients with HIV/AIDS. OBJECTIVE: To validate the SPNS adherence survey as an accurate and effective way to assess adherence and to determine whether any other independent variables correlate with a significant reduction in viral load. METHODS: The study was a retrospective chart review of 300 patients actively enrolled in an HIV/AIDS clinic from January 2007 to September 2007. Patients were eligible for the study if they had been on HAART for at least 6 months, were > or =18 years old, and had completed at least 2 surveys. RESULTS: A total of 74 patients met the criteria; the majority were male (75.3%) and African American (91.9%). Twenty-six (35.1%) patients had scores < or =10, indicating poorer adherence, and 48 (64.9%) patients had scores > or =11. The mean number of antiviral plus other medications was 4.4. Dosing of HAART drugs was once (5 nonadherent, 23 adherent pts.) and twice (21, 25 pts., respectively) daily, and mean number of different antiretroviral tablets/capsules being taken was 1.7 and 1.5, respectively. The nonadherent patients' average viral load was 15,202.3 copies/mL, while the adherent patients' average viral load was 163.8 copies/mL (p = 0.001) The SPNS score was significantly associated with HIV-RNA viral load (-0.482, p < 0.001). There also was a significant association between a higher HIV-RNA viral load and the total number of medications a patient was taking, as well as the number of different antiretroviral tablets/capsules being taken (0.299, p = 0.01; 0.249, p = 0.03). There was no significant difference in HIV-RNA viral load when comparing age, sex, race, income, and frequency of HIV drug dosing. CONCLUSIONS: The SPNS survey is a valid and simple tool in measuring adherence that can aid health-care professionals in assessing adherence to HAART.