Background: Efavirenz has been used for HIV despite side effects. The development of other regimens to treat HIV+ patients have increased options. The CNS side effects associated with Atripla may be lessened by changing to newer regimens. The study was designed to evaluate how patients faired when changing from Atripla to Stribild.
Methods: A 24 week Phase IV, prospective, observational cohort study examined patients changed from Atripla to Stribild for continued suppression of viral load, effect on CD-4 cells, quality of life and sleep using blood tests and standardized questionnaires. Patients were taking Atripla for at least 3 months with viral loads <50 copies/ml, age >18 yo and eGFR ≥70mL/min/1.73m2. The primary endpoint was maintenance of viral load <50 copies/ml. The secondary endpoints included changes in CD4 cell count, changes in sleep quality as measured by the Pittsburg Sleep Quality Index (PSQI) and changes in quality of life as measured by the St Stephens Aids Trust 047 Questionnaire (SSAT). Visits and evaluations were conducted at 0, 4, 12 and 24 weeks.
Results: Of 28 patients screened, 25 were enrolled and 21 completed. 3 patients had elevated viral loads at visit 1; 2 patients moved; and 2 patients withdrew consent. Patients were: 95% male; 76% white, 19% black, and 5% Native American.
After 24 weeks, 95% of patients (20/21) had viral load <50 copies/ml. All values were <50 copies/ml with the exception of two patients: one with a VL of 154 at week 12 and one had a level of 61 at week 24, neither was clinically significant. There was an increase in CD 4 cells from 691 to 772 (Graph 1). A slight increase of creatinine from 0.99 mg/dl to 1.12 mg/dl occurred.
PSQI scores, reported as sum of seven responses, decreased from 7.3 to 5.1 correlating with improved sleep quality. (Graph 2.)
Conclusion: Changes in patients HAART regimens did not cause any loss of viral control. Patients may benefit from changing their regimens to newer options that do not include efavirenz. This change is consistent with the new DHHS guidelines. It is not adequate to attain viral suppression at the expense of quality of life. Providers have options that allow us to optimize patients treatment with fewer side effects. The paradigm is changing and the goals for HIV treatment are higher.