Switch to Quad Pill Maintained HIV Suppression (CME/CE)
HIV patients can be successfully switched from a twice-daily integrase inhibitor regimen to a once-daily, single-tablet regimen without loss of viral suppression, researchers reported here.
At 48 weeks, all 46 patients who switched from a raltegravir-based (Isentress) regimen to the four-drug, elvitegravir-cobicistat-tenofovir-emtricitabine (Stribild) pill were able to maintain undetectable viral load using the 50 copies/ml assay, said Gordon Crofoot, MD, a Houston-based HIV researcher in private practice.
"Switching to once-daily Stribild from twice-daily raltegravir plus Truvada [tenofovir plus emtricitabine] may be a viable regimen simplification option," Crofoot told MedPage Today
at his poster presentation at the 7th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention.
Crofoot and colleagues recruited 48 patients who had achieved viral suppression on raltegravir -- the first-in-class integrase inhibitor that is taken twice daily -- and who had achieved that suppression for at least 6 months, and offered them treatment with the so-called "quad" pill that has been approved by the Food and Drug Administration as a combination product. Cobicistat and elvitegravir have not yet received FDA approval as individual drugs.
The mean age of the patients in the study was 44 years, and 96% were men; 17% were nonwhite; their mean CD4-positive cell count at the time of the switch was 713 cells/mm3.
Crofoot said that 96% of the patients in the study indicated they wanted to switch because they desired a once-daily treatment, 15% were concerned about long-term safety of their current regimen, 13% suggested they wanted to contribute to the science of HIV treatment, and 2% said they were unable to tolerate the raltegravir-based therapy.
The four-drug tablet was well tolerated through 48 weeks, the researchers reported. "There were no adverse events leading to study drug discontinuation," Crofoot said. "There were no clinically relevant changes in serum creatinine after switching to Stribild. There were no clinically relevant trends in total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, or in triglycerides."
Crofoot noted that 38 of the 38 patients who had been enrolled in the study for 48 weeks at the time the study was being prepared for publication had reached undetectable viral loads. However, since that time, another eight patients reached the 48-week milestone and also had undetectable viral loads, he said.
"These data are reassuring that patients can safely switch from one regimen to this simplified regimen," Saye Khoo, MD, MBBS, of the University of Liverpool, told MedPage Today
as he reviewed the presentation.
A total of 56% of the patients on Stribild complained of various adverse events, considered Grade 1 toxicities, Crofoot said. About 27% had Grade 2 toxicities. One patient (2%) was hospitalized twice for conditions related to his chronic obstructive pulmonary disease which were unrelated to the study drug.
None of the patients discontinued treatment and no deaths occurred, he noted. The most common adverse event was upper respiratory infections experienced by six patients; diarrhea was reported by five patients; fatigue was reported by five patients; insomnia occurred among five patients.
Primary source: International AIDS Society
Source reference:
Crofoot G, et al "Safety and tolerability of switching from twice daily raltegravir plus Truvada to STRIBILD in virologically suppressed, HIV-1-infected subjects at week 24" IAS
2013; Abstract TUPE283.
