Published: Sep 15, 2013 | Updated: Sep 16, 2013
By Michael Smith, North American Correspondent, MedPage Today
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner
- This study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
- A four-drug pill quad pill (containing elvitegravir, cobicistat, emtricitabine, and tenofovir) for HIV works as well in older patients as it does in those under 50.
- Note that the older patients (50 and 0ver) taking the quad pill had significantly less dizziness and fewer abnormal dreams compared to those getting efavirenz, emtricitabine, and tenofovir.
DENVER -- A four-drug "quad" pill for HIV works as well in older patients as it does in those under 50, a researcher said.
The quad pill (approved last year and marketed as Stribild) has been shown in several clinical trials to have equivalent efficacy and safety to major first-line HIV regimens, according to Joel Gallant, MD, of the Southwest CARE Center in Santa Fe.
But as the HIV-positive population ages, it becomes important to study the efficacy and safety of medications in older patients specifically, he argued here at the annual Interscience Conference on Anti-Microbial Agents and Chemotherapy.
To address the issue, the authors analyzed two randomized phase III clinical trials in treatment-naïve patients divided by age -- under 50 or 50 and over.
In one of the two trials, the quad pill (containing elvitegravir, cobicistat, emtricitabine, and tenofovir) was compared with the single-pill combination of efavirenz, emtricitabine, and tenofovir (Atripla).
In the second, the quad was compared with boosted atazanavir (Reyataz) and the single-pill combination of emtricitabine and tenofovir (Truvada).
In both cases, efficacy, defined as the ability of the regimen to control viral replication, was similar after 96 weeks of therapy -- 84% and 83%, respectively, for the quad and 82% in both studies for the comparator regimen.
In both studies, tolerability was slightly better for the quad, Gallant noted.
For this analysis, Gallant and colleagues combined the efficacy and safety data from both studies, but compared how older patients stacked up against their younger counterparts.
The proportion of men 50 or older ranged from 14% to 16% in the four original study arms, Gallant said.
For those 50 and older in the quad-Atripla study, efficacy was identical at 96 weeks at 82%. By comparison, the quad pill did slightly better in those under 50 -- 85% versus 81% -- but the difference was not significant.
Results were similar in the other study -- 82% and 81% for those under 50 and 90% in both arms for those 50 and older.
Over the 2 years of the studies, only two patients developed resistance, Gallant noted.
In both age groups, treatment led to a recovery of the immune response that was slightly blunted among those 50 and older but did not differ between treatment arms.
On the adverse events front, the older patients taking the quad:
- Had significantly less dizziness and fewer abnormal dreams compared to those getting Atripla.
- Had an early increase in serum creatinine that stabilized through week 96, was greater than with Atripla, but similar to that experienced by patients on atazanavir/emtricitabine/tenofovir.
- Had similar median increases in lipid parameters to those taking the other comparator regimens.
The study adds to the "comfort level" of clinicians prescribing the quad pill to older patients, commented Joseph Eron, MD, of the University of North Carolina Chapel Hill, who was not involved in the study but who co-moderated the session at which the data was presented.
"You didn't see any peculiar toxicities among the older group," Eron told MedPage Today. "It was reassuring."
It's also gratifying that the analysis could be done at all, Eron said, adding that "it's good to see that we have enough older patients to do the study."
The study was supported by Gilead Sciences. Gallant reported financial links with Bristol-Myers Squibb, Gilead Sciences, Janssen Therapeutics, Merck and Co, and Takara Bio. Several authors are employees of Gilead.
Eron previously disclosed financial relationships with Bristol-Myers Squibb, GlaxoSmithKline, Merck, Tibotec, and ViiV Healthcare.
Primary source: Interscience Conference on Anti-Microbial Agents and Chemotherapy
Source reference: Gallant JE, et al "Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF (E/C/F/TDF) demonstrates comparable efficacy and favorable tolerability to efavirenz (EFV)/FTC/TDF and to ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in subjects 50 years and older at week 96" ICAAC 2013; Abstract H-1459.