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Switch to Genvoya maintains HIV suppression, increases BMD, renal function
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Switching patients with HIV from a regimen containing Viread to one with recently FDA-approved Genvoya could lead to improved bone mineral density and renal function without compromising viral suppression, according to the results of a recent phase 3 study.
“Although most patients with HIV-1 infection have durable virological suppression with their first [ART] regimen, switching to an alternative regimen could reduce pill burden or dosing frequency, improve adherence and tolerability, and reduce toxicity and costs,” David A. Wohl, MD, associate professor of infectious diseases at the University of North Carolina, and colleagues wrote.
David A. Wohl
Alternative regimens could be of significant use to patients currently prescribed Viread (tenofovir disoproxil fumarate, Gilead Sciences; TDF) due to reported reductions in bone mineral density (BMD) and renal function, the researchers wrote. To evaluate the efficacy, safety and tolerability of Genvoya — which contains 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide (E/C/F/TAF; Gilead Sciences) — Wohl and colleagues enrolled 1,443 virologically suppressed HIV patients currently prescribed one of four TDF-containing regimens into a randomized, multicenter, open-label noninferiority trial. Patients were randomly assigned to either continue TDF treatment (n = 477) or switch to the once-daily, single tablet with TAF (n = 959). Participants were enrolled into the study between April 12, 2013 and April 3, 2014, and were taking a TDF-containing regimen for at least 96 weeks before enrollment. The primary endpoint was the proportion of patients with HIV-1 RNA fewer than 50 copies per mL after 48 weeks, while other observed outcomes included changes in hip and spine BMD, serum creatinine and safety.
The researchers found greater levels of viral suppression among patients who switched to the TAF-containing regimen (97% vs. 93%; adjusted difference = 4.1%; 95% CI, 1.6%-6.7%), and a 1% rate of virologic failure in both groups. All regimens were well-tolerated, but study drug-related adverse events were more common among the TAF group (21% vs. 16%). In addition, BMD and glomerular filtration were significantly improved in patients who switched to TAF.
“Virologically suppressed HIV-1-infected patients who switched to a [TAF]-containing regimen maintained virological suppression at a statistically higher rate at 48 weeks compared with those who remained on one of four [TDF]-containing regimens,” the researchers wrote. “Virologically suppressed patients can be switched from [TDF]-containing regimens to regimens containing [TAF] without a loss of efficacy.”
In a related editorial, Shireesha Dhanireddy, MD, medical director of the Infectious Diseases Clinic at the University of Washington School of Medicine, and Jared M. Baeten, MD, PhD, vice chair and professor of global health at the School of Public Health at the University of Washington, acknowledged the hesitancy of health care providers to change regimens, but argued that treatments limiting the adverse effects of ART should be given serious consideration.
“In many settings worldwide and for many patients, HIV is now a well-controlled chronic disease, and non-AIDS disorders, including drug-related toxicities, will cause substantially more morbidity and mortality than do AIDS-related diseases,” Dhanireddy and Baeten wrote. “The days of achieving viral suppression at the expense of quality of life and consideration of long-term health are gone. As newer drugs become available with safer side-effect profiles, we must consider these factors in addition to virological efficacy.” – by Dave Muoio
Disclosures: Mills reports relationships with Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck and ViiV Healthcare. Wohl reports being the lead investigator for the Genvoya efficacy analysis and participating on advisory boards for Gilead Sciences. Please see the full study for a list of all other authors’ relevant financial disclosures.
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