August 23, 2016
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Epclusa shows manageable drug interaction profile with antiretrovirals

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Epclusa showed a manageable drug interaction profile with commonly used antiretrovirals in treating patients co-infected with chronic HCV and HIV, according to a phase 1 trial.

“Overall, [sofosbuvir/velpatasvir (Epclusa, Gilead)] did not have clinically relevant drug interactions with the majority of antiretroviral regimens evaluated,” Annie Luetkemeyer, MD, associate professor at University of California San Francisco School of Medicine, told Healio.com/Hepatology. “Sofosbuvir/velpatasvir has a well characterized and manageable drug interaction profile with commonly used antiretroviral regimens.”

Annie Luetkemeyer, MD
Annie Luetkemeyer

Due to shared transmission routes, about one-third of people living with HIV are co-infected with HCV, according to Luetkemeyer. Further, “HIV accelerates the progression of HCV disease; thus, antiviral agents are a high priority for HCV treatment.”

Therefore, Luetkemeyer and colleagues evaluated drug–drug interactions between Epclusa and nine commonly used antiretrovirals to support coadministration in patients co-infected with HIV and HCV. They administered Epclusa alone or in combination with the antiretrovirals in 230 patients. Afterward, they assessed steady-state plasma concentrations of each medication on the last day of dosing.

The researchers noted no clinically significant changes in the pharmacokinetics of the coadministered medications, except efavirenz. Further, current prescribing information recommends that patients taking Epclusa with efavirenz should be monitored for adverse reactions.

The researchers concluded that Epclusa can be safely administered with all tested antiretrovirals except efavirenz.

“It should be noted that the efavirenz containing regimens reduced serum concentrations of velpatasvir secondary to efavirenz’s capability to induce drug metabolizing enzymes,” the researchers wrote. “Therefore, coadministration of sofosbuvir/velpatasvir is not recommended with efavirenz containing regimens.” – by Will Offit

Reference:

Luetkemeyer A, et al. Abstract WEAB03. Presented at: AIDS 2016 Annual Meeting; July 18-22, 2016; Durban, South Africa.

Disclosure: Luetkemeyer reports receiving research grants from AbbVie, Bristol-Myers Squibb, Gilead and Merck.