September 15, 2016
1 min read

Epclusa demonstrates manageable drug interaction profile with commonly used ART

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Annie Luetkemeyer

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

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

Due to shared transmission routes, about one-third of people living with HIV are coinfected 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 sofosbuvir/velpatasvir and nine commonly used antiretrovirals to support coadministration in patients coinfected with HIV and HCV. They administered the treatment 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 Sustiva (efavirenz, Bristol-Myers Squibb). Current prescribing information recommends that patients taking sofosbuvir/velpatasvir with efavirenz should be monitored for adverse reactions.

The researchers concluded that sofosbuvir/velpatasvir 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

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