September 01, 2016
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8-week Harvoni safe, effective in patients coinfected with HIV/HCV

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Researchers from Germany found that 8 weeks of Harvoni was safe and effective in patients coinfected with HIV and HCV, according to recent findings published in Clinical Infectious Diseases.

“These interim results of the German multicenter GECCO cohort show that high SVR rates obtained in clinical trials with 8 weeks of oral [Harvoni (sofosbuvir/ledipasvir, Gilead Sciences)] are reproducible in a real-world setting,” Patrick Ingiliz, MD, at the Center for Infectiology, Berlin, and colleagues wrote. “In a mainly Caucasian population, the interim results of GECCO-01 confirm the results of the ION-3 phase 3 trial and are indeed encouraging, as a shorter treatment duration might reduce costs and therefore enable a larger number of patients to have access to treatment.”

The combination treatment can be shortened to only 8 weeks in noncirrhotic HCV genotype 1 patients with low viral load, the researchers wrote. However, there were not enough data about the safety and efficacy of an 8-week treatment course, they said.

Ingiliz and colleagues extracted data from 193 patients from an ongoing prospective German cohort of nine treatment centers. All patients in this cohort began 8-week sofosbuvir/ledipasvir treatment in 2014. The researchers determined the safety and efficacy of the treatment in both mono-infected (n = 160) and coinfected (n = 28) participants.

The SVR rate 12 weeks after treatment was 93.5%. The on-treatment response rate was 99.4% in monoinfected patients and 96.4% in coinfected patients.

The researchers concluded that 8-week treatment was highly effective and safe in this cohort.

“Data from the real-world GECCO cohort confirm that a short course of sofosbuvir plus ledipasvir for 8 weeks is highly effective in well selected patients with chronic hepatitis C,” the researchers wrote. “Future guidelines should carefully take these findings into account.” – by Will Offit

Disclosure: Ingiliz reports being on the speakers bureau for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen and Merck. He also reports being on the advisory board for Gilead Sciences, AbbVie and ViiV. Please see the full study for a list of all other authors' relevant financial disclosures.