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Harvoni safe, effective for HCV–infected patients with sickle cell disease
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Harvoni, a fixed-dose combination of ledipasvir and sofosbuvir, safely and effectively treated hepatitis C virus infection in patients with sickle cell disease, according to findings from a small study published in Clinical Infectious Diseases.
“More recently, ribavirin- and interferon-free, oral, direct-acting antiviral (DAA) regimens have provided an opportunity to expand HCV treatment options for [patients with sickle cell disease] for whom older regimens were relatively contraindicated,” Mark S. Sulkowski, MD, medical director of the Viral Hepatitis Center at Johns Hopkins University School of Medicine and an Infectious Disease News Editorial Board member, and colleagues wrote. “Despite widespread use globally, the safety, tolerability and efficacy of ledipasvir/sofosbuvir has not been stablished in HCV–infected patients with sickle cell disease.”
Researchers evaluated the safety and efficacy of ledipasvir/sofosbuvir (LDV/SOF; Gilead Sciences) in patients with sickle cell disease — a population that until recently may have been ineligible for HCV treatment. In this open-label, single-center study, they enrolled 10 patients with HCV genotype 1 or 4 infection who received medical care for sickle cell disease at the Johns Hopkins Sickle Cell Center or treatment centers in the Baltimore area between April 2015 and January 2016. One patient with cirrhosis received one tablet of LDV/SOF (100 mg/400 mg) each day for 24 weeks. Nine patients without cirrhosis received the same medication daily for 12 weeks. The primary efficacy outcome was sustained virologic response (SVR) at 12 weeks after stopping treatment. They collected safety and efficacy data through the end of treatment and again at follow-up weeks 4 and 12.
The results showed that the overall rate of SVR was 90%. All nine patients without cirrhosis who achieved HCV RNA less than the lower limit of quantification by week 4 also achieved SVR. The one patient who relapsed after stopping treatment had evidence of nonadherence to the study drug during the first 4 weeks of treatment.
According to Sulkowski and colleagues, the safety, tolerability and efficacy of LDV/SOF in HCV–infected individuals with sickle cell disease was consistent with that observed in patients without hemoglobinopathy, and DAA treatment was not associated with worsening pre-existing anemia. The findings also demonstrated that patients could concurrently take treatment for hemoglobinopathy with hydroxyurea and for iron overload with oral iron chelators.
“We demonstrated that HCV–infected patients with sickle cell disease can be safely and effectively treated with LDV/SOF for 12 or 24 weeks,” the researchers wrote. “While larger studies are needed with longer follow-up to determine the safety of HCV DAAs and long-term benefit of SVR in patients with [sickle cell disease], the treatment of HCV infection with interferon- and ribavirin-free regimens should be priorities in this patient population, particularly those with hepatic iron deposition.” – by Savannah Demko
Disclosure: Sulkowski reports receiving a grant in addition to a consulting fee from Gilead Sciences. Please see the full study for a list of all other authors’ relevant financial disclosures.
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