In the Journals

Sovaldi with ribavirin safe, effective for children aged 3 years to 12 years

Treatment with Sovaldi and ribavirin was well-tolerated and highly effective in children aged 3 years to less than 12 years in pediatric patients with hepatitis C genotype 2 or genotype 3, according to a study published in Hepatology.

Previously, the only approved HCV treatment for patients aged younger than 12 years was pegylated interferon with ribavirin, which is “undesirable due to safety concerns, poor tolerability, and its parenteral route of administration,” according to Philip Rosenthal, MD, from the university of California San Diego, and colleagues. “Concern for the effects of pegylated interferon and ribavirin on growth and development in this age group also limits their use.”

To evaluate the safety and efficacy of Sovaldi (sofosbuvir, Gilead Sciences), the researchers enrolled 54 patients aged between 3 years and less than 12 years from 28 international sites.

All 41 patients aged 6 years to less than 12 years achieved sustained virologic response. Twelve of the 13 patients aged 3 years to less than 6 years also achieved SVR. One of the thirteen younger patients was a 4-year-old who discontinued treatment due to an adverse event of “abnormal drug taste.”

Of the 40 patients assessed for swallowability, 34 were able to swallow the 100 mg pill while the rest of the patients received sofosbuvir as granules. The researchers noted that the patient who discontinued was administered granules with applesauce and yogurt, “both of which are acidic and may have broken down the taste-mask coating of the granules,” the wrote.

All treatment-related adverse events were mild to moderate. For the older age group, the most common events were vomiting and headache, while the younger group most often experienced vomiting and diarrhea. All events of diarrhea lasted 5 days or fewer and resolved during treatment except for one case that lasted 2 months and resolved posttreatment. Cases of vomiting lasted for 1 or 2 days.

Study treatment did not affect pubertal development through 12 weeks of posttreatment follow-up.

“The availability of an all-oral, interferon-free, direct-acting antiviral regimen for younger children remains an unmet medical need,” Rosenthal and colleagues wrote. “The safety and efficacy of treatment with sofosbuvir plus ribavirin observed in this study supports its use in children. Treating HCV infection in pediatric patients could limit both horizontal and perinatal transmission of the virus, which could be important in reaching the World Health Organization’s goal of eliminating chronic HCV infection as a major public health threat by 2030.” – by Talitha Bennett

Disclosures: Rosenthal reports research support from AbbVie, Albireo, Bristol-Myers Squibb, Gilead, Merck, Retrophin and Roche; and consults for AbbVie, Albireo, Alexion, Audentes, Dicerna, Gilead, Intercept, Mirum, Retrophin and Roche. Please see the full study for all other authors’ relevant financial disclosures.

Treatment with Sovaldi and ribavirin was well-tolerated and highly effective in children aged 3 years to less than 12 years in pediatric patients with hepatitis C genotype 2 or genotype 3, according to a study published in Hepatology.

Previously, the only approved HCV treatment for patients aged younger than 12 years was pegylated interferon with ribavirin, which is “undesirable due to safety concerns, poor tolerability, and its parenteral route of administration,” according to Philip Rosenthal, MD, from the university of California San Diego, and colleagues. “Concern for the effects of pegylated interferon and ribavirin on growth and development in this age group also limits their use.”

To evaluate the safety and efficacy of Sovaldi (sofosbuvir, Gilead Sciences), the researchers enrolled 54 patients aged between 3 years and less than 12 years from 28 international sites.

All 41 patients aged 6 years to less than 12 years achieved sustained virologic response. Twelve of the 13 patients aged 3 years to less than 6 years also achieved SVR. One of the thirteen younger patients was a 4-year-old who discontinued treatment due to an adverse event of “abnormal drug taste.”

Of the 40 patients assessed for swallowability, 34 were able to swallow the 100 mg pill while the rest of the patients received sofosbuvir as granules. The researchers noted that the patient who discontinued was administered granules with applesauce and yogurt, “both of which are acidic and may have broken down the taste-mask coating of the granules,” the wrote.

All treatment-related adverse events were mild to moderate. For the older age group, the most common events were vomiting and headache, while the younger group most often experienced vomiting and diarrhea. All events of diarrhea lasted 5 days or fewer and resolved during treatment except for one case that lasted 2 months and resolved posttreatment. Cases of vomiting lasted for 1 or 2 days.

Study treatment did not affect pubertal development through 12 weeks of posttreatment follow-up.

“The availability of an all-oral, interferon-free, direct-acting antiviral regimen for younger children remains an unmet medical need,” Rosenthal and colleagues wrote. “The safety and efficacy of treatment with sofosbuvir plus ribavirin observed in this study supports its use in children. Treating HCV infection in pediatric patients could limit both horizontal and perinatal transmission of the virus, which could be important in reaching the World Health Organization’s goal of eliminating chronic HCV infection as a major public health threat by 2030.” – by Talitha Bennett

Disclosures: Rosenthal reports research support from AbbVie, Albireo, Bristol-Myers Squibb, Gilead, Merck, Retrophin and Roche; and consults for AbbVie, Albireo, Alexion, Audentes, Dicerna, Gilead, Intercept, Mirum, Retrophin and Roche. Please see the full study for all other authors’ relevant financial disclosures.