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FDA Approves Harvoni and Sovaldi for Adolescents with Hepatitis C

The U.S. Food and Drug Administration (FDA) on April 7 approved the first direct-acting antivirals for the treatment of chronic hepatitis C virus (HCV) infection in adolescents age 12 to 17 years. Sofosbuvir/ledipasvir (Harvoni) is now indicated for adolescents with HCV genotypes 1, 4, 5, or 6, while sofosbuvir (Sovaldi) plus ribavirin is approved for those with genotypes 2 or 3.

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CROI 2017: Glecaprevir/ Pibrentasvir for HCV Can Be Safely Administered with Common Antiretrovirals

AbbVie's investigational glecaprevir/pibrentasvir treatment for hepatitis C is not expected to interact with or require dose adjustment when taken with commonly used antiretroviral regimens, offering a new option for HIV/HCV coinfected people, according to a study presented at the Conference on Retroviruses and Opportunistic Infections this month in Seattle.

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8. More Treatment Options for More Types of HCV

This year saw the approval of new highly effective direct-acting antiviral therapies for hepatitis C, with more in the pipeline and due for approval in 2017.

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Gilead and AbbVie Seek FDA Approval of Pangenotypic Hepatitis C Treatments

Gilead Sciences and AbbVie both announced this month that they have applied for U.S. Food and Drug Administration approval of new all-oral ribavirin-free combination regimens to treat all genotypes of hepatitis C virus (HCV). Gilead's sofosbuvir/velpatasvir/ voxilaprevir and AbbVie's glecaprevir/pibrentasvir have demonstrated high cure rates in Phase 3 clinical trials.

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9. Primary Care Providers Can Treat Hepatitis C

Interferon-free direct-acting antiviral therapy for hepatitis C is effective and simple enough that care can be managed by primary care providers, helping relieve the shortage of liver disease specialists.

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