FDA Addresses Concerns Over Chronic Hepatitis C Therapy Approvals

FDA Addresses Concerns Over Chronic Hepatitis C Therapy Approvals

The treatment options available to address chronic hepatitis C, a serious and life-threatening infection, have substantially improved over the years, and an ever-increasing number of novel HCV regimens with shorter treatment duration and improved safety profiles and efficacy levels are now available to the public.

However, in spite of these recent therapeutic advancements for the treatment of the disease, several groups have expressed concern over the scientific evidence used to support some of the newer drug approvals, raising doubt among the HCV patient population about how effective the latest therapies really are in treating Hepatitis C.

In order to address these concerns, the United States Food and Drug Administration’s Division of Antiviral Products in the Center for Drug Evaluation and Research (CDER) has published a paper high-lightening the agency’s regulatory processes and scientific approaches that support the advancement and approval of promising drugs to address treat hepatitis C.

“FDA’s approach to evaluation of recent hepatitis C drugs underscores the Agency’s flexibility in considering innovative or alternative trial designs for drugs that have demonstrated highly promising outcomes in early phase development. Expedited approaches can be used without compromising efficacy standards for drugs that demonstrate breakthrough therapy potential,” explained Dr. Poonam Mishra, lead author of the new paper and deputy director for Safety, Division of Antiviral Products/Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

The new paper, entitled “Direct-acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: Scientific and regulatory approaches to clinical trial designs,” is published in the “Public Policy Corner” of Heptology, and seeks to present all pertinent data supporting the FDA’s statement that therapeutic options for hepatitis C have substantially improved in recent years, particularly with the advent of direct-acting antiviral agents (DAAs).

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The daclatasvir-sofosbuvir regimen to treat genotype 1 hepatitis C patients received amended Breakthrough Therapy Designation by United States Food and Drug Administration (FDA). In the beginning of 2015, the FDA had planned to remove Breakthrough-Therapy Designation for the daclatasvir-sofosbuvir treatment since other therapies were available and had higher success for other genotypes. However, the FDA revised its first decision and decided to continue the advancement of this therapy for the genotype 1 hepatitis C patients addressed in ALLY-1 Trial due to its promising outcomes.


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Isaura Santos graduated with a BS in Cell and Molecular Biology from Universidade Nova de Lisboa and a MA in Communication, Culture and Information Technologies from University Institute of Lisbon (ISCTE-IUL). Her professional interests include science communication, public awareness of science and communication of science through entertainment.

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