Hepatitis C Infection: FDA Approves a new drug that treats all genotypes

US Food and Drug Administration has approved Epclusa an oral, fixed-dose combination drug for adults, containing sofosbuvir 400 mg plus velpatasvir 100 mg last week. Epclusa is the first agent of its kind approved to treat all six variants of the Hepatitis C infection genotype in a patient, with or without cirrhosis.

Gilead Sciences, Inc. is the manufacturer of the first of its kind drug therapy for chronic Hepatitis C infection.

Almost 75% of Americans with HCV carry genotype 1, 20-25% carry genotype 2 or 3, and small numbers are infected with genotypes 4, 5, and 6. Patients suffering from chronic severe HCV infections tend to face complications such as bleeding, jaundice, ascites, hepatocellular cancer and death. The Hepatitis C infection turns chronic in 75-85% of infected patients. [2]

HCV is a major cause of liver disease worldwide and a potential cause of morbidity and mortality in the future. The complexity related to the geographic distribution of HCV infection and chronic hepatitis, determination of its associated risk factors, and evaluation of cofactors that accelerate its progression, underscore the difficulties in global prevention and control of HCV. This is compounded by a lack of vaccine and post-exposure prophylaxis for HCV. In 2013, the latest national data rates of acute HCV infection have been recorded to be 1.7 per 100 000 American Indians/Alaska Natives. From 2009 to 2013, the HCV-related mortality rate has increased by 23.2%, leading to 324 deaths in 2013. [3]

Epclusa has been administered as a monotherapy for patients with mild or no cirrhosis and as a combination therapy with ribavirin for patients with decompensated cirrhosis. The efficacy and safety of Epclusa was evaluated in three 12-week, phase 3 trials. 1,558 patients with a proven HCV infections and cirrhosis or mild cirrhosis participated. The result showed that 95-99% of patients who had received Epclusa had no detectable viral loads in the blood after 12 weeks of the treatment. [4]

Epclusa, the new miracle drug, could herald an eventual end to combination therapy with the molecules ribavirin/ or interferon for numerous HCV patients, freeing a large number of individuals from prolonged and severe side effects.

The commonest side effects of Epclusa are headache and fatigue. A combination of amiodorane and sofosbuvir along with a HCV direct-acting antiviral has reported cases with slowing of heart rates and some requiring pacemaker intervention; thus, a warning for patients and healthcare providers has been announced by the FDA. Epclusa and ribavirin combination therapy is contraindicated for patients for whom ribavirin is contraindicated. Ribavirin can cause birth defects and hence is contraindicated during planning and pregnancy. [2]

It should be noted that Epclusa will not prevent one from transmission of HCV to other people, and thus, other necessary precautions must be taken to prevent increase in prevalence of this lethal Hepatitis C infection.

John Milligan, Ph.D., President and CEO of Gilead stated that “Today’s approval represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more costly and complex regimens.” He further added that “As the first and only pan-genotypic cure for hepatitis C infection, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings.” [5]

Credit: Dr. Rachita on behalf of Borderless Access

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