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FDA Approves Epclusa Combo Pill for All Types of Hepatitis C

, by Liz Highleyman

EpclusaOn June 28 the Food and Drug Administration (FDA) approved Gilead Sciences Epclusa, a new once-daily combination pill that cures all genotypes of hepatitis C virus (HCV) in 12 weeks. In a welcome move, the price for this new treatment was set lower than most other direct-acting antivirals for hepatitis C.

“The introduction of Epclusa marks another exciting step in HCV treatment,” said Andrew Reynolds, Hepatitis C Education Manager at Project Inform. “It’s really quite astonishing to think where we’ve come in just the last couple of years.”

Epclusa contains the HCV polymerase inhibitor sofosbuvir (marketed separately as Sovaldi) plus the new HCV NS5A inhibitor velpatasvir. It is the first “pangenotypic” regimen that can be used without interferon or ribavirin, meaning it is active against HCV genotypes 1, 2, 3, 4, 5, and 6. It was approved for both previously untreated and treatment-experienced adults with chronic hepatitis C, with or without liver cirrhosis.

“First we saw interferon-free regimens, but most still needed ribavirin, and that drug can be rough on people,” Reynolds told BETA. “We now have the potential to treat and cure HCV without ribavirin, with a single pill for 12 weeks at near 100% cure rates in patients with all genotypes.”

HCV genotype 1 is the most common type in the U.S. and Europe. It now has several good treatment options, including Gilead’s earlier Harvoni combo pill containing sofosbuvir plus an older NS5A inhibitor (ledipasvir) that is not active against genotypes 2 or 3.

Genotype 2 is often treated with sofosbuvir alone or sofosbuvir plus ribavirin, but these are not as effective as regimens containing two direct-acting antivirals. Genotype 3 is the hardest to treat. It can be effectively treated with sofosbuvir plus a second drug from another company, such as Bristol-Myers Squibb’s daclatasvir (Daklinza), but this requires multiple pills and can nearly double the cost.

The remaining HCV genotypes are more common in other parts of the world—including genotype 4 in the Middle East and North Africa, genotype 5 in South Africa, and genotype 6 in parts of Asia—and have not been as well studied. Pangenotypic regimens like Epclusa are especially important in low- and middle-income countries, as they can be used without the need for genotypic testing, which adds to the cost and complexity of treatment.

An estimated 150 to 200 million people worldwide are living with hepatitis C and more than 2 million are thought to be HIV/HCV coinfected. People living with both HIV and HCV typically experience more rapid liver disease progression than those with HCV alone. Epclusa is approved to treat people with HIV and HCV coinfection. However, it should not be used with some antiretrovirals—including efavirenz and tipranavir—and people taking tenofovir should have their kidney function monitored regularly.

FDA approval of Epclusa was based on clinical studies showing that it produces high rates of sustained virological response (SVR), or continued undetectable HCV viral load three months after finishing treatment, which is considered a cure.

In the Phase 3 ASTRAL trials, sofosbuvir/velpatasvir alone cured 99% of chronic hepatitis C patients with genotypes 1, 2, 4, 5, and 6, and 95% of those with genotype 3. Cure rates were similar regardless of prior treatment experience or the presence of cirrhosis. For people with decompensated cirrhosis, who have more severe liver impairment, sofosbuvir/velpatasvir plus ribavirin cured 94% of participants in ASTRAL-4. And ASTRAL-5 showed a cure rate of 95% for HIV-positive people with HCV coinfection.

In these studies, treatment with Epclusa was generally safe and well tolerated, with few serious drug-related adverse events or drug discontinuations. The most common side effects include headache and fatigue.

Gilead set the list price for Epclusa at $74,760—lower than the retail cost of Sovaldi ($84,000) and Harvoni ($94,500). The only regimen with a lower list price is Merck’s grazoprevir/elbasvir (Zepatier), at $54,600, but it is only approved for HCV genotypes 1 and 4.

This price makes Epclusa the preferred treatment for people with genotypes 2 or 3. However, Harvoni may remain a more attractive option for previously untreated genotype 1 patients without liver cirrhosis who can usually be cured in just 8 weeks, dropping the cost to $63,000—a shorter treatment duration that is not approved for Epclusa.

Gilead has added Epclusa to its patient assistance and co-pay programs for people in the U.S. (www.MySupportPath.com), and said it is working with regional partners, generic drug makers, and the Medicines Patent Pool to make Epclusa more widely available worldwide. Epclusa has already been licensed to generic manufacturers in India for use in more than 100 low-income countries. But advocates say discounts and generics are also needed in middle-income countries that have a large number of people living with hepatitis C.

“Sofosbuvir/velpatasvir gets us closer to the goal of highly efficacious, well tolerated HCV therapy for patients with all genotypes and all stages of liver disease,” said Joanna Eveland, MD, from Clínica Esperanza at Mission Neighborhood Health Center.

“The challenge with HCV remains the limited access to these life-saving medications,” she told BETA. “I continue to hope that Gilead will lower the price of these drugs to a more reasonable level, and that they will expand their patient assistance program so that all patients can have a chance at a cure.”

Liz Highleyman is a freelance medical writer and editor-in-chief of HIVandHepatitis.com.

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