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Surprising price break for newly-approved hepatitis C drug

, by Liz Highleyman

The U.S. Food and Drug Administration (FDA) has approved two new once-daily combination pills to treat all genotypes of hepatitis C virus (HCV). Gilead Sciences’ Vosevi (sofosbuvir/velpatasvir/voxilaprevir) was approved on July 18 and AbbVie’s Mavyret (glecaprevir/pibrentasvir) was approved on August 3. Both combos cure more than 95% of treated people in two or three months, and Mavyret is priced well below existing therapies.

MavyretAbbVie surprised and pleased advocates when it launched Mavyret with a price of $26,400 for 8 weeks. The lower cost is in part due to its shorter treatment duration, but even people who need 12 or 16 weeks would still pay less than they would for existing therapies (which have been as high as $94,500 for a full course of treatment).

The development of direct-acting antivirals (DAAs) has made hepatitis C treatment shorter, easier and much more effective than the old interferon-based therapy, which caused severe side effects and only worked about half of the time. Like antiretroviral therapy for HIV, DAA treatment works best when it combines drugs that attack different steps of the virus lifecycle. Current recommended DAA regimens can cure most people in 12 weeks.

But there is still room for improvement, including shorter regimens and better options for hard-to-treat people such as those with HCV genotype 3 or advanced liver disease. Having more options on the market also lowers the cost of therapy, which has been a major barrier to getting everyone living with hepatitis C on treatment.

Vosevi approved for “salvage therapy”  

Vosevi is a single-tablet regimen taken once daily with food for 12 weeks. It contains the HCV NS5B polymerase inhibitor sofosbuvir (sold separately as Sovaldi), the NS5A inhibitor velpatasvir (currently combined with sofosbuvir in the Epclusa coformulation), and the NS3/4A protease inhibitor voxilaprevir. All of these drugs are pangenotypic, meaning they work against all six genotypes of HCV.

VoseviThe FDA approved Vosevi as “salvage therapy” for people with HCV genotypes 1 through 6 who were not previously cured with prior DAA therapy. Re-treatment can be challenging for this population because HCV can develop resistance to one medication that reduces the effectiveness of other drugs in the same class.

In the Phase 3 POLARIS trials, Vosevi taken for 12 weeks cured around 97% of study participants with all HCV genotypes who were previously treated with DAAs, performing better than the two-drug Epclusa pill. For people starting treatment for the first time, 8 weeks of Vosevi did not quite match 12 weeks of Epclusa (response rates of 95% vs 98%, respectively), and the FDA did not approve this shorter regimen. But Vosevi taken for either 8 or 12 weeks did cure 96% of people with genotype 3 and liver cirrhosis—considered one of the most difficult groups to treat.

Mavyret: The first FDA-approved 8-week DAA therapy

Mavyret is a coformulation containing the NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir, both approved for the first time. These drugs also work against all HCV genotypes. Treatment involves three combination pills taken together once daily with food.

The FDA approved Mavyret for previously untreated people with HCV genotypes 1 through 6, using a treatment duration of 8 weeks for those without cirrhosis and 12 weeks for those with cirrhosis. This is the first FDA-approved 8-week DAA regimen.

The FDA also approved a longer course of Mavyret for people with genotype 1 who were previously treated with either an HCV protease inhibitor or a NS5A inhibitor—but not both—and for people with genotype 3 who previously used interferon-based therapy or sofosbuvir. Treatment-experienced people should extend therapy to 12 or 16 weeks.

In the Phase 3 ENDURANCE AND EXPEDITION trials, Mavyret taken for 8 or 12 weeks cured 98% to 100% of people with HCV genotypes 1, 2, 4, 5 and 6 with or without cirrhosis, and 95% of those with genotype 3 and cirrhosis. The combo also cured 98% of people with HIV/HCV coinfection and 98% of patients with chronic kidney disease, including those on dialysis.

Vosevi and Mavyret were generally safe and well tolerated in clinical trials. The most common adverse events were headache, fatigue, diarrhea and nausea. Few participants experienced serious drug-related adverse events or stopped treatment for this reason. The drugs in Vosevi and Mavyret can interact with some other medications. In general, HCV protease inhibitors and HIV protease inhibitors should not be used together.

Both Vosevi and Mavyret were approved for people without liver cirrhosis or with compensated cirrhosis (meaning the liver can still carry out its vital functions), but they are not recommended for people with decompensated cirrhosis (the start of liver failure).

What about cost?

Due to the high cost of DAAs, many private insurers and public payors have restricted access to hepatitis C treatment, for example limiting it to people with advanced liver disease or excluding people who inject drugs. But the latest AASLD/IDSA guidelines recommend that everyone living with hepatitis C should have access to therapy, which can both stop liver disease progression and prevent HCV transmission.

Gilead set the price for its first DAA, solo sofosbuvir, at a notorious $1,000 per pill, or $84,000 for a 12-week course of treatment, though due to negotiated prices and volume discounts, most individuals and insurers don’t pay the full amount. The first all-in-one combo, Harvoni (sofosbuvir/ledipasvir) was set at $94,500.

AbbVie’s first DAA combo, Viekira, undercut Harvoni with a price of around $83,000, but it proved less popular, in part due to its twice-daily dosing. Approved a year later, Merck’s Zepatier combo (grazoprevir/elbasvir) lowered the price further, to $54,600 for 12 weeks.

Last year Gilead launched Epclusa, the first pangenotypic combo, at a price of $74,760 for 12 weeks, and the company has kept the same price for Vosevi, even though it includes an additional drug.

At $26,400 for 8 weeks of treatment, Mavyret’s price falls well below the threshold of $40,000 that University of California San Francisco researchers deemed manageable for U.S. health systems without requiring treatment delays or cuts to other services. Medicaid programs and prison systems especially stand to benefit, as they cover a large proportion of people with hepatitis C.

“The company did the right thing in launching with a [wholesale] price that is, we believe, within the bounds of what the U.S. market can reasonably bear—public and private payor negotiations will ultimately reduce the cost further,” said Emalie Huriaux of Project Inform and the Fair Pricing Coalition. “State Medicaid programs and correctional systems have, understandably, cried foul with respect to ensuring coverage for these life-saving therapies. With Mavyret’s significant price differential, the issue of unencumbered access is now in payors’ hands.”

Previously approved DAA regimens are cost-effective, because most people who are cured early enough will not require expensive care for end-stage liver disease or liver transplants. But these benefits are only realized after 10 or 20 years, Annette Gaudino of the Treatment Action Group (TAG) told BETA. Public payors with limited budgets need lower prices to address a condition as common as hepatitis C.

“This is very good news for people living with HCV in the United States,” said Tim Horn of TAG and the Fair Pricing Coalition. “The favorable U.S. launch price set by AbbVie should also be good news to public and private payors, resulting in fewer access barriers, a substantial increase in the number of cures, and significant progress toward HCV elimination.”

San Francisco AIDS Foundation offers free HCV testing and linkage to treatment. Drop in on Tuesday, Wednesday or Thursday from 3 pm – 5 pm for HIV and hepatitis C testing to 1035 Market Street, Suite 400 in San Francisco.

For people outside of San Francisco, the Centers for Disease Control has a website where you can search for free HCV testing in your area by entering your zip code.

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

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