MONDAY, June 18 (HealthDay News) — Nearly 27 percent of homeless adults in Los Angeles may have hepatitis C, and nearly half don’t know they have the potentially deadly infection, researchers say.
Hepatitis C virus can destroy the liver and lead to a liver transplant. Recent research shows that it kills more American adults than AIDS.
For the study, researchers surveyed 534 homeless adults, most of them black men, between June 2003 and February 2004.
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Gilead Sciences, Inc. (NASDAQ:GILD) announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Vosevi®, an investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients. The data included in the application support the use of SOF/VEL/VOX in patients with and without compensated cirrhosis, with all genotypes (GT1-6) of HCV infection regardless of prior therapy, including 8 weeks of treatment for HCV direct-acting antiviral (DAA)-naïve patients without cirrhosis, as well as 12 weeks of treatment for patients who have previously failed therapy with a DAA-containing regimen.
The CHMP positive opinion was adopted following an accelerated assessment procedure, reserved for medicinal products expected to be of major public health interest. The recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.
The MAA for SOF/VEL/VOX is supported by data from four Phase 3 studies. Two studies (POLARIS-1 and POLARIS-4), evaluated 12 weeks of the single tablet regimen in patients with genotypes 1-6 HCV infection previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Two other studies (POLARIS-2 and POLARIS-3) evaluated 8 weeks of SOF/VEL/VOX in DAA-naïve patients with genotypes 1-6 HCV infection. Across POLARIS-1 and POLARIS-4, 97 percent of patients treated with SOF/VEL/VOX (n=431/445) achieved the primary efficacy endpoint of SVR12. In POLARIS-2, 95 percent of patients with genotypes 1-6 HCV infection with and without cirrhosis treated with SOF/VEL/VOX (n=477/501) achieved the primary efficacy endpoint of SVR12. In POLARIS-3, 96 percent of patients with genotype 3 infection and cirrhosis treated with SOF/VEL/VOX (n=106/110) achieved the primary efficacy endpoint of SVR12. The most common adverse events among patients who received SOF/VEL/VOX in the POLARIS studies were headache, fatigue, diarrhea and nausea.
WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted AbbVie a positive opinion recommending marketing authorization of MAVIRET™ (glecaprevir/pibrentasvir), an investigational, pan-genotypic treatment for adults with chronic hepatitis C virus (HCV) infection. If approved, MAVIRET will be a once-daily, ribavirin-free, 8-week treatment option for HCV patients across all genotypes (GT1-6) without cirrhosis and new to treatment, who comprise the majority of people living with HCV.1 The European Commission will now review the CHMP opinion and a final decision is expected in the next quarter. Glecaprevir is Enanta’s second protease inhibitor being developed through its collaboration with AbbVie and is one of the two new direct-acting antivirals (DAAs) combined in MAVIRET.
As an unprecedented number of Americans die from opioid overdoses, the Senate’s new health care bill is trying to put a Band-Aid over a gaping wound.
The Better Care Reconciliation Act of 2017, the Senate’s plan to repeal and replace Obamacare, would appropriate $2 billion in 2018 to fund state grants to boost treatment and recovery services for those struggling with drug addiction and mental health disorders. There’s no mention of more money going to fund drug treatment beyond 2018.
The $2 billion number proposed is a fraction of what two key Republican senators from states hardest hit by the opioid crisis were asking for in the bill’s final version. Ohio Sen. Rob Portman and West Virginia Sen. Shelley Moore Capito had requested $45 billion over the next 10 years.
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Pennsylvania: Newly diagnosed hepatitis C cases in Beaver County more than doubled between 2015 and 2016, prompting a free local screening next week organized by the Pennsylvania Department of Health.
There were 333 new hepatitis C cases last year in the county, up from 152 in 2015, according to the health department.
The disease, which is transmitted through blood-to-blood contact, is often asymptomatic for years, sometimes even decades, before causing significant liver damage through inflammation, scarring and eventually cirrhosis. Those with untreated hepatitis C also have an increased risk of getting liver cancer.
