New treatment for hepatitis C infection now available at ANMC

Since 2013, more effective drug therapies for treating hepatitis C have increased the rate at which our people are completing treatment that leads to a cure for the deadly virus. Joining a family of highly effective direct acting antiviral therapies available at ANMC is a newly licensed drug consisting of sofosbuvir and valpatasvir (Epclusa®, Gilead Sciences, Inc.). This is a fixed-dose combination tablet that covers six hepatitis C virus genotypes and is approved for use in persons with serious liver disease, most of whom had no treatment options available prior to this drug’s approval.

Through the Liver Disease and Hepatitis Program, ANTHC is currently supporting two programs to increase treatment rates for our people who are living with hepatitis C infection. First is the Hepatitis C Treatment strategic initiative, which has made the new treatment options available for the past three years. Through this initiative at ANMC, 270 patients have completed treatment with more than 95 percent completing treatment as prescribed by their provider. For patients who have completed treatment, 93 percent of them have been cured (i.e., no detectable virus in their blood, 12-weeks post-treatment completion). Statewide, outside of ANMC, more than 100 persons have received hepatitis C treatment.



CDAR Researcher Studying Appalachian Cohort Seeks to Stem Opioids Abuse, Hepatitis C

Note:  There is an excellent video embedded in the news story that explains the study- Alan

LEXINGTON, Ky. (Oct. 21, 2016) — With the rise in injection drug use, infectious disease has permeated through cohesive social networks in Appalachia, causing another dimension of devastation in the wake of the opioid epidemic.

About 15 years ago, a shift toward injection drug use behaviors occurred in rural Appalachia. These changes in drug use patterns signaled the potential for infiltration of blood-borne pathogens transmitted through shared needles. Increases in hepatitis C (HCV) infections have paralleled the increase in injection drug use behaviors among opioid users, with the rate of HCV infection in three Appalachian states tripling within six years.

With staggering rates of injection drug use and HCV in Appalachia, the National Institutes on Drug Abuse (NIDA) issued planning grants in 2016 to support researchers expediting and implementing solutions to the epidemic. Jennifer Havens, an epidemiologist in the University of Kentucky Center for Drug and Alcohol Research, was recently awarded two of the competitive planning grants to launch projects that will inform interventions and policies directed at opioid abuse across Appalachia. Havens has followed the simultaneous rise in injection drug use and HCV in Appalachia since 2004, accruing valuable data imperative for informing interventions and effective health policies.



National Progress Toward Hepatitis C Elimination — Georgia, 2015 — 2016

Note:  This is Georgia the European country.

Georgia’s hepatitis C elimination program, the first of its kind in the world, can provide information and experience that will assist similar goal-setting and programmatic efforts in other countries. The country of Georgia has one of the highest hepatitis C prevalence rates in the world, affecting 8% of the 3.7 million population. Georgia is the first country to take on the challenge of eliminating hepatitis C and has, as part of a comprehensive hepatitis C elimination plan, committed to treat and cure every hepatitis C-infected person in the country. In April 2015, in collaboration with CDC and other partners, Georgia embarked on a program to eliminate hepatitis C infection, subsequently defined as achieving a 90% reduction in prevalence by 2020. The initial phase of the program focused on providing free, curative HCV treatment to infected people with advanced liver disease. By April 2016, a total of 27,392 HCV-infected people registered for the program; 31% started treatment, 69% completed treatment, and 83% of those who completed treatment were cured of HCV.


MMWR News Synopsis for October 20, 2016 click here

CDC Media Relations


Having HIV and chronic HBV/HCV coinfection may increase cancer risk

In HIV-infected patients receiving antiretroviral therapy (ART), chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) coinfection is associated with an increased risk for non-Hodgkin’s lymphoma. The findings are published in Annals of Internal Medicine.

The incidence rate of non-Hodgkin’s lymphoma in HIV-infected persons is about 10 times higher than in the HIV-negative population, and is an important cause of AIDS and death, even for patients receiving ART. Growing evidence indicates that some infections increase the risk for non-Hodgkin’s lymphoma through chronic immune stimulation that occurs in immunocompromised patients. It is unclear whether chronic HBV and HCV infection promote non-Hodgkin’s lymphoma in HIV-infected patients.

Read more….


SAMHSA, CDC announce funding to address opioid epidemic in rural US

The Substance Abuse and Mental Health Services Administration recently announced a new federal funding opportunity to address the opioid use and overdose epidemic and associated comorbidities in rural U.S. regions.

Funding will go towards research on comprehensive, integrated approaches to prevent opioid injection and related consequences, including substance use disorder, overdose, HIV, hepatitis C and associated conditions such as hepatitis B and STDs.

The initiative will focus on coal-impacted counties within Appalachia and other rural communities across the country.

Read more…


Hepatitis C cases on the rise in young adults in Alaska, Southeast by Joe Viechnicki

Note:  Includes audio

Southeast Alaska has seen a nearly 500 percent increase in the rate of young adults with Hepatitis C in the last five years. Hepatitis C is the most common chronic blood-borne infection in the U.S. An estimated three and a half million people are infected in the U.S.

For many years it was mainly reported in older generations, the Baby Boomers, infected with blood transfusions and organ transplants done before blood screening became widespread in 1992. The infection can also be spread by sharing needles and intravenous drug use and health officials say that’s likely a factor in the spike in cases in adults age 18 to 29 in Alaska. Other parts of the state are also seeing a rise in young adults with Hep C, but Southeast has seen the biggest increase.

Read and hear more…


Hepatitis C Prevalence and Genotype Distribution Worldwide | Lauren Santye, Assistant Editor

Researchers recently conducted a comprehensive review of recently published literature to estimate anti-hepatitis C virus (HCV) prevalence, the viraemic rate (HCV-RNA positive), and genotype distribution in order to create a global estimate of hepatitis C disease burden.

The systematic study published in the World Journal of Gastroenterology is representative of one of the most comprehensive efforts to quantify global HCV epidemiology. Recent estimates have shown an increase in HCV seroprevalence over the last decade to 2.8%, which equates to 185 million infections globally.

For the study, a comprehensive review of literature from 2000 to 2015 was conducted in order to gather country-specific prevalence. The regions included in the analysis were defined by the Global Burden of Diseases, Injuries, and Risk Factors 2010 (GBD) study.



Gilead Announces SVR12 Rates From Four Phase 3 Studies of a Once-Daily, Fixed-Dose Combination of Sofosbuvir, Velpatasvir and Voxilaprevir in Treatment-Naïve and Treatment-Experienced Genotype 1-6 Chronic HCV-Infected Patients

– If Approved, SOF/VEL/VOX Would Be the First Once-Daily Single Tablet Regimen Available for Salvage for Patients Who Have Failed Prior HCV Therapy with Oral Direct-Acting Antiviral Agent Regimens –

– U.S. NDA Planned for Q4 2016 –

FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 20, 2016– Gilead Sciences, Inc.(NASDAQ: GILD) today announced topline results from four international Phase 3 clinical studies (POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4) evaluating an investigational, once-daily, fixed-dose combination of sofosbuvir (SOF), a nucleotide analog NS5B polymerase inhibitor; velpatasvir (VEL), a pangenotypic NS5A inhibitor; and voxilaprevir (VOX; GS-9857), an investigational pangenotypic NS3/4A protease inhibitor, for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection.

In the POLARIS-1 and POLARIS-4 studies, 445 patients with genotype 1-6 HCV infection who were previously treated with direct-acting antiviral agents (DAAs) received 12 weeks of SOF/VEL/VOX. The POLARIS-1 study enrolled patients who failed prior treatment with an NS5A inhibitor. The POLARIS-4 study enrolled patients who failed prior treatment with a DAA that was not an NS5A inhibitor, most with either an NS5B inhibitor alone (73 percent) or an NS5B inhibitor and an NS3/4A protease inhibitor (25 percent).

In the POLARIS-2 and POLARIS-3 studies, 611 patients who were not previously treated with a DAA received 8 weeks of SOF/VEL/VOX. The POLARIS-2 study enrolled patients with genotype 1-6 HCV infection with or without compensated cirrhosis. The POLARIS-3 study enrolled patients with genotype 3 HCV infection, all of whom had compensated cirrhosis.

The primary endpoint for all studies was SVR12. The intent-to-treat SVR12 rates observed in the POLARIS studies are summarized in the following table. Complete results from all four studies will be presented at The Liver Meeting® 2016 in Boston.

Study Population Genotype Treatment Duration SVR12 Rates
POLARIS-1 NS5A inhibitor-experienced

41 percent (172/415) had cirrhosis

1, 2, 3, 4, 5, 6 SOF/VEL/VOX 12 Weeks



Placebo 12 Weeks




DAA-experienced (No NS5A inhibitor)

46 percent (153/333) had cirrhosis

1, 2, 3, 4 SOF/VEL/VOX 12 Weeks



SOF/VEL 12 Weeks




18 percent (174/941) had cirrhosis

1, 2, 3, 4, 5, 6 SOF/VEL/VOX 8 Weeks



SOF/VEL 12 Weeks




All had cirrhosis

3 SOF/VEL/VOX 8 Weeks



SOF/VEL 12 Weeks



Patients treated with SOF/VEL/VOX for 12 or eight weeks had similar overall incidence of adverse events compared to placebo-treated or SOF/VEL-treated patients. The most common adverse events among patients who received SOF/VEL/VOX were headache, fatigue, diarrhea and nausea. Among the 1,056 patients who received SOF/VEL/VOX in the four studies, one patient (less than one percent) receiving SOF/VEL/VOX for 12 weeks discontinued due to an adverse event.

“Despite recent advances that have provided high cure rates and simplified treatment for most HCV patients, those who have failed previous treatment with direct acting antivirals continue to represent an unmet medical need. The POLARIS study results demonstrate that combining three potent antivirals with different mechanisms of action and high barriers to resistance can provide high cure rates for patients who have failed other highly effective oral DAA regimens,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “Based on these Phase 3 results, we plan to submit regulatory applications for SOF/VEL/VOX for the treatment of chronic HCV in the United States in the fourth quarter of 2016 and shortly thereafter in Europe.”

About the POLARIS Studies

The POLARIS-1 study was a double-blind, placebo-controlled study in 415 genotype 1-6 NS5A inhibitor-experienced patients. The most common prior NS5A inhibitors were ledipasvir (55 percent) and daclatasvir (23 percent).

The open-label POLARIS-4 study evaluated the use of SOF/VEL/VOX or SOF/VEL for 12 weeks in 333 genotype 1-4 HCV-infected patients with prior DAA experience that did not include an NS5A inhibitor. Most patients (85 percent) had prior DAA experience with sofosbuvir.

The open-label POLARIS-2 study evaluated the use of SOF/VEL/VOX for eight weeks or SOF/VEL for 12 weeks in 941 genotype 1-6 DAA-naïve HCV-infected patients, including 18 percent with cirrhosis and 23 percent who had previously failed treatment with an interferon-based regimen.

The open-label POLARIS-3 study randomized patients with genotype 3 HCV infection and cirrhosis to receive SOF/VEL/VOX daily for eight weeks or SOF/VEL for 12 weeks. Of the 219 patients treated, 31 percent had previously failed treatment with an interferon-based regimen.

The POLARIS-1, POLARIS-3 and POLARIS-4 studies met their respective pre-specified primary endpoints for the patients receiving SOF/VEL/VOX. The POLARIS-2 study did not meet its primary endpoint; with a pre-specified 5 percent margin, the SVR12 rate for patients receiving treatment with SOF/VEL/VOX for eight weeks was not statistically non-inferior to the SVR12 rate for patients receiving SOF/VEL for 12 weeks.


The SOF/VEL/VOX fixed-dose combination is an investigational product and its safety and efficacy have not been established. It has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration for the treatment of chronic genotype 1 HCV patients who have previously failed an NS5A inhibitor-containing regimen.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that future trials involving the SOF/VEL/VOX fixed-dose combination may have unfavorable results. In addition, Gilead may be unable to file for U.S. regulatory approval of the SOF/VEL/VOX fixed-dose combination in the United States and Europe in the currently anticipated timelines. In addition, the FDAand other regulatory agencies may not approve the SOF/VEL/VOX fixed-dose combination, and any marketing approvals, if granted, may have significant limitations on its use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company’s website at, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.