Outcomes in patients with chronic Hep C treated with different anti-viral regimens

Outcomes in patients with chronic Hep C treated with different anti-viral regimens

The latest issue of the American Journal of Gastroenterology performs an in-depth analysis of patient-reported outcomes in patients with chronic hepatitis C treated with different anti-viral regimens.

Interferon- and ribavirin-containing regimens negatively impact patients’ experience.

Dr Zobair Younossi and colleagues from Virginia, USA quantified the impact of different anti-viral regimens for hepatitis C on patients’ work productivity, fatigue, and other patient-reported outcomes.

The patient-reported outcome data from multicenter multinational phase 3 clinical trials of sofosbuvir with and without interferon or ribavirin were retrospectively used.

Treatment regimens were classified as interferon+ribavirin-containing, interferon-free ribavirin-containing, and interferon-free ribavirin-free.

The team administered 4 patient-reported outcome instruments to subjects at baseline, during, and up to 24 weeks after treatment.

Interferon was associated with up to −26% worsening of the patient-reported outcome scores
American Journal of Gastroenterology

The researchers included 3,425 subjects with chronic hepatitis C infection with patient-reported outcome data.

The team found that patients were 63% male, 62% treatment naive, 18% with cirrhosis, and 73% with HCV genotype 1.

Of the study participants, 546 received interferon+ribavirin+sofosbuvir, 1,721 received sofosbuvir+ribavirin, and 1,158 received interferon- and ribavirin-free ledipasvir+sofosbuvir.

At baseline, there were no difference in patient-reported outcomes between treatment groups.

During treatment, the decrements in patient-reported outcomes were up to −24% for the interferon+ribavirin group, up to −7% in the sofosbuvir+ribavirin group, whereas there was an improvement of up to +12% in the interferon-free ribavirin-free group.

The researchers found that use of interferon was independently associated with up to −26% worsening of the patient-reported outcome scores during treatment and the use of ribavirin with up to −9% worsening.

The team noted that after 12 weeks post-treatment, in patients with sustained virologic response-12, improvements were observed regardless of the regimen, and these improvements continued to increase by week 24 of follow-up.

Dr Younossi's team concludes, "The use of interferon- and ribavirin-free regimens for HCV is associated with better patients’ experience, and work productivity during treatment."

Am J Gastroenterol 2016; 111:808–816
14 June 2016

Source - http://www.gastrohep.com/news/news.asp?id=111895

Ireland: HSE to expand hepatitis C treatment programme

HSE to expand hepatitis C treatment programme

Paul Cullen, Sorcha Pollak

An estimated 20,000 to 50,000 people in Ireland chronically infected with the disease

Anti-viral drugs that can cure Hepatitis C are to be provided to an additional 1,500 people with the disease, the HSE has announced.

The drugs, which can cure 90 per cent of cases, have already been used to treat 700 people with severe Hepatitis C.

The HSE said it is extending the clinical eligibility to Directly Acting Antivirals (DAAs) as part of the next phase of a plan to eliminate Hepatitis C in Ireland by 2026.

Some €30 million has been made available for the plan, which has been welcomed by Minister for Health Simon Harris.

“Expanding the programme will enable more people to get that chance at a cure, improving their lives immeasurably, while also helping free up scarce resources in our hospitals.”

Continue reading....

Photograph: iStock

Weekend Reading - Treating HCV genotype 4 and Treating HCV patients with diabetes & obesity

Welcome To Weekend Reading

Greetings, hope everyone is enjoying a lovely Saturday. Before heading out to plant a seed, yes one seed that was given to Nana by the little people, I wanted to add a few June updates for your reading pleasure this weekend. 

In this issue of "Weekend Reading" I suggest a new learning activity, as well as some great articles written by a small group of dedicated bloggers who share their personal stories about living with and treating HCV.

We begin with this awesome video presentation; "Eliminating the HCV Scourge: Together We Can Do It," released last month over at ViralEd.

Sit back and watch HCV experts Nezam H. Afdhal, MD and Mark Sulkowski, MD discuss the most critical aspects of HCV prevention, management and treatment, here are a few highlights to get you started;

Treating HCV: patients with diabetes & obesity
Treating HCV genotype 4
Treating HCV: intravenous drugs users

Launch the on-demand program, here.

In Case You Missed It
Nezam H. Afdhal, MD 
25 Years From Discovery To Cure: The Hepatitis C Story
Dr. Afdhal discusses how discovery of the virus lead to understanding the global epidemiology and modes of spread of hepatitis C and the recognition that it was the commonest cause of cirrhosis, liver cancer and need for liver transplantation.
Begin, here....

Regimens for treating genotype 2, 3, 4, 5, or 6 HCV infection

New At Clinical Care Options
Non–Genotype 1 HCV Now and in the Near Future
Posted June 9   

In this downloadable slideset, Jordan J. Feld, MD, MPH, and Andrew J. Muir, MD, review current and emerging regimens for treating patients with genotype 2, 3, 4, 5, or 6 HCV infection.

Download slides here, view all updates here...

** Free registration required

Special NVHR Conference Call: A National Strategy for the Elimination of Hepatitis B & C

This call was held on Monday, May 16, 2016 at 2 pm Eastern. It has been archived, to access the slides, please click here.

Publication Updates Around The Web

June Issue of HCV Next
Fighting the War on HCV Within the Veterans Health Administration System

Other Highlights
Our Call to Arms: HCV Kills More Than Any Other Infectious Disease
Q & A: Treating People Who Inject Drugs
HCV Treatments Increase Amount of Spared Livers for Transplantation
Ledipasvir/Sofosbuvir Leads to High Real-World SVR in HIV/HCV Coinfection
AGATE-I: '3-D Regimen' Plus Ribavirin Yields High Response in Genotype 4 HCV
DAA Non-Adherence Results in Lower Virologic Response Rates
Chronic Liver Disease Represents 'Excessive Burden' for Individuals, Health Care System
FDA Issues Recommendations for Development of DAAs for HCV
CDC: More People Die of HCV Than any Other Infectious Disease

HCV Advocate Monthly Pipeline Update

Each month HCV Advocate presents an update on the HCV Pipeline written by Alan Franciscus. Review study results with commentary from the following pharmaceutical companies that make hepatitis C medications; AbbVie, Gilead, Janssen (Achillion/Alios), Merck and Regulus.

A note from Alan Franciscus
Within this section, I will list the genotype(s) being studied and the phase of the study with a brief recap of the study . You will note that many of the drugs or combinations of drugs are pan-genotypic—that is they work on many or most of the HCV genotypes . Many of the drugs listed have been updated with the latest information from the Liver Meeting 2015 and the International Liver Congress 2016 .
Begin, here..

Just So You Know

The HCV Advocate produces two monthly newsletters;
HCV Advocate is posted on the first of the month and the Mid-Month Edition is published on the 15th of the month.

The Monthly HCV Advocate: Monthly columns include “HealthWise,” written by Lucinda Porter, RN, “What’s New,” written by Alan Franciscus, and “Snapshots,” written by Alan Franciscus.

The Mid-Month Edition: Monthly columns include “Snapshots” by Alan Franciscus, “What’s New” by Alan Franciscus, and updates of our HCV drug pipeline.

Monthly Publications:
Hepatitis C Newsletters
On this blog each month an index of HCV Newsletters is posted with noteworthy updates from around the web. 

Blog Updates

With direct acting antivirals approved for all Australians with hepatitis C, regardless of severity of damage, the figures are looking good!

June 10, 2016 • By Grace Campbell

It's very exciting to be part of this first wave of successful treatment. I didn't think I could imagine Australia free of hepatitis C, but maybe it's a possibility. We can but hope.

Begin, here....

Of Interest

June 6

Australia shows an alternative to rationing hepatitis C treatment..

#3LiverTransplants: First Recovery (Part 1)

June 9, 2016 • By Colton Cooper
Colton Cooper shares his inspirational story about his third liver transplant
​Although I had a fresh ten-inch scar across my chest, multiple IV lines running through my veins, taking a ton of medicines that I can’t pronounce and stuck lying in a hospital bed, I felt healthier than I had been in a very long time.
Begin, here...  

Reducing Medical Costs
By Lucinda K. Porter, RN - June 9, 2016

I am insured though the Affordable Care Act (ACA), also known as Obamacare. Before ACA, I was uninsurable because of hepatitis C. However, the Health Insurance Portability and Accountability Act (HIPAA) allowed me to keep my insurance plan when I left Stanford Medical Center.

Begin, here...

The Quiet Creeping of Corruption

June 9, 2016 • By Greg Jefferys

It looks likely that in 2016 generic Hepatitis C medicines will reduce Gilead's profits by a few billion dollars. In the scheme of things, for a company that makes tens of billions of dollars profit each year it is not a big thing but for greedy people and greedy, rapacious corporations, every dollar counts.

Begin, here...

Hepatitis C, Asparagus and Tending Our Gardens With Meditation
June 7, 2016 • By Matt Starr

I meditate to settle into myself, to heal my overly busy mind and body from the ravages of liver disease.  Sitting with awareness only on the breath, you can discover health of mind, body, and spirit.

Begin, here...

When the Pain Won’t Go Away

June 6, 2016 • By Kimberly Morgan Bossley

My movement throughout my house is slower as the hardwood floors under my feet cause me to be overly cautious with my steps. Throughout my journey with hep C, I have lost feeling in my feet. Sure I have nerve pain, but there is a numbness that warrants me to insure each step is planted firmly.

Begin, here..

How Not to Feel Stupid with Hepatitis C
By Karen Hoyt - June 9, 2016
When you get diagnosed with hep C, you don’t know a lot about what’s going on. Sure, you get on websites like this one and try to get some information – (loud...

Begin, here...

Sodium and the Liver: What those with Hepatitis C Should Know

By Jenelle Marie Davis - June 9, 2016
What does the liver do? The liver’s primary purpose is to clean the blood. Blood needs to be cleaned both because the body naturally produces some toxins and because some of the...

Begin, here..

Strategy: Next treatment

By Rick Nash - June 8, 2016
How it helps combat the treatment: When the first treatment failed there wasn’t anything in the near future. But there is always hope, at the time medical advances in genomics were finding...

Begin, here..

One in Three People Worldwide Has Had Hepatitis B, So Why Do We Feel So Alone?

By Christine Kukka - June 8
Hepatitis B is the global pandemic no one talks about, yet one in three people worldwide has been infected. In 2013, hepatitis B and C together was the seventh-leading cause of death worldwide, with hepatitis B causing 780,000 deaths annually.
Begin, here..

Gastroenterology Special Issue on Alcoholic vs Non-Alcoholic Fatty Liver Disease
By Dr. Kristine Novak - June 9
A special issue of Gastroenterology is devoted to comparing alcoholic vs nonalcoholic fatty liver disease. In an introduction to the issue, Arun Sanyal et al write that alcoholic liver disease (ALD) and nonalcoholic fatty liver disease (NAFLD) have much in common, including histologic features and activation of pathways involved in their pathogenesis.

Begin, here..

Published on Jun 9, 2016

Boise Dr. Magni Hamso with Terry Reilly Health Services talks about hepatitis C

Related
Idaho forced to ration costly hepatitis C cure
By Cynthia Sewell
June 11
Limited funds and high demand have forced many states to restrict coverage to those patients with the most severe liver scarring, called fibrosis.

“I certainly sympathize with the people who have to create these thresholds or these qualifications for treatment,” Box said. “I do not think anybody is withholding therapy out of any other motive than they are in charge of a budget, and these are budget-busting costs.”
Hepatitis C patients also draw limited sympathy because of the self-inflicted nature of the disease. That means treatment costs draw more resistance than, say, the cost of treating cancer, Box said.
Begin, here....

2,436 patients with hepatitis C in one Alabama ER since implementing widespread testing in 2013

Hepatitis C testing in the emergency department at the University of Alabama at Birmingham Hospital has discovered 2,436 positive cases since testing began in September 2013.

Begin, here..

Have a safe weekend.

Tina

2,436 patients with hepatitis C in one Alabama ER since implementing widespread testing in 2013

UAB Tackling Hepatitis C Infection Through Emergency Department Testing

Hepatitis C testing in the emergency department at the University of Alabama at Birmingham Hospital has discovered 2,436 positive cases since testing began in September 2013.

UAB physicians say identifying those patients and linking them to appropriate therapy is one successful step in an effort to reduce the infection rate locally. The program can also serve as a model that could one day eradicate hepatitis C in the United States if done on a national scale.

The testing began as part of a Centers for Disease Control and Prevention initiative designed to identify patients with hepatitis C and get those patients into treatment. UAB began by testing the most at-risk populations — the baby boomer generation and those with a history of injection drug use — who presented for any reason at UAB Hospital’s emergency department. In September 2015, UAB expanded the testing to include all patients at the ED, ages 18-75.

“We’re finding that about 8 percent of those tested have a positive result,” said James Galbraith, M.D., associate professor in the Department of Emergency Medicine, part of the UAB School of Medicine. “The overall target is the estimated 3.2 million people in the United States who have chronic hepatitis C virus infection — many of whom are unaware they are infected because they don’t look or feel sick.”

Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. It is caused by a virus, referred to as HCV, which is spread primarily through contact with the blood of an infected person. Today, most people acquire HCV through sharing needles or other equipment used to inject drugs. Prior to 1992, the virus could be spread through blood transfusion or organ transplants, although widespread screening has now virtually eliminated that risk.

The antibody test given at the UAB ED simply indicates exposure to HCV at some prior point in a person’s life. About 25 percent of those who test positive have actually cleared the virus and are not infected with HCV. A second test, also given at the ED, can confirm those with a positive infection with results available in about a week.
“Increasing awareness is the key. Only about half of those with HCV nationwide know they are infected. We have options for treating and curing HCV, but we have to identify the infection first.”

“Increasing awareness is the key,” Galbraith said. “Only about half of those with HCV nationwide know they are infected. We have options for treating and curing HCV, but we have to identify the infection first.”

The recent programmatic change to universal HCV testing in the UAB ED has identified a large number of HCV-infected patients outside of the baby boomer generation.

“We found an infection rate of 12 percent for white individuals born after 1965,” Galbraith said. “The virus is most commonly transmitted by injectable drug use, so that population has become a key demographic to identify.”

The HCV testing program combines identification of those with infection with linkage to appropriate antiviral treatment services through the UAB Liver Center, Liver Transplant Clinic and 1917 Liver Clinic. A linkage coordinator helps those who test positive establish a primary care physician to maintain consistent health care throughout the progression of their disease.

“Not only does the testing help link these patients to treatment for hepatitis, it also gives us an opportunity to reach out and provide therapy for addiction,” Galbraith said. “We think we are making a huge difference in this population. We think if this type of type of screening were done nationally on a large scale, we could potentially eradicate HCV in 20 years.”

Galbraith says there is no national policy to conduct screening in secondary care settings, including the ED. He believes the emergency department is a unique and critical location for such programs.

“Most screening is done in the primary care setting, which misses those individuals who do not have a relationship with a primary care physician, a common occurrence in this population,” he said. “Coupled with test reimbursement issues, these are major barriers to establishing a national screening program and possibly eradicating the disease.”

Source

Drug Rationing Plays Russian Roulette With Patients’ Lives

Drug Rationing Plays Russian Roulette With Patients’ Lives

Stacey Worthy | June 10, 2016

This game of Russian roulette is played every day.  Consumers can find their health at risk because their insurance companies wanted to boost profit margins until they are sure patients are sick enough for the medications prescribed by their doctor – the only person who has personally evaluated the medical condition.

In addition to delays in care and restrictions on access to life-saving medications, ICER’s rationing formulas lead to treatment that is inconsistent with medical standards of care.  Insurers may impose overly restrictive medical necessity requirements on more costly treatments, such as with Hepatitis C. While we know newer Hepatitis C medications cure 90 percent of patients who take them, insurers are actually requiring patients to wait until their disease progresses to the point where they need a liver transplant before receiving the more expensive treatment.

Read more....

Survival rates rise with new hepatitis C treatments

Survival rates rise with new hepatitis C treatments

Just a few years ago the outlook for treating patients with chronic hepatitis C was grim.

For almost a year, patients would receive a complicated regimen of shots and up to 18 pills a day with drugs that caused major side effects. After that, there was a six-month follow-up period to see if the treatment was successful.

And the cure rate was less than 50 percent.

Thanks to recent research ― some of it conducted in San Antonio ― most patients now can be cured with direct-acting antivirals, a gentler combination of drugs in one or a few pills with only a few months of treatment. Continuing research is promising for new treatments for the groups of patients who don’t respond well to the new standard therapy.

“The good news is patients should know that a paradigm shift has occurred as we now can give all-oral therapy that is simple, safe and highly effective with cure rates of about 95 percent for most patient populations,” said Dr. Eric Lawitz, professor in the School of Medicine at the UT Health Science Center San Antonio.

Lawitz and Dr. Fred Poordad, also a professor of medicine at the UT Health Science Center, see patients at the Texas Liver Institute in San Antonio. They have been researching cures for hepatitis C for years with great success. They have presented oral presentations at international liver meetings and published peer-reviewed articles in major journals that have changed the standard of care for patients.

The FDA-approved drugs they have evaluated include Harvoni (a combination of ledipasvir and sofosbuvir), Olysio (simeprevir), Viekira Pak (ombitasvir, paritaprevir and ritonavir packaged with dasabuvir tablets), Zepatier (elbasvir and grazoprevir) and Daklinza (daclatasvir).

‘Silent epidemic’
The tragedy of hepatitis C is that is that it has no symptoms until the disease progresses, so patients can have the disease for many years and not know it.

“For that reason it is often called a silent epidemic,” Poordad said. “If not identified early, the disease can progress to cirrhosis of the liver, liver cancer and the need for a liver transplant. And even if the patient receives a liver transplant, the disease must be cured or it can infect the new liver 

What causes hepatitis C?
According to the Centers for Disease Control, hepatitis C is the leading blood-borne disease in the U.S. Although some people have only a mild form of the disease, 75 percent to 85 percent of patients who become infected with the hepatitis C virus will develop a chronic infection. This is estimated to be more than 3.5 million people in the nation.

The virus spreads through contact with the blood of an infected person. This often occurs through sharing needles, syringes or other equipment used in drug use. Another common way is through needle-stick injuries in a health-care setting. Mothers with hepatitis C can pass the disease on to their unborn children. Less common ways of spreading the virus are by sharing toothbrushes and razors, or by having sexual contact with a person who has hepatitis C. Some people contracted the disease years ago through blood transfusions before widespread screening of the blood supply began in 1992.

Find out if you have hepatitis C
According to the CDC, baby boomers ― people born between 1945 and 1965 ― are five times more likely to be infected with hepatitis C than other adults. “You can find out if you have hepatitis C through a simple blood test at your doctor’s office. All you have to do is request it,” Poordad said.

More information about hepatitis C, the blood test for the virus, and the newest treatments are available at the CDC website, www.cdc.gov.

Continue reading...

Delaware will treat all Medicaid patients with hepatitis C

Delaware will treat all Medicaid patients with hepatitis C

The state of Delaware said Tuesday that it would phase in a new policy to treat all hepatitis C patients in its Medicaid program.

States have been under pressure from the Obama Administration and lawsuits - in Delaware's case, Harvard Law School's Center for Health Law & Policy Innovation had threatened litigation - to abandon money-saving policies that limited treatment with effective but costly new medications to the sickest patients.

Continue reading...

Regulus Reports Positive Data/Phase II studies of RG-101 for the treatment of Hepatitis C

Regulus Reports Positive Top-line Data

- Results Demonstrate First Successful Shortened 4-week Treatment Regimen to Date -
- Conference Call Today at 8:30 AM EST -

LA JOLLA, Calif., June 7, 2016 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced  top-line results from the primary endpoint analysis of one of the company's ongoing Phase II studies of RG-101 for the treatment of Hepatitis C Virus infection (HCV). The study was designed to evaluate a shortened, four-week treatment regimen containing a subcutaneous administration of 2 mg/kg of RG-101 at Day 1 and Day 29, in combination with 4 weeks of once/daily approved anti-viral agents Harvoni®, Olysio®, or Daklinza™.  The study enrolled 79 treatment naïve genotype 1 and 4 HCV patients (Harvoni® arm, n=27, Olysio® arm, n=27, Daklinza™ arm, n=25).  The primary endpoint of the study is virologic response 12 weeks following conclusion of treatment.

Time Since Treatment  Completion	RG-101 + Harvoni	RG-101 + Olysio	RG-101 + Daklinza
Week 12	27/27 (100%)	26/27 (96.3%)	22/24 (91.7%)*
Week 16	21/21 (100%)	19/20 (95.0%)	20/22 (90.9%)
Week 20	14/14 (100%)	13/15 (86.7%)	13/13 (100%)
Week 24	10/10 (100%)	8/10 (80.0%)	8/9 (88.9%)

*One patient missed the Week 12 visit. Viral load results for this patient at Week 8 and 16 were collected and indicate that the patient was a responder at both time points.

The results from this interim analysis demonstrate significant virologic response through 24 weeks of follow-up.  RG-101 plus Harvoni continues to demonstrate 100% response rates.  As previously reported, the combination of RG-101 plus either Olysio or Daklinza monotherapies have seen small numbers of viral relapse.  The results reported today include four new relapses: two in the Olysio arm (weeks 20 and 32) and two in the Daklinza arm (weeks 12 and 24).  RG-101 in combination with four weeks of oral DAA therapy has been generally well tolerated with the majority of adverse events considered mild or moderate, and with no study discontinuations.  Commonly reported adverse events (AEs) included fatigue, headache, and injection site reactions. 

"These data strengthen our conviction in the clinical utility of RG-101 to shorten oral HCV treatment regimens to four weeks or less. We are very encouraged by the consistent trend in safety and efficacy, which positions RG-101 to play an important role in advancing the current treatment options for HCV patients worldwide," said Paul Grint, M.D., President and CEO of Regulus.

Conference Call & Webcast Information
Today at 8:30 a.m. EST, Regulus will host a conference call and webcast to discuss the topline results. A live webcast of the call will be available online at www.regulusrx.com. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 25993262. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 25993262. The webcast and telephone replay will be archived on the company's website following the call.

About Hepatitis C Virus Infection (HCV)
Hepatitis C is a result of a hepatocyte specific infection induced by the virus known as HCV.  Chronic HCV may lead to significant liver disease, including chronic active hepatitis, cirrhosis, and hepatocellular carcinoma. Up to 185 million people are chronically infected with HCV worldwide, and more than 500,000 people die from HCV annually.  The CDC estimates that there are currently approximately 3.5 million persons infected with HCV in the United States.  HCV shows significant genetic variation in worldwide populations due to its frequent rates of mutation and rapid evolution. There are six genotypes of HCV, with several subtypes within each genotype, which vary in prevalence across the different regions of the world. The response to treatment varies from individual to individual underscoring the inadequacy of existing therapies and highlights the need for combination therapies that not only target the virus but endogenous host factors as well, such as microRNA-122 (miR-122). Regulus believes that its miR-122 antagonist, RG-101, may be a useful agent in emerging combination regimens to address difficult-to-treat genotypes and to potentially expand upon the current therapies available to clinicians treating HCV patients.

About RG-101 for HCV
RG-101 is Regulus' wholly-owned, GalNAc-conjugated anti-miR targeting miR-122, which the HCV virus uses to replicate. Therapies that interfere with miR-122 could inhibit viral replication, acting earlier in the viral life cycle than currently approved oral agents.  In a completed Phase I human proof-of-concept study, Regulus demonstrated that treatment with a single subcutaneous dose of RG-101 as monotherapy resulted in significant and sustained viral load reductions in all treated HCV patients, including patients with difficult to treat genotypes, various liver fibrosis status and those who have experienced viral relapse after a prior IFN-containing regimen. 

Earlier this year, Regulus began enrolling patients in an open-label Phase II clinical trial combining RG-101 and GSK2878175 for the treatment of HCV to evaluate the potential to achieve sustained viral responses post treatment with a single subcutaneous administration of 4 mg/kg of RG-101 in combination with daily oral administrations of 20 mg of GSK2878175 for up to 12 weeks in treatment-naïve patients chronically infected with HCV genotypes 1 and 3.  Regulus and GSK anticipate reporting interim results from this study by year-end.  In an expanded collaboration with GSK, the companies plan to conduct a multi-centered, randomized, dose-ranging Phase II study evaluating the combination of RG-101 and GSK's long-acting parenteral ("LAP") formulation of GSK2878175 as a potential single-visit cure in patients chronically infected with HCV.  This study will be conducted outside the United States and is planned to begin in the fourth quarter of 2016.  Based on predicted enrollment rates, interim results from this expanded collaboration should be available in the second half of 2017, enabling a potential initiation of a pivotal study in late 2017. 

About microRNAs
The discovery of microRNAs in humans during the last decade is one of the most exciting scientific breakthroughs in recent history.  microRNAs are small RNA molecules, typically 20 to 25 nucleotides in length, that do not encode proteins but instead regulate gene expression. More than 800 microRNAs have been identified in the human genome, and over two-thirds of all human genes are believed to be regulated by microRNAs.  A single microRNA can regulate entire networks of genes. As such, these molecules are considered master regulators of the human genome.  microRNA expression, or function, has been shown to be significantly altered or dysregulated in many disease states, including oncology, fibrosis, metabolic diseases, immune-inflammatory diseases and HCV. Targeting microRNAs with anti-miRs, chemically modified, single-stranded oligonucleotides, offers a unique approach to treating disease by modulating entire biological pathways and may become a new and major class of drugs with broad therapeutic application.

About Regulus
Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs.  Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a well-balanced microRNA therapeutics pipeline complemented by a maturing microMarkers^SM biomarkers platform and a rich intellectual property estate to retain its leadership in the microRNA field.  Regulus is developing RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment of chronic hepatitis C virus infection, and RG-012, an anti-miR targeting microRNA-21 for the treatment of Alport syndrome, a life-threatening kidney disease driven by genetic mutations with no approved therapy.  In addition, RG-125, a GalNAc-conjugated anti-miR targeting microRNA-103/107 for the treatment of NASH in patients with type 2 diabetes/pre-diabetes, has entered Phase I clinical development through its strategic alliance with AstraZeneca.  Regulus is also advancing several programs toward clinical development in renal, hepatic and central nervous systems diseases, both independently and with our strategic alliance partners, Sanofi and AstraZeneca. Regulus' commitment to innovation has resulted in multiple peer-reviewed publications in notable scientific journals and has resulted in the formation of strategic alliances with AstraZeneca and Sanofi.  Regulus maintains its corporate headquarters in La Jolla, CA.  For more information, please visit http://www.regulusrx.com.

Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Regulus to undertake certain activities and accomplish certain goals (including with respect to development and other activities related to RG-101), the projected timeline of clinical development activities, and expectations regarding future therapeutic and commercial potential of Regulus' business plans, technologies and intellectual property related to microRNA therapeutics and biomarkers being discovered and developed by Regulus.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.  These and other risks concerning Regulus' financial position and programs are described in additional detail in Regulus filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.