Showing posts with label GS-7977 now Sofosbuvir Plus Riba. Show all posts
Showing posts with label GS-7977 now Sofosbuvir Plus Riba. Show all posts

Friday, October 11, 2013

Sofosbuvir Interferon-free therapy alters lipid metabolism, glucose homeostasis in chronic HCV patients

Interferon-free therapy alters lipid metabolism, glucose homeostasis in chronic HCV patients

SAN FRANCISCO – Patients with chronic hepatitis C treated with an interferon-free regimen consisting of sofosbuvir and ribavirin experienced changes in LDL, triglycerides, hemoglobin A1C and metabolic and hepatic lipid gene expression in a study presented at ID Week 2013.

Eric Meissner, MD, PhD, and colleagues administered sofosbuvir with low- or full-dose ribavirin to 60 treatment-naive patients with chronic hepatitis C genotype 1 for 24 weeks, and periodically measured hemoglobin A1C (HbA1c) and serum lipid levels. Paired liver biopsy specimens also were collected from seven patients before and at end of treatment (EOT), and targeted quantitative RT-PCR was performed for genes related to the metabolism of glucose and lipids.

Fifty-five patients completed the study, and 38 maintained a sustained virologic response 24 weeks after EOT (SVR24), with the remainder relapsing after EOT. Investigators observed increases in LDL (91 ± 4 mg/dL to 104 ± 5 mg/dL; P=.0027) and decreases in triglycerides (137 ± 10 mg/dL to 98 ± 8 mg/dL; P<.0001) 4 weeks after treatment initiation, changes that were sustained through EOT.

Patients who relapsed had lower LDL levels than patients who achieved SVR24 at baseline (78 ± 7 mg/dL vs. 97 ± 5 mg/dL; P=.031) and at 48 weeks (82 ± 7 mg/dL vs. 109 ± 6 mg/dL; P=.005), but no difference was observed during treatment or at EOT. Regardless of outcome, glycosylated hemoglobin (HbA1c) was lower 24 weeks after EOT compared with baseline among 39 evaluable patients (P=.0033).

All seven patients who provided biopsy specimens achieved SVR24. Among them, lipid transport genes APOB, APOC3 and APOL3 had significantly up-regulated intrahepatic expression at EOT, while lipid assembly and signaling genes LEPR and MTTP were down-regulated.

“Our data demonstrate changes in lipid metabolism pathways and glucose homeostasis in CHC genotype-1 infection following interferon-free antiviral therapy,” the researchers concluded. “The early changes in LDL and triglycerides associated with treatment implicate a direct effect of viral clearance on lipid homeostasis.”

Disclosure: Susanna Naggie, MD, reports serving as a grant investigator and scientific advisor, as well as receiving consulting fees and grants, from Gilead Sciences. Keyur Patel, MD, reports serving as a consultant and scientific advisor and receiving a consulting fee from Gilead. John McHutchison, MD, is an employee and shareholder at Gilead.

For more information:

Meissner EG. #1830. Presented at: ID Week 2013; Oct. 2-6, San Francisco

Saturday, June 23, 2012

Hepatitis C News Ticker- GS-7977 + Ribavirin Pre-Transplant Open-Label Study


This is one of many interesting anatomical works in quilled paper by artist Sara Yakawonis. You can see more of her work on her blog or on her Society6 page.

Photo courtesy Sara Yakawonis
Via Colossal

HCV News Ticker


Open-Label Study of GS-7977 + Ribavirin Pre-Transplant

This study is currently recruiting participants.
Verified April 2012 by Gilead Sciences

The primary objective is to determine if the administration of a combination of GS 7977 and ribavirin to HCV-infected subjects with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation for up to 24 weeks can prevent post-transplant re-infection as determined by a sustained post-transplant virological response (HCV RNA < LLoQ) at 12 weeks post-transplant.

Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: March 2013

Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Gilead HCV SVR Registries

This Registry is designed to provide long term clinical and virologic follow up in subjects who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored Hepatitis C Virus (HCV) study.

This Registry is designed to obtain long term data on subject who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C study.

HCSP HCV Guides Updated

HCV Advocate has updated the following guides to HCV.

HCV Awareness

Peter Moore is embarking on a HCV awareness campaign unlike any other; on world hepatitis day he will be spreading the word from atop three peaks spread across the British Isles.

 Donations for the event are being accepted through the "Just Giving Program" with all funds going directly to the Hepatitis C Trust. Please visit Peters page and consider making a contribution, your donations will make a difference.

For anyone interested in taking part in this ambitious awareness campaign please contact Recently, Peter was mentioned in an update published on the Hepatitis C Trust website: Peter Moore is looking for walkers to join him on the 3 Peaks Challenge in July.

As you can imagine this is a huge physical undertaking. Follow Peter as he trains through his Facebook page, blog or contact him on Twitter

Donohue: Patient needs to be tested for hepatitis

Dear Dr. Donohue: Today in the paper a frightening article about hepatitis C appeared. When I was 12, I had jaundice (yellowing of skin and the whites of the eye). I was out of school a good while. I have since been told that I had hepatitis. I donated blood for many years, but I am no longer accepted when I tell them I had jaundice. Is there any way to know what kind of hepatitis I had? -- N.F.

Dr. Donohue: People who have had hepatitis after age 10 usually are not permitted to donate blood. Those who had it before 10 almost always have had hepatitis A and are allowed to donate.
You shouldn't continue in a state of ignorance about having had hepatitis and knowing which kind. Your blood can be tested for the various kinds.

Dear Dr. Donohue: I am a blood donor. The last time I went to donate, a new question was on the form. It asks if I have had any current sexual contact with someone who has had hepatitis in the past. Many years ago, my husband had hepatitis C. He was successfully treated but told never to donate blood. I was rejected as a donor. Should I be tested? -- C.G.

Dr. Donohue: Both you and your husband ought to be tested for hepatitis C. The results of those tests will determine if you can still be a donor.

The booklet on hepatitis discusses the common forms of this illness, A, B and C. To obtain a copy, write: Dr. Donohue -- No. 503, Box 536475, Orlando, FL 32853-6475. Enclose a check or money order (no cash) for $4.75 U.S/$6 Can. with the recipient's printed name and address. Please allow four weeks for delivery.

Dr. Donohue regrets that he is unable to answer individual letters, but he will incorporate them in his column whenever possible. Readers may write him or request an order form of available health newsletters at P.O. Box 536475, Orlando, FL 32853-6475. Readers may also order health newsletters

Medics want to screen fathers-to-be for hepatitis C to prevent liver disease epidemic

FATHERS-TO-BE should be screened for hepatitis at the same time as their pregnant partners to combat a looming epidemic of liver disease in Australia.

Medics at the Centenary Institute liver research centre say early detection is the key to preventing a surge in new liver disease cases.

While its common for pregnant women to be screened for hepatitis, institute scientist, Dr Nick Shakel, said he believed men should be encouraged to do the same.

Chronic liver damage affects on in five Australians and can lead to cancer if not diagnosed in early stages.

Infections with the hepatitis B and C virus are among the key precursor conditions that can lead to chronic liver damage, also known as cirrhosis.

Both Hepatitis B and C can be transmitted through contaminated instruments in tattoo parlours, sharing razors, intravenous needles and contact with infected blood.

Many patients infected with hepatitis C do not display symptoms until their liver starts to fail, which can be up to 15 years after it was first contracted. The Institute believes around 220,000 Australians have hepatitis C, but fewer than one in fifty are being treated.

Untreated hepatitis can lead to liver cirrhosis and the need for a transplant.
With a chronic organ shortage in Australia, fewer than 220 liver transplants are conducted each year.
Dr Shakel, also a specialist hepatologist at the RPA Liver Transplant Unit, said early screening could patients better manage their condition.

"Cirrhosis of the liver results in about 3000 deaths annually, and the biggest problem is that by the symptoms present themselves, it can be too late," he said. "A lot of people who are being infected with hepatitis are quite young and so we are predicting a significant burden of disease to come upon by 2050.

"The more people that get screened, such as fathers, means the more people we
can treat."

Other causes of liver damage include auto-immune hepatitis, which affects Socceroos star Harry Kewell.

Kewell was diagnosed with the potentially-fatal blood disorder during a routine check-up in 2002.

Hepatitis C — Urgency to Fight Viral Foe Grows in the Suburbs and on the Streets
By Jeffrey Norris on June 20, 2012

At the edge of a San Francisco neighborhood that has been riddled with drug addiction for decades, UCSF epidemiologist Kimberly Page, PhD, MPS, leads a research team that provides outreach, screening and prevention programs for drug users.

Those who come to the Tenderloin Clinical Research Center on Market Street for Page’s study are young — the average age is 22. Most are white, and almost all inject drugs.
This profile is not unique to San Francisco — the population of young injection drug users appears to be growing in towns and cities across the country, and it is one that is especially vulnerable to hepatitis C infection.
Continue Reading....

U.S. Health Care

3.1 Million Young People Covered After Health Care Law
Kelly Kennedy
(USA Today, June 19, 2012)

"More than 3.1 million Americans ages 19 through 25 are covered by their parents' medical insurance policies because of a provision in the 2010 health care law...About 75% of people in that age group now have insurance, up from 64% in 2010...The provision has become so popular -- both for security reasons for consumers and financial reasons for insurers -- that several health companies and employers say they intend to keep it even if the Supreme Court were to strike down the law, or portions of it, this month...Gains in coverage were highest for young men...the new data show. Men ages 19 through 25 are the least likely of any group to have insurance, which probably played into the large increase, according to HHS [Department of Health and Human Services]."

NHS - Behind The Headlines

Behind The Headlines - H5N1 avian flu virus 'could spread in people'

June 22

Bird flu 'could mutate to cause deadly human pandemic',” BBC News has reported. The BBC says that Dutch researchers have identified mutations that could allow the H5N1 virus to spread rapidly in humans. The tone of the headlines is somewhat alarmist for coverage of a theoretical risk. Nevertheless, this is a controversial study, with the researchers having rebuffed requests from a US bioterrorism prevention agency to limit the publication of their findings.

H5N1, the “bird flu” virus, has caused several outbreaks among wild birds and domesticated poultry. H5N1 can, but usually doesn’t, affect humans and, so far, it has not been shown to spread between people. However, it is possible that genetic mutations could change the virus so that it could spread between humans.

The current research – in ferrets – looked at whether H5N1 in its normal form or in genetic variants could be spread between ferrets by airborne transmission (that is by sneezing or breathing). The researchers found that, while the wild type could not be passed by airborne transmission, some of the mutated viruses could spread, and these shared five key mutations. None of the ferrets died after airborne infection with the mutant H5N1 viruses. The researchers found that the mutated virus was sensitive to the flu drug Tamiflu, and ferrets that had been given an H5N1 vaccine produced antibodies against the mutant strains.

This lab research provides some evidence that it may be possible for the bird flu virus to acquire mutations that could allow it to spread between people via respiratory droplets. However, this research should not cause alarm as these mutations have not arisen naturally in the wild, they have only been created in the lab.

The findings will help national public health agencies that monitor influenza viruses, allowing them to make plans to cope with the next epidemic or pandemic flu that may emerge in humans.

Where did the story come from?
The study was carried out by researchers from Erasmus Medical Center, The Netherlands, the University of Cambridge, and US National Institutes of Health. Funding sources included the National Institutes of Health. The study was published in the peer-reviewed journal, Science.

While the BBC’s headline presented the most threatening issue to stem from the research, overall, the media gave a fair representation of this research. However, there has been considerable media coverage of the ongoing controversy over the publication of all of the research against the advice of the US National Science Advisory Board for Biosecurity.

What kind of research was this?
This laboratory research looked at whether genetic mutations in the H5N1 “bird flu” virus would allow it to spread between mammals via airborne transmission (that is by sneezing and breathing). Currently, H5N1 isn’t spread in this way between humans, but if it were it would be more contagious. All human epidemic and pandemic flu strains in the past century have been able to spread by airborne transmission.

H5N1 is one of many subtypes of the influenza A virus. It is the variant that has been identified in the majority of poultry outbreaks over the past decade. It is also the cause of most of the rare cases of infection in humans who have had contact with infected birds. However, to date there has been limited evidence of transmission of H5N1 between humans, and the virus can’t be transmitted by airborne droplets.

The research was carried out in ferrets because they are susceptible to both bird and human flu viruses. The researchers created a number of genetically altered variants of H5N1 to see whether these mutations could result in a virus that could be spread between the ferrets by airborne droplets.

Animal research such as this is useful for investigating how viruses can spread between mammals, because it gives us clues to how viruses can also spread between humans.

What did the research involve?
The research involved a series of experiments using an H5N1 strain that was isolated in Indonesia, and genetically modified variants of this strain. The variants had been engineered to have mutations that the researchers predicted might help them to spread through the air.

In the first experiment, the researchers took four groups of six ferrets. Into the noses of one group of ferrets they put the H5N1 virus, and into the other three they put three mutant variants of H5N1. On the third and seventh days they measured levels of the virus in the ferrets’ noses, throats, windpipes and lungs.

In the second experiment, the researchers had housed four uninfected ferrets in cages adjacent to those ferrets infected with an H5N1 variant, to see if the viruses would spread without direct contact. When the researchers found no airborne transmission of the viruses, they designed a third experiment to ‘force’ the virus to adapt to replicating in the ferrets’ respiratory system. To do this they carried out a process called “passaging” where viruses are passed from one ferret to the next a number of times. This encourages natural accumulation of mutations, and they hoped some would help the virus to be transmitted in an airborne fashion.

They started this experiment by giving one ferret the normal H5N1 virus, and one a genetic variant. They collected samples from the noses of these ferrets and gave another two ferrets their respective samples. This was repeated for a total sequence of 10 new ferrets for both the normal and genetic variant viruses. The nasal samples from the 10th set of ferrets were then tested in a further experiment to see whether these viruses could cause airborne transmission.

In this experiment the samples were used to infect six more ferrets. Non-infected ferrets were then placed in cages adjacent to, but separate from, each infected ferret. They then took samples from the non-infected ferrets to see whether they had become infected by airborne transmission.

Once they found H5N1 variants that could be transmitted in an airborne fashion, they looked at their genetic make-up to identify which mutations had allowed them to spread through the air. They also tested whether these viruses were susceptible to antiviral drugs, and whether ferrets that had been given an H5N1 vaccine could produce antibodies against the mutant strains.

What were the basic results?
The researchers found that the ‘normal’ H5N1 virus acquired mutations as it passed along the 10 ferrets. However, they found no evidence that this virus was able to spread via airborne transmission to the neighbouring ferrets. By contrast, they found that three out of four of the ferrets neighbouring those inoculated with the mutant H5N1 line did become infected with H5N1 as a result of airborne transmission. None of the ferrets died as a result of this airborne transmission.

All of the viruses that were able to spread through the air had the three mutations that the researchers had engineered, plus another two naturally acquired mutations affecting the same protein. The viruses had other mutations, but these were not shared by all the airborne-spread viruses.

They also found that when they tested one of the airborne viruses it was similarly sensitive to the antiviral drug Tamiflu (oseltamivir) as the normal H5N1 virus. They also showed that ferrets that had been given an H5N1 vaccine produced antibodies against the mutant strains.

How did the researchers interpret the results?
The researchers concluded that “avian A/H5N1 influenza viruses can acquire the capacity for airborne transmission between mammals and therefore constitute a risk for human pandemic influenza”. They say that while they have proved that the virus can be transmitted though the air, they cannot say if it is an efficient mode of transmission. They also caution that further research is needed to help prepare for a pandemic.

This is valuable yet controversial scientific research. It has explored whether genetic variants of the H5N1 bird flu virus can acquire mutations allowing the virus to spread through the air between mammals such as humans.

H5N1 is the “bird flu” virus and has been the cause of several outbreaks among wild birds and domestic poultry. While it does not usually affect humans, rare cases have occurred in people in close contact with infected poultry. So far it has not been demonstrated to be capable of spreading through the air between people. To test whether genetic mutations could enable this to happen, researchers tested H5N1 variants on ferrets. They found that airborne transmission of the mutant variants was possible, although none of the ferrets died after being infected with the mutant H5N1 viruses this way. The researchers also noted that one of the mutated viruses was similarly sensitive to Tamiflu as the “normal” H5N1 virus. Ferrets given an H5N1 vaccine could produce antibodies against the mutant strains.

This lab research provides some evidence that it is theoretically possible for the bird flu virus to acquire mutations that could allow it to spread between mammals by coughs, sneezes and breathing. This may mean that a mutated form of bird flu could also spread between humans.

The news is not a cause for alarm, as these mutations have not yet arisen in the wild. This information may help national public health agencies which monitor influenza, enabling them to make plans about how to cope with the next epidemic or pandemic flu that may emerge in humans.

Links to the headlines
H5N1 human pandemic 'possible'. BBC News, June 21 2012

Bird flu virus could evolve to pass from human to human. The Daily Telegraph, June 21 2012

Study shows how easily pandemic H5N1 bird flu could evolve. The Guardian, June 21 2012

Bird flu H5N1 papers released. Mutations make bird flu MORE contagious (but less deadly).
Daily Mail, June 22 2012

Links to the science

Special issue: H5N1. Science. Published online June 22 2012

Herfst S, Schrauwen EJA, Linster M, et al. Airborne Transmission of Influenza A/H5N1 Virus Between Ferrets. Science. 2012;336:1534-41

Russell CA, Fonville JM, Brown AEX, et al. The Potential for Respiratory Droplet–Transmissible A/H5N1 Influenza Virus to Evolve in a Mammalian Host. Science. 2012;336:1541-7

All resarch is open access

Source- Behind The Headlines

Healthy You

How Safe Is Your Seafood?
If you’re like most health-conscious people, you’re probably eating more fish these days. But along with heart-healthy omega-3 fats, you may be getting something in your seafood that’s not so welcome: contaminants. A cautionary note regarding drug residues in imported fish comes from a study from the Johns Hopkins Center for a Livable Future. Published online in Environmental Science & Technology last November, it analyzed government-collected seafood inspection data from the U.S., Europe, Japan, and Canada between 2000 and 2009.

Importing bad news

Some 85 percent of the seafood Americans consume is imported. And much of that is farm-raised (a practice called aquaculture) in Asia and elsewhere in the developing world. The problem is that other countries may have different standards for aquaculture, sometimes employing drugs banned here—and that most overseas fish farms are not inspected by U.S. officials. Moreover, though the government can detain suspect food imports without examining them (based on a history of prior recalls, for instance), only a fraction of imported seafood is actually tested for drug residues when it enters the country.

In fact, the FDA checks just 2 percent of imports for contaminants (including drug residues, microbes, and heavy metals), the study reported, compared to 20 to 50 percent in Europe, 18 percent in Japan, and up to 15 percent in Canada. And when the FDA does inspect seafood imports, it looks for residues from only 13 drugs. In contrast, Europe tests for 34 drugs. That means overseas fish farms can be using a range of drugs that the U.S. doesn’t even screen for.

Last spring, the U.S. Government Accountability Office reported that only 0.1 percent of imported seafood was inspected specifically for drug residues in 2009 and concluded that the FDA’s oversight of the safety of imported seafood is “limited”—an understatement indeed.

Shrimp top the list

Though seafood violations varied depending on the different inspection systems used across countries, the Hopkins researchers found that shrimp and prawns, overall, exceeded drug residue limits most frequently. Other problematic imported seafood included crab, basa (a type of catfish), eel, and tilapia, most or all likely farmed. Of all countries, Vietnam had the most drug violations, followed by China and then other countries in Asia, including Thailand, Indonesia, Taiwan, India, and Malaysia.

Antibiotics, antifungals, and antiparasitics, as well as pesticides and disinfectants, are often used in fish farming to control diseases that can spread rampantly in crowded conditions. While routine exposure to such substances can pose a risk to aquaculture workers, the health effects of chronic low-level exposure in fish eaters are not fully known. At the very least, widespread use of antibiotics in aquaculture can contribute to the development of antibiotic-resistant bacteria and cause important antibiotic drugs to become ineffective in people.

Are other fish off the hook?

Contaminants in seafood are not limited to just farmed fish from developing countries. For example, as reported in a well-publicized study in Science in 2004, farmed salmon from Europe had the most PCBs and other potentially harmful industrial pollutants, while Chilean farmed salmon had less, which shows that problems in aquaculture occur in the developed world, too. (Changes in feeding practices in recent years may be reducing that problem.) And larger wild-caught fish, such as swordfish, have high levels of mercury, which can impair the nervous systems of developing fetuses, infants, and young children.

Still, despite this concern over contaminants, the health benefits of fish outweigh potential risks. The U.S. Dietary Guidelines, the American Heart Association, the World Health Organization, and other health authorities around the world recommend eating fish at least twice a week (at least 8 ounces total), preferably types rich in omega-3 fats such as salmon and sardines (though with certain caveats for pregnant and nursing women and young children).

A COOL idea

The 2011 Food Safety Modernization Act includes several provisions to help the FDA better monitor imported seafood. But given budgetary constraints, don’t expect a quick fix. Ideally the agency would not only test more imports, it would also check more overseas fish farms to make sure they meet U.S. standards in the first place.

That means it’s up to you to choose fish wisely—and your best recourse for limiting exposure to potential drug residues is to look primarily for domestic farmed seafood, suggests Dr. David Love, lead author of the Hopkins study, because it’s subject to more government oversight, including farm visits and inspection of safety plans. Certain wild-caught fish are also good options (see box at right for some farmed and wild seafood recommendations.) Seafood from Canada should be fine too, since no import violations were noted from there.

“Country of origin labeling” (COOL) regulations that went into effect in 2005 can help you identify the source of seafood. They require supermarkets—but not restaurants, processed fish products, or, oddly enough, fish markets—to indicate where the fish come from and whether they were farmed or wild-caught.

In particular, you may want to limit or avoid imported Asian shrimp and prawns and all seafood from Vietnam (a big exporter of basa or “Asian catfish”). This is advice we don’t give lightly, since such exports help the economies of developing countries. Farmed imports, especially from Asia, are cheaper (think affordable shrimp), so forgoing or limiting them may mean a higher fish bill.

Three more fish tips

• Select fish lower on the food chain—anchovies, mackerel, and sardines, for example. As larger predatory fish eat smaller fish, contaminants are concentrated and accumulated. Another benefit is that these smaller fish tend to have higher levels of omega-3 fats.

• Vary your seafood choices to minimize overexposing yourself to any particular contaminants they may contain. It’s okay to eat some farmed salmon, but perhaps not every week. Wild salmon is always a good option—and most canned salmon is wild (and cheap).

• Buy from a local fishmonger who has been in business for a while, buys direct from distributors, and can answer specific questions about the fish. Despite the good intentions of the COOL regulations, there is little oversight, so going to a trusted source is a better bet for getting high-quality fish.

Putting fish oil capsules to the test
If you don’t eat a lot of seafood (or any at all), fish oil supplements can be a good way to reel in some healthful omega-3 fats. But how do they stack up in terms of safety? Pretty well, according to, which, in its most recent testing of 24 products, found none that contained detectable mercury or unsafe lead levels, and only one that slightly exceeded the contamination limit for PCBs. (Because of highly sensitive testing, all had at least trace levels of PCBs, since virtually all fish have some—but much less than what you’d get eating fish, according to ConsumerLab.) Even the one cod liver oil product in the group passed testing, though liver oils tend to have more toxins than whole-fish oils.It’s not surprising that fish oil supplements are low in contaminants, since they are typically made from smaller species (such as anchovies and sardines), which accumulate fewer contaminants, or from algae. And since mercury is water-soluble, it tends to accumulate in the flesh of the fish, not in the fat or oil. Moreover, many manufacturers process their products to remove contaminants.On the downside, three products contained about 20 percent less omega-3s than the labels claimed. And three products were spoiled. Spoilage compounds may cause burping and other gastrointestinal complaints. But it’s not known if spoilage has any long-term health effects (it could, at least in theory, since rancid oils contain potentially harmful oxidized compounds). Some of the rancid products tested had no odor, but if your supplement smells or tastes off, toss it.
Choosing Wisely
Nine leading medical specialty societies in the US have identified specific tests or procedures that, according to them, are commonly used but not always necessary.
Listen To Radio Show Or View Transcript 
  Hello and welcome to this week’s Health Report with me Norman Swan.
Today: working up a sweat over dementia prevention and saving yourself time and money, the health care budget, as well as reducing potential harm by choosing your tests and treatments wisely with your doctor – from back pain to headaches, to your heart and asthma and beyond.

It’s a project in the United States called Choosing Wisely where specialists have agreed on five things doctors and their patients should question in each of a number of specialties. Dr Christine Cassel is President of the American Board of Internal Medicine and the ABIM Foundation which is behind Choosing Wisely.
View All Latest Programs

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11 weeks, 7 days - How Else Do You Expect Me to Act?
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Thursday, April 19, 2012

EASL-Early SVR Rates for GS-7977 Plus Ribavirin in Geno 1 Treatment-Naïve Hepatitis C Patients

Gilead Announces Early Sustained Virologic Response Rates for GS-7977 Plus Ribavirin in Genotype 1 Treatment-Na ïve Hepatitis C Patients

- Interim Results Reported from ELECTRON and QUANTUM Studies -
BARCELONA, Spain, Apr 19, 2012 (BUSINESS WIRE) --Gilead Sciences, Inc. (Nasdaq: GILD) today announced interim data from the Phase 2 ELECTRON study examining the investigational once-daily oral agent GS-7977 plus ribavirin (RBV) in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. Of the 25 patients who completed 12 weeks of treatment with the GS-7977-based regimen, 88 percent of patients (n=22/25) remained HCV RNA undetectable four weeks after completion of treatment. Three patients experienced viral relapse. These findings are being presented this week during a poster session (Poster #1113) at the 47th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2012) in Barcelona, Spain.

"These preliminary results suggest that 12 weeks of therapy with once-daily oral GS-7977 and ribavirin may be enough to cure hepatitis C in many genotype 1 patients, including those who are currently not candidates to receive interferon," said Professor Edward Gane, MD, Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand, and principal investigator of the ELECTRON study. "Further investigation of GS-7977 in a variety of patient populations and combinations will be important in assessing the drug's potential as part of an all-oral regimen for hepatitis C."

Results from three additional arms of the ELECTRON study examining GS-7977-based therapy in various patient populations are also being presented this week at the International Liver Congress. These include null responder genotype 1 patients, and genotype 2 and genotype 3 patients, both treatment-naïve and prior non-responders.
Overall, GS-7977 was well tolerated and exhibited a favorable safety profile. No patients experienced viral rebound during treatment. No patients discontinued therapy due to an adverse event. The most common adverse events were fatigue, dizziness and headache, and two grade 3/4 laboratory abnormalities were reported.

Gilead today also announced interim results from a second Phase 2 trial (QUANTUM) examining a 12- and 24-week duration of GS-7977 plus RBV in treatment-naïve patients. Twenty-five patients were randomized to the 12-week treatment arm: 19 genotype 1 patients; four genotype 3 patients; and two genotype 2 patients. Two genotype 1 patients discontinued therapy prematurely during the 12-week treatment period. At the four-week post-treatment time period, data were available for 17 genotype 1 patients. Of these, 10/17 (59 percent) remained HCV RNA undetectable. Seven patients (41 percent) experienced viral relapse. Additionally, seven of the patients who have reached the eight week post-treatment time period, and who achieved SVR4, remain HCV RNA undetectable.
The overall safety and efficacy profile of GS-7977 was consistent with that seen in ELECTRON. No patients experienced viral rebound while on treatment and no patients discontinued therapy due to an adverse event.

Eleven of the 25 patients (44 percent) in ELECTRON and three of 19 patients (16 percent) in QUANTUM had the IL28B C/C genetic polymorphism. Each of the three patients who relapsed in the ELECTRON study had a different IL28B polymorphism (C/C, C/T or T/T). The seven patients who relapsed in the QUANTUM study either had IL28B C/T (n=4) or IL28B T/T (n=3) genetic polymorphisms. Patients in both studies will continue to be observed to determine sustained virologic response rates at weeks 12 and 24 of follow-up (SVR12 and SVR24).

"The early results from these studies confirm that GS-7977 has the potential to become the cornerstone of an efficacious, all-oral combination regimen for many patients with chronic hepatitis C infection," said John McHutchison, MD, Senior Vice President, Liver Disease Therapeutics, Gilead Sciences. "We look forward to more data unfolding as our trials progress and we expect to initiate additional studies with GS-7977 in combination with other oral antivirals in our pipeline in the coming months. Our goal is to develop a short, simple, safe and effective single tablet regimen for HCV patients throughout the world."

ELECTRON is an ongoing Phase 2 randomized open-label clinical study evaluating GS-7977 for the treatment of chronic HCV infection. The primary endpoint of the trial is the safety and tolerability of GS-7977 400 mg once-daily for 8 or 12 weeks, with and without RBV and/or Peg-IFN in HCV patients with genotypes 1, 2 or 3. Study populations include treatment-naïve non-cirrhotic patients and those who have failed prior interferon based therapies or "null" responders.

QUANTUM is a Phase 2 randomized double-blind placebo-controlled clinical study evaluating GS-7977 for the treatment of chronic HCV infection. The current active arms of the trial are examining GS-7977 400 mg once-daily plus RBV for 12 or 24 weeks in cirrhotic and non-cirrhotic treatment-naïve HCV patients with genotypes 1, 2 and 3. The results announced today are for the cohort of patients who have received and completed 12 weeks of therapy with GS-7977 plus RBV (n=25).

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 worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

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 possibility that the proportion of patients who maintain a sustained virologic response 12 and 24 weeks post-treatment will not be as favorable as the sustained virologic response rates reported in this press release and the possibility of unfavorable results from additional arms of the ELECTRON and QUANTUM studies and subsequent clinical trials involving GS-7977 and RBV. As a result, GS-7977, including in combination with other oral antivirals in Gilead's pipeline, may never be successfully commercialized. Further, Gilead may make a strategic decision to discontinue development of the compounds if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. In addition, Gilead may be unable to develop an all-oral antiviral regimen for HCV genotype 1 patients or a pangenotypic regimen for all HCV patients. 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 Annual Report on Form 10-K for the year ended December 31, 2011, 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 or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

SOURCE: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Susan Hubbard, 650-868-5215 (Investors)
Patrick O'Brien, 650-522-1936 (Investors)
Cara Miller, 650-576-7849 (Media)
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