Tuesday, May 5, 2015

JAMA Author Interview: Daclatasvir, Asunaprevir, and Beclabuvir for HCV Genotype 1


Original Investigations | May 5, 2015

Oral Antiviral Treatment of Hepatitis C Genotype 1 Infection

Author Interview @ JAMA - Daclatasvir, Asunaprevir, and Beclabuvir for HCV Infection With CirrhosisThese cohort studies describe outcomes for HCV genotype-1 infected patients with and without cirrhosis who were treated with an all-oral antiviral regimen.

Full Text Available @ NATAP
Editorial: Continued Progress Against Hepatitis C Infection

Daclatasvir in Combination With Asunaprevir and Beclabuvir for Hepatitis C Virus Genotype 1 Infection With Compensated Cirrhosis 

Fixed-Dose Combination Therapy With Daclatasvir, Asunaprevir, and Beclabuvir for Noncirrhotic Patients With HCV Genotype 1 Infection 

Abstract Free - Full content is available to subscribers only

Interferon-free therapy daclatasvir, asunaprevir,and beclabuvir clears hepatitis C in 93 percent of patients in trial

Related - JAMA Author Interview: Daclatasvir, Asunaprevir, and Beclabuvir for HCV Genotype 1

Interferon-free therapy clears hepatitis C in 93 percent of patients in trial

A 12-week dose of an investigational three-drug hepatitis C combination cleared the virus in 93 percent of patients with liver cirrhosis who hadn't previously been treated, according to a study in the May 5, 2015, issue of The Journal of the American Medical Association.

Bristol-Myers Squibb funded the trial of the combination of three drugs—daclatasvir, asunaprevir, and beclabuvir. None of the three drugs are FDA-approved, but daclatasvir is currently under review by the FDA. Duke Medicine researchers collaborated on the design and analysis of the trial and authored the findings.

The trial recruited patients with hepatitis C-related cirrhosis, or scarring of the liver, 112 of whom had not previously been treated for hepatitis C, and 90 who had previous unsuccessful therapies. For those with past failed therapies and potential resistance, the drugs were slightly less successful, eliminating the virus in 87 percent.

However, for those with past failed therapies, incorporating a fourth drug, ribavirin, appeared to enhance results. Ribavirin is a commonly used hepatitis C treatment. When added to the investigational regimen, success rates in previously treated patients reached 93 percent—on par with those receiving treatment for the first time.

No vaccine has been developed to protect patients from the hepatitis C virus, which is spread through blood and can lead to liver failure and death if untreated. Most who are infected don't know they have the disease until they have symptoms and have already sustained liver damage, said Andrew Muir, M.D., M.H.S., chief of the division of gastroenterology at Duke and the study's lead author. For this reason, Americans born between 1945 and 1965—baby boomers—should automatically be tested, he urged.

For most of the past 20 years, therapies for hepatitis C relied on interferon drugs, which require regular injections for as long as one year and trigger miserable, flu-like side effects that prompt many patients to quit the regimen. Some patients aren't eligible for this treatment if they have anemia, low platelets or other conditions, Muir said.

"Those with more advanced disease were unlikely to tolerate interferons, and many patients would decide against even getting treatment," Muir said. "For those who could tolerate it, it was only moderately effective."

Since late 2013, several drug companies have released new, interferon-free regimens. In many cases, these have proven to be more effective than previous treatments.

"The development of interferon-free treatments has been a tremendous step forward in the standard of care," Muir said. "These drugs are highly effective and well-tolerated by patients at all stages of liver disease."

The trial was conducted between December 2013 and September 2014 at nearly 50 sites across the United States, Canada, France, and Australia. All patients were infected with genotype 1 hepatitis, a common strain of the C virus in North America, Western Europe and Australia.

The drugs had minimal side effects for most participants. Nine patients experienced serious adverse events three of which were considered related to treatment, the study states.

Among the study's limitations were the absence of a placebo group that could pinpoint the sources of side effects, and a lack of racial diversity, with 88 percent white participants. The study also did not statistically distinguish the impact of the addition of ribavirin to some participants' daily regimen.

In addition to Muir, study authors include Fred Poordad; Jacob Lalezari; Gregory Everson; Gregory J. Dore; Robert Herring; Aasim Sheikh; Paul Kwo; Christophe Hézode; Paul J. Pockros; Albert Tran; Joseph Yozviak; Nancy Reau; Alnoor Ramji; Katherine Stuart; Alexander J. Thompson; John Vierling; Bradley Freilich; James Cooper; Wayne Ghesquiere; Rong Yang; Fiona McPhee; Eric A. Hughes; E. Scott Swenson; and Philip D. Yin.

Bristol-Myers Squibb sponsored the study. Muir received grant funding from Bristol-Myers Squibb during the conduct of the trial, as well as grant funding and personal fees from AbbVie, Achillion, Bristol-Myers Squibb, Gilead, and Merck, personal fees from Theravance, and grant funding from Roche outside of the work submitted for this JAMA article.

Provided by Duke University Medical Center

Monday, May 4, 2015

Gilead’s Gaffe Leads Drugmakers to Pledge More Openness on Price

Gilead’s Gaffe Leads Drugmakers to Pledge More Openness on Price

Drugmakers worried about a backlash over soaring drug prices are increasingly talking with insurers ahead of time about paying for new therapies that could cost six figures a year.

Companies such as Biogen Inc., Amgen Inc. and Sanofi are wary of the negative attention Gilead Sciences Inc. received over hepatitis C cure Sovaldi, which surprised the industry in late 2013 with its cost -- $84,000 for 12 weeks of treatment. The price tag had House Democrats calling for an explanation from Gilead executives, and Gilead was spurned by the biggest manager of drug insurance benefits in the U.S., which backed a rival’s discounted hepatitis C drug instead.

Egypt opens first factory for locally produced Sovaldi

Egypt opens first factory for locally produced Sovaldi

Egypt's health minister said Hepatitis C is "one of the most dangerous threats to Egypt", on Sunday during the opening ceremony of a factory for the local production of Hepatitis C medication Sovaldi.

Egyptian Health Minister Adel el-Adawi said the ministry is making efforts to lower the prevalence of the disease by prevention, raising awareness and treatment, through opening up the factory, which will produce a medicine called Sovaldi.

In July 2014, Henk Bekedam, the World Health Organisation (WHO) representative in Egypt said the disease kills "40,000 Egyptians a year". According to the WHO, Egypt has a "very high prevalence", with approximately 20% of Egyptian blood donors testing positive.

The local manufacture involves a joint venture called Pharmed Healthcare and an Indian pharmaceutical giant, which will provide the active ingredient in the drug, since the Indian company has received a license to manufacture and market it from American firm Gilead Sciences.

Muhammad Mabrouk, the CEO of Pharmed Healthcare said the medication will be available in markets starting June.

He said that beside the active ingredient, all materials used to make the product are local, which gives Egypt's pharmaceutical sector an "unprecedented" boost. Mabrouk added that the factory will provide 1,000 job opportunities and create 10,000 other indirect opportunities.

Mylan launches hepatitis-C Sovaldi tablets in India

Mylan launches hepatitis-C Sovaldi tablets in India

HYDERABAD: Pharma giant Mylan NV today said its subsidiary Mylan Pharmaceuticals has launched Gilead Sciences' Sovaldi (sofosbuvir 400mg tablets) in the country.

Sovaldi is used for the treatment of chronic hepatitis-C infection as a component of a combination anti-viral treatment.

It is estimated that around 12 million people are chronically infected with hepatitis-C in India, Mylan said in a release.

In February this year, Gilead appointed Mylan as its exclusive distributor of Sovaldi in India.

Mylan president Rajiv Malik said they have a history of partnering with Gilead to tackle key public health issues in India and around the world, beginning with expanding access to high quality and affordable HIV/AIDS anti-retrovirals.

"We are proud to continue our work together with the launch of Sovaldi as it supports our joint committment to meeting the unmet medical needs of patients in India," Malik said.

Gregg Alton, Executive Vice-President, Corporate and Medical Affairs, Gilead Sciences said it makes an important milestone in the company's ongoing effort to make its hepatitis-C medicines accessible to as many patients, in as many places, as quickly as possible.

Sovaldi is sold by Mylan's dedicated sales force as part of its Hepato Care segment.


Sunday, May 3, 2015

Joint Pain a Major Issue in Chronic HCV Infection

Joint Pain a Major Issue in Chronic HCV Infection
by Diana Swift
Contributing Writer


Smoking increases risk of arthralgias in hepatitis C.

Patient-reported joint pain is prevalent in those with chronic monoinfection with hepatitis C virus (HCV) or monoinfection with immunodeficiency virus (HIV), as well as in patients with HIV/HCV coinfection, according to a study published online in BMC Musculoskeletal Disorders on April 19, 2015. But chronic HCV patients report more arthralgia.

The study, led by Alexis R. Ogdie, MD, a rheumatologist at the University of Pennsylvania in Philadelphia, found that chronically HCV-monoinfected patients more frequently reported arthralgias compared with HIV/HCV-coinfected or HIV-monoinfected persons.

Joint pain was more commonly reported in HCV-monoinfected than HIV/HCV-coinfected (71% versus 56%; P=0.038) and HIV-monoinfected patients (71% versus 50%; P=0.035).

"These results suggest that joint pain remains a major health concern and a determinant of health-related quality of life among these patients," wrote Ogdie and her associates, adding that healthcare providers should address modifiable risk factors for joint pain such as smoking.

HCV is the most common blood-borne infection in the U.S., infecting 4 million persons and having a range of extrahepatic manifestations, including renal, dermatological, neurological, and rheumatological. "While chronic HCV-induced inflammation is generally thought to be a key contributor to these manifestations, the mechanisms by which they occur remain unclear," the researchers wrote.

The cross-sectional study enrolled 202 patients (173 males) and conducted standardized interviews in 79 HIV/HCV-coinfected, 93 HCV-monoinfected, and 30 HIV-monoinfected patients in hepatology and infectious-disease clinics at three U.S. centers. Age and gender distributions were similar across all three groups, while, racially, more than half of participants were black. The Multi-Dimensional Health Assessment Questionnaire (MD-HAQ) evaluated joint pain and associated symptoms, and interviewers collected information on potential risk factors.

Logistic regression determined adjusted odds ratios (aORs) with 95% confidence intervals (CIs) of joint pain associated with risk factors among chronic HCV-infected and HIV-infected patients. Joint pain was reported by more HCV-monoinfected than HIV/HCV-coinfected patients: 71% versus 56% (P=0.038) and by more HIV-monoinfected patients: 71% versus 50% (P=0.035).

In all groups, the fingers, knees, and back were the most frequently cited areas of joint pain. The distribution of painful joints was similar among the groups, although HCV-monoinfected patients more commonly reported finger pain compared with coinfected patients (41% versus 27%, P=0.035) and HIV-monoinfected patients (41% versus 23%, P=0.067).

A previous diagnosis of arthritis and current smoking were risk factors for arthralgias in both infections. In chronic HCV-infected patients, arthritis had an aOR of 4.25 (95% CI 1.84-9.81), and smoking an aOR of 5.02 (95% CI 2.15-11.74). In HIV-infected patients the aOR for arthritis was 5.36 (95% CI 2.01-14.25) and for current smoking 6.07 (95% CI 2.30-16.00).

Smoking has been associated with musculoskeletal pain and the development of, and worse disease activity in rheumatoid arthritis. This is the first study to report on its link to joint pain in chronic HCV. The authors cited the need for further research to determine whether smoking cessation improves arthralgia in chronic HCV patients.

While the etiology of joint pain in chronic HCV remains unclear, the authors noted that immune activation, direct deposition of viral particles in the synovium, and the high prevalence of concomitant mood disorders might be important contributors to the arthralgias commonly reported by chronic HCV-infected patients. More than half of patients reporting joint pain also self-reported depression and anxiety on the MD-HAQ.

The differences in joint pain prevalence among the three groups raise important questions for further study, the authors wrote. "Hypothesized explanations for these findings include differences in unmeasured environmental exposures among the groups or potentially a decrease in local inflammation related to immune dysfunction in HIV infection, resulting in a decreased effect of chronic HCV in the HIV/HCV-coinfected patients." Additionally, HIV-infected patients may be more tolerant of joint discomfort because of the higher priority placed on more serious complications of their disease. With HCV patients reporting a high prevalence of depression, anxiety, and sleep disturbance, depression and anxiety could have contributed to a higher prevalence of joint pain since mood and arthralgia are strongly linked.

Addressing study limitations, the authors noted the cross-sectional design, use of convenience sampling, the inability to perform physical examinations and imaging studies to rule out osteoarthritis, the relatively small sample, and the biasing possibility that patients with joint pain may have been more likely to complete the survey. Additionally, the study was unable to determine the specific etiologies for joint pain. Furthermore, some patients were prescribed analgesic medications and have self-reported joint pain less frequently. Also, because the study evaluated joint pain present within the week before the interview date, some patients with intermittent joint pain may not have been identified in this study.

"Future studies should determine the etiologies and strategies for management of joint pain, including fibromyalgia, in patients with chronic HCV and HIV infection, as well as the mechanisms for modulation of joint symptoms in HIV/HCV-coinfected patients," the authors concluded.

This study was funded by the American College of Rheumatology Research Foundation. The lead author was supported by the American College of Rheumatology Research and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and another author by the National Institute of Allergy and Infectious Diseases.

The authors declared no competing interests.
Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

Last updated 05.03.2015

Friday, May 1, 2015

The Pharmafocus debate: Is the price of new hepatitis C treatments fair?

The Pharmafocus debate: Is the price of new hepatitis C treatments fair?
Published on 27/04/15 at 01:26pm

YES - says Richard Bergström, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), who argues that blaming the pharma patent system for hepatitis C drugs’ prices is a non-starter.

New hepatitis C treatments have been a regular feature in healthcare news of late, not least because they offer that most elusive of gifts: a cure.

There has been much discussion about their price, but also a recognition of the value that these treatments offer to society. If a patient is successfully treated, ongoing treatment costs are nullified, including significant expenditure on care – and that patient may return to work, delivering further economic benefits to society.

Patent challenge

However, in February the charity Doctors of the World (also known as Médecins du Monde) filed a challenge against the patent for Gilead’s drug Sovaldi (sofosbuvir). The NGO maintained that while the medicine clearly represented a real breakthrough in the treatment of hepatitis C, it was not innovative enough to warrant a patent, particularly at the price that Gilead was charging.

Doctors of the World argues that if it wins the patent challenge, this would open the gates for generic companies to enter the field, copy the drug and sell it for a considerably lower price.

Doctors of the World is not alone in challenging the patent. To date a total of ten challenges have been registered against the makers of hepatitis C drugs. What is strikingly obvious, though, is that Doctors of the World and others who have fi led challenges against the Sovaldi patent are taking aim at the wrong target.

The bottom line is that without their patents, Sovaldi – and other drugs such as Janssen’s Olysio (simpeprevir) and AbbVie’s Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir) – would never have been developed, and millions of people with hepatitis C across the world would be left without the possibility of a cure for this often-debilitating condition.

'Selective memory approach'

This selective memory approach to the issue offers no comfort to hepatitis C patients. In the case of the Doctors of the World patent challenge, it also points to the lack of affordability of Sovaldi as being a result of its high price.

However, what this argument ignores is that the manufacturer has differentiated the price across the range of countries where the drug has been provided to patients. EFPIA may not be in a position to assess the validity of the claims against Gilead’s patent, but we have serious concerns that these proceedings are challenging a patent on grounds that are wholly unrelated to the patent system. To put it plainly: the price of a product plays no part in the decision of a patent office to grant a patent.

Medicines prices are in fact determined by those who buy them. This means, for the most part, that prices are determined by governments – and not patent offices, who have no influence over prices whatsoever.

EFPIA acknowledges that European governments understandably may be concerned with debt and liabilities in different areas, including healthcare. However, the overall medicines bill in Europe is currently under control and does not pose a threat to the sustainability of healthcare financing in Europe.

In fact, overall medicines across Europe represent less than 15% of total expenditure – although variances exist among therapy areas.

To achieve both economic and health care efficiency, it makes sense to limit spending on low benefit areas and enhance spending on cost-effective areas, such as primary care and medicines, especially in areas of societal priority.

Pharma must play its part

We must ensure that health spending is as smart as possible, which might mean greater upfront investment, but higher efficiencies in the long term. The pharma industry is prepared to play its part in getting this right by showing flexibility when engaging with payers around the world. The industry’s objective is not to promote spending on health or medicines at all costs, but decisions relating to public resource allocation should be informed by understanding the trade-offs involved where possible.

It must be underscored, though, that healthcare budgets, drug prices and the patent system are distinct and separate entities. What the patent system is in fact designed to do is to support the development of new drugs for patients by offering firms an incentive to invest in innovation.

It also serves to ensure the dissemination of scientific information to encourage research and the development of further innovative and even more effective drugs for posterity. No suitable alternative system has so far emerged that is capable of engaging comprehensively with the clinical trials process to bring new medicines to patients.

Questions may continue to be raised about the price of innovative drugs, but mostly this will be done while ignoring the medicine’s significant value to disease sufferers and the wider society.

There is a need to move away from traditional categorisation considerations and to embrace a more holistic approach to healthcare issues. This means abandoning the silo mentality of focussing solely on the price of drugs and moving towards more joined-up thinking that includes the outcomes and benefits for patients and society.

NO - says Katy Athersuch, medical innovation and access policy adviser at the MSF (Médecins Sans Frontières) Access Campaign, who argues that high hepatitis C treatment prices are hurting us all – and should prompt fundamental changes to how we fund pharma R&D.

April should have been a month of celebration for people living with hepatitis C virus in the UK. NICE recommended that the drug Sovaldi – a faster, more tolerable and more effective treatment for the disease – should be made available for patients on the NHS.

Until recently, hepatitis C treatments were long and involved weekly injections. Side effects were so toxic that some people chose to stop treatment early or never even start. For those that persevered, the cure rate was only 35-80 per cent.

Yet instead of celebrating, patients are left waiting. In an unprecedented move, the NHS is delaying the introduction of the treatment for all but the most severe cases.

Why is this occurring when the treatment is so clearly needed? The answer is the sheer exorbitance of the price. At £35,000 per patient just for Sovaldi, it would cost £1 billion for every 20,000 patients treated.

The NHS has responded by saying that this is simply too much. So why is Sovaldi so expensive? Peer-reviewed estimates indicate that a full three-month treatment course could be manufactured for around £68 – well under £1 per pill, compared to the astonishing £670-per-pill price tag in the US.

Pharma monopolies

The high price is completely unrelated to the cost of manufacture, and entirely related to the monopoly that pharmaceutical company Gilead has on the sale of the drug.

We often hear that high prices are necessary for pharma firms to recoup the investments they make in developing drugs. While we don’t know the exact costs of drug research and development – because companies won’t provide transparent data – economist Jeffrey Sachs estimates total private R&D costs for Sovaldi are as low as £200 million. Even with limited access to treatment, in one year Gilead has already earned in sales revenues 34 times that estimated level of investment.

Having presumably recouped its R&D costs long before reaching almost £7 billion in sales of Sovaldi last year, Gilead now argues that the price of Sovaldi represents the ‘value’ of cost savings from ‘averted’ future treatment needs, including rare, end-stage treatments like liver transplants.

Why should we accept Gilead’s ‘value’ defence of their prices? We certainly don’t expect the price of a root canal to be based on the price of a full set of dentures, or the price to remove a pre-cancerous tumour to be based on the price for a full course of chemotherapy for late-stage cancer.

Value vs price of patents

Crucially, the value these drugs provide to the millions who can’t access them is zero. In reality, Gilead’s pricing strategy attempts to reap as much profit as possible under a system that allows unfettered profiteering, regardless of the repercussions for public health. Gilead can charge these exorbitant prices because it has been granted patents that give it monopoly control over sales of the drug. But these patents are not even valid under the laws of some countries.

In India for example, the patent office rejected Gilead’s application for one of Sovaldi’s key patents because it did not meet India’s patentability criteria, which allows patents for demonstrably ‘new’ drugs but not for incremental innovations.

Additional patent oppositions are ongoing in India and elsewhere. As Doctors of the World (Médecins du Monde) explained when filing their patent opposition in Europe, “the improvement in the quality of life that [Sovaldi] offers to patients is a breakthrough, but the molecule that comprises the drug is not.”

And it isn’t just UK patients losing out. Chronic hepatitis C infection affects an estimated 150 million people worldwide, and is responsible for approximately half a million deaths each year. While Gilead has made the treatment available at lower prices in some countries through ‘tiered pricing’, and through a voluntary licence that permits generic competition in other countries, the discounts offered are not sufficient to allow widespread treatment scale-up by ministries of health or other providers.

An estimated 75% of the world’s poor and over 70% of people living with hepatitis C live in middle-income countries (MICs). But prices for Sovaldi in 50 MICs locked out of Gilead’s voluntary license –where more than 49 million people live with hepatitis C – can range from £1,300 to £10,000 per treatment course.

Some countries will have access to prices of £200 per month or less through generic companies with which Gilead has entered a licensing agreement, but for countries with low per capita income and high inequality, this significant mark-up is unaffordable.

Though it may sound like a discount compared to the colossal prices in the US and UK, Gilead’s tiered pricing still unduly impedes access. We shouldn’t be comparing the cost-effectiveness of liver transplants; we should be testing and treating everyone in need. This is an infectious disease and reducing the reservoir of the virus in the population should be a public health priority.

New models for R&D

Delayed and denied treatment due to unaffordability has ignited a global outcry, but the reasons we continue to face high drug prices are rarely discussed or challenged.

We are trapped by the way we finance the development of medical products. Instead of asking how pharma companies accountable to shareholders should price treatments of public health importance when the sky is the limit, we should ask why we accept an R&D system that allows companies to charge high prices indiscriminately.

How can we develop drugs that don’t threaten to bankrupt our national healthcare systems or exclude millions from affordable access in other countries? Doing this will mean rethinking how we fund the costs and risks of drug development, rather than relying on monopolies to incentivise the industry to deliver new treatments.

Unless we start to look at new models for financing R&D, we will remain beholden to a system that inevitably leads to higher and higher drug prices. We must have greater transparency about R&D costs, as well as greater accountability, oversight and intervention to ensure that drug companies do not simply sell drugs at the prices they choose.

We all want drug companies to successfully develop new medicines, but this success cannot come at the expense of ensuring access to the innovations that people everywhere need.

What’s your opinion? Have your say @Pharmafocus with the hashtag #pfdebate


Reducing the cost of new hepatitis C drugs
Daclatasvir, Harvoni (ledipasvir/sofosbuvir)/Sovaldi/Viekira Pak.
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.

Gilead - Strong hepatitis C drug sales

Gilead first-quarter profit doubles on strong hepatitis C drug sales

(Reuters) - Gilead Sciences Inc on Thursday said its quarterly profit nearly doubled, driven by strong sales of its hepatitis C drugs, as it topped Wall Street estimates.

Gilead signaled that, with its hepatitis C franchise established, it is a good time for the company to consider business development opportunities. "We want to stick very closely to therapeutic areas we are in today," Gilead Chief Operating Officer John Milligan said on a conference call.

Excluding items, Gilead earned $2.94 per share in the first quarter, beating the average Wall Street estimate of $2.32, according to Thomson Reuters I/B/E/S. The company's shares, which fell 1.8 percent in regular trading, rose 2 percent to $102.52 after hours.

Product sales rose 52 percent to $7.41 billion, including $4.55 billion for hepatitis C drugs Sovaldi and Harvoni. Analysts had expected hepatitis C sales of $3.54 billion, according to Deutsche Bank.

"It was an extremely strong quarter," said RBC Capital Markets analyst Michael Yee, noting that the sales guidance "signals confidence in the year."

Gilead said it now expects full-year product sales of $28 billion to $29 billion, up from a previous estimate of $26 billion to $27 billion.

In late 2013, Gilead prompted howls of protest about prescription drug prices when it launched Sovaldi at $1,000 a pill, and later Harvoni at an even higher price. But since AbbVie Inc launched a rival treatment late last year, both have fought for market share by offering rebates to group payers.

Gilead said earlier this year that its "gross-to-net" adjustment for hepatitis C sales would average 46 percent in 2015. The company declined to revisit that estimate on Thursday.

Gilead said more than 70,000 U.S. patients and 20,000 European patients were started on its hepatitis C drugs in the first quarter. Because the drugs cure nearly all patients, the market opportunity is limited.

Around 3.3 million Americans are believed to be infected with the liver-destroying hepatitis C virus, but only about half of them are aware that they are infected.

Gilead posted net income of $4.3 billion, or $2.76 per share, up from $2.2 billion, or $1.33 per share, a year earlier. Cash on hand at the end of the quarter totaled $14.5 billion.

"They could pretty much buy anything," said Sanford Bernstein analyst Geoffrey Porges. "The big question is whether they are going to swing the big bat that they have at their disposal."

(Reporting by Deena Beasley; Editing by Cynthia Osterman and Frances Kerry)