Gay Men Should Be Tested for Hepatitis C

Provided by The Huffington Post

Lawrence D. Mass, M.D.

Co-founder, GMHC; author, 'We Must Love One Another or Die: The Life and Legacies of Larry Kramer'

Posted: 10/30/2013 7:54 pm

Hepatitis C is the most common blood-borne infection in the U.S., and one of the most common worldwide. One in 50 Americans is infected. It accounts for more than 50 percent of all cases of end-stage liver disease and 50 percent of cases of liver cancer, and it is the reason for more than 50 percent of liver transplants. Yet it remains severely underdiagnosed. It's estimated that upwards of 75 percent of those infected remain untested and undiagnosed, as compared with 25 percent of those with HIV. More people now die from hepatitis C than from HIV.

Those of us who struggled through the early period of AIDS understand the meaning of "Silence = Death," the motto used by the AIDS activist organization ACT UP. So when hepatitis C began to emerge among MSM (men who have sex with men), the silence that ensued seemed eerily familiar. When I first started reporting on hepatitis C in gay men nearly a generation ago, the disease was already being called "the stealth epidemic," in part because of the typically long, silent progression of the disease in its chronic form, sometimes taking 20 to 30 years from acute infection to cirrhosis of the liver, but also because of the public silence about it. If people had the disease, they mostly didn't know it, and if they did have it and did know it, they didn't go public with it. Nor did those with the disease often seek treatment, which had the reputation of being prolonged, difficult and of mixed efficacy. Since the principal risk group for the disease was injection drug users, the public wasn't exactly clamoring to know more or be more involved. There was no megacelebrity out there to help galvanize public interest and support who would admit to having hep C the way that Magic Johnson came out as having HIV. How much has changed in the intervening years?

Despite newer and often highly effective treatments that are essentially curative, not much has changed in terms of public awareness and indifference. Hepatitis C remains a stealth disease. Public health officials have long resisted the call to sound the alarm for hep C as an STI (sexually transmitted infection), citing the weak transmissibility of hep C sexually. For years, they didn't even urge that the partners of those who were hep C-positive be tested. Granted that HCV hasn't shown itself to be nearly as transmissible sexually as HIV, I expressed my concerns about what seemed to be excessive cautiousness around testing recommendations -- in the gay press, for New York magazine as well as in a public health forum co-hosted by the CDC in Atlanta.^{1, 2} I argued that there needed to be greater awareness of and testing for hepatitis C as an STI, especially among MSM. As the call-out in New York put it, "Hepatitis C infections are spreading beyond high-risk groups, causing a few physicians to call for widespread testing. But the medical establishment is stalling. Sound familiar?"

Why was this so controversial? Why not just test everybody who might be at risk, even if that risk were "small"? The reason I was given by CDC epidemiologists and other public health officials was that urging everyone to get tested for hep C, even all MSM, could create unwarranted alarm and would be an unjustifiable expense in view of the relative minority of cases. Also, despite the increasing numbers of cases in gay men/MSM, those numbers remain "small," and it wasn't clear that other undisclosed risk factors such as injection drug use weren't responsible, since increased rates of sexual spread weren't being observed among heterosexuals.

So where do we stand with all this now? Amidst growing reports of new cases among clusters of gay men/MSM, especially in Europe, and growing numbers of cases in MSM generally, the latest review and recommendations from USPSTF (U.S. Preventive Services Task Force) from June 25, 2013, include the following:

The Task Force reviewed recent research studies on screening for and treatment of hepatitis C infection in adults. The final recommendation statement summarizes what the Task Force learned about the potential benefits and harms of screening: (1) Adults at high risk for hepatitis C infection should be screened for the infection. (2) Health care professionals should offer 1-time hepatitis C screening to adults born between 1945 and 1965.

And who are they designating as being at "high risk"?

The most important risk factor for hepatitis C infection is the use of injection drugs. Other risk factors include having had a blood transfusion before 1992, having multiple sex partners, and getting a tattoo with an unsterilized needle.

OK, so there, they've said it: "those having multiple sexual partners." But that recommendation is absent from their final, summary recommendations. There, they define those at "high risk" to be as follows:

People who use injection drugs now or have used them in the past. Having a blood transfusion before 1992 also puts a person at increased risk. Be screened only once. Some people with ongoing risk factors, such as injection drug users, need to be screened more than once.

There's no mention in these final recommendations of those having "multiple sexual partners," which would include the majority of gay men/MSM, apparently because they are more "at risk" than at "high risk." OK, but then why not designate MSM as "at risk," even if that risk is believed to be low? Clearly, public health advisories re hepatitis C testing for MSM remain unclear.

So where does all this leave us? When it comes to hepatitis C screening, gay men must once again be proactive. If you are a sexually active gay man/MSM, if you've had sex with multiple partners over time, get tested for hepatitis C. If your doctor or health care provider declines to offer the testing based on perceived low risk and unclear public health services recommendations, seek testing from another health care provider.

References:

1. Mass, Lawrence D., "C-Sick," New York, March 29, 1999.

2. "AIDS and Hepatitis C: Lessons from AIDS," from Emerging Illnesses and Society: Negotiating the Public Health Agenda, edited by Randall M. Packard et al., Johns Hopkins University Press, 2004.

Lawrence D. Mass, M.D., is a co-founder of Gay Men's Health Crisis and wrote the first published press reports on AIDS.

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United States to approve potent oral drugs for hepatitis C

Nature | News

Improved treatments offer hope for eradication of viral liver infection.

Sara Reardon

30 October 2013

Cocktails of new oral antiviral drugs to fight hepatitis C have aced clinical trials.

JAMES CAVALLINI/SCIENCE PHOTO LIBRARY

For decades, people with hepatitis C virus (HCV) have had to endure gruelling treatment regimens that include injections of the drug interferon, which can cause severe nausea and depression. But with the imminent approval of several highly effective oral antiviral drugs, and more on the way, researchers say that eradicating the infection worldwide is now a realistic goal.

Unlike previous HCV treatments, which sought to enhance the immune system with interferon and other drugs, the latest group of oral medications interferes with the virus’s ability to replicate and make proteins. A US Food and Drug Administration (FDA) board recommended two such drugs — simeprevir, made by Johnson & Johnson in New Brunswick, New Jersey, and sofosbuvir from Gilead Sciences in Foster City, California — for approval last week. When each is taken in combination with a drug called ribavirin, the treatment eliminates hepatitis C in around 80% of people.

“This is the first time in the history of humankind that we have a cure for a viral disease,” says pharmacologist Raymond Schinazi of Emory University in Atlanta, Georgia.

Findings from trials of different drug combinations are set to be released this week. A phase II study called COSMOS tested a combination of sofosbuvir and simeprevir in 197 people with HCV who had either not responded to interferon or who had advanced liver fibrosis caused by the virus. After 12 weeks of treatment, the drugs completely cleared the virus in more than 90% of participants.

Another study, led by physician Kazuaki Chayama at Hiroshima University in Japan, treated 220 people with a combination of daclatasvir and asunaprevir, two new drugs from Bristol-Myers Squibb in New York. The cocktail cured 85% of participants. Eric Hughes, lead global medical researcher at the company, says that it plans to submit the drugs for FDA approval in 2014.

Stopped short

Despite such encouraging results, larger studies of drug combinations involving multiple drug companies seem to be unlikely. Charlotte Edenius, vice-president of development at Medivir, a drug company in Stockholm that collaborated with Johnson & Johnson on the COSMOS study, says that Gilead and Johnson & Johnson do not plan to work together for a phase III trial. Similarly, a Bristol-Myers Squibb spokesperson says the company has no plans to collaborate with Gilead on larger trials of a combined sofosbuvir–daclatasvir therapy, despite a phase II trial completed earlier this year in which the drug pairing cured all 41 participants.

Even without phase III trials or FDA approval for this approach, David Thomas, a hepatitis C researcher at Johns Hopkins University in Baltimore, Maryland, expects that some physicians will begin prescribing such combinations 'off-label' for difficult-to-treat cases.

And, he says, the impressive cure rates achieved in clinical trials suggest that potent drug combinations could eradicate HCV worldwide — at least in theory. The virus does not have an animal reservoir, meaning that it is not harboured by other animals, and it is not easily spread between people, except through blood. Improved screening of blood supplies used for transfusions and better patient-screening techniques have already greatly cut transmission rates over the last 15 years. Emergence of drug-resistant virus strains could be a hurdle, adds Thomas, but they might be rare because the latest antiviral drugs are so potent in combination.

Price problem

Hepatologist Rajender Reddy at the University of Pennsylvania in Philadelphia sees a second stumbling block: getting such treatments to people who need them. Many of the roughly 170 million people worldwide who carry hepatitis C will not be able to afford the drugs, he says. There is also little incentive for drug companies to lower costs — unlike antiviral therapies for HIV, which must be taken for a patient's lifetime, HCV treatment is given for only 12 weeks.

Identifying HCV carriers is also challenging, because most people do not know that they have the disease until they develop severe cirrhosis or liver cancer — sometimes decades after being infected. Mandatory screening of at-risk populations such as the elderly and drug users would need to be a major part of an eradication effort, says virologist Charles Rice of Rockefeller University in New York. Crucial too is education to prevent people from contracting the disease in the first place. Even the most effective oral drugs do not raise a lasting immune response against the virus, and people can be reinfected.

That is why the search for a preventative HCV vaccine continues, with the most promising ones currently in phase II clinical trials. “Even if we have all the drugs we need — which is still an open question — it will be decades, if not a century, before it’s gone,” says Rice.

Journal name: Nature

DOI: doi:10.1038/nature.2013.14059

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Changes to Incivek (telaprevir) product labeling

You are receiving this message as a subscriber to the FDA hepatitis electronic list serve. The purpose of the list serve is to relay important information about viral hepatitis-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

Please do not reply to this message.

FDA approved changes to the Incivek (telaprevir) product labeling to include results from trial C211 (OPTIMIZE) to support a twice daily dosing regimen. In addition new contraindications were added for anticonvulsant medications (carbamazepine, phenobarbital and phenytoin) and other revisions to the section 7 Drug Interactions. Below is a summary of the changes

• Section 2: Dosage and Administration of telaprevir were updated throughout the label: from 750 mg three times a day to 1125 mg twice daily.
• The anticonvulsant medications carbamazepine, phenobarbital, and phenytoin were moved from the Drug Interaction section (Section 7, Table 5) to the Contraindications section (Section 4, Table 3)
• Section 6: Adverse Reactions was updated as follows:

Additional Data from Clinical Trials

In the analysis of an additional study (Trial C211), the safety profile of combination treatment with INCIVEK 1125 mg twice daily was similar to the safety profile for patients receiving combination treatment with INCIVEK 750 mg every 8 hours (q8h) [see Clinical Studies (14.2)]. No new safety findings were identified.

• The analgesic medications alfentanil and fentanyl were added in section 7 Drug Interactions Table 5 as potential drug interaction drugs when used with telaprevir. Specifically, careful monitoring of therapeutic and adverse effects (including respiratory depression) is recommended when telaprevir is co-administered with alfentanil or fentanyl, including extended-release transdermal or transmucosal preparations of fentanyl.
• Section 12 Clinical Pharmacology was updated with information regarding the twice daily dosing regimen.

Telaprevir total exposure (AUC24h,ss) was similar regardless of whether the total daily dose of 2250 mg was administered as 750 mg every 8 hours or 1125 mg twice daily.

Additionally the data from interaction trials with carbamazepine and phenytoin were included.

• Section 12.4 Microbiology was updated as follows:

In the C211 Phase 3 clinical trial, there were no differences in the types of emerging variants between subjects receiving telaprevir 1125 mg twice daily and subjects receiving telaprevir 750 mg every 8 hours. Similar proportions of subjects in both treatment groups had telaprevir-resistant variants at the time of failure.

• Section 12.5 Pharmacogenomics was updated to include the sustained virologic response rates at 12 weeks post treatment (SVR12) for the twice daily dosing regimen as follows:

In Trial C211, all subjects were prospectively tested for IL28B variants; there were no clinically relevant differences in SVR12 responses between q8h and twice-daily dosing within the genetic subgroups.

Trial	rs12979860 Genotype	SVR, n/N (%)	SVR, n/N (%)
C211 (treatment-naïve)		T12 Twice Daily/PR	T12 q8h/PR
	C/C	97/105 (92%)	92/106 (87%)
	C/T	139/206 (67%)	141/208 (68%)
	T/T	38/58 (66%)	37/57 (65%)

• Section 14 Clinical Studies was updated to include results from Trial C211 (OPTIMIZE)

Trial C211 was a randomized, open-label, Phase 3 trial conducted in treatment‑naïve subjects. Enrolled subjects received 12 weeks of either INCIVEK 750 mg every 8 hours [T12 (q8h)/PR] or INCIVEK 1125 mg twice daily [T12 (twice daily)/PR] in combination with peginterferon alfa‑2a and ribavirin. The trial was designed to compare twice-daily dosing [T12 (twice daily)/PR] versus q8h dosing [T12 (q8h)/PR] of INCIVEK. At week 12, INCIVEK dosing ended and subjects continued on peginterferon alfa‑2a and ribavirin treatment. The total treatment duration was determined based on the subjects’ individual on-treatment viral response. If a subject achieved undetectable HCV RNA < 25 IU/mL (target not detected) at week 4, the total treatment duration was 24 weeks. Otherwise, the total treatment duration was 48 weeks.

The 740 enrolled subjects had a median age of 51 years (range: 18 to 70); 60% of the subjects were male; 21% had a body mass index ≥ 30 kg/m²; 5% were Black; 2% were Asian; 85% had baseline HCV RNA levels ≥ 800,000 IU/ml; 15% had bridging fibrosis; 14% had cirrhosis; 57% had HCV genotype 1a; and 43% had HCV genotype 1b.

Table 11 shows the response rates for the T12 (twice daily)/PR group and the T12 (q8h)/PR groups by treatment outcomes. The overall SVR rates were similar at 74% [T12 (twice daily)/PR; 274/369] and 73% [T12 (q8h)/PR; 270/371], respectively.

Table 11: Response Rates: Trial C211

Treatment outcome	T12 (twice daily)/PR N = 369% (n/N)	T12 (q8h)/PR N = 371% (n/N)
SVR	74% (274/369)	73% (270/371)
Undetectable HCV RNA (target not detected) at week 4a	69% (256/369)	67% (250/371)
SVR in subjects with undetectable HCV RNA (target not detected) at week 4	86% (221/256)	85% (213/250)
SVR in subjects who did not have undetectable HCV RNA at week 4	47% (53/113)	47% (57/121)
Outcome for Subjects without SVR	26% (95/369)	27% (101/371)
On‑treatment virologic failureb	10% (38/369)	10% (36/371)
Relapsec	8% (23/300)	6% (19/293)
Otherd	9% (34/369)	12% (46/371)

T12 (twice daily)/PR: INCIVEK 1125 mg twice daily for 12 weeks with peginterferon alfa‑2a and ribavirin for 24 or 48 weeks; T12 (q8h)/PR: INCIVEK 750 mg every 8 hours for 12 weeks with peginterferon alfa‑2a and ribavirin for 24 or 48 weeks

^{a   Subjects with planned total treatment duration of 24 weeks.}

^{b   On‑treatment‑virologic failure includes subjects who met a protocol‑defined virologic stopping rule and/or who had detectable HCV RNA at the time of their last dose of study drug and had viral breakthrough.}

^{c   Relapse was defined as having less than 25 IU/mL at the planned end of treatment followed by HCV RNA ≥ 25 IU/ml at the last observation within the SVR follow-up visit window.}

^{d   Other includes subjects with detectable HCV RNA at the planned end of treatment but who did not have viral breakthrough, and subjects with a missing SVR assessment during planned follow-up.}

SVR rates were similar for the T12 (twice daily)/PR and T12 (q8h)/PR groups across subgroups determined by sex, age, race, ethnicity, body mass index, HCV genotype subtype, IL28B genotype, baseline HCV RNA (less than 800,000, greater than or equal to 800,000 IU per mL), and extent of liver fibrosis. However, there were small numbers of subjects enrolled in some key subgroups. 

• Fifty-four and 49 subjects in T12 (twice daily)/PR and T12 (q8h)/PR groups, respectively, had cirrhosis at baseline. The SVR rate in these subjects was 54% (29/54) in the T12 (twice daily)/PR group and 49% (24/49) in the T12 (q8h)/PR group. In the T12 (twice daily)/PR group, 52% (28/54) of subjects with cirrhosis achieved undetectable HCV RNA (target not detected) at week 4; their SVR rate was 68% (19/28). In the T12 (q8h)/PR group, 59% (29/49) achieved  undetectable HCV RNA (target not detected) at week 4; their SVR was 59% (17/29). The SVR rate for subjects assigned 48 weeks of treatment was 38% (10/26) in the T12 (twice daily)/PR group and 35% (7/20) in the T12 (q8h)/PR.

• Thirty-five subjects were Black/African Americans. The overall SVR among Black/African American subjects was 50% (10/20) in the T12 (twice daily)/PR group and 60% (9/15) in the T12 (q8h)/PR group. Among these subjects, 46% (16/35) were assigned to 24 weeks of treatment and of those 88% (14/16) achieved SVR.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

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Gileads’ CEO Discusses Sofosbuvir During Q3 2013 Earnings Call

Gilead Sciences' CEO Discusses Q3 2013 Results - Earnings Call Transcript

Excerpt from page 4

“And finally, as all of you are aware, we had a successful FDA advisory committee last week. The panel [ph] voted unanimously in favor of approval of sofosbuvir with ribavirin for the treatment of genotype 2 and 3 hepatitis C infected patients and approval of [indiscernible] course of sofosbuvir pegylated interferon with ribavirin for the treatment of genotype 1 and 4 hepatitis C infected patients.

In addition, the majority of panel members were in favor of broadening the indication to improve genotype 1 treatment experienced patient in the label. [indiscernible] the use of sofosbuvir plus ribavirin in the pre-transplant setting quotations with ACC. At the advisory committee meeting, new data were presented from the VALENCE study which indicated that treatment-naïve and treatment experience genotype 3 hepatitis C infected patient was so faster by providing with 24 weeks with SVR rate of 84%.

We are naturally excited about bringing sofosbuvir to the market and we feel like panel members commented that this is a historic moment, for which every employee at Gilead is proud of. We look forward to working with FDA to complete the review of the sofosbuvir NDA and ultimately launch the product.

Meanwhile the clinical development program of the sofosbuvir [indiscernible] dose combination is also proceeding rapidly. Three phase 3 studies IN-1, IN-2 and IN-3 explore the utility of the fixed dose combination both treatment, naïve treatment experience genotype 1 hepatitis C infected patients, with and without ribavirin, therefore treatment durations of eight, 12 and 24 weeks, we anticipate having data from these studies that we have about towards the end of this year and into early next year as we are on track for NDA, MAA filings in the second quarter of 2014.

The development of sofosbuvir in combination with ribavirin for genotype 2 infected patients in Japan is progressing. The single-arm phase 3 study with 12 weeks treatment duration was fully enrolled in September and we are on track to submit the marketing application in Japan towards the middle of 2014. This is a significant opportunity as genotype 2 infected patients in Japan constitute over 25% of the total and sofosbuvir and ribavirin will be the first on oral interferon free option for these patients.

In addition, the phase 3 program after fixed dose combination of sofosbuvir/ledipasvir with and without ribavirin genotype 1 hepatitis C infected patients was initiated in September 2013 that we anticipate this study to be fully enrolled by the end of this year. This two-arm study in three [indiscernible] genotype 1 infected both treatment, naïve treatment experienced patients, randomized to a 12-week course of the fixed dose combination with and without ribavirin.

Finally, the potentially pan-genotypic interferon and ribavirin free regimen, the combination of sofosbuvir [indiscernible] GS-5816 is advancing to phase 2 development, two studies in treatment naïve and treatment experienced patients in various genotypes are fully enrolled, and depending on the emerging data, we should be in a position to initiate phase 3 studies in the second half of 2014.

More information on our programs will be presented at the annual AASLD meeting which will commence this week in Washington DC. Over 50 abstracts were submitted on Gilead's various liver disease programs and importantly, new data will be presented on the safety and efficacy of sofosbuvir,

Ribavirin in HIV core affected patient and in the post liver transplant setting.

In summary, very rapid progress has been made across all our therapeutic areas in all other programs. Our pipeline provides us with numerous opportunities with continued growth, both short-term and longer-term. We want to take this opportunity to thank all of our employees for their continued hard work and dedication.

So with that, we will now open the call for questions. Operator?”

Continue reading the full transcript here ……

The Rise and Fall of a Revolutionary Drug

Provided by The Motley Fool

By Brian Orelli | More Articles
October 29, 2013

One of the best drug launches in history has become one of the fastest run downs.

Approved in May 2011, Vertex Pharmaceuticals' (NASDAQ: VRTX ) hepatitis C drug Incivek hit $457 million in sales in its second full quarter on the market. Many drugs never hit $457 million in annual sales at their peak.

Less than two years later, sales are down to $86 million in the most recent quarter. You can't say I didn't warn you.

Ironically, what made Incivek so popular to begin with is also what caused the crash. Hepatitis C is a slowly developing disease, so there's a limited downside to patients waiting a few years to be treated if the virus isn't doing much damage to the liver yet.

Doctors could see that Incivek and Merck's (NYSE: MRK ) Victrelis were working well in clinical trials, so they cut back on the prescribing the standard of care at the time -- Roche's Pegasys or Merck's Pegintron with a generic called ribavirin -- because they only cured about half the patients and make many people feel like they have the flu.

Once Incivek was approved, the warehoused patients were prescribed Incivek, which had a little better data than Merck's Vicrelis, and sales skyrocketed.

Rinse and repeat
But then doctors heard about the next generation of drugs and started warehousing again. Doctors are going to prescribe Johnson & Johnson's (NYSE: JNJ ) simeprevir and Gilead Sciences' (NASDAQ: GILD ) sofosbuvir, which both look like they're going to get approved this year after getting unanimous endorsements from their respective advisory committees. The large number of drugs in clinical trials also siphoned off some patients.

Vertex has seen the writing on the walls, so the biotech is cutting 370 positions, about 15% of its workforce, to conserve cash while it ramps up its cystic fibrosis business. Vertex also has a next-generation hepatitis C drug, VX-135, but it'll take a few years to get approved -- if side effects don't kill it first -- so it doesn't make sense to keep the hepatitis C sales force on the payroll.

All those workers can find new homes at Johnson & Johnson or Gilead Sciences. At least until doctors start warehousing again.

These two biotechs should have longer legs
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Gilead posts 17 pct profit rise, readies for HCV launch

UPDATE 2-Gilead posts 17 pct profit rise, readies for HCV launch

Tue Oct 29, 2013 6:18pm EDT

By Deena Beasley

Oct 29 (Reuters) - Biotechnology company Gilead Sciences Inc reported a 17 percent jump in quarterly net profit on Tuesday and raised its outlook for full-year sales as revenue and demand for its flagship HIV drugs exceeded Wall Street estimates.

Analysts expect the company's sales to surge even higher next year when Gilead plans to launch a new so-called HCV treatment for people infected with the liver-destroying hepatitis C virus.

Adjusting for one-time items, Gilead earned 52 cents a share in the third quarter, exceeding the average analyst estimate of 48 cents a share, according to Thomson Reuters I/B/E/S.

"They beat, ... driven by better product revenues and lower expenses," said RBC Capital Markets analyst Michael Yee. "It was also positive that they took up their product sales guidance."

Sales of HIV drug Atripla rose 4 percent to $899.7 million, while sales of an older product, Truvada, rose 1 percent to $813.7 million. Sales of newer HIV drug Complera more than doubled to $210.7 million, and the recently launched Stribild had sales of $144 million in the quarter.

Gilead is the world's largest maker of branded drugs to treat the human immunodeficiency virus, the cause of AIDS.

Quarterly revenue rose 15 percent to $2.78 billion, beating the $2.72 billion forecast by analysts.

For the full year, Gilead raised its estimate for net product sales to between $10.3 billion and $10.4 billion, from a previous range of $10.0 billion to $10.2 billion.

An advisory panel to the U.S. Food and Drug Administration last week voted to recommend that the agency approve Gilead's application for experimental HCV drug sofosbuvir to combat the hepatitis C virus. A final FDA decision is expected by early December.

Gilead estimates that over 4 million Americans are infected with hepatitis C, which causes deadly illnesses such as cirrhosis and liver cancer.

Wall Street analysts have forecast sofosbuvir sales of $1.85 billion next year alone, assuming a price of $85,000 per patient, according to ISI Group.

"We feel we've got a very strong value proposition with sofosbuvir," Kevin Young, head of commercial operations at Gilead, said on a conference call with analysts and investors.

Clinical trials of sofosbuvir in combination with other experimental oral Gilead drugs - a regimen that has not yet been submitted for regulatory approval - resulted in more than 95 percent of patients being cured.

Gilead's third-quarter net profit rose to $788.6 million, or 47 cents per share, from $675.5 million, or 43 cents per share, a year earlier. The number of shares outstanding rose in the latest quarter from the prior-year period.

Chief Financial Officer Robin Washington said those buybacks will continue next year.

Shares of Gilead, which have more than doubled over the past 12 months, were up 1 percent in after-hours Nasdaq trading at $70.25.

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