Cures for hepatitis C are an investment worth making

New cures for hepatitis C are helping Medicare beneficiaries live longer, healthier lives. It is disingenuous to look at Medicare spending on these treatments without considering the substantial rebates and competition in the program [“Medicare spending for hepatitis C drugs surges,” news, Oct. 18].

Competition and robust negotiation in Medicare Part D are controlling costs. Private plans command steep discounts on prescription prices under Part D, including groundbreaking cures for hepatitis C. In fact, additional treatment options approved in the past year led to competition-generated savings for a variety of payers, including Medicare. Average rebates on some of these products increased from 22 percent in 2014 to 46 percent in 2015. Average rebate levels in Part D have increased each year of the program. Even the 2015 Medicare trustees report that rebates are substantial.

Moreover, researchers at Harvard University suggest new hepatitis C therapies may generate cost savings for the health-care system over the long run. Medicare is uniquely positioned to take advantage of these savings, as beneficiaries remain in the program once they become eligible.

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Patients have mixed feelings about hepatitis drugs

By Vickie Aldous
Mail Tribune

Posted Oct. 4, 2015 at 12:01 AM

Patients who have coped for years with hepatitis C have had mixed reactions to new drugs that can cure the disease, from elation about the treatment to shock about the price.

One Southern Oregon woman who asked not to be named said she went through a six-month course of older medication, but suffered side effects such as internal bleeding that required her to be hospitalized and given blood transfusions. The grueling treatment cleared her body of the virus, but three months later, the virus reemerged.

In March 2014, she started a three-month course of Sovaldi, a new medication which produced no side effects and wiped the virus from her body. The virus has not returned.

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September 2015 Mid-Month Edition - SNAPSHOTS —Alan Franciscus, Editor-in-Chief

This month’s Snapshots is about recently published studies on all-oral therapies to treat hepatitis C in people coinfected with HIV.  We have really come a long way in such a short period of time with medications to treat a population in high need of effective therapies.    
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Article: Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1—S Naggie et al.

Source:  New England Journal of Medicine DOI: 10.1056/NEJMoa1501315

Results and Conclusions
The study included 335 patients coinfected with HIV-1 and hepatitis C genotype 1 or 4.  The median age was 52 yo (48-58 yo).  The majority of patients were White 61% (203 pts) and Black 34% (115 pts), male 82% (276), genotype 1a 75%, genotype 4 two percent, cirrhosis 20%, median CD 4+ cell count 628 (469-823), treatment naïve 45%, previously treated 55%. The treatment period was 12 weeks.  Note: I am not including the genotype 4 patients since there were only 8 patients.  

The Bottom Line
The cure rates were 96% for genotype 1a, and 96% for genotype 1b. The cure rates were similar regardless of prior response or degree of liver damage.  The most common side effects were headache, fatigue and diarrhea.  No patients discontinued treatment due to side effects.

Editorial Comment
These results are excellent across subtypes (1a/1b), races, and prior treatment responses.  Gilead has filed for marketing approval with the Food and Drug Administration.  The American Association for the Study of Liver Disease (AASLD) and the Infectious Disease Society of America (IDSA) recommend Harvoni as a treatment for HCV for people coinfected with HIV and hepatitis C.

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Article: Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial—J K Rockstroh, et al

Source:  The Lancet HIV Volume 2, No. 8, e319–e327, August 2015

Results and Conclusions
The study was conducted in people with HIV/HCV coinfection to evaluate grazoprevir/elbasvir (one pill, once-a-day) to treat HCV genotype 1, 4, and 6. The treatment period was 12 weeks. There were 218 patients in the phase 3 trial.  The trial was conducted in Europe, the United States and Australia.

The Bottom Line
The overall cure rate was 96% (210 of 218 patients).  All patients who had cirrhosis were cured.  The most common side effects were fatigue, headache and nausea. No patients discontinued treatment due to side effects.

Editorial Comment
The high cure rates and fewer side effects plus no treatment discontinuation due to treatment-related side effects equals very good news for patients.

The once-a-day combination of grazoprevir/elbasvir when approved is going to be a welcome addition to the other therapies to treat hepatitis C in people who are HIV and HCV coinfected.  

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Article: Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1—D L Wyles et al.  
Source:  New England Journal of Medicine DOI: 10.1056/NEJMoa1503153

Results and Conclusions
There were 3 different treatment groups. All the groups received daclatasvir plus sofosbuvir. Note: Since there was a small number of genotype 2, 3, and 4 patients—I omitted these results.  For this article I am just listing the genotype 1 results.    

The Bottom Line
The patient characteristics, treatment durations and cure rates are included below:

1. Naïve (untreated patients): 101 patients; median age 52 yo; male sex 91%; race: White 65%, Black 30%; genotype 1a: 70%, genotype 1b: 12%; cirrhosis 9%; median CD4+ count 520 (122-1147). Treatment duration = 12 weeks. Cure rate = 96%
2. Naïve (untreated patients): 50 patients; median age 51 yo; male 84%; race White 56%, Black 38%; Genotype 1a 70%, Genotype 1b 12%; cirrhosis 10%; treatment duration = 8 weeks.  Cure rate = 76%
3. Treatment Experienced:  52 patients; median age 57 yo; male 83%; race White 60%, Black 38%; genotype 1a 63%, genotype 1b 21%; cirrhosis 29%; treatment duration =12 weeks.  Cure rate = 98%

The most common side effects were fatigue, nausea, and headache.  No patient discontinued due to side effects.

Editorial Comment
The 12-week treatment groups had good cure rates as opposed to the 8-week treatment response group.  The treatment-experienced group #3 with a 38% Black population and a relatively high cirrhotic population achieved nearly perfect cure rates. The drawback of this combination is going to be the high price tag of the combination of these two drugs.

Note:  Another issue with treating hepatitis C in people with HIV is the potential drug-drug interactions with HIV medications.  For more information visit the AASLD/IDSA  HCV Guidelines http://www.hcvguidelines.org/full-report-view.

Achillion Reports 100% SVR12 From Second Cohort of Patients in the Previously-Completed Six Week Phase 2 Trial Evaluating Odalasvir (ACH-3102) and Sofosbuvir for Genotype 1 HCV ("Proxy Study")

- 100% SVR12 reported for all patients treated for six- (n=18) or eight-weeks (n=12) —
- Odalasvir (ACH-3102) is the subject of an exclusive, worldwide development and commercialization license granted to Janssen -

NEW HAVEN, Conn., Sept. 17, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced additional interim results from a Phase 2 study evaluating odalasvir (also known as ACH-3102), a NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for either six or eight weeks of treatment in patients with treatment-naïve genotype 1 chronic hepatitis C virus (HCV) infection. Of the patients treated for six weeks in this cross-over cohort, 100 percent (n=6/6) remained HCV RNA undetectable twelve weeks after completing therapy (SVR12). Previously, Achillion reported results from this study including 100 percent SVR24 for the initial cohorts including 12 patients treated for eight weeks and 100 percent SVR24 for 12 patients treated for six weeks.

In May 2015, Achillion announced it had granted Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir, ACH-3422, and sovaprevir.

ACH-3102 - 017: Phase 2 pilot study evaluating six- and eight-weeks of treatment in combination with sofosbuvir for genotype 1 treatment-naïve HCV

Achillion conducted a Phase 2, open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight weeks or six weeks of odalasvir and sofosbuvir, a marketed nucleotide polymerase inhibitor, without ribavirin, in treatment-naïve genotype 1 HCV-infected patients. The primary objective of the study was determination of sustained viral response 12 weeks (SVR12) after the completion of therapy. Eighteen patients were initially enrolled, including six observational patients (group 1). Twelve patients completed eight weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily while observational patients received no drug during this phase of the trial. Ten of the 12 patients receiving eight weeks of treatment had genotype 1a HCV. At baseline, the median HCV RNA was 7.15 log10 (range 5.5 — 7.8 log10). Of the 12 patients, 100 percent achieved SVR24. Odalasvir and sofosbuvir were well tolerated with no significant adverse events, ECG findings, or lab abnormalities observed during treatment.

Following achievement of the pre-specified response rate of 100 percent, the six observational patients plus six additional patients (group 2) were enrolled and received six weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily. Median HCV RNA at baseline was 6.95 log10 (range 6.2 — 8.0 log10) and six patients had GT 1a HCV. Of the 12 patients, 100 percent achieved SVR24.

Six additional rollover patients (group 3), enrolled into the final cohort, also received six weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily. Baseline characteristics included five of six patients with genotype 1a HCV, four of six patients with non-CC IL28B (two patients with IL28B TT), and a median baseline HCV RNA of 6.32 log10 IU/ml (range 6.0 — 7.3 log10 IU/ml). In all, a total of 18 patients (group 2 and 3) received six weeks of treatment and all subjects, 100 percent, achieved SVR12.

About the Achillion Worldwide HCV Collaboration with Janssen

On May 19, 2015, Achillion announced it had granted Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir (ACH-3102), ACH-3422, and sovaprevir. A key objective of the collaboration is to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. Achillion announced on August 3, 2015 that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) had initiated a Phase 1 clinical trial to evaluate the potential effect of simeprevir and odalasvir on the pharmacokinetics of AL-335 in healthy volunteers. Janssen previously stated its goal of initiating Phase 3 development with a triple regimen for HCV by early 2017.

About HCV

The hepatitis C virus (HCV) is one of the most common causes of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide including more than 5 million people in the United States. Three-quarters of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection.

About Achillion Pharmaceuticals

Achillion is seeking to apply its expertise in biology and structure-guided design and a deep understanding of patient and clinician needs to develop innovative treatment solutions aimed at improving patients' lives. Achillion believes that its scientific excellence, integrated capabilities and experienced team position it to successfully achieve its goal of advancing new products along the entire continuum from the bench to the patient. Achillion's pipeline is currently focused on small molecule therapeutics for infectious disease and complement-related diseases. www.achillion.com

Cautionary Note Regarding Forward-Looking Statements

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 important factors that could cause actual results to differ materially from those indicated by such forward-looking statements. Achillion may use words such as "expect," "anticipate," "project," "intend," "plan," "aim," "believe," "seek," " estimate," "can," "focus," "will," and "may" and similar expressions to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: comply with its obligations under and otherwise maintain its collaboration agreement with Janssen on the agreed upon terms; demonstrate, either alone or through its collaborators, the requisite safety, efficacy and combinability of its drug candidates, and advance the preclinical and clinical development of its drug candidates under the timelines it projects in current and future clinical trials; obtain and maintain necessary regulatory approvals; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete effectively and successfully; manage expenses; manage litigation; raise the substantial additional capital needed to achieve its business objectives; and successfully execute on its business strategies. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2014, its quarterly report on Form 10-Q for the quarter ended June 30, 2015, and its subsequent SEC filings.

In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any duty to update any forward-looking statement, except as required by applicable law.


Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
gschulman@achillion.com

Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com

Investors:
Tricia Truehart
The Trout Group, LLC
Tel. (646) 378-2953
ttruehart@troutgroup.com

Eliminating Hepatitis C Means Treating Prisoners

Barry Michaelson is one of several people with hepatitis C who have sued this year to get access to new and very expensive treatments for the virus. But Michaelson’s lawsuit, unlike most of the others, isn’t against his insurance company. He’s suing the Minnesota Department of Corrections.

In May, Michaelson and another inmate filed a class-action lawsuit on behalf of Minnesota prisoners to gain access to new, highly effective drugs for hepatitis C, a virus that’s now essentially curable but can cause cirrhosis, liver failure and cancer if left untreated. In the weeks since, similar lawsuits have been filed by inmates in Pennsylvania and Massachusetts.

It wasn’t until 1992 that we could even test for the hepatitis C virus (HCV). Now we effectively have a cure, but at about $84,000 a person, it’s one of the most expensive drugs to ever hit the market. Insurers, including Medicaid and Medicare, are paying for treatment only for people with advanced liver disease in most cases, causing experts to push the White House to expand treatment. But prisoners, though they are the only group in the U.S. with a constitutional right to health care, are even more limited in access to treatment.

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Goodbye to the Boys on the Bus: How the VA Cured My Hepatitis C

They were a rough-looking crew, the boys on the bus. To be fair, practically no one looks great at 5:45 in the morning, the time you have to show up at the Veteran's Administration Outpatient Clinic in Redding to catch the van to Mather Medical Center in Sacramento. I say “boys” but occasionally a woman or two joined us, all of us veterans who for a variety of reasons choose the VA for our healthcare needs, even if it means occasionally riding the short bus 200 miles to see a specialist.

Most of us kept to ourselves, perhaps because the hour was early and talk would have inevitably turned to the illness that had earned each of us our seat. Cancer, lung disease and diabetes don't make for great breakfast conversation, especially if you happen to be suffering from one of those maladies and you're on the way to the doctor to find out how long you've got to live. Hepatitis C was my illness and I've never been keen to share that information with anyone. Our silence was stoic, not uncomfortable.

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Canada-Ontario decision to cover costly hepatitis C drug a lifesaver, doctor says

Ottawa liver specialist Dr. Curtis Cooper is calling Ontario’s decision to pay for new treatments that can cure hepatitis C a “landmark event” that will change the lives of thousands of people with the disease.

Cooper, director of The Ottawa Hospital and Regional Hepatitis Program, sees thousands of hepatitis C patients, many of whom will benefit from the new drug therapy now that it is covered by the province.

“This is going to mean the difference between health or illness and death,” for many patients, he said.

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Sustained virological response represents a long-term cure for people with hepatitis C treated with sofosbuvir

Almost all patients with hepatitis C virus (HCV) alone or HIV and HCV co-infection who achieved sustained virological response (SVR) to treatment with sofosbuvir (Sovaldi) plus ribavirin or sofosbuvir/ledipasvir (Harvoni) still had undetectable HCV RNA up to two years later, confirming that SVR represents a cure, according to a poster presented at the recent Conference on Retroviruses and Opportunistic Infections (CROI 2015) in Seattle, USA.

The advent of interferon-free therapy using combinations of direct-acting antiviral drugs has brought about a revolution in hepatitis C treatment. Sustained virological response, or continued undetectable HCV RNA at 12 or 24 weeks post-treatment, is considered a cure, but rare cases of apparent late relapse have been observed after this point. (More often, HCV recurrence is due to reinfection.) 

While some studies have detected residual bits of HCV in the blood or the liver after successful treatment, this does not appear to indicate ongoing active disease. Interferon-based therapy has been shown to have a late relapse rate below 5% – usually occurring within two years after treatment – but this is not yet well defined for interferon-free therapy because it is so new.

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Doctors urge Hepatitis C patients to seek help now due to rising costs

INDIANAPOLIS - Doctors say many who have Hepatitis C don't know it.

There is a new cure, but in part, because of its high cost, insurance companies are looking to cut coverage.

Dr. Steven Norris with Community Health says new drugs to the market are a dramatic game changer for Hepatitis C patients who, until now, endured treatments with multiple side effects and a low 20 percent success rate.

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McHenry man cured of hepatitis through new drugs

McHENRY – Ray Roach reflects on the grim prognosis a doctor delivered to him during a hospital stay nearly four years ago and smiles.

He smiles a lot these days, in fact. Twisting free of a noose will do that for a person.

Roach, 52, of McHenry is among the first of a new crop of patients celebrating a remarkable cure. Diagnosed at age 46 with Hepatitis C, a liver disease caused by the Hepatitis C virus, Roach spent years on a health see-saw, and at one point, was near death.

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UK; Hunting a Silent Killer: How to Cure Hepatitis C in the Undiagnosed

Hepatitis C has a cure, but how do we find those who need it? Patrick Strudwick reports on one attempt to identify some of the estimated 100,000 undiagnosed people in the UK.

A young woman – jeans and boots and wild hair – is sitting in a cubicle in the Accident and Emergency department of the Royal London Hospital as a junior doctor swishes back the curtain.

"I'm just going to take some blood," says Dr Emma Wallis.

"Just one?" asks the patient, spying the paraphernalia.

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New drugs, price war provide hope for hepatitis C patients

Sallie Wickens’ life followed a death-defying narrative that traced the medical arc of hepatitis C:

A blood-transfusion infection after a car accident in 1959, when she was 5; a positive test for the virus when she was 30; 10 years of deteriorating health; a debilitating course of interferon drug treatments that didn’t work; a liver so damaged she needed a transplant.

And then, her doctor, hepatologist Laura Alba, walked into an exam room last month at St. Luke’s Hospital and gave Wickens, 60, a big smile.

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Photo gallery: Hepatitis C more curable than ever

New and costly drugs have revolutionized the treatment of hepatitis C. Kansas City Care Clinic (formerly the Kansas City Free Clinic) has been successfully treating patients, many of whom are uninsured. The clinic has also helped patients find financial assistance for the extremely costly medications.

Read the personal stories and see the photos here

Read more here: http://www.kansascity.com/news/local/article9314771.html#storylink=cpy

Longmont Woman Cured Of Hepatitis C, Credits New Drugs

DENVER (CBS4)- A woman from Longmont has been cured of Hepatitis C during her participation in a clinical trial testing an expensive new drug.

Kim Bossley is thanking the drug Sovaldi for changing her life.

It was 2005 when Bossley learned she had Hep C. Both Kim and her mother were infected during Kim’s birth through a blood transfusion. Kim’s mother died when the disease destroyed her liver.

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