OBAMA ADMINISTRATION GUIDANCE WILL INCREASE ACCESS TO HEPATITIS C CURE DRUGS Urges State Medicaid Programs to Lift Restrictions for the Nation’s Most Vulnerable

National Policy Office - Washington, DC: 202-835-8373

Program and Administrative Office - Tampa, FL: 813-258-5929

For Immediate Release: 11.05.15   

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Media Contact: Carl Schmid: (202) 669-8267 cschmid@theaidsinstitute.org

                                                                                    

OBAMA ADMINISTRATION GUIDANCE WILL INCREASE ACCESS TO HEPATITIS C CURE DRUGS

Urges State Medicaid Programs to Lift Restrictions for the Nation’s Most Vulnerable  

Washington, DC – The AIDS Institute praises the Obama Administration for their letter sent today to State Medicaid Directors that suggests states lift their onerous restrictions that have prevented people living with hepatitis C access to medications that can cure them.  “Denying drugs that can cure people of a deadly infectious disease is just bad public health policy. This announcement demonstrates that Medicaid beneficiaries with hepatitis C, who represent some of the Nation’s most vulnerable, deserve access to a cost-effective cure just like anyone else,” commented Carl Schmid, Deputy Executive Director of The AIDS Institute.

The AIDS Institute, a national public policy and advocacy organization dedicated to ensuring people living with HIV and hepatitis have access to quality and affordable health care, along with others, have urged the Centers for Medicare and Medicaid Services (CMS) to take this corrective action.  Most state Medicaid programs have instituted barriers to accessing hepatitis C cure drugs by limiting them to only individuals with advanced liver disease.  States have also used a number of other restrictions which have no scientific basis such as limits on who can obtain and prescribe the drugs. In one recent study, 46 percent of Medicaid beneficiaries were denied access to hepatitis C drugs. 

Medicaid is a joint federal-state funded program.  States must cover all medications produced by pharmaceutical manufactures that participate in the Medicaid Drug Rebate Program.  While states may be putting the hepatitis C drugs on their formularies, many are making it extremely difficult for patients in need of the drugs to access them. Today’s announcement makes it clear that this is wrong and states need to remove restrictions that have no clinical or scientific basis. 

Nationwide, an estimated 3.2 million people are living with hepatitis C; however, up to 75 percent have not yet been diagnosed.  There are approximately 20,000 deaths attributed to hepatitis C annually in the U.S. and it is the leading cause of costly liver cancer and liver transplants. 

Clinical experts at the American Association for the Study for Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) have recently updated their guidance on the treatment of hepatitis C virus.  They have concluded that treatment would benefit nearly all of those who are chronically infected and the goal should be to treat all patients as promptly as feasible to improve their health and to reduce HCV transmission.

Since many Medicaid beneficiaries are now being served by Medicaid Managed Care Organizations (MCOs), the directive announced today makes it clear that MCOs cannot impose restrictions on patient access that are more restrictive than the state’s fee-for-service program.  In some states, Medicaid MCOs have instituted even far wider restrictions than the state run programs.

“Now, we call on all state Medicaid programs to remove patient barriers to hepatitis C treatment that the federal government has called to be eliminated,” said Michael Ruppal, Executive Director of The AIDS Institute.  “In the long run, it will save the health care system billions of dollars, save the lives of hundreds of thousands of people, and help eradicate a deadly infectious disease.” 

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The AIDS Institute is a bipartisan, national nonprofit organization that promotes action for social change through public policy, research, advocacy and education.

For more information and to become involved, visit www.TheAIDSInstitute.org or write to us at Info@theaidsinstitute.org, and follow The AIDS Institute on Twitter @AIDSAdvocacy and Facebook at www.facebook.com/The-AIDS-Institute.

Carl Schmid

Deputy Executive Director

The AIDS Institute

Washington DC

202/462-3042-office
202/669-8267-cell
202/328-0467-faxcschmid@theaidsinstitute.org

Medicaid officials want to expand access to pricey hepatitis C drug

Health care officials in Washington state thought thousands of Medicaid patients would line up to receive a breakthrough hepatitis C treatment that went on the market late last year.

Yet by June, the state had treated only a third as many hepatitis C patients as it had planned for — about 1,200 people.

Now, the state’s Medicaid authority wants to use the $44 million it didn’t spend over the past year to start covering the drug for a wider range of patients, instead of just the sickest ones.

State officials estimate about 75,000 to 100,000 people in Washington have hepatitis C, a blood-borne virus that can cause liver failure or liver cancer if left untreated. Nationwide, many people living with the disease are low-income patients who are eligible for Medicaid, officials said.

Read more....

Cherokee Nation Working to Eliminate Hepatitis C

The Cherokee Nation is on a mission to eliminate Hepatitis C, which officials call an epidemic.

According to the Centers for Disease Control and Prevention, the highest increase in Hepatitis C incidence from 2000 to 2013 was among Native Americans.

Dr. Jorge Mera oversees Cherokee Nation Health Services’ infectious diseases division. He said the first step is screening everyone age 20–69 for Hepatitis C, even though two out of three Americans with the disease were born between 1945 and 1965.

Read more...

Study suggests unprecedented 3-week hepatitis C cure

Yet another stunning victory in the drug battle against the liver-damaging hepatitis C virus (HCV) may be in the offing: A small study suggests it may be possible to cure some people of their infections in as few as 3 weeks.

Fresh on the heels of recent approvals of four new combinations of HCV drugs that clear infections of many different types of the virus in about 3 months, a team led by hepatologist George Lau of the Humanity & Healthy GI and Liver Centre in Hong Kong, China, has mixed and matched various compounds to see whether they could further shorten the route to a cure. Following 3 weeks of treatment, 18 HCV infected people given three different combinations of drugs met the standard definition of being cured—at 12 weeks after treatment began, they had no signs of HCV’s genetic material, RNA, in their blood on standard tests. The researchers plan to present this data publicly for the first time at a scientific conference known as The Liver Meeting in 2 weeks.

Until the new HCV drugs emerged, infected people required treatment for 8 months, and the therapies often failed and had severe side effects. Now, standard treatment protocol calls for taking HCV drugs for just 12 weeks. Cutting that treatment time even more dramatically is “really, really intriguing” says Shyam Kottilil, an HCV researcher at the Institute of Human Virology in Baltimore, Maryland. And if the results hold, it could slash the overall treatment cost of $100,000 required by the most popular drugs used for the 12-week treatment. Kottilil’s own study of a 4-week treatment—which tested different drug combinations on a different patient population—had only a 40% cure rate in the 50 participants. (That study is in press at Annals of Internal Medicine.)

Read more....

Medication Adherence Trial In Hepatitis C Patients Launched

A new medication adherence application from emocha helps keep HCV patients on track.

According to the CDC, approximately three to four million individuals are chronically infected with Hepatitis C Virus (HCV) in the United States and at least three quarters of those who become infected will develop chronic infection which, if left untreated, can produce long-term complications and even death.

HCV therapy has been revolutionized by recent developments in treatments, including oral options that achieve high levels of HCV cure when taken as directed. That means medication adherence is a high priority for both healthcare providers and payers, both in terms of the potential benefits and because of the high costs of these medications, which can be up to $1,000 per pill or more than $80,000 for an entire course of treatment.

Read more....

How insurance providers deny hepatitis C patients lifesaving drugs - Doctors say up to 80 percent of patients are denied expensive but effective drugs like Harvoni

Amber Rojas was almost eight months pregnant when she learned she had hepatitis C. After her daughter was born on Dec. 23, 2014, Rojas had hoped to start treatment with a newly approved, highly effective drug called Harvoni.

After filing for prior authorization and waiting for months, the 34-year old mother received an unwelcome letter on August 27, 2015 — her treatment request had been denied because her liver was still too healthy. Rojas said that even though she felt very sick with flu-like symptoms, her insurance provider deemed her “not sick enough to qualify.”

Rojas is one of an estimated 3.2 million Americans with hepatitis C, an infection that attacks the liver. In the United States, hepatitis C kills more people every year than HIV. Drugs like Harvoni promise to cure more than 90 percent of patients, yet many insurance providers authorize treatment only if a patient has extensive liver damage, or a fibrosis score of 3 or 4.

Read more....

Drug costs a bitter pill

TALLAHASSEE

An estimated 17 percent of America’s prison population could have hepatitis C, a severe viral disease that can lead to cirrhosis, liver failure and cancer if left untreated.

There is a cure. A miracle drug with a 95 percent recovery rate was introduced in 2013. But Sovaldi has an extremely high cost: $84,000 for a standard treatment, although costs can vary with the length of the treatment.

Late last year, Gilead Sciences, which makes Sovaldi, won approval for an even better hepatitis C drug, which doesn’t have to be taken in combination with other drugs that have major side effects. But Harvoni costs about $1,125 per pill, with a standard 12-week treatment priced at $94,500

Read more....

Surge in Youth HCV Presents Hepatologists With Tough Choices

Recently Mark S. Sulkowski, MD, of the John Hopkins University School of Medicine, in Baltimore, saw a teenage patient who had contracted hepatitis C after starting to shoot up as a 12-year-old.

The case is but one in a spike of new infections with the hepatitis C virus (HCV) being driven largely by an epidemic of injection drug use, particularly among adolescents and young adults, according to the Centers for Disease Control and Prevention.

“Sadly, with the heroin epidemic, I’m increasingly seeing teenagers in my practice,” Dr. Sulkowski said earlier this year at the inaugural midyear meeting of the American Association for the Study of Liver Diseases.

See more at: 

Treating 5 Percent of Hepatitis C Patients with New Drugs Would Reduce Cost, Infections: Study

Treating 5 percent of all hepatitis C patients with the latest drugs would be more effective at reducing infections and health care costs than the current approach, a new study shows.

 

The cost-benefits analysis by researchers from the USC Schaeffer Center for Health Policy and Economics and other institutions compares three treatment options to the current approach, or "baseline" scenario, which treats patients in the most advanced stages of the disease when they may need a costly liver transplant.

 

"We made a mistake with HIV by limiting access to treatment to just people who had AIDS, and we ended up with a virus that has been with us for decades," said corresponding author Dana Goldman, the Schaeffer Center director and a professor at the USC School of Pharmacy and the USC Price School of Public Policy. "We didn't initially treat HIV aggressively enough in part because the science wasn't there to justify it. With hepatitis C, we have the science. We just need to find a way to finance it."

Read more....

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.

Read more....

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.

Gilead Drug Combo Could Be Indicated for All Forms of Hepatitis C

Study shows drug may eliminate need for HCV genotype testing altogether

A new Gilead Sciences drug combination that targets six genotypes of the hepatitis C virus (HCV) has achieved promising results in four international phase III clinical studies.

 Gilead has announced results from ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4. The studies evaluated a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) with velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of genotype 1 to 6 chronic HCV infection.

In the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 1,035 patients with genotype 1 to 6 HCV infection received 12 weeks of SOF/VEL. Among these patients, 21%% had compensated cirrhosis and 28% had failed prior treatments. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. The primary endpoint for all studies was a sustained virological response at week 12 post-treatment (SVR12)

Read more.....

Researchers find HCV treatment uptake declined over time among HIV/HCV coinfection

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In the Swiss HIV Cohort Study, researchers found that hepatitis C virus infection treatment uptake over the last 13 years has been low and many patients co-infected with HIV and hepatitis C remained untreated since 2013.

“The Swiss HIV Cohort Study offers an ideal platform to study the natural course of HCV infection and long-term influence of HCV treatments in a nationwide representative population of HIV-infected patients,” the researchers wrote in the Journal of Hepatology. “We aimed to assess the changes in epidemiology, clinical course and therapy of HCV infection between 2001 and 2013 and to characterize the population who remains eligible for the new HCV treatment options by the end of 2013.”

Of 12,401 patients, 17% were positive for HCV RNA (n = 2,107) and 23.8% were seropositive for HCV. Thirty-percent of the HCV RNA-positive patients (n = 636) began therapy with an incidence of 5.8 per 100 person-years (95% CI, 5.3-6.2). Of the patients treated with pegylated interferon and ribavirin, 50% achieved sustained virologic response, which represented 15% of all participants with replicating HCV infection, according to the research. Also, of the 636 treated patients, 11% were treated twice and 2% were treated at least 3 times.

Read more....

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