It was supposed to be a miracle, but now it’s what keeps Laura Bush, a nurse-practitioner near Albuquerque, awake at night.
There’s a drug called Sovaldi that works astonishingly well to cure people with the liver disease Hepatitis C. The rub? It costs $1,000 per day for all 12 weeks of treatment.
Bush’s clinic, First Choice Community Healthcare, is a federally qualified health center in the rural town of Los Lunas, New Mexico, which means she sees a disproportionate number of patients who are uninsured, underinsured, and on Medicaid, the government insurance program for the poor. In other words, they can’t afford Sovaldi.
Read more....
Tuesday, September 29, 2015
PCORI approves $83m for hepatitis C and other studies
The Patient-Centered Outcomes Research Institute (PCORI) has approved $83m to fund 26 patient-centered, comparative clinical effectiveness research (CER) studies on a range of conditions and patient populations.
About $29.5m will support studies on caring for people affected with hepatitis C virus (HCV). Awards totaling around $7.4m will fund research on rare conditions in response to PCORI's offer of a special pool of funding for supportingt rare disease research.
The HCV studies will include national advocacy organizations, professional associations, and stakeholder groups in their research design and implementation.
Read more....
About $29.5m will support studies on caring for people affected with hepatitis C virus (HCV). Awards totaling around $7.4m will fund research on rare conditions in response to PCORI's offer of a special pool of funding for supportingt rare disease research.
The HCV studies will include national advocacy organizations, professional associations, and stakeholder groups in their research design and implementation.
Read more....
HCV Current Initiative: Addressing the National Epidemics of Prescription Opioid misuse and Hepatitis C through Unique Partnerships
By Dominique Saunders, Viral Hepatitis Prevention Coordinator, Kansas Department of Health and Environment and Sarah Knopf-Amelung, Project Manager, Mid-America ATTC, University of Missouri-Kansas City School of Nursing and Health Studies - See more at: https://blog.aids.gov/2015/09/hcv-current-initiative-addressing-the-national-epidemics-of-prescription-opioid-misuse-and-hepatitis-c-through-unique-partnerships.
Recently, there has been a spotlight on America’s prescription opioid misuse and overdose epidemics. However, too often, people remain unaware of the related hepatitis C virus (HCV) epidemic. The Centers for Disease Control and Prevention (CDC) reported an estimated 150% increase in new HCV infections from 2010 to 2013 and, further, that most of the new infections were associated with injection drug use. An analysis of state and national data indicate that a large proportion of new HCV infections are occurring in young people (<30 years of age) in rural and suburban areas who use oral prescription opioid analgesics before transitioning to injecting. - See more at: https://blog.aids.gov/2015/09/hcv-current-initiative-addressing-the-national-epidemics-of-prescription-opioid-misuse-and-hepatitis-c-through-unique-partnerships.
At the same time, recent years have seen advances that have revolutionized the field of hepatitis C. Groundbreaking treatments with cure rates as high as 90-100% are now available. Preventive screenings without cost-sharing under the Affordable Care Act make HCV screening more accessible for many people. And the national Viral Hepatitis Action Plan increases coordination across federal programs and includes among its priorities the urgent need to reduce viral hepatitis associated with drug use behaviors. - See more at: https://blog.aids.gov/2015/09/hcv-current-initiative-addressing-the-national-epidemics-of-prescription-opioid-misuse-and-hepatitis-c-through-unique-partnerships.
Read more....
Recently, there has been a spotlight on America’s prescription opioid misuse and overdose epidemics. However, too often, people remain unaware of the related hepatitis C virus (HCV) epidemic. The Centers for Disease Control and Prevention (CDC) reported an estimated 150% increase in new HCV infections from 2010 to 2013 and, further, that most of the new infections were associated with injection drug use. An analysis of state and national data indicate that a large proportion of new HCV infections are occurring in young people (<30 years of age) in rural and suburban areas who use oral prescription opioid analgesics before transitioning to injecting. - See more at: https://blog.aids.gov/2015/09/hcv-current-initiative-addressing-the-national-epidemics-of-prescription-opioid-misuse-and-hepatitis-c-through-unique-partnerships.
At the same time, recent years have seen advances that have revolutionized the field of hepatitis C. Groundbreaking treatments with cure rates as high as 90-100% are now available. Preventive screenings without cost-sharing under the Affordable Care Act make HCV screening more accessible for many people. And the national Viral Hepatitis Action Plan increases coordination across federal programs and includes among its priorities the urgent need to reduce viral hepatitis associated with drug use behaviors. - See more at: https://blog.aids.gov/2015/09/hcv-current-initiative-addressing-the-national-epidemics-of-prescription-opioid-misuse-and-hepatitis-c-through-unique-partnerships.
Read more....
Monday, September 28, 2015
Hepatitis and the Sustainable Development Goals: time for an end run - Here, Jeffrey Lazarus talks about the need for a global goal of eliminating viral hepatitis.
This is unfortuante especially with a 'cureable' disease.....AF
Well it’s official. The governments of the world have committed to ending HIV, tuberculosis and malaria, but merely ‘combatting’ viral hepatitis.
When the United Nations General Assembly voted to adopt the Sustainable Development Goals (SDGs) on 25 September, I don’t doubt that advocates of many stripes were left feeling that this highly influential agreement did not sufficiently recognize the urgency of their claims.
It is not my intention to argue that viral hepatitis advocates have been short-changed any more than those who care deeply about other issues. I do, however, think it is important for everyone committed to ending viral hepatitis to think about what this aspect of the SDGs means to us.
Read more....
Well it’s official. The governments of the world have committed to ending HIV, tuberculosis and malaria, but merely ‘combatting’ viral hepatitis.
When the United Nations General Assembly voted to adopt the Sustainable Development Goals (SDGs) on 25 September, I don’t doubt that advocates of many stripes were left feeling that this highly influential agreement did not sufficiently recognize the urgency of their claims.
It is not my intention to argue that viral hepatitis advocates have been short-changed any more than those who care deeply about other issues. I do, however, think it is important for everyone committed to ending viral hepatitis to think about what this aspect of the SDGs means to us.
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:
- 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%
- 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%
- 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.
MediaplanetUSA’s “Hepatitis & Liver” campaign
We recently participated in MediaplanetUSA’s “Hepatitis & Liver” campaign where industry professionals and associations came together to draw attention to the importance of liver health, while highlighting hepatitis awareness, testing education, and treatment to erase the stigma and judgments attached to the disease. The campaign was distributed within the centerfold of USA Today on September 23, 2015 and is published on a Mediaplanet original site.
Hepatitis C drug costs challenges DOC budget
Covering the cost of a new treatment for hepatitis C treatment for a growing number of patients is a challenge for the Department of Corrections.
Oregon faces budget-busting costs for expensive new treatments for hepatitis C, and the issue is not limited to the state’s Medicaid program.
The prison system also faces higher costs from a new drug that cures many people of the potentially deadly disease, but costs the Department of Corrections roughly $70,000 per inmate for the 12-week treatment. The Legislature already approved an additional $3.2 million in a supplemental budget bill earlier this year to cover the drug Harvoni for inmates, after the number of inmates treated rose sharply in December. The increase was also part of the reason the Legislature boosted the Department of Corrections’ latest two-year budget for medical supplies by nearly 32 percent.
Read more.....
Oregon faces budget-busting costs for expensive new treatments for hepatitis C, and the issue is not limited to the state’s Medicaid program.
The prison system also faces higher costs from a new drug that cures many people of the potentially deadly disease, but costs the Department of Corrections roughly $70,000 per inmate for the 12-week treatment. The Legislature already approved an additional $3.2 million in a supplemental budget bill earlier this year to cover the drug Harvoni for inmates, after the number of inmates treated rose sharply in December. The increase was also part of the reason the Legislature boosted the Department of Corrections’ latest two-year budget for medical supplies by nearly 32 percent.
Read more.....
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