| |
The global AIDS response can help in fighting hepatitis C - problems/solutions
|
| |
| |
HCV USA/Global Problems & resource-intensive Solutions needed - below my comments is the published commentary on HCV Global Response by Paul Farmer published in the Washington Post which prompted me to comment
from Jules: can Washington & global govts/forces respond to HCV like they did to HIV is the question Farmer raises. HCV is a different disease with HIV being lifetime therapy at an annual cost of about $15,000 for each patient plus of course labs etc and associated costs related to housing etc/RWCA. Over the course of a 20-30 years lifetime for a patient we could be talking about $1 million. HCV will be 12-24 weeks of interferon-free therapy with close to 100% "cure rates" with at this point in time the retail cost being about $75-80,000 but negotiated costs are different after discounts, rebates, etc, and future costs might be different, and of course labs & associated medical costs in addition. So one can make a case the costs associated with treating HCV are much lower. According to a poster presentation at 2013's AASLD the cost of a telaprevir SVR[which can be up to 48-weeks therapy] was $189,000 [http://www.natap.org/2013/AASLD/AASLD_103.htm], but this was with telaprevir plus peg/r Rbv, but if you read the linked to report above you will see a considerable amount of the expenses will not be necessary including extra costs for those that did not achieve SVR and had continued lab & other costs. With a concerted response in theory HCV is curable/we can eradicate HCV for almost everyone in the USA & globally but of course we need screening for those undiagnosed with an estimated 75% undiagnosed in the USA; the CDC estimates 3.2 million with HCV but a real-world estimate starts at 5 million and goes as high perhaps as 7-8 million including immigrant populations, incarcerated, IDUs, 'baby boomers', disenfranchised patient communities, homeless.....How Many/Who HAS HCV in USA: http://www.natap.org/2014/HCV/011414_03.htm......HCV: who/how to screen-HCV is a Disease of the Marginalized....http://www.natap.org/2014/HCV/011614_01.htm. Globally an estimated 170 million have HCV where IDUs are a big part of the problem & solution. But here in the USA as well IDUs are at the core of the problem & solution IF we want to & will "eradicate HCV". For challenged patient communities we will need awareness & screening programs, linkage to care & treatment services supporting the needs of these challenged patients. WHO will provide this in the USA & globally?? Of course as we move into 2014 where 3 new IFN-free regimens will be introduced on top of the new regimens just approved by the FDA which includes 2 new IFN-free regimens, and the several INF-free regimens still in phase 2/3 study development, we will find out by the end of 2014 & the beginning of 2015 what will initially emerge as services for screening & for patients from pharma, local/state/federal govts in the USA & in Western countries that include Western Europe, Australia. But this will be the beginning because still 75% will remain undiagnosed with high numbers undiagnosed among homeless & IDU communities who will need the most resource-intensive support services. The incarcerated in the USA remain a challenged population with an estimated approximate 30% HCV-infected. To adequately address these marginalized/disenfranchised communities governments will have to step into the breach: federal, state & city. Will they? So far they have not although NYS has been I think the leader in recently passing an unfunded state mandate to screen baby boomers for HCV & budgeting about 2 million for various HCV projects. This is still not enough in NYS where I estimate a cool $12 million is needed. NYC is the global HCV epicenter, but other major cities also is where HCV lives, particularly where marginalized patient populations live: Miami, LA, Chicago, Wash DC, Baltimore, Houston, Dallas, Detroit, SF, and of course more. So I estimate we are talking about $60 million to roll out meaningful programs for awareness, screening, linkage to care & treatment services. To launch an adequately wide in scope awareness & screening/linkage to care program just in NYC I estimate requires $6 million. Many disenfranchised would not even know where to go to get screened so they must be directed to a site in an easy manner where they can be linked to care in a way that works for them, where they can receive care in a way that works for them. Again I think HCV is a MUCH easier disease than HIV to conquer for many reasons including the short therapy duration & because its a cure you will not have to revisit, but this is IF the resources needed are provided, which remains the key question here in the USA & globally. But of course globally the problem remains of access to new treatments, who will pay, because as in the earlier HIV days as discussed below by Farmer in is commentary outside Western countries govts were not paying for HIV treatment so now HCV presents the same issue. BUT HCV is here different as well because we have learned from the HIV problem as already Gilead is in discussions with generic manufacturers for global access....http://www.natap.org/2014/HCV/020514_02.htm. So there is the potential that new & improved solutions may emerge for HCV, but pharma will have to step up and play a big role in helping to mold these solutions. Globally pharma & local activists can work together with local govts to forge solutions, but of course pharma will have to do this. Again this is where I believe it will show we have learned from HIV in that I expect pharma will step up in this way. I believe pharma already knows they will have to do this & they are discussing internally how. They will have to meet with activists globally & begin to address the barriers to care & treatment.
There remains a lot of work needed to be done in the USA, in Western Europe and in other under-resourced countries. Let's see what happens in the 2nd half of 2014 after Gilead, Abbvie, BMS & Boehringer Inngelheim receive the expected FDA approvals. I hope & expect major media splashes, lets see if that does in fact occur. Public response is the major driver of govt response as that is why the federal govt initially responded to HIV, because the activist community made the politicians in Wash DC look bad. For HCV we need a broader activist response from the broad swath of affected communities, from the disenfranchised communities, this would I think make a big difference in pursuading Wash DC & the state & local govts to launch adequate responses. But of course gathering such a broad patient/activist response in HCV has not yet happened & will be a challenge, that needs a solution.
Here are links reports on the global HCV problem, epidemiology, and to the latest treatment data from the latest studies & links to new studies providing INF-free 12-24 week therapy regimens that have shown 96-100% cure rates:
Global epidemiology of hepatitis C virus infection: New estimates of age-specific antibody to HCV seroprevalence - "requires a global response".....http://www.natap.org/2013/HCV/041713_02.htm
Global HCV....http://www.natap.org/2011/HCV/120111_01.htm
Global HCV 150 Million: reused syringes, IDU, sexual transmission, HIV coinfection, China/India/Pakistan, Africa.....http://www.natap.org/2011/HCV/080211_01.htm
Global HCV Access & Eradication & INF-free combinations with 96-100% cure rates--.....http://www.natap.org/2013/HCV/122013_01.htm......
AbbVie Completes Largest Phase III Program of an All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1 - (01/31/14)
........GILEAD ANNOUNCES SVR12 RATES FROM THREE PHASE 3 STUDIES EVALUATING A ONCE-DAILY FIXED-DOSE COMBINATION OF SOFOSBUVIR AND LEDIPASVIR FOR GENOTYPE 1 HEPATITIS C PATIENTS - For Immediate Release - (12/18/13)
.......SVR results of a once-daily regimen of simeprevir (SMV, TMC435) plus sofosbuvir (SOF, GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naïve and prior null responder patients: The COSMOS study - (11/05/13).....
Daclatasvir+Sofosbuvir-new studies, VX135, Daclatasvir Phase 3 IFN-free, EMA Compassionate Use, Accelerated EMA Marketing Review Recommendation
AASLD: Phase 2b Study of the Interferon-Free and Ribavirin-Free Combination of Daclatasvir, Asunaprevir, and BMS-791325 for 12 Weeks in Treatment-Naive Patients With Chronic HCV Genotype 1 Infection - (11/05/13)
High Efficacy and Safety of the All-Oral Combination Regimen, MK-5172 / MK-8742 ± RBV for 12 Weeks in HCV Genotype 1 Infected Patients: The C-WORTHY Study - (11/05/13)
HELIX-2, a phase II all-oral combination study of Simeprevir, TMC647055 and Samatasvir (IDX719) for the treatment of hepatitis C has been initiated - (12/03/13).........http://www.natap.org/2013/HCV/060213_04.htm
-----------------------------------
Opinions
The global AIDS response can help in fighting hepatitis C
......"Today, the world faces a "1996 moment" in the fight against hepatitis C......an international response.....activists.......highly effective new therapies are coming online.....just 12 to 24 weeks......plan that can link funding to delivery for those living in poverty"
By Paul Farmer, Published: February 12
http://www.washingtonpost.com/opinions/the-global-aids-response-can-help-in-fighting-hepatitis-c/2014/02/12/aa76ecc2-89e3-11e3-833c-33098f9e5267_story.html
Paul Farmer is a professor at Harvard University and an infectious disease physician with the Brigham and Women's Hospital in Boston. He co-founded Partners in Health.
A decade after the global AIDS response began in earnest, it's worth asking whether the lessons learned will be sustained over time and used to avoid past mistakes when tackling new challenges.
One such challenge is chronic hepatitis C infection, which afflicts an estimated 170 million people worldwide. Since its discovery 25 years ago, hepatitis C has become the leading indication for liver transplant in the United States and a common cause of liver failure around the world. For some, however, it is about to become eminently curable.
When I trained as an infectious disease physician in the mid-1990s, I traveled frequently between Boston's teaching hospitals and rural Haiti. AIDS had become a leading cause of death in both places but was rapidly declining in Boston while soaring in Haiti, as it was across Africa.
This divergence was thrown into relief at a 1996 AIDS conference where researchers presented data showing that combination antiretroviral therapy could transform HIV infection from a death sentence into a manageable chronic disease. The conference's theme that year was "One World, One Hope." A coalition of activists, noting the $15,000 annual cost of the lifesaving drugs and the lack of an international plan for ensuring access among those living in poverty, held up their own signs reading "One World, No Hope."
By 2000, more than 6 million people were dying in poor countries each year from HIV, tuberculosis and malaria - diseases for which effective therapeutics were available to those who could afford them. Here was a failure not of science but of delivery.
Thankfully, and in no small part because of the relentless efforts of AIDS activists, an abiding cynicism about the limits of an international response to these pandemics gave way to an unprecedented "delivery decade." This was inaugurated in the early 2000s with the U.S. President's Emergency Plan for AIDS Relief and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
As I recounted in the New England Journal of Medicine in December, linking this funding to effective delivery mechanisms had profound effects in some of the world's poorest and most disrupted places. By the end of 2012, almost 10 million patients in low- and middle-income countries were on antiretroviral therapy. In Haiti and Rwanda, AIDS-related mortality rates fell more sharply than in the United States after its introduction of antiretroviral therapy in the mid-1990s.
Despite such progress, much remains to be done. Nearly half of all people living with HIV who need treatment still don't receive it. But the coupling of an equity plan with a commitment to building effective delivery systems surely ranks among the most important achievements in the history of medicine and public health.
Today, the world faces a "1996 moment" in the fight against hepatitis C.
As in 1996, highly effective new therapies are coming online. Regimens containing the new polymerase inhibitor sofosbuvir, in particular, have the potential to cure more than 90 percent of patients with common strains of the virus after just 12 to 24 weeks of once-daily pills. But is there a plan that can link funding to delivery for those living in poverty?
Sofosbuvir's initial price has been set at $80,000 to $90,000 per 12-week course - about $1,000 per pill. Like those infected with HIV, 90 percent of hepatitis C patients live in low- and middle-income countries; most would not earn $80,000 over the course of two lifetimes.
In the face of such numbers, it is tempting to give in to pessimism. "Poor countries could never afford these prices; the demand simply isn't there," some say. But when the share of those infected with hepatitis C reaches 1 in 40 people alive today, claims of weak demand are not credible. Such language is often code for ability to pay, not actual burden of disease. In many years practicing medicine, I have yet to meet a patient - rich or poor - with a treatable disease who doesn't want to get better.
Drug prices are not immutable, and price is not the same as cost. Pharmacologists with Liverpool University recently analyzed manufacturing processes for new hepatitis C regimens and concluded that they could be sold at profit in poor countries for less than $500 per course. Arecent pledge by Gilead, the developer of sofosbuvir, to work with generic pharmaceutical firms in India is a promising start, but it is just a start.
Precipitous drops in price are not unprecedented; in the delivery decade, innovative partnerships through financing mechanisms such as UNITAID led to declines of as much as 99 percent in the effective price of antiretroviral therapy for the world's poorest.
Smart investments in accurate diagnosis and in effective therapy for hepatitis C could save millions of lives in the coming years, radically cut transmission and pave the way toward eradication of the virus. Or, we could choose to ignore the lessons of the AIDS response and stand by as outcomes improve solely among the fortunate few who enjoy ready access to the fruits of modern medicine.
Divergence of outcomes occurs within nations and across them; they grow whenever innovation is not coupled with implementation among the most vulnerable.
But we live in one world. As infectious pathogens such as HIV and hepatitis remind us, our hopes are tied together more closely than we might imagine.
|
|
| |
| |
|
|
|
