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HCV Key Topics - IDUs/African-Americans/Latinos/treatment-experienced cirrhotics 24 weeks
  Jules Levin, NATAP
With FDA approval closing in, Oct 10 is the deadline for Gilead's sofosbuvir/ledipasvir and around this time or a little later for JNJ's simeprevir+sofosbuvir, Abbvie's 3D & BMS' daclatasvir, here are some key issues. (1) response rates (SVR) for African-Americans & Latinos are the same as for whites in the Gilead & Abbvie studies, (see link below.....http://natap.org/2014/HCV/081814_01.htm), yet African-Americans & Latinos suffer harsh disproportionate burdens. (2) easier to treat patients are those never treated before, called treatment-naive with 95-100% SVR rates with 12 weeks therapy, but for treatment-experienced patients with cirrhosis 12 weeks provides lower SVR rates while 24 weeks provides high SVR rates, the same as 12 weeks for treatment-naives, see link below[http://natap.org/2014/HCV/090314_01.htm]. (3) We need accessible treatment facilities for IDUs. Often this group needs specialized care & services & the usual treatment clinics cannot or will not treat difficult-to-treat IDUs, so we need facilities in inner cities where IDUs can be treated. Injection drug use is the leading cause for HCV transmission and the numbers of IDUS that may have HCV is high, at the NYC AASLD/EASL Conference last week John Ward in his talk [http://natap.org/2014/AASLDEASL/AASLDEASL_03.htm] estimated 50% of the 3.2 mill with HCV that the CDC officially estimates has HCV, 50% are IDUs, which I think is an underestimate. (4) A bunch of state medicaid programs are imposing severely harsh restrictions on access to treatment by denying access to drug users, allowing treatment only for patients with advanced F3/F4 disease, and denying treaters including experienced HIV doctors and permitting only hematologists to treat HCV. They also claim there isn't data to support that these marginalized patient populations will respond the same to treatment, not true there is data for African-Americans & for those on opoid replacement therapy showing the same results as others, see links below. (5) So perhaps we need a new model for evaluating & paying for new innovative medical treatment, with HCV coming now new cancer treatments are coming as well [http://www.natap.org/2014/HCV/080614_02.htm].
Racial Differences in the Progression to Cirrhosis and Hepatocellular Carcinoma in HCV-Infected Veterans....."Hispanics with HCV had a 28 and 61% increased risk of developing both cirrhosis and HCC" - (09/03/14)
NHANES: "non-Hispanic blacks bore the greatest burden of HCV infection in the United States... IDU remains Strongest Risk Factor for HCV infection" - (07/30/14) ......Changing Hepatocellular Carcinoma Incidence and Liver Cancer Mortality Rates in the United States..... "US liver cancer mortality rates increased with age in all racial/ethnic groups..... Among individuals aged 50-64 years, blacks had the highest mortality rate (18.6), followed by Hispanics (13.5), Asians/Pacific Islanders (13.0), and whites (7.7).".....http://www.natap.org/2014/HCV/050514_01.htm
HCV: who/how to screen-HCV is a Disease of the Marginalized......http://www.natap.org/2014/HCV/011614_01.htm
Estimating the Number of Persons Who Inject Drugs in the United States by Meta-Analysis to Calculate National Rates of HIV and Hepatitis C Virus Infections - (05/30/14) .....we estimated that persons who ever injected drugs comprised 2.6% (CI: 1.8%-3.3%) of the U.S. population......This represents approximately 6,612,488 million PWID (range: 4,583,188-8,641,788) aged 13 years or older in 2011.......we estimate that approximately 774,434 adults and adolescents (range: 494,605-1,054,263) injected drugs in the past year in the United States


Medicaid HCV Treatment Restrictions Denying Care & Treatment, which HCV Guidelines Committee Supported - (09/11/14)
SVR Rates: predictors/liver disease stage(cirrhosis) - Abbvie 3D, Gilead's LDV/SOF, JNJ's SIM/SOF, BMS's Daclatasvir+Sofosbuvir - (09/03/14)
Emerging Epidemic of Hepatitis C Virus Infections Among Young Non-Urban Persons who Inject Drugs in the United States, 2006-2012 - (08/20/14) African-Americans Respond as Well as Whites in HCV DAA Studies:
Medicaids Restrictions Based on Misleading Information: African-Americans/ Opoid Replacement (Methadone) Users SVR Rates, comorbidities - (08/18/14)
HCV Could be a "Rare Disease" by 2026, "1-time HCV screening for all/test & treat"..... need for more aggressive screening strategies and higher treatment capacity.....1-time universal screening - new study projects - (08/06/1)
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