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Alan Franciscus


HCV Advocate

Saturday, February 28, 2015

Combos Cure HCV in Almost All With HIV Co-infection

Just 12 weeks of treatment eliminated hepatitis C virus in HIV patients.

SEATTLE -- Two drug combinations aimed at hepatitis C (HCV) yielded almost perfect cure rates in patients also infected with HIV, researchers reported here at the 2015 Conference on Retroviruses and Opportunistic Infections.

When the drugs were given for 12 weeks, 96% to 98% of patients had undetectable HCV 12 weeks after the end of therapy -- the so-called SVR12, which is regarded as a cure.

The only blot on the horizon was a 76% SVR12 rate when the combination of daclatasvir and sofosbuvir (Sovaldi) was given for just 8 weeks, reported David Wyles, MD, of the University of California San Diego.


Friday, February 27, 2015

Doctor Panel to Weigh Hepatitis C Drugs’ Costs in Guidelines

(Bloomberg) -- An influential advisory panel of doctors and health experts will for the first time address the cost-effectiveness of pricey hepatitis C drugs in updated guidelines that may change prescribing and coverage for the medicines.

The 30-member panel is a joint effort by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, which together represent more than 10,000 physicians, health workers and scientists. The guidelines are used by doctors for expertise on how to treat patients and by insurers and governments in setting policy.

Health insurers and government programs have been grappling with the cost of the pills. Made by Gilead Sciences Inc. and AbbVie Inc., they offer higher cure rates and fewer side effects than older medicines, though their $1,000-a-day price tag has generated criticism.


Gilead Announces SVR12 Rates From Phase 3 Study Evaluating Harvoni® for the Treatment of Chronic Hepatitis C in Patients Co-Infected With HIV

– 96 Percent SVR12 Rate for Hepatitis C Genotypes 1 and 4 Among HIV-infected Patients on Antiretroviral Therapy – 

SEATTLE--(BUSINESS WIRE)--Feb. 26, 2015-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced results from a Phase 3 study, ION-4, evaluating the once-daily single tablet regimen Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of genotypes 1 or 4 chronic hepatitis C virus (HCV) infection among patients co-infected with HIV. In the trial, 96 percent (n=321/335) of HCV patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. These data were presented in a late-breaker oral session (Session 152LB) at the 22nd Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

“This trial provides strong evidence that people who are co-infected with HIV can achieve very high rates of hepatitis C cure with a combination direct-acting antiviral regimen,” said Susanna Naggie, MD, MHS, Director of Infectious Diseases Research at Duke Clinical Research Institute and Principal Investigator for the ION-4 study. “These high cure rates were observed in most of the historically difficult-to-treat sub-populations, including those who failed previous treatment and those with cirrhosis. We are greatly encouraged by these findings.”

ION-4 is a Phase 3, multicenter, open-label study investigating the efficacy, safety and tolerability of Harvoni treatment for 12 weeks in 335 patients with HCV genotype 1a (75 percent), 1b (23 percent) or 4 (2 percent) and HIV-1 co-infection. The study included HCV treatment-naïve (45 percent) and treatment-experienced (55 percent) patients, including patients with compensated cirrhosis (20 percent), whose HIV was suppressed using one of three HIV antiretroviral (ARV) regimens: tenofovir and emtricitabine with efavirenz (Atripla®), raltegravir or rilpivirine (Complera®).

SVR12 rates did not differ significantly by prior HCV treatment status, presence or absence of cirrhosis, or ARV regimen. No patients discontinued Harvoni due to an adverse event (AE). Of the 14 patients that did not achieve SVR12, two patients experienced virologic failure during treatment (likely due to non-compliance per physician reporting), 10 experienced virologic relapse post-treatment, one was lost to follow up and one died due to causes unrelated to study drug. The most common AEs reported were headache (25 percent), fatigue (21 percent) and diarrhea (11 percent).

Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014. Based on the ION-4 trial results, Gilead plans to file a supplemental New Drug Application with the U.S. Food and Drug Administration for Harvoni to include the results from this study in the U.S. label. Harvoni received marketing authorization in Europe in November 2014, where data from a small study in HIV-HCV co-infected patients (ERADICATE) are included in the prescribing information. -

See more at: http://gilead.com/news/press-releases/2015/2/gilead-announces-svr12-rates-from-phase-3-study-evaluating-harvoni-for-the-treatment-of-chronic-hepatitis-c-in-patients-coinfected-with-hiv#sthash.MHNmiL6v.dpuf

Boone faces heroin, hep C epidemics

Heroin abuse and hepatitis C infections are at epidemic levels in Boone County, local officials told several dozen people attending an Indiana Youth Institute Kids Count 2015 data workshop Tuesday at the Lebanon Public Library.

“We have a heroin epidemic in Boone County,” Sheriff Mike Nielsen said. Cindy Murphy, RN, administrator of the Boone County Health Department, said 40 percent of people who come to the agency’s sexually transmitted diseases clinics admit that they use intravenous drugs.

“We have a hepatitis C epidemic because of IV drug abuse,” Murphy said.


Baker's hepatitis C screening bill gains House approval

HARRISBURG - The Pennsylvania House of Representatives this week approved House Bill 59 authored by Rep. Matt Baker (R-Tioga/Bradford/Potter), chairman of the House Health Committee, that would require physicians to offer hepatitis C screening to patients born between 1945 and 1965.

"If it is determined a patient tests positive for hepatitis C, he or she would then be offered follow-up health care," said Baker. "Treatment today can vastly improve a person's quality of life and result in better health outcomes, including being cured of the disease."

Baker noted that actively screening for hepatitis C, as opposed to waiting for symptoms and more serious diseases to arise from having the disease, will also result in major cost savings for taxpayers. In fact, the estimated medical costs associated with treating Baby Boomers with hepatitis C, many of whom will age into the Medicare system at age 65, will rise from $30 billion in 2009 to $85 billion annually by 2024.

Thursday, February 26, 2015

ALLY Trial Demonstrates 97% Hepatitis C Cure Rates Among Patients Coinfected with HIV After Ribavirin-Free Investigational 12-Week Regimen of Daclatasvir and Sofosbuvir

Daclatasvir-sofosbuvir 12-week regimen resulted in: 
  • 96% hepatitis C cure rate among patients with HVC genotype 1 disease (n=80/83) 
  • 100% hepatitis C cure rate among patients with HCV genotype 2, 3 and 4 disease (n=26/26) 
High HCV cure rates seen with no need to alter existing HIV medication regimens 

Thursday, February 26, 2015 3:15 pm EST
"The ALLY-2 results show that daclatasvir paired with sofosbuvir produced high cure rates in this trial regardless of the coinfected patients’ HCV genotype."

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced results from ALLY-2, a Phase III clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) coinfected with HIV – a patient population that historically has been challenging to treat in large part due to potential drug-drug interactions between the therapy regimens used to treat each infection.

“The results of ALLY-2 signal that nearly all HIV-HCV coinfected patients in the study could be cured of hepatitis C with a 12-week regimen on daclatasvir and sofosbuvir,” said David Wyles, M.D., ALLY-2 Lead Investigator and Associate Professor of Medicine in the Department of Medicine, Division of Infectious Diseases at the University of California San Diego. “The trial demonstrated the dosing flexibility afforded by the daclatasvir-sofosbuvir regimen did not require alteration of HIV medications because of potential drug-drug interactions. This is a paramount consideration for clinicians treating this patient population.”

Among ALLY-2 patients treated for 12 weeks (treatment-naïve and -experienced), 97% (n=149/153) achieved cure (sustained virologic response 12 weeks after treatment; SVR12). The study met the primary endpoint, with 96% (n=80/83) of treatment-naïve genotype 1 patients achieving SVR12. Treatment with daclatasvir in combination with sofosbuvir in this study showed high SVR rates, with no discontinuations due to adverse events, and no serious adverse events related to study medications throughout the treatment phase.

“While substantial strides have been made in the battle against hepatitis C, a significant number of patients with complicated disease and treatment histories need additional treatment options to help them achieve hepatitis C cure,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “The ALLY-2 results show that daclatasvir paired with sofosbuvir produced high cure rates in this trial regardless of the coinfected patients’ HCV genotype.”

According to the Centers for Disease Control and Prevention (CDC), about one quarter of HIV-infected persons in the United States - approximately 300,000 people - are also infected with hepatitis C, and HCV infection progresses more rapidly to liver damage in people living with HIV.
In ALLY-2, high SVR rates occurred among all patients treated for 12 weeks, regardless of prior treatment experience, HCV genotype, cirrhosis status, concurrent combination antiretroviral therapy regimen, or race. African-American patients comprised 34% of study participants; in this patient demographic, SVR12 rates were 98% (n=49/50). ALLY-2 also included an 8-week arm; 38 of 50 treatment-naïve patients with HCV achieved SVR12. However, study investigators concluded that further studies are needed to assess the potential of shorter-duration, all-oral treatment regimens.
Additional safety data demonstrated a low rate of Grade 3/4 lab abnormalities in the study: INR (1%), AST (0.5%), Tbili (4%), Lipase (3%).
About ALLY-2: Study Design
This Phase III open-label clinical trial randomized 151 treatment-naïve and 52 treatment-experienced HCV (genotypes 1-4) patients coinfected with HIV-1 on a broad range of antiretroviral regimens, into 3 cohorts. Among treatment-naïve patients, one cohort received daclatasvir 30, 60, or 90 mg (dose adjusted for concomitant antiretroviral therapy) plus sofosbuvir 400 mg once daily for 12 weeks, and another received the same dosage and combination for 8 weeks.

The treatment-experienced cohort also received daclatasvir 30, 60, or 90 mg plus sofosbuvir 400 mg once daily for 12 weeks. Daclatasvir was dose-adjusted to accommodate concomitant antiretrovirals: 30 mg with ritonavir-boosted PIs, 90 mg with NNRTIs except rilpivirine. All cohorts had follow-up through post-treatment week 24. The primary endpoint was the SVR12 rate among genotype 1 treatment-naïve patients after 12 weeks of treatment. Patients with cirrhosis were permitted.
Read complete press release here:

Langford: Doctors prescribe, not insurance companies

"Our legislators have the opportunity this year to support legislation designed to address problems with excessive use of prior authorization and step therapy, that too often let patients in Florida slip through the cracks with no coverage for appropriate therapies."

More than 15 years ago, I was diagnosed with Hepatitis C. While the disease has created a number of challenges, one particularly frustrating and troublesome problem has been obtaining coverage for medications that my physicians have prescribed because I've been forced into “fail first,” or “step therapy,” protocols.

Fail first protocols are management processes used by health plans that require a patient to try the least expensive treatment to address a problem, despite what his or her physician recommends. Only after trying and failing on the least expensive option, and possibly additional treatments, can a patient receive coverage for the medication the physician originally prescribed.

In 1998, my physician advised me to try a recently approved Hepatitis C treatment, Ribavirin, meant to be taken in addition to Interferon. My insurance company required me to fail on Interferon by itself before I could get the superior combination of the two as prescribed by my doctor.

Read more....

Georgia: New Hepatitis C medicine to enter Georgian market in April

Hepatitis C could soon be "completely eliminated” in Georgia, says the country’s Health Minister.

Georgia is preparing to sign a trilateral agreement that will allow a new medicine to be introduced to the market, which aimed to completely eradicate the infectious disease in Georgia.

Today Georgia’s Minister of Health David Sergeenko held a press conference and said the contract about the new Hepatitis C medication would be signed in April between the Government of Georgia, the United States Disease Control Centre and American biotechnology company Gilead Sciences.


San Francisco Doctors Report Two Hepatitis C Infections Among PrEP Users

Doctors at Kaiser Permanente in San Francisco have reported that two previously hepatitis C negative men who have sex with men have contracted the virus through sexual activity and while on PrEP. The news was reported in the Feb. 19 edition of Clinical Infectious Diseases.

AIDSMap reports the two men were part of a cohort of people receiving the HIV prevention drug through the health programs. There were 485 people who started the drug between February 2011 and December 2014.

Hep C hadn't been thought as sexually transmitted. But the study that underscored that finding relied on heterosexual couples. Recent studies have found probable sexual transmission of the virus -- which attacks the liver -- in men who have sex with men in the U.S., Europe and Australia.

Read more....

NICE guidance recommends sofosbuvir (Sovaldi, Gilead Sciences) and simeprevir (Olysio, Janssen) for treating hepatitis C

Healthcare guidance body NICE has today published final guidance recommending sofosbuvir (Sovaldi, Gilead Sciences) and simeprevir (Olysio, Janssen) as treatment options for some people with chronic hepatitis C.

Hepatitis C is a virus that infects the liver. It is spread by contact with infected blood, for instance by using contaminated needles for injecting drugs or sharing razors or toothbrushes. The virus can cause inflammation of, and damage to, the liver, preventing it from working properly.

About a third of people infected with the hepatitis C virus will eventually develop liver cirrhosis, where normal liver tissue is replaced by scar tissue. A small number of people with chronic hepatitis C and cirrhosis also go on to develop liver cancer.

The aims of treatment are to clear the virus from the blood to prevent progression of liver disease, and to prevent the transmission of the hepatitis C virus. Sofosbuvir and simeprevir are oral antiviral drugs used to prevent hepatitis C viral replication in infected cells.

Sofosbuvir has a marketing authorisation in the UK for use in combination with other medicinal products for treating chronic hepatitis C in adults. The guidance on sofosbuvir recommends its use in combination with ribavirin, with or without peginterferon alfa, as an option for some people with genotypes 1- 6 chronic hepatitis C.[1]

Simprevir has a marketing authorisation in the UK for use in combination with other medicinal products for treating adults with genotype 1 or 4 chronic hepatitis C. The guidance on simeprevir recommends its use, in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults.

More data on the use of simeprevir in combination with sofosbuvir to treat chronic hepatitis C in people who can’t tolerate or aren’t eligible for treatment with interferon is due to become available soon. Therefore recommendations on this treatment combination will now be developed in separate guidance.

Commenting on today’s guidance Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “Poor diagnosis rates - estimates suggest around 50% of people with the condition in England remain undiagnosed - combined with a high number of new infections annually make hepatitis C a major public health challenge. But even when people are diagnosed, the long duration and potentially unpleasant side-effects of current interferon-based treatments can discourage people with the disease from completing the full course, or even from seeking treatment in the first place.

“New treatments, like sofosbuvir and simeprevir, can shorten the length of interferon-based therapy and in some situations don’t need to be taken with interferon at all. Both drugs can also be given to people who have previously been treated but did not clear the virus, in people whose condition has relapsed, or in people who have become re-infected after treatment.

“Sofosbuvir and simeprevir could therefore be valuable treatment options for people with chronic hepatitis C. This is good news, not just for people with chronic hepatitis C, but also because having more effective treatments for the condition could reduce the spread of the virus.”
Following a request from NHS England and consultation with stakeholders, the period during which NHS England has to comply with the recommendations for sofosbuvir is extended to 31 July 2015. The period during which NHS England has to comply with the recommendations for simeprevir has not been extended.

For further information, please contact the NICE press office on 0300 323 0142 / pressoffice@nice.org.uk or out of hours on 07775 583 813.

About the guidance on sofosbuvir
  1. The guidance on sofosbuvir is available from the NICE website (from 00:01 on 25 February 2015).
  2. The guidance states that:
1.1  Sofosbuvir is recommended as an option for treating chronic hepatitis C in adults, as specified in table 1.
1.2  People currently receiving treatment initiated within the NHS with sofosbuvir that is not recommended for them by NICE in this guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.

Table 1 Sofosbuvir for treating adults with chronic hepatitis C

Sofosbuvir in combination with peginterferon alfa and ribavirin
Sofosbuvir in combination with ribavirin
GenotypeTreatment historyRecommendationTreatment historyRecommendation
Adults with genotype 1 HCVAllRecommendedAllNot recommended
Adults with genotype 2 HCVAllNot licensed for this populationTreatment- naiveOnly recommended for people who are intolerant to or ineligible for interferon
Treatment- experiencedRecommended
Adults with genotype 3 HCVTreatment-naiveOnly recommended for people with cirrhosisTreatment-naiveOnly recommended for people with cirrhosis who are intolerant to or ineligible for interferon
Treatment-experiencedRecommendedTreatment-experiencedOnly recommended for people with cirrhosis who are intolerant to or ineligible for interferon
Adults with genotype 4, 5, or 6 HCVAllOnly recommended for people with cirrhosisAllNot recommended
HCV – hepatitis C virus
Treatment-naive – the person has not had treatment for chronic hepatitis C
Treatment-experienced – the person’s hepatitis C has not adequately responded to interferon-based treatment

About sofosbuvir
  1. Sofosbuvir (Sovaldi, Gilead Sciences) is an antiviral drug used to prevent hepatitis C viral replication in infected cells. It is administered orally.
  2. Sofosbuvir has a UK marketing authorisation for use ‘in combination with other medicinal products for treating chronic hepatitis C in adults’. The recommended dose is one 400mg tablet daily. The summary of product characteristics for sofosbuvir states that peginterferon alfa and ribavirin, or ribavirin only, are the recommended co-administered medicinal products for use with sofosbuvir.
  3. The duration of treatment is 12 or 24 weeks depending on the patient’s hepatitis C virus genotype and history of prior treatment with interferon.
  4. The cost of sofosbuvir is £11,660.98 per 28-tablet pack of 400 mg tablets (excluding VAT, ‘British national formulary’ [BNF] May 2014). The cost of a 12-week course of treatment is £34,982.94 and a 24-week course is £69,965.88 (both excluding VAT), not including the cost for ribavirin and peginterferon alfa. Costs may vary in different settings because of negotiated procurement discounts.
Summary of Appraisal Committee’s key conclusions on cost effectiveness
Genotype 1
  1. The ICER for treatment with sofosbuvir plus peginterferon and ribavirin compared with peginterferon and ribavirin was £17,500 per QALY gained in treatment naïve patients.
  2. The Committee also considered sofosbuvir plus peginterferon and ribavirin to be cost effective compared with boceprevir plus peginterferon and ribavirin, and telaprevir in combination with peginterferon and ribavirin (ICERS of approximately £10,300 and £15,400 per QALY gained respectively).
  3. The Committee considered sofosbuvir plus peginterferon and ribavirin to be cost effective in treatment experienced patients compared with peginterferon and ribavirin, boceprevir plus peginterferon and ribavirin, and telaprevir plus peginterferon and ribavirin with ICERs of approximately £12,600, £700 and £8200 per QALY gained respectively.
  4. Sofosbuvir plus ribavirin was not recommended in people for whom interferon was unsuitable (regardless of previous treatment) because of the higher ICER compared with standard care (no treatment) which was in excess of £47,500 per QALY gained in the combined population of people with and without cirrhosis .

Genotype 2
  1. The ICER for sofosbuvir plus ribavirin compared with peginterferon and ribavirin in people who were treatment experienced was £12,500 per QALY gained. However, in the treatment naïve group the treatment was not recommended because of the high ICER of £46,300 per QALY gained.
  2. The Committee considered sofosbuvir plus ribavirin to be clinically effective and cost effective compared with no treatment in people for whom treatment with interferon was unsuitable regardless of treatment experience (with ICERs of approximately £8200 and £8600 per QALY gained respectively).

Genotype 3
  1. The Committee considered the extended treatment duration (24 weeks) of sofosbuvir plus with ribavirin to be clinically effective compared with peginterferon alfa and ribavirin. The Committee considered sofosbuvir plus peginterferon alfa and ribavirin to be cost effective in people with treatment-naive HCV with cirrhosis (with an ICER of approximately £6600 per QALY gained) but not in people with treatment-naive HCV without cirrhosis (with a high ICER of approximately £40,600 per QALY gained). Treatment was recommended in people with treatment-experienced HCV regardless or cirrhosis status with ICERs of below approximately £19,000 per QALY gained
  2. The Committee considered the cost effectiveness of sofosbuvir plus ribavirin to be acceptable in people with cirrhosis who were not eligible for peginterferon alfa regardless of previous treatment with ICERs of approximately £10,500 per QALY gained for treatment-naive HCV and £19,200 per QALY gained for treatment-experienced HCV. The Committee did not consider sofosbuvir in combination with ribavirin to be cost effective in people without cirrhosis with ICERs of approximately £28,000 and £31,400 per QALY gained in treatment-naive and experienced HCV respectively.

Genotypes 4, 5 and 6
The Committee considered sofosbuvir in combination with ribavirin with or without peginterferon alpha to be clinically effective compared with peginterferon and ribavirin in people with treatment naïve and experienced HCV genotypes 4, 5 and 6.
  1. The Committee noted that the ICER for sofosbuvir plus peginterferon alfa and ribavirin compared with peginterferon and ribavirin in the combined cohort of people with treatment naive genotype 4, 5 and 6 HCV was £39,100 per QALY gained. The Committee did not consider sofosbuvir plus peginterferon alfa and ribavirin to be cost effective in people with genotype 4, 5 or 6 HCV without cirrhosis. The Committee considered that ICERs in the population with cirrhosis are consistently lower than in people without cirrhosis and that considering the high unmet need in the population of people with genotype 4, 5 and 6 with cirrhosis, the Committee could consider sofosbuvir plus peginterferon alpha and ribavirin to be cost effective in the treatment naive or experienced populations with ICERs that could be between £20,000 and £30,000 per QALY gained. In addition the Committee did not consider sofosbuvir plus ribavirin in people who were not eligible for interferon to be cost effective. 

About the guidance on simeprevir
  1. The guidance on simeprevir is available from the NICE website (from 00:01 on 25 February 2015).
  2. The guidance states that:

    1.1  Simeprevir, in combination with peginterferon alfa and ribavirin, is recommended within its marketing authorisation as an option for treating genotype 1 and 4 chronic hepatitis C in adults.
  3. As part of this appraisal the Committee originally considered the effectiveness of simeprevir in combination with sofosbuvir. In the appraisal consultation document the Committee concluded that the true magnitude of the effect of simeprevir in combination with sofosbuvir could not be robustly estimated in people who cannot tolerate or are not eligible to have interferon treatment. At its second meeting, the Committee heard that mature observational data for simeprevir in combination with sofosbuvir would become available in the near future, and that this would include data on people who cannot tolerate or are not eligible to have interferon treatment. The Committee considered that it would be more appropriate to postpone making a decision on this combination until the more mature data become available. To avoid postponing the recommendations for the combination of simeprevir with peginterferon alfa and ribavirin for treating genotype 1 and 4 hepatitis C, the Committee recommended that this appraisal be split. Therefore, this appraisal no longer includes a recommendation for simeprevir in combination with sofosbuvir with or without ribavirin for treating people with genotype 1 and 4 HCV who are intolerant or ineligible for treatment with interferon.
  4. Following a request from NHS England to extend the period during which funding must be made available, NICE consulted on a proposal to grant an extension to the deferred funding period until 31 July 2015. Following consideration of comments received during the consultation on a decision to amend the deferred funding, the NICE Guidance Executive decided that no extension to the normal period was required for simeprevir in combination with peginterferon alpha and ribavirin.  This is because simeprevir will be used in the same way as boceprevir and telaprevir. Both these interventions have been funded by the NHS since the publication of NICE appraisal guidance in early 2012. The resources and arrangements for safe delivery of treatment are already in place as a result of the availability of telaprevir and boceprevir.  Therefore, additional resources or training are not required to support the implementation of simeprevir. In addition, simeprevir treatment is less complex to administer than telaprevir and boceprevir, and the additional small patient population with genotype 4, for whom simeprevir is licensed is not expected to constitute a substantial challenge to the implementation.  Consequently, section 5 of the FAD states that clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities are required to comply with the recommendations in this appraisal within 3 months of its date of publication.
About simeprevir
  1.  Simeprevir (Olysio, Janssen) is a protease inhibitor; it inhibits the NS3/4A enzyme that the hepatitis C virus (HCV) depends on to replicate. Simeprevir is administered orally.
  2. Simeprevir has a UK marketing authorisation in the UK for use in combination with peginterferon alfa and ribavirin or in combination with sofosbuvir (with or without ribavirin) for treating adults with genotype 1 or 4 chronic hepatitis C, including people with or without cirrhosis, and people with HIV.
  3. For people who have not had previous treatment or whose disease has responded to previous treatment but subsequently relapsed, simeprevir in combination with peginterferon alfa and ribavirin is indicated for 12 weeks, followed by 12 weeks of peginterferon alfa and ribavirin alone.
  4. For other people, the course of simeprevir is the same, but the course of pegylated interferon and ribavirin is longer than 24 weeks; specifically, for people whose disease did not respond to previous treatment, and for people with HIV who also have cirrhosis, simeprevir in combination with peginterferon alfa and ribavirin is indicated for 12 weeks, followed by 36 weeks of peginterferon alfa and ribavirin alone.
  5. Simeprevir costs £1866.50 per pack of 7x150 mg tablets (excluding VAT, MIMS online, accessed July 2014). A course of simeprevir (for 12 weeks) plus peginterferon alfa and ribavirin (both for 24 weeks) costs £27,220. A course of simeprevir (for 12 weeks) plus peginterferon alfa and ribavirin (both for 48 weeks) costs £32,155.
  6. For treating genotype 1 HCV, the ICERs for simeprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin alone was between £14,200 and £9800 per QALY. Simeprevir dominated both telaprevir and boceprevir (both with peginterferon alfa and ribavirin), that is simeprevir was less expensive and provided more QALYs.
  7. The Committee noted that, in all scenarios for genotype 4 HCV, the ICERs for simeprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin remained below £20,000 per QALY gained. 
About chronic hepatitis C
  1. 15 to 20% of people infected with the hepatitis C virus naturally clear their infections within 6 months, the remainder develop chronic hepatitis which can be life-long.
  2. Figures from 2012 suggest that around 160,000 people are chronically infected with the hepatitis C virus in England. More than half of people with chronic hepatitis C do not know they are infected because they only have mild symptoms or no symptoms at all for a long period of time.
  3. About 1 in 3 people infected with the hepatitis C virus will eventually develop liver cirrhosis, where normal liver tissue is replaced by scar tissue.
  4. A small percentage of people with chronic hepatitis C and cirrhosis also develop liver cancer.
  5. For people with mild disease, a ‘watchful waiting’ approach may be agreed, on an individual basis, between the patient and clinician.
  6. Current NICE guidance (NICE technology appraisal 75 and NICE technology appraisal 106) recommends that standard treatment for the majority of people with chronic hepatitis C is peginterferon alfa and ribavirin combination therapy. Monotherapy with peginterferon alfa-2a or peginterferon alfa-2b is recommended for patients who are unable to tolerate ribavirin or for whom ribavirin is contraindicated.
  7. Other NICE guidance on hepatitis C (NICE technology appraisal 200) also recommends that people who have been previously treated with peginterferon alfa and ribavirin or with peginterferon alfa monotherapy have an option to receive further courses of peginterferon alfa and ribavirin.
  8. Shortened courses of peginterferon alfa and ribavirin are also recommended as an option for certain patient subgroups (NICE technology appraisal 200).
  9. For people with genotype 1 chronic hepatitis C, who have not been previously treated or who have been previously treated, NICE guidance also recommends telaprevir in combination with peginterferon alfa and ribavirin (NICE technology appraisal 252) or boceprevir in combination with peginterferon alfa and ribavirin (NICE technology appraisal 253).

[1] There are 6 major genotypes and several subtypes of the hepatitis C virus, the prevalence of each vary geographically. Genotypes 1 and 3 account for the majority of chronic hepatitis C cases in England (46% and 43% respectively). People with genotype 2 hepatitis C generally respond to treatment better than those with genotype 1, 3, 4, 5 or 6.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.
Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.
Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.
To find out more about what we do, visit our website:www.nice.org.uk and follow us on Twitter: @NICEComms.

Transmission of Hepatitis C Virus Associated with Surgical Procedures — New Jersey 2010 and Wisconsin 2011

Morbidity and Mortality Weekly Report (MMWR)

February 27, 2015 / 64(07);165-170

Incidents of health care–associated hepatitis C virus (HCV) transmission that resulted from breaches in injection safety and infection prevention practices have been previously documented (1,2). During 2010 and 2011, separate, unrelated, occurrences of HCV infections in New Jersey and Wisconsin associated with surgical procedures were investigated to determine sources of HCV and mechanisms of HCV transmission. Molecular analyses of HCV strains and epidemiologic investigations indicated that transmission likely resulted from breaches of infection prevention practices. Health care and public health professionals should consider health care–associated transmission when evaluating acute HCV infections.

An estimated 3.2 million U.S. residents have chronic HCV infections; during 2011, approximately 16,500 acute HCV infections were diagnosed. Molecular analyses of HCV strains have enhanced investigations of health care–associated transmission (3–5) by determining the relatedness of strains infecting persons with acute and chronic HCV infection. Two investigations of HCV infection among patients who had surgical procedures highlight the potential for HCV contamination of medications or equipment, which can result in transmissions that are difficult to recognize.

Read more....

Wednesday, February 25, 2015

India: Mylan to distribute both Sovaldi and Harvoni for HCV

"Mylan Pharmaceuticals Private Limited, a subsidiary of Mylan Inc., has entered into an agreement with Gilead Sciences to be an exclusive distributor of Sovaldi and Harvoni in India for the treatment of hepatitis C virus infection, according to a press release.

Under the agreement, Mylan will distribute Sovaldi (sofosbuvir, Gilead) and Harvoni, a combination of ledipasvir (Gilead) and sofosbuvir, and also have the rights to manufacture and distribute generic versions of both regimens. In addition, Mylan will also retain manufacturing and distribution rights for the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816 upon approval, according to the release.

Hepatitis C is a growing public health concern, particularly in developing countries such as India where access to high quality, effective and affordable treatment remains a challenge,” Rajiv Malik, president of Mylan, said in the release. “Mylan is proud to partner with Gilead to expand access to Sovaldi and Harvoni, life-saving medications that offer an improvement in the standard of care for the 12 million hepatitis C patients in India.”


Tuesday, February 24, 2015

SVR rates up with new regimens for HCV and HIV coinfection

For patients with hepatitis C virus genotype 1 and HIV coinfection, new regimens are effective and correlate with high rates of sustained virologic response after treatment, according to two studies published online Feb. 23 in the Journal of the American Medical Association.

(HealthDay)—For patients with hepatitis C virus (HCV) genotype 1 and HIV coinfection, new regimens are effective and correlate with high rates of sustained virologic response (SVR) after treatment, according to two studies published online Feb. 23 in the Journal of the American Medical Association.

Mark S. Sulkowski, M.D., from Johns Hopkins University in Baltimore, and colleagues conducted an open-label trial at 17 sites in the United States and Puerto Rico. Sixty-three patients with HCV genotype 1 and HIV-1 coinfection received the all-oral 3 direct-acting antiviral (3D) regimen of ombitasvir, paritaprevir (co-dosed with ritonavir), dasabuvir, and ribavirin for 12 or 24 weeks. The researchers found that 94 and 91 percent, respectively, of those receiving 12 or 24 weeks of 3D and ribavirin achieved SVR at post-treatment week 12 (SVR12). Fatigue, insomnia, nausea, and headache were the most common treatment-emergent (48, 19, 18, and 16 percent, respectively).


Worldwide treatment of hepatitis C could be within sight at the right cost

The FINANCIAL -- Lowering the cost of hepatitis C drugs is possible and key to achieving global access to treatment, according to new research by the University of Liverpool and Imperial College London. 

There are an estimated 185 million people infected with the hepatitis C virus worldwide and 160,000 in Britain. Currently there is no vaccine and, if left untreated, infection can lead to cirrhosis and liver cancer, causing up to 500,000 related deaths globally per year.

Hepatitis C is particularly problematic in low to middle income countries; for example 12 million people are infected in Egypt.

A new and effective generation of direct-acting antiviral drugs (DAAs) has been developed to treat hepatitis C. However, at present these drugs are highly expensive. A 12-week course of the new drug sofosbuvir in the US is priced at as much as $84,000 per person and £55,440 in the UK. The NHS has recently delayed introduction of sofosbuvir due to its high price.


Canada: With hep C, no province is an island

Let the hepatitis C treatment wars begin.

Prince Edward Island has quietly announced that it will fund a costly new treatment for sufferers of the disease – an announcement with potentially dramatic public-policy repercussions.

For patients infected with hepatitis C virus, a potentially deadly liver disease, this is good news. The new antiviral treatments are the closest thing to miracle drugs that have come along in a long while – with a cure rate in the range of 95 to 97 per cent.

Why it took so long for the world to start using ‘smart,’ self-destructing syringes

The World Health Organization called Monday for the worldwide use of needle syringes that self-destruct after a single injection.

These "smart" syringes are a response to a problem that medical authorities have recognized for decades -- the frequent reuse of disposable shots. An estimated 25 percent of the 18 billion medical injections performed worldwide each year are done with dirty needles. Unsafe injections cause as many as 1.7 million new hepatitis B infections annually, 315,000 hepatitis C infections and 33,800 HIV infections, according to the World Health Organization. Stopping these infections would be a boon for public health.

“This is a risk we don’t have to be taking,” the WHO's Lisa Hedman said.


Daclatasvir for hepatitis C: Hint of added benefit in genotype 4

Daclatasvir (trade name Daklinza) has been approved since August 2014 for the treatment of adults with chronic hepatitis C (CHC) infection. According to the dossier assessment conducted by the German Institute for Quality and Efficiency in Health Care (IQWiG) in December 2014, no added benefit could be derived for daclatasvir.

In an addendum, the Institute now examined information subsequently submitted by the drug manufacturer in the commenting procedure: According to the findings, there is a hint of an added benefit for treatment-naive with genotype 4. The extent is non-quantifiable, however. The study for patients infected with hepatitis C virus (HCV) of genotype 3, which was presented for the first time, is unsuitable to derive an added benefit.


Monday, February 23, 2015

Results from AbbVie's Study of VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Chronic Hepatitis C Patients with HIV-1 Co-Infection (TURQUOISE-I) Published Online in JAMA; Sub-analyses to be Presented at the Annual Conference on Retroviruses and Opportunistic Infections (CROI)

- In adult patients co-infected with genotype 1 (GT1) hepatitis C virus (HCV) and human immunodeficiency virus type 1 (HIV-1), TURQUOISE-I, using VIEKIRA PAK with ribavirin (RBV), demonstrated sustained virologic response rates 12 weeks post-treatment (SVR12) of 94 percent with 12 weeks of treatment and 91 percent with 24 weeks of treatment, respectively

 - TURQUOISE-I results published online today in The Journal of the American Medical Association (JAMA) - 

Additional sub-analyses of TURQUOISE-I data to be presented this week at the Annual Conference on Retroviruses and Opportunistic Infections (CROI)

NORTH CHICAGO, Ill., Feb. 23, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that results from part one of the Phase 2 portion of its Phase2/3 open-label study, TURQUOISE-I, in genotype 1 chronic hepatitis C patients with human immunodeficiency virus type 1 (HIV-1) co-infection were published online in The Journal of the American Medical Association (JAMA). Additional sub-analyses also will be presented in both oral and poster presentations on Feb. 26, at the Annual Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, Wash.

As published today in JAMA, and originally presented at The Liver Meeting® 2014, the TURQUOISE-I study showed patients co-infected with genotype 1 (GT1) hepatitis C virus (HCV) and HIV-1 receiving VIEKIRA PAK™ and ribavirin (RBV) for 12 weeks or 24 weeks achieved sustained virologic response rates 12 weeks post-treatment (SVR12) of 94 percent (n=29/31) and 91 percent (n=29/32), respectively. The SVR12 rates were 91 percent (n=51/56) for subjects with HCV GT1a infection and 100 percent (n=7/7) for those with HCV GT1b infection.

"It is common for people to live with both GT1 chronic HCV and HIV, but data supporting treatment of chronic HCV in these co-infected patients have been limited," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "TURQUOISE-I is one of the few dedicated studies looking specifically at this historically difficult-to-treat population and we are proud to offer the HCV community an important new treatment option."

VIEKIRA PAK is contraindicated with efavirenz (Sustiva) because co-administration is poorly tolerated and results in liver enzyme elevations. The ritonavir component of VIEKIRA PAK is an HIV-1 protease inhibitor and can select for HIV-1 protease inhibitor resistance. To reduce this risk, HCV/HIV-1 co-infected patients should also be on a suppressive antiretroviral (ART) drug regimen. The most common adverse events occurring in at least 10 percent of patients in TURQUOISE-I were fatigue (48%), insomnia (19%), nausea (17%), headache (16%), itching (13%), cough (11%), irritability (10%), and yellowing of the eyes (10%).

Sub-analyses of these data will be presented later this week at CROI in oral and poster presentations:
  • High SVR Regardless of Time to Suppression with Paritaprevir/r/Ombitasvir & Dasabuvir + RBV Oral Presentation #147
    February 26, 2015, 10:30-10:45 p.m. PST, Room 6AB 
    Analysis of time to HCV suppression in HCV/HIV co-infected patients in TURQUOISE-I
  • Hematologic Analysis of Paritaprevir/r/Ombitasvir and Dasabuvir + RBV in TURQUOISE-I Poster #691
    February 26, 2015, 2:30-4 p.m. PST, Poster Hall 
    In this analysis of the TURQUOISE-I study, certain laboratory values in patients taking paritaprevir/r/ombitasvir and dasabuvir with RBV were examined, including hemoglobin, CD4+ T cells, and lymphocyte count
About TURQUOISE-I  TURQUOISE-I is an ongoing Phase 2/3, multi-center, randomized, open-label study evaluating the efficacy and safety of VIEKIRA PAK (ombitasvir, paritaprevir, ritonavir (25/150/100 mg once daily) and dasabuvir (250 mg twice daily) with RBV (weight based dosing of 1000 mg or 1200 mg per day divided twice daily) for 12 or 24 weeks in adult patients with chronic GT1 HCV infection with or without compensated liver cirrhosis who are also infected with HIV-1.

Study patients were either new to therapy (treatment-naïve) or had failed previous treatment with pegylated interferon and RBV (treatment-experienced), had a stable immune status (CD4+ counts of ≥200 cells/mm3 or CD4+ % ≥14%). Patients were on a stable HIV-1 ART regimen that included tenofovir disoproxil fumarate plus emtricitabine or lamivudine, administered with ritonavir-boosted atazanavir or raltegravir. Patients on atazanavir stopped the ritonavir component of their HIV-1 ART regimen upon initiating treatment with VIEKIRA PAK + RBV. Atazanavir was taken with the morning dose of VIEKIRA PAK. The ritonavir component of the HIV-1 ART regimen was restarted after completion of treatment with VIEKIRA PAK and RBV. Of the five patients who were non-responders, one experienced virologic failure, one discontinued treatment, one experienced relapse and two patients had evidence of HCV reinfection post-treatment. Based on the results of this study, prescribers should follow the same dosing recommendations for mono-infected patients as outlined in the VIEKIRA PAK prescribing information.

Elevations in total bilirubin were the most common laboratory abnormality, were mainly composed of indirect bilirubin, and were not associated with elevations in commonly measured liver enzymes. Reductions in RBV dose because of anemia or reduced hemoglobin occurred in 10 percent of patients (n=6/63); all six patients achieved SVR12.

Snapshots —Alan Franciscus, Editor-in-Chief

Abstract: Hepatitis C Virus Antibody Positivity and Predictors Among Previously Undiagnosed Adult Primary Care Outpatients: Cross-Sectional Analysis of a Multisite Retrospective Cohort Study—B. Smith et al.
  Source: Clin Infect Dis. 2015 Jan 16. pii: civ002. [Epub ahead of print]

Prior to ‘Baby Boomer’ age-based testing the Centers for Disease Control and Prevention (CDC) recommended that everyone with specific risk factors should be tested for hepatitis C antibodies.  The current study analyzed data between 2005 and 2010 in 4 primary care service sites.  The records included people who had no documented evidence of a prior diagnosis of hepatitis C. 

There were 209,076 patients observed for 5 months—17,464 patients were tested for HCV—6.4% (1,115 people) tested as HCV antibody positive.  Factors associated with a positive HCV antibody test were injection drug use, 1945-1965 birth-cohort (Baby Boomers), and elevated ALT enzymes.  The researchers commented that, “In these outpatient primary settings risk-based testing may have missed 4 of 5 newly enrolled patients” who were HCV antibody positive.
Editorial Comment:  Age-based testing has been slow to catch on.  Hopefully, this study will help to dispel the naysayers and speed up the implementation of testing.  Just imagine if we could get all those undiagnosed people identified and into medical care, management and treatment.
Abstract:  Interferon therapy in hepatitis C leading to chronic type 1 diabetes—T Zornitzki et al.
  Source:  World J Gastroenterol. 2015 Jan 7;21(1):233-9. doi: 10.3748/wjg.v21.i1.233.

Interferon-based therapy is known to exacerbate some autoimmune diseases. A recent study reviewed published data from 1992 to December 2013 to see if there was a correlation between interferon treatment and type1 diabetes. 

Type 1 diabetes is an autoimmune disease—that is the body’s immune system attacks the pancreas and prevents it from producing insulin to process carbohydrates or sugars.  Type 1 diabetes patients must inject insulin to process the sugars. 

One hundred and seven cases of type 1 diabetes were identified.  This meant that interferon treatment increased the risk of type 1diabetes by 10 to18-fold compared to the general population developing type 1 diabetes.  The patients diagnosed with type 1 diabetes required insulin therapy.  Most of the patients (105 of 107 patients) continued to take insulin permanently (at year 4 of follow-up).
Editorial Comment:  This is the first study that has found an association between interferon therapy and type 1 diabetes.  If people did develop type 1 diabetes or another autoimmune disease during or right after treatment and didn’t know the reason, interferon may very well be the cause.  Thankfully, we now have interferon-free therapies so we don’t have to worry about these types of treatment-related auto-immune conditions. 


Saturday, February 21, 2015

Hepatitis C drug a costly but promising cure

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; debilitating 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.

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.

Friday, February 20, 2015

Spain: Hepatitis C patient feels like a new man

ISIDORO ESCAMILLA was tired of feeling like he always had the flu, an effect of suffering from Hepatitis C that was diagnosed in 2007.

A drug called Sovaldi was hailed as something that would completely change things for him and has been prescribed in Spain for 18 months. Unfortunately, until January 2015 it was not available to patients in Andalucia, where Escamilla lives.

He fought to get the drug to Andalucia, and even tweeted Susana Diaz, president of the Junta de Andalucia regional government.


Widow’s Right to Workers’ Comp Benefits Affirmed, Without Direct Proof of Harm

St. Peters, MO, (Law Firm Newswire) February 20, 2015 – A Missouri Court of Appeals has affirmed the decision of a lower court to award workers’ compensation benefits to Dorothy Smith, a widow who lost her husband to hepatitis C.

Smith’s husband, Stephen Smith, worked in a medical laboratory for more than 30 years, beginning in 1969. There, he could have been exposed to the disease before protective equipment and procedures became common in the 1990s.

“In this case, the employer tried to argue that Ms. Smith should not get benefits because she could not definitively prove that the workplace was the source of her husband’s infection,” remarked Charlie James, a Missouri workers’ compensation attorney not involved with the case. “But the court ruled that Ms. Smith did not have to provide absolute proof. Ms. Smith only needed to show that it was probable that her husband’s workplace was the source of the infection.”


Canada: New Hepatitis C drug Sovaldi needed in B.C., say desperate patients

Hepatitis C patients in B.C. are fighting to get access to new drug Sovaldi, which could cure them, but could also cost the provincial government up to $2.75 billion.

There are currently up to 25,000 British Columbians living with the contagious liver disease, which begins as a mild viral infection lasting a few weeks but can lead to a chronic, lifelong illness.

Desmond McKilligan of Kaslo, B.C., who contracted hepatitis C after receiving tainted blood 45 years ago, says going through life with the virus is exhausting.


Needle Exchange - A Matter of Public Health So why is the government playing politics with this ticking time bomb?

Alan Franciscus
Editor-in-Chief, HCV Advocate

The following article originally appeared in the April/June 2003 issue of Hepatitis, and is so current that we thought we would repost it here, now.

The American Medical Association (AMA), the American Nurses Association, the American Public Health Association (APHA), the American Society of Addiction Medicine, the American Bar Association, and the Society of Christian Ethics, to name a few, all endorse needle exchange programs. So why has it not been possible to achieve federal funding for such programs from 1988 to the present?

Needle exchange programs, which increase the availability of sterile syringes, are an important means of reducing the transmission of HIV infection and other blood-borne diseases such as hepatitis B and C among injection drug users and their often unsuspecting sexual partners and children - the most rapidly growing population of people with HIV. Most needle exchange programs operate on a one-for-one basis, so they also reduce the presence of infected needles in playgrounds, streets, and trash receptacles, thus protecting children, sanitation workers, and others from accidental needle sticks.

The use of federal funds to support needle exchange programs has been prohibited by Congress since 1988. The original intent was that the ban on federal support would remain in effect until the U.S. Secretary of Health and Human Services determined that such programs were effective in preventing the spread of HIV and did not encourage the use of illegal drugs. In the years since the funding ban was put instituted, an impressive number of researchers and medical organizations have carefully examined the issue and concluded that needle exchange programs are effective, necessary, and did not increase injection drug use.

In April 1998, then Secretary of Health and Human Services Donna Shalala publicly announced that the scientific evidence was in: needle exchange programs were effective in preventing the spread of HIV and did not encourage illegal drug use. But after Secretary Shalala made this determination, she nonetheless continued the federal ban on needle exchange funding. The decision was criticized by Mohammed Akhter, MD, MPH, executive director of the APHA, the oldest and largest organization of public health professionals representing more than 50,000 members from over 50 organizations. "The administration today has recognized that needle exchange programs work to protect the health of the American people,"said Dr. Akhter. "In the face of such overwhelming scientific evidence, not releasing federal funds gives the impression that politics takes precedence over saving lives".

The scientific evidence is so overwhelming that the AMA encourages needle exchange programs and supports legislation revoking the 1988 federal funding ban. Additionally, the AMA encourages state medical associations to initiate state legislation to modify drug paraphernalia laws so that injection drug users may legally purchase and possess needles and syringes without a prescription. In 2002 former President Bill Clinton said he had made a mistake in not supporting needle exchange programs to prevent the spread of HIV and other diseases among injection drug users

As a presidential candidate, George W. Bush opposed needle exchange programs. That policy continues to the present day. Bush's Secretary of Health and Human Services, Tommy Thompson, has said that the administration has no plans to permit federal funding of needle exchange. In an administration known for demanding loyalty, Bush's "AIDS Czar" Scott Evertz nonetheless once let it be known that in his own view, needle exchange saves lives and the evidence in its favor is conclusive.

In July 2002 the Bush administration announced that Joseph O'Neill, MD, would replace Evertz as director of the White House Office of National AIDS Policy. Dr. O'Neill is a career civil servant who has been acting director of the Department of Health and Human Services' Office of HIV/AIDS Policy. With the Bush administration, the terms of the debate on AIDS have changed. Needle exchange, although recommended by a majority of medical authorities, is not even up for discussion. Instead, questions are being raised about the effectiveness of condoms and -despite the increasing number of people living with HIV/AIDS - AIDS funding is leveling off.

The harm reduction paradigm is simple and approaches addictive behavior on the basis of three fundamental principles. First, excessive behaviors occur along a continuum of risk ranging from minimal to extreme. Addictive behavior is not an all-or-nothing phenomenon. Second, changing addictive behavior is a stepwise process, with complete abstinence as the final step. Those who embrace the harm reduction model believe that any movement in the direction of reduced harm, no matter how small, is positive. Third, sobriety simply isn't for everyone. This principle requires acceptance of the fact that many people live under horrible conditions. Some are able to cope without the use of drugs, while others use drugs as a primary means of coping. Until we as a society are able to offer an alternative means of survival to these people, we are in no position to cast moral judgment. Harm reduction holds that the health and well-being of the individual is of primary concern; if individuals are unwilling or unable to change addictive behaviors at this time, they should not be denied services. Attempts should be made to reduce the harm of their habits as much as possible. This approach to addiction is viewed by some as compassionate and pragmatic; by others as selfish and dangerous.

State laws prohibiting syringe sales without a prescription or possession of syringes for the purpose of injecting illegal drugs have made sterile needles hard to obtain and have led to substantial needle sharing, resulting in the spread of incurable diseases. In minority populations that are subject to considerable police presence, injection drug users avoid carrying syringes in order to avoid arrest, thereby increasing the frequency of needle sharing. An African American injection drug user is almost five times more likely, and a Latino more than three times more likely, to be diagnosed with HIV than a white drug injector.

Needle exchanges have been operating legally and illegally in the United States since at least the late 1980s. The first needle exchange program was developed in 1984 in Amsterdam in the Netherlands by a drug users' advocacy group called the Junkie Union. The goal was to avoid an epidemic of hepatitis B when an inner-city pharmacist intended to put an end to the sale of syringes to injection drug users. The first person to hand out drug injection equipment openly in the U.S. was Jon Parker in New Haven, CT, and Boston, MA, in 1986. The first U.S. needle exchange program to provide all-inclusive services was established in Tacoma, WA, in 1988. Much has changed in the past decade. From its beginnings with a few lone individuals exchanging syringes on the streets, there are now over 100 needle exchange programs in some 80 cities and 30 states around the country and over 17 million syringes were exchanged in 1997 (the year of the last official survey). While the debate in Washington has been fairly inactive in recent years, steps forward have been made on the state level in many areas. In fact, 68 out of 113 of the needle exchanges participating in the 1997 survey were either legal or illegal but tolerated by local officials.

The Canadian experience with needle exchange programs has been quite different from that of the U.S. As early as 1989, the Canadian federal government offered to co-fund comprehensive pilot HIV prevention programs for injection drug users that included needle exchange. By 1993, nearly 30 Canadian cities had active needle exchange programs. While some Canadian community and neighborhood groups have opposed needle exchange, the debate has generally been less politically charged than in the U.S. The fact that the pilot needle exchange programs were part of a comprehensive approach to drug use that combines education, counseling, law enforcement, and linkages to other services, including drug treatment, helped diminish community resistance. In Britain, pharmacies and more than 250 agencies distribute clean needles. Before 1987, 60 percent of injection drug users regularly shared needles; today the figure in Britain is about 10 percent. Australia has also been a pioneer in the area of harm reduction. Three Catholic agencies sponsor needle exchanges in that country. According to David Waterford of the Adelaide Diocesan AIDS Council, Southern Australia (with 55 exchange programs for a population of 1.2 million) has reported no new HIV infections resulting from needle sharing over the past three years.

So what is the religious view of the morality of needle exchange? There are some extremes, from a Jesuit doctor who called on Catholic leaders to support such programs because "needle exchange saves lives," to a Catholic priest and member of the New Jersey Governor's Advisory Council on AIDS who stated that needle exchange undermines society.

An excerpt from Dawn Day's article on moral issues related to the spread of HIV/AIDS among injection drug users puts this issue in perspective for those struggling with the morality of supporting needle exchange. "With the best of intentions, our legislators passed laws prohibiting people from gaining access to sterile needles - the legislators were trying to protect people from the harm that comes from injecting drugs," wrote Day. "Medical science now tells us that these laws are not effective in stopping drug use and are causing the further spread of HIV/AIDS. It is a tragic irony that the laws prohibiting access to sterile needles, laws meant to protect people, are now the cause of people dying with AIDS. As a religious person, I feel I have an obligation to work to correct this deadly situation". Relating to medical care for all she wrote, "[I]f a women has a life-threatening hemorrhage after giving birth, we want the doctor to provide medical treatment at once. We do not want the doctor to first inquire about the circumstances under which the woman became pregnant. Or when an ambulance goes to the scene of an accident, we want all those who need help to be treated, even the person that caused the accident."

Day continues with the following analogy: "There is a dangerous curve in the road. One speeding driver dies. Then another. Then another. They should not be speeding. They are responsible. But we know the curve is dangerous. Don't we have an obligation to post a warning sign? Put in a stop light? Change the traffic pattern? Perhaps even straighten the road? And the driver is not always alone. Sometimes a wife or husband is along. Sometimes a newborn child. And so it is with injecting drugs in the age of AIDS. People who inject drugs know they are taking a risk. But we know too. I believe we have an obligation to permit people who inject drugs to have access to sterile needles so they can protect their health. Injection drug users are also God's children. And, like the reckless driver in the example above, people who inject drugs have wives, husbands, and babies. When we abandon the person who injects drugs to HIV/AIDS, we are abandoning their non-drug injecting partners and babies as well. God has given us knowledge with which to slow the spread of HIV/AIDS to all these people. Let us use it."

With over a 100 people in the United States becoming infected with HIV, HCV, or HBV every day as a result of injection drug use, it is clear that we must do more. We must continue to educate people about the harms of drug use, particularly injection drug use. We must pay attention to the expertise and knowledge of public health officials and scientists who urge that sterile syringes be made legally available to people who inject drugs. This can be accomplished by permitting and funding needle exchange programs wherever they are needed, permitting possession of sterile syringes, permitting pharmacies to sell syringes without a prescription. In addition, drug treatment programs must be made available to everyone who seeks their services. As a humane society, we must reach the point where injection drug users in every state can legally protect themselves from hepatitis C, hepatitis B, HIV, and other blood-borne diseases, and where needle exchange workers in every state are treated not as criminals but as the public health workers they are.

Contact one of the following organizations for more information about needle exchange:

Thursday, February 19, 2015

Portugal: Hepatitis C treatment 100% subsidised

Innovative drug, Sofosbuvir, to treat hepatitis C is 100% subsidised in Portugal since Tuesday evening and will be given to all patients who need it.

Eurico Castro Alves was speaking at the end of a meeting with the administrators of all hospital that treat hepatitis C in Portugal, Infarmed and the secretary of state of health.

Alves said that an agreement had been signed with the laboratory that makes Sofosbuvir and the drug is now 100% state subsidised.

The Infarmed chairman said that all patients who needed the treatment would receive the drug and added that there are currently 602 receiving Sofosbuvir.


PrEP Users’ Sexually Acquired Hep C Suggests Need for Routine Testing

Evidence of sexual acquisition of hepatitis C virus (HCV) among men who have sex with men (MSM) receiving pre-exposure prophylaxis through a San Francisco clinic has prompted a call for routine monitoring for the virus among PrEP users. In a letter to the editor in Clinical Infectious Diseases, clinicians from Kaiser Permanente San Francisco Medical Center describe new cases of hep C among two men out of 485 HIV-negative MSM receiving PrEP at the clinic between February 2011 and December 2014.

Considering the infections occurred during 304 person-years of follow-up, the hep C incidence rate was 0.7 per 100 person-years. This infection rate is lower than those observed among populations of HIV-positive MSM in published research. But the two cases add evidence to previous findings that the risk of sexual transmission of hep C is likely not reserved to those who are living with HIV. Additionally, however small the risk of hep C may be, its existence adds to the larger dialogue about having sex without a condom while on PrEP (or not on it, for that matter).


Hepatitis C drug patent challenged in Europe

A French healthcare campaign group has launched a legal challenge to the patent covering Sovaldi (sofosbuvir), the blockbuster hepatitis C virus (HCV) drug marketed by Gilead. Médecins du Monde (MDM) has told the European Patent Office (EPO) ‘the molecule itself is not sufficiently innovative to warrant a patent’.

HCV infection can clear within a few months. But for about 80% of those infected, it develops into a chronic condition. According to the World Health Organization, 130–150 million people are living with chronic HCV infection.


Canada: Campaigns launched to promote awareness of and try to prevent Hep C infections in Guelph area

GUELPH—About 300,000 Canadians have potentially deadly Hepatitis C, including 100,000 in Ontario, but up to 50 per cent don't know they're harboring the harmful viral infection, area Hep C Dr. Chris Steingart told a Guelph audience Thursday.

The Sanguen Health Centre executive director said the infection from tainted blood from a variety of sources, which attacks the liver, can cause physical, mental and emotional injury, yet each year more people are infected than seek treatment. 

"The good news is we can do something about that," Steingart told audience members in the health care/harm reduction field at the launch of an information video and color-coded syringes program. He stressed the local availability of effective Hep C testing and treatment. 

Researchers tackle gaps in hepatitis C treatment

“Do One Thing” seeks to provide screenings, treatment to underserved communities

A program run by University researchers aims to quickly identify and provide comprehensive treatment for medically underserved patients who are chronically infected with the hepatitis C virus, according to a new study published in the Feb. 14 issue of the Journal of General Internal Medicine.

Hepatitis C — a blood-borne disease that inflames the liver — is an “underfunded, understudied and seriously large health problem,” said Amy Nunn, assistant professor of behavioral and social sciences and medicine, who co-authored the study.

“Its magnitude is not to be underestimated and there are at least five to seven times as many people living with hepatitis C than its more infamous counterpart, HIV,” Nunn said. Unlike for hepatitis A and B, there is no vaccination available for hepatitis C. 

Reallocation; ACOs; ABLE Accounts (Update on Federal Government Actions) Jacques Chambers, CLU

This column normally focuses on benefits issues, not politics; but government actions have a large impact on benefits and the disabled persons who receive them. This month’s article takes a look at three actions by the federal government that directly affect people dealing with disability, namely:
  • Reallocation of funds between Social Security trust funds, which could have a dramatic effect on anyone collecting Social Security Disability;
  • Accountable Care Organizations (ACOs) under Obamacare which looks to become an effective tool at reducing medical costs; and,
  • Enactment of ABLE accounts, a recent federal law which could help disabled persons save money tax-free.
Reallocation of Trust Funds
This is the item that could have the quickest and most severe impact on people collecting Social Security Disability Insurance (SSDI).

A little background: The F.I.C.A. payroll taxes that pay Social Security Retirement and Disability beneficiaries go into two separate trust funds, the Retirement Trust Fund and the Disability Trust Fund. They are split by a formula that has been in effect for many years.

Because the formula does not accurately reflect the payouts from each fund, periodically, the House of Representatives, which initiates budget issues, must “reallocate” funds from one trust fund to the other in order to maintain full payments to both groups of beneficiaries. This is usually a fairly routine procedure and has been done eleven times since 1968 with no opposition or problems, regardless of the political party in control of the House. Due to the age of the allocation formula and the shifts in types of labor, age of workforce, and advancing the retirement age to 67, the reallocation of funds usually has been from the Retirement Fund into the Disability Fund.

If there is no reallocation of money into the Disability Trust Fund from the much larger Retirement Fund, before December, 2016, SSDI benefits will be cut 16 – 20% for the 11,000,000 disabled people currently receiving benefits.

On the first day of the new Congress, the new majority adopted a “rule” about reallocation without consulting the minority party. Instead of simply approving the reallocation as in the past, now a reallocation bill can only be considered if it comes with an accompanying proposal which “improves the actuarial balance” of both funds. In other words, disabled people’s SSDI benefits will be cut by up to 1/5 unless there is a plan on the table to put both Trust Funds into more permanent solvency, i.e., a major rewrite of the entire Social Security retirement and disability system.

Note that this is only a “rule” change, not a law. So it is now in effect; neither the Senate nor the President can do anything to stop it.

Supporters of this new rule have frequently tried to portray SSDI as too easy to get and claim almost anyone can walk in and get it. Any disabled person who has gone through the application and appeal process will have no problem appreciating the total inaccuracy of that.

One senator maintains that over half the recipients are either anxious or have a sore back, saying, “Join the club. Who doesn’t get up a little anxious for work and their back hurts.”

In 2011, the last year for when numbers are available, all types of mood disorders plus all types of musculoskeletal issues comprised less than 45% of total worker beneficiaries, which includes far more conditions than anxiety and a “sore back.”

The reason for the new rule, according to its supporters, is to push Congress to address the inadequacy of current revenue and benefits payouts and stop “kicking the can down the road.”
Those opposed to the new rules, which include virtually all of the disabled community and its advocates, accused the House of holding the disabled hostage. Who is correct?

While the supporters focused on anecdotes, the Government Accounting Office (GAO) performed an audit of improper SSDI payments and issued its report in 2013 (GAO13-635). It concluded only 0.4% of beneficiaries received overpayments, or payments for which they were not able–not even 1% of the total benefits paid.

The proposed budget recently issued by The White House specifically calls for a reallocation into the Disability Trust Fund, but that is only a proposal at present.

There is a possibility that, if pushed, the majority in the House may postpone this rule, however, that risks the rule or something like it being brought up in future years similar to other issues such as expanding the debt limit or threatening to cut successful, popular, and necessary programs. At present the rule is in place, and, if not changed or postponed, SSDI beneficiaries will see a large cut in their benefits by the end of 2016.

Accountable Care Organizations (ACOs)
One of the provisions of the Affordable Care Act (aka Obamacare) created ACOs in an attempt to control the rapidly rising medical costs. An ACO is a group of doctors, hospitals, and other health care providers who come together voluntarily to give coordinated high quality care to their patients. This would save costs by avoiding unnecessary duplication of services and prevent medical errors.
The goal of coordinated care is to ensure that patients, especially the chronically ill such as those with HCV and HIV, get the right care at the right time. When an ACO succeeds both in delivering high quality care AND spending health care dollars more wisely, it will share in the savings it achieves.

This may sound a little like the HMO model for health care, and the goals are definitely similar in that it attempts to move away from paying by the treatment provided (fee-for-service) and tie payment more to health outcomes. What separates an ACO from an HMO is the patient is not locked in to any set of providers or hospitals where they must go for treatment. Beneficiaries can still go to any doctor or hospital. 

Under the terms of Obamacare, the ACO will be responsible for all the care needs for a group of patients and will be paid based on those patients’ health outcomes, satisfaction, and costs.

At present, ACOs are primarily being tried with beneficiaries who are on original, (or fee-for-service) Medicare. Private insurance companies are watching closely and are also starting to work with it on a smaller scale. Kaiser Health News reports that Medicare ACOs are already serving over one million Medicare recipients with promising results. For an interactive map showing current Medicare ACOs, see the site below: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/

By having the various medical providers working together more closely, health outcomes will be improved, there will be less wasted dollars from duplicate and unnecessary procedures being performed, fewer and shorter hospital stays, and greater patient satisfaction. The indications so far are good.

ABLE Savings Accounts
In December, 2014, Congress passed and the President signed the Achieving a Better Life Experience (ABLE) Act. Similar to the tax-sheltered 529 College Savings Accounts, it allows people with disabilities to establish a tax-sheltered fund to assist with expenses.

To qualify, a person must have been diagnosed by age 26 with a disability that results in “marked and severe functional limitations;” those receiving Social Security disability benefits would also qualify. Note that there is no age limit to establishing the fund, but diagnosis of the condition must have occurred while the disabled beneficiary is age 26 or less. While this would eliminate anyone diagnosed with HCV after age 26, it could be a significant tool for those who are eligible.

The beneficiary, family, and friends could set up and fund a tax-free at financial institutions, depositing up to $14,000 per year. Funds could be used for housing, health care expenses, transportation, education, employment training, personal support services, financial management, and administrative services. The contributions would be with after-tax dollars but earnings would grow tax-free.

The maximum amount of the fund would be the same as each state’s maximum for the 529 Education Tax-Free Funds. A major advantage is that as long as the fund remains below $100,000, the beneficiary would still be eligible for Supplemental Security Income (SSI) benefits. Regardless of the fund size, eligibility for Medicaid would continue.

The ABLE Fund would have significant advantages over the Special Needs Trust, currently used to maintain eligibility for needs-based public programs. They are much less expensive to set up, and they do not have the significant limitations on the use of the funds.

For more information contact a financial planner or a banker. States may also set up funding plans as they do with the Education Accounts.


Wednesday, February 18, 2015

Texas needs needle exchange program

A needle exchange program to help reduce the spread of HIV and hepatitis C may finally be a reality for Bexar County.

The launch of what is sometimes referred to as harm reduction programs was first attempted in 2008. At issue was vagueness in the wording of the law that exposed participants in the program to possible prosecution under state drug laws for possession of drug paraphernalia.

Rep. Ruth Jones-McClendon, D-San Antonio, has introduced HB 65, which would allow for pilot needle exchange programs in Bexar, Dallas, El Paso, Harris, Nueces, Travis and Webb counties. It provides for the the exchange of needles and syringes, education about communicable diseases such as HIV, hepatitis B and hepatitis C, and helps program participants access substance abuse and treatment and bloodborne disease testing.