Free pipes distributed to curb disease

Free crack pipes are being handed out to addicts in Vancouver's Downtown Eastside as part of a Vancouver Coastal Health harm-reduction project aimed to stop the spread of HIV and hepatitis B and C.

One distribution centre has handed out roughly 3,500 of the kits - which include shatterproof glass pipes - since the beginning of the month. The intention is to provide safe pipes that should reduce injury to users' lips and mouths that can make them more susceptible to disease.

Read more: http://www.vancouversun.com/health/Free+pipes+distributed+curb+disease/5932454/story.html#ixzz1i97wPJK8

Participants Needed for Hepatitis C Treatment Study. Reimbursement Available.

RIS Christie, a Market Research Company, is currently recruiting respondents to participate in an on-line survey.

The objective of the study is to understand the opinions of Americans living with hepatitis C virus (HCV).   The main purpose of the survey is to learn how a person may think about different treatments for the hepatitis C virus.

The online survey will take approximately 30-40 minutes to complete. Respondents will be asked to imagine being in a situation where they are being treated for Hepatitis C, and these situations will vary slightly in their attributes. Then, we would like to understand their opinion or preference for these scenarios. We will conclude by asking some demographic and clinical questions.

For their time, participants will be compensated $50.00.  A cheque will be mailed to them upon completion of the survey.  

Please feel free to contact us if you have any questions or would like additional information.  You can reach us at 1-800-277-7530 ext. 218 or you can email us at beau@rischristie.com 

Our interviewers can be reached at 1-800-277-7530 Ext. 217 or 246 (ask to speak with Antonia). 

Depending on the state the person is calling from, they may not be able to get through to our 1-800 number, in which case they can send an email to fai@rischristie.com and we’ll take it from there.



Regards,



Beau Rakhra
Director of Operations
R.I.S. Christie
14 Verral Avenue
Toronto, ON  M4M 2R2

Tel 1-800-277-7530 ext 218
email: beau@rischristie.com
http://www.rischristie.com

Gregg Allman touts importance of hepatitis C testing, reflects on his recovery

The soft-spoken co-founder of the Macon-based Allman Brothers Band, who peppers his conversation with “sweetheart” and “my dear,” is using his visibility to inform others about the quiet symptoms of hep C – mostly fatigue – on the website, www.TuneInToHepC.com.

“People have gotta listen to what this site has to say. Doing nothing is not an option,” Allman said. “It is a blood disease and I had it since I was 20 and didn’t know it until 1999. Everybody needs to get checked for this diabolical disease. If I hadn’t had a liver transplant, I wouldn’t be talking to you right now.”

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Peregrine Provides Update on HCV Clinical Program

Preliminary Data From Phase II Study Shows Antiviral Activity and Positive Safety Profile at Both Bavituximab Doses Evaluated; Supporting Further Dosing and Combination Studies; Company to Seek Collaboration to Advance HCV Program While Continuing to Focus on Its Lead Bavituximab Clinical Program in Multiple Solid Tumor Indications Including Lung Cancer

TUSTIN, CA -- (MARKET WIRE) -- 12/29/11 -- Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today provided an update from its randomized Phase II bavituximab study in patients infected with genotype-1 chronic hepatitis C virus (HCV). Patients were randomized in the three-arm study to receive one of two doses of bavituximab (0.3mg/kg or 3mg/kg) or pegylated interferon alpha-2a, in combination with ribavirin. The goals of the study were to determine if bavituximab plus ribavirin has a better safety profile as compared to interferon plus ribavirin, to confirm that the combination of bavituximab and ribavirin has antiviral activity defined as 12 week early virologic response (EVR)(1) and to compare antiviral activity of peg-interferon plus ribavirin versus bavituximab plus ribavirin.

A preliminary data analysis indicates that the combination of bavituximab and ribavirin appeared safe and well tolerated with patients reporting fewer side effects than in the interferon-containing arm. Initial data from the study also indicated that both dose levels of bavituximab with ribavirin demonstrated antiviral activity, however the antiviral effects in patients receiving the 0.3 mg/kg dosing level were more pronounced. A comparison of the viral data indicated that the kinetics of antiviral activity were different between the interferon and bavituximab treatment groups with a high percentage of those patients achieving EVR in the interferon arm of the study doing so between week 4 and 8 and the majority of patients achieving EVR in the bavituximab groups doing so at the week 12 end of study timepoint. More patients had achieved EVR in the interferon-containing group by the end of the study, however based on the nature of late EVR development in the bavituximab containing arms at the very end of the 12 week trial, a longer-term evaluation is needed to adequately compare the effectiveness of bavituximab and interferon. The company plans to present full results from the study at a medical conference in 2012.

"We are pleased with the initial results we have seen from this clinical study evaluating the combination of bavituximab with an established antiviral drug in HCV patients. We see good evidence that the combination of bavituximab with ribavirin has a better safety profile than an interferon containing regimen which was one of the primary objectives of the study," said Joseph S. Shan, vice president of clinical and regulatory affairs at Peregrine Pharmaceuticals. "In addition, we also see that while both dose levels of bavituximab were active, the lower dose level appears more active in HCV patients than the high dose level. Taken together, these early results are very important in validating that the combination of bavituximab with its immunological mechanism of action with an active antiviral agent has a good safety profile and promising antiviral activity. These results suggest that future studies evaluating longer bavituximab treatment durations at or around the lower dose level in combination with ribavirin and potentially direct acting antivirals in certain patient populations may hold promise as interferon-free HCV therapeutic regimens."

"The early data from this trial are promising and suggest that continued development of bavituximab in HCV patients is warranted to explore the full immune-modulating potential of the compound in combination with antiviral agents," said Steven W. King, president and chief executive officer of Peregrine. "With this data in hand, we plan to actively seek development partners interested in working with us to move the PS-targeting antiviral program forward while we continue to focus our resources on the advancement of our bavituximab oncology clinical program in multiple solid tumor indications including non-small cell lung cancer (NSCLC) and pancreatic cancers as well as other indications with high unmet medical need. With as many as six data points coming over the next six months or so from our ongoing phase II trials in front and second line NSCLC and the additional possible data points coming from five additional oncology trials, this is a good time to seek partners for the antiviral program which has shown promise in this study. We look forward to sharing full data from the HCV trial in 2012 and to moving the program forward in the future."

1. EVR is defined as equal or greater than a 2 log reduction in HCV RNA from baseline.

About the Phase II HCV Trial
In this multicenter Phase II randomized trial, 66 patients with previously untreated genotype-1 chronic HCV infection were randomly assigned to one of three treatment arms. Patients received daily oral ribavirin (1000 mg) with either weekly bavituximab (0.3 mg/kg or 3 mg/kg) or pegylated interferon alpha-2a (180 µg) for up to 12 weeks and were tested for safety parameters and antiviral activity.

About Bavituximab's Antiviral Approach
Bavituximab is the first in a new class of patented antibody therapeutics that target and bind to phosphatidylserine (PS), a specific phospholipid component of cell membranes. Bavituximab helps reactivate and direct the body's immune system to destroy infected cells and virus particles that exhibit this specific phospholipid on their surface. Since their target is host-derived rather than pathogen-derived, PS-targeting antibodies have the potential for broad-spectrum antiviral activity and are also expected to be much less susceptible to the viral mutations that often lead to drug resistance.


About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing multiple clinical programs in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.

 Read complete release here

State denies benefits for cop's widow

(FOX 25 / MyFoxBoston.com) - The widow of an honored Boston police officer is fighting the state for accidental death benefits 13 years after her husband died.

Maura Shaw believes her husband, Kenneth Shaw, who processed grisly crime scenes as part of the Boston Police Department's identification unit, was essentially killed in the line of duty, but the state has denied her application over and over again because she can't show exactly how he contracted hepatitis C decades ago.

Read more: http://www.myfoxboston.com/dpp/news/undercover/state-denies-benefits-for-cops-widow-20111227#ixzz1hr819j50

FDA Hepatitis Update - Tyzeka (telbivudine) labeling updates re: use with pegylated interferon alfa-2a

On December 23, 2011, the Food and Drug Administration approved revisions to the product labeling for Tyzeka (telbivudine) to include a contraindication regarding the use of Tyzeka with Pegasys (pegylated interferon alfa-2a) due to increase risk and severity of peripheral neuropathy. The Medication Guide was also revised accordingly. The following sections were revised:

Contraindications
Combination of Tyzeka with pegylated interferon alfa-2a is contraindicated because of increased risk of peripheral neuropathy

Warnings and Precautions

Peripheral Neuropathy
Peripheral neuropathy has been reported with Tyzeka alone or in combination with pegylated interferon alfa-2a and other interferons. In one clinical trial, an increased risk and severity of peripheral neuropathy was observed with the combination use of Tyzeka 600mg daily and pegylated interferon alfa-2a 180 micrograms once weekly compared to Tyzeka or pegylated interferon alfa-2a alone [see Contraindications (4) and Drug Interactions (7)]. Such risk cannot be excluded for other dose regimens of pegylated interferon alfa-2a, or other alfa interferons (pegylated or standard). The safety and efficacy of Tyzeka in combination with pegylated interferons or other interferons for the treatment of chronic hepatitis B has not been demonstrated. Patients should be advised to report any numbness, tingling, and/or burning sensations in the arms and/or legs, with or without gait disturbance. Tyzeka therapy should be interrupted if peripheral neuropathy is suspected, and discontinued if peripheral neuropathy is confirmed

Drug Interactions:
A clinical trial investigating the combination of Tyzeka, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of peripheral neuropathy occurrence and severity, in comparison to Tyzeka or pegylated interferon alfa-2a alone

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Incivek and Victrelis Usage as Part of Triple Therapy Hepatitis C Regimen is Emerging as the New Standard of Care for Genotype 1 Patients According to a Newly Released Report by BioTrends Research Group

EXTON, Pa.--(BUSINESS WIRE)-- Six months post-launch of Vertex’s Incivek (telapravir) and Merck/Roche’s Victrelis (boceprevir), specialists report a significant increase in usage of both products in their genotype 1 HCV patients compared to one month post-launch. Incivek remains the market share leader, though the gap in preference for Incivek over Victrelis is beginning to narrow compared to previous waves of research. Surveyed hepatologists reported using significantly more Incivek than infectious disease specialists.

Not all Genotype 1 patients are being treated with this new standard of care, however. Patient resistance to being re-treated with any interferon regimen is still quite high. On the flip side, 49% of the surveyed physicians do report trial for the protease inhibitors in other genotypes despite a lack of supportive clinical data. With regards to products in development, surveyed physicians report the greatest familiarity with Pharmasett’s PSI-7977, an investigational nucleoside polymerase inhibitor that is currently being tested in a phase 3 clinical trial without the use of interferon.

Read more....

Updated: Hepatitis B Vaccination for Adults with Diabetes Mellitus: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

Use of Hepatitis B Vaccination for Adults with Diabetes Mellitus: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

Hepatitis B virus (HBV) causes acute and chronic infection of the liver leading to substantial morbidity and mortality. In the United States, since 1996, a total of 29 outbreaks of HBV infection in one or multiple long-term–care (LTC) facilities, including nursing homes and assisted-living facilities, were reported to CDC; of these, 25 involved adults with diabetes receiving assisted blood glucose monitoring (1; CDC, unpublished data, 2011). These outbreaks prompted the Hepatitis Vaccines Work Group of the Advisory Committee on Immunization Practices (ACIP) to evaluate the risk for HBV infection among all adults with diagnosed diabetes. The Work Group reviewed HBV infection–related morbidity and mortality and the effectiveness of implementing infection prevention and control measures. The strength of scientific evidence regarding protection was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology,* and safety, values, and cost-effectiveness were incorporated into a recommendation using the GRADE system. Based on the Work Group findings, on October 25, 2011, ACIP recommended that all previously unvaccinated adults aged 19 through 59 years with diabetes mellitus (type 1 and type 2) be vaccinated against hepatitis B as soon as possible after a diagnosis of diabetes is made (recommendation category A). Data on the risk for hepatitis B among adults aged ≥60 years are less robust. Therefore, ACIP recommended that unvaccinated adults aged ≥60 years with diabetes may be vaccinated at the discretion of the treating clinician after assessing their risk and the likelihood of an adequate immune response to vaccination (recommendation category B). This report summarizes these recommendations and provides the rationale used by ACIP to inform their decision making.

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Incivo approved in Scotland

Scottish Medicines Consortium approves INCIVO® (telaprevir), a new treatment for genotype-1 chronic hepatitis C, for use within NHS Scotland¹

Janssen PharmaceuticalPosted on:23 Dec 11

Shortens the course of treatment for many (58%) treatment naive genotype-1 chronic hep C patients compared to current standard treatment²

High Wycombe, 12th December 2011 – Today the Scottish Medicines Consortium (SMC) has recommended that INCIVO® (telaprevir)* should be made available for the treatment of genotype-1 chronic hepatitis C (hep C), in combination with peginterferon alfa and ribavirin (i.e. current standard treatment), in adults in Scotland who have not previously had treatment and adult patients for whom treatment has previously failed¹.

Telaprevir, a new direct acting antiviral (DAA) protease inhibitor (PI), one of a new class of medicines which directly targets the Hep C virus, now offers significantly more patients infected with genotype 1 chronic hep C in Scotland the chance of clearing the virus (achieving sustained virologic response, SVR)^2,3,4 compared to current standard treatment.

“I welcome the news that telaprevir can now be prescribed for patients living with chronic genotype-1 hep C in Scotland. Before the introduction of protease inhibitors, of which telaprevir is the latest, treatment for hep C required a long duration and less than 50% of chronic genotype-1 hep C patients got rid of the virus” said Dr John F Dillon, Consultant Hepatologist and Gastroenterologist, University of Dundee Ninewells Hospital. “For many adults with chronic genotype-1 hep C, treatment with a telaprevir based regimen could provide a shorter treatment duration with improved response rates compared to standard treatment.”

In Scotland, it is estimated that 50,000 individuals are infected with hep C⁵. Hep C is a significant public health threat. It is highly infectious, often has no symptoms and can lead to fatal liver conditions. Of those who develop hep C an estimated 30% will develop cirrhosis (deterioration of the liver), others will develop liver cancer, some of whom may require liver transplantation⁶. Hep C is the most common reason for liver transplants in Europe7. A model, developed in Scotland, which looks at transmission rates for hep C has shown that effective treatment of the disease, assuming a 62.5% SVR rate, could reduce the onward transmission of the virus and its occurrence in the community. Taking this into account it could be expected that effective treatment of hep C with a treatment regimen that achieves a higher SVR rate will, in the longer term, reduce the risk of transmission among the population and lower the burden of hep C on NHS Scotland⁸. The standard treatment for hep C, peginterferon alfa and ribavirin, is successful in only about 50% of patients with genotype 1, leaving the other 50% without a successful treatment outcome⁶.

Clinical trials have shown that a telaprevir based regimen is significantly more effective than standard treatment in all genotype-1 patient types, including those with advanced liver disease such as cirrhosis. The addition of telaprevir cleared the Hep C virus in almost twice as many previously untreated patients (79% vs. 46%, p<0.0001) and almost four times as many who had previously relapsed following treatment (84% vs. 22%, p<0.001)^3,4,9. It also offers the potential to halve the current total treatment duration to just six months in many (58%) previously untreated patients and prior treatment relapsers^2,3,9.

The marketing authorisation for telaprevir was based on results from three phase III clinical trials, ADVANCE, REALIZE and ILLUMINATE^3,4,9 which evaluated the efficacy and safety of telaprevir in combination with peginterferon alfa and ribavirin in more than 2,290 treatment-naïve and previously-treated chronic genotype 1 hep C patients. Data from ADVANCE and REALIZE were published in the 23rd June 2011 edition of the New England Journal of Medicine (NEJM). Data from the ILLUMINATE study were published in the 15th September 2011 edition of the NEJM. This marked the sixth paper to be published on telaprevir in the NEJM^10,11,12.

The overall safety and tolerability profile of telaprevir is based on the phase II and III clinical development programme. The most frequently reported moderate adverse reactions (incidence = 5.0%) were anaemia, rash, pruritus, nausea, and diarrhoea, and the most frequently reported severe adverse reactions (incidence = 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea2.Rash events were reported in 55% of patients with telaprevir based treatment compared with 33% in the control arm (peginterferon alfa and ribavirin only). More than 90% of rashes were of mild or moderate severity. Severe rashes were reported with telaprevir based treatment in 4.8% of patients. Rash led to discontinuation in 5.8% of patients. Anaemia was reported in 32.1% of patients compared with 15% in the control arm (peginterferon alfa and ribavirin only). It led to discontinuation in approximately 3% of patients².

* INCIVO® (telaprevir), a direct acting antiviral protease inhibitor, was co-developed by Vertex Pharmaceuticals and Tibotec, an affiliate of Janssen Pharmaceutical Companies of Johnson & Johnson, and the company responsible for marketing telaprevir in Europe.

References
1.The Scottish Medicines Consortium (http://www.scottishmedicines.org.uk/Home), accessed December 2011
2.Telaprevir Summary of Product Characteristics 2011
3.Jacobson, Ira M. Telaprevir for Previously Untreated Hepatitis C Virus Infection. N Engl J Med. 2011; 364; 2405-16.
4.Zeuzem, Stefan MD. Telaprevir for Retreatment of HCV Infection. N Engl J Med. 2011; 364; 2417-28.
5.Hepatitis C Action Plan for Scotland Phase II May 2008-March 2011
6.TA200: Peginterferon Alfa and Ribavirin for the treatment of chronic hepatitis C. Part review of NICE technology appraisal guidance 75 and 106. Issued September 2010
7.Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Rev Vaccines. 2008;7(7): 915-923
8.Martin NK, Vickerman P, Foster GR, Hutchinson SJ, Goldberg DJ, Hickman M. Can antiviral therapy for hepatitis C reduce the prevalence of HCV among injecting drug user populations? A modeling analysis of its prevention utility. J Hepatol 2011 Jun;54(6):1137-44
9.Sherman et al. Duration of Initial Telaprevir Treatment for HCV Infection: A phase 3 study of treatment duration, N Engl J Med. 2011: 365; 1014-24.
10.McHutchinson et al. Telaprevir for Previously Treated Chronic HCV Infection. Engl J Med. 2010; 362; 1292-1303.
11.Hezode et al. Telaprevir and Peginterferon Alfa with or without Ribavirin for Chronic HCV. Engl J Med 2009; 360; 1839-50.
12.McHutchinson et al. Telaprevir with Peginterferon Alfa and Ribavirin for Chronic HCV Genotype 1 Infection 2009 N Engl J Med 2009; 360: 1827-38.

For more information:
http://www.janssen.co.uk

Read more: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=52319#ixzz1hNu34mYg

Hepatitis outbreak grows

Health Department secures vaccine; now seven cases confirmed

--Outbreak comes as the Lincoln County Commission has scheduled to close the local Health Department office on Friday, Dec. 30, for budget cuts--

An outbreak of Hepatitis C has surfaced in Lincoln County, according to Marci Johnson, communicable diseases coordinator of Lincoln County.

“We’re still investigating it, but right now we’ve got seven confirmed cases,” Johnson said Sunday afternoon. “I’ve been in contact with the state, and they have agreed to supply us with the vaccines for Hepatitis A and B at no charge.”

 Read more....

Bristol-Myers liver cancer drug Brivanib fails

BRISK-PS Study with Investigational Compound Brivanib in Hepatocellular Carcinoma Completed

--Primary endpoint of study not met--

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today reported that the Phase III BRISK-PS (Brivanib Study in HCC Patients at Risk Post Sorafenib) clinical trial in patients with hepatocellular carcinoma (HCC; liver cancer) who failed or are intolerant to sorafenib did not meet the primary endpoint of improving overall survival versus placebo.

BRISK-PS is a multicenter, double-blind, randomized study of the investigational agent brivanib plus best supportive care (BSC) versus placebo plus BSC in HCC in patients who have progressed on sorafenib. Bristol-Myers Squibb and the lead investigators plan to present the findings of the study, including secondary efficacy and safety endpoints, at an upcoming scientific meeting. The BRISK-PS study is one of four Phase III clinical trials evaluating brivanib in different HCC patient populations. These ongoing Phase III studies continue as planned.

“The treatment options for patients with HCC following failure of sorafenib are limited, and thus we are disappointed that the primary endpoint was not met,” said Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. “We remain committed to the development of brivanib as a potential treatment option for patients with liver cancer, and the ongoing study investigating brivanib ‘first-line’ is expected to complete in 2012.”

About Bristol-Myers Squibb’s Commitment to Liver Disease and Brivanib

Bristol-Myers Squibb is advancing a portfolio of compounds that aim to address unmet medical needs across the liver disease continuum, including hepatitis C, hepatitis B and liver cancer. Brivanib is an investigational, oral, anti-tumorigenic being developed by Bristol-Myers Squibb for the treatment of hepatocellular carcinoma (HCC). Brivanib inhibits vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptors (FGFR). Brivanib has been investigated in 29 studies to date, including more than 4,000 patients around the world.

Read complete press release here

Child gets hepatitis C from transplant at Boston hospital

A child treated at Children’s Hospital Boston was infected with hepatitis C by a piece of a blood vessel that was transplanted in September from a donor who was infected. Two people in Kentucky who received kidneys from the same donor also were infected, the federal Centers for Disease Control and Prevention reported today.

The agency traced the transmission in Massachusetts to an error in tissue testing and delays in communication between the Kentucky transplant center and public health officials. The incident highlights the need for improvements in transplant safety and tracking, said Dr. Matthew J. Kuehnert, director of the Office of Blood, Organ, and Other Tissue Safety at the CDC.

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Drug Users in California to Have Better Access To Clean Needles

Starting next year, injection drug users will have easier access to clean syringes. Two new laws are part of an effort to prevent transmission of diseases such as Hepatitis C and HIV.

Studies show needle exchange programs are effective in reducing HIV transmission.

California has thirty-seven exchange programs, and a new law could help authorize more.

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Bioethicist: Slashing funds for clean needles is risky for rest of us

Giving clean needles to IV drug addicts saves lives – and money. That’s why the federal government should be spending your tax dollars to keep drug users -– and the people who have sex with them -- from getting AIDS and hepatitis.

But Republicans in Congress have decided that despite a veritable mountain of scientific evidence showing that needle-exchange work, they are not going to pay for this sort of program any more.

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Chinese doctors find way to detect liver cancer earlier

SHANGHAI, Dec. 19 (Xinhua) -- A simple test using just one milliliter of a patient's blood can tell whether the patient has liver cancer -- even if the tumor is less than two centimeters in diameter, new medical research in Shanghai shows.

Doctors at the Zhongshan Hospital, a major medical institution affiliated with Fudan University, have found that seven microRNAs, or ribonucleic acid molecules, are strongly related to liver problems. This discovery can raise the accuracy of tests for early-stage liver cancer to almost 90 percent.

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Safe injection site plan is scientifically sound: health official

Despite Ottawa's opposition, strategy reduces ODs, infections, doctors agree


A report released Friday by the Montreal public health department recommends that three supervised injection sites and a mobile one be established next year in city neighbourhoods where intravenous drug use is rampant.


"We are convinced - and all the scientific studies back us up on this point - that supervised injection sites do not create new problems," Lessard told The Gazette. "On the contrary, they reduce the problem of syringes found on the streets and in the parks, and they reduce the number of overdose deaths."

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Congress to Restore Federal Syringe Exchange Funding Ban as Part of 2012 Spending Package

Drug Policy Alliance

www.drugpolicy.org

For Immediate Release: December 16, 2011
Contact: Tony Newman or Bill Piper

Congress to Restore Federal Syringe Exchange Funding Ban as Part of 2012 Spending Package

Ban on Allowing States to Use HIV Prevention Money on Life-Saving Syringe Programs was Overturned in 2009 After 20-Year Struggle

Reinstatement of Ban will Lead to Thousands of New HIV/AIDS, Hepatitis C Cases Annually

As part of the 2012 spending package being voted on today, Congress is restoring a ban on using federal funding for syringe exchange programs that reduce the spread of HIV/AIDS, hepatitis C, and other infectious diseases. The ban, enacted in the 1980s and repealed in 2009, was largely responsible for hundreds of thousands of Americans contracting HIV/AIDS directly or indirectly from the sharing of used syringes. Advocates warn that restoring the ban will result in thousands of Americans contracting HIV/AIDS, hepatitis C or other infectious diseases next year alone.

“The federal syringe funding ban was costly in both human and fiscal terms – it is outrageous that Congress is restoring it given how overwhelming and clear the science is in support of making sterile syringes widely available,” said Bill Piper, director of national affairs for the Drug Policy Alliance. “Make no mistake about it – members of Congress who supported this ban have put the lives of their constituents in jeopardy.”

House Republicans passed restrictive language in three separate appropriations bills, and succeeded in getting two of three bans in the current House-Senate compromise omnibus for Fiscal Year 2012 being voted on today. In addition to the overarching ban on domestic use of federal funds contained in the Labor-HHS spending bill, House republicans also succeeded in imposing a ban on use of State Department funds for syringe access in international programs. In large parts of the world the HIV/AIDS epidemic is being driven by injection drug use. The international syringe funding ban will mean the global HIV/AIDS epidemic will continue to grow.

The existing federal syringe exchange policy, signed into law by President Obama in December of 2009, allows states and local public health officials to use federal funds for syringe access, in consultation and with the consent of  local law enforcement. The policy change is widely credited with having prevented thousands of new cases of HIV and Hepatitis C, thereby saving many lives and improving public health and safety.

The Centers for Disease Control and Prevention (CDC), American Medical Association, National Academy of Sciences, American Public Health Association, and numerous other scientific bodies have found that syringe exchange programs are highly effective at preventing the spread of HIV/AIDS and other infectious diseases. Increasing the availability of sterile syringes through exchange programs, pharmacies and other outlets also helps injection drug users obtain drug education and treatment. Eight federal reports have found that increasing access to sterile syringes saves lives without increasing drug use.

“We may have lost this battle, but we have just begun to fight,” said Piper. “The Republicans who insisted on restoring the ban, and the Democrats who didn’t fight hard enough to oppose it, will be responsible for thousands of Americans contracting HIV/AIDS or hepatitis C. We will make sure Americans know which members of Congress care about their health and well-being and which do not.”

Safety (Still) Trumps Acquisitions in Hep C

The euphoria over Gilead Sciences' (Nasdaq: GILD ) acquisition of Pharmasset (Nasdaq: VRUS ) and Roche's purchase of Anadys Pharmaceuticals seems to have caused memory loss in investors.

But they got a reminder of reality today, when Pharmasset announced it was discontinuing all treatment arms in one of its phase 2b trials that contain the drug PSI-938. The drug candidate caused laboratory abnormalities in tests associated with liver function.

This is nothing new.

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Research could solve donor liver shortage

Research from Curtin University could see bio-engineered liver tissue used instead of donor tissue for liver transplants.

The research aims to address the increasing burden of liver disease and shortage of donor organs occurring in all Western countries.

Dr Nina Tirnitz-Parker, research fellow at Curtin’s School of Biomedical Sciences, has spent the past eight years developing a method of bio-engineering liver cells, or hepatocytes, to replace tissue lost to disease or injury.

Read more.......

Outbreak of Hepatitis A on Vancouver Island Hitting Aboriginals Hard

Aboriginal people on the West Coast of Vancouver Island are being hit hard by an outbreak of Hepatitis A, according to Vancouver Island Health Authority (VIHA) chief medical health officer Paul Hasselback.

“Of the last 17 cases that were diagnosed, 15 of them are from the Alberni Valley and West Coast,” Hasselback said in early December. “We’ve seen clusters of Hep A in various locations, but right now the cluster is there.”


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Pharmasset Halts Studies with PSI-938

Pharmasset Inc. has discontinued use of an experimental hepatitis C drug in a clinical trial because of safety concerns, but the drug maker said the setback wouldn't derail its planned sale to Gilead Sciences Inc. for nearly $11 billion.

The company said Friday it discontinued use of a drug code-named PSI-938 in a midstage study of people with hepatitis C infection, citing "laboratory abnormalities associated with liver function." However, it will continue testing its lead hepatitis C drug candidate, PSI-7977, which was the primary selling point behind the Gilead deal and ...

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Merck and Roche team up for hepatitis C studies

The first study will look at a regimen based on Merck's recently-approved oral NS3/NS4a inhibitor Victrelis (boceprevir) alongside Roche's investigational NS5B inhibitor mericitabine (RO5024048) and already-marketed drugs Pegasys (peginterferon alfa-2a) and Copegus (ribavirin).

The phase II study - called DYNAMO 1 - will enrol adult patients with HCV genotype 1 infection who have failed to respond to prior treatment with peginterferon alfa/ribavirin therapy.

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Clinical Care Options Launches CCO Hepatology inPractice™, Adding a Third Specialty to its Comprehensive Online Resource

RESTON, Va., Dec. 15, 2011 -- /PRNewswire/ -- Clinical Care Options (CCO), a leader in the development of innovative online, print, and live medical education programs and medical education technologies for healthcare professionals, is proud to announce the launch of CCO Hepatology inPractice™, the third specialty area for the free, online point-of-care resource for clinicians that provides critical information for the management of viral hepatitis. CCO HIV inPractice™ and CCO Oncology inPractice™, now used around the world, are available at inPractice.com.

CCO Hepatology inPractice™, authored by 14 world-renowned experts and led by Editors in Chief Nezam H. Afdhal, MD, FRCPI, of Harvard University; Norah Terrault, MD, MPH, of the University of California, San Francisco; and Stefan Zeuzem, MD, of JW Goethe University Hospital, provides a single easy-to-use search interface. Performing a search on Hepatology inPractice initially allows the busy clinician direct access to the first 10 original, expert-authored chapters designed specifically for point-of-care use, integrated with drug information, treatment guidelines, conference coverage, PubMed abstracts, and ClinicalTrials.gov.

Read more: http://www.sacbee.com/2011/12/15/4125174/clinical-care-options-launches.html#ixzz1gj0rNIog

Pharmasset Announces Intent to Amend QUANTUM Trial

PRINCETON, N.J., Dec. 16, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that the company will amend the design of the QUANTUM Phase 2b trial of the guanine nucleotide analog PSI-938 and discontinue all treatment arms with a regimen containing PSI-938. There are 235 individuals with hepatitis C virus (HCV) in the study who are receiving treatment with PSI-938 alone or in combination with PSI-7977 or PSI-7977 and ribavirin.  During routine safety monitoring, the company detected laboratory abnormalities associated with liver function in subjects receiving PSI-938 300 mg once daily.  These laboratory abnormalities have not been observed in patients receiving PSI-7977 and ribavirin in the QUANTUM study or in other trials evaluating PSI-7977.  Both the 12 and 24-week PSI-7977 and ribavirin arms will continue unchanged, data from which will support  NEUTRINO, an interferon free, 12-week Phase 3 study of PSI-7977 and ribavirin in patients with HCV genotype 1 (GT-1).

The subject of today's announcement does not trigger the "key product event" clause set forth in section 4.1(t) of the Agreement and Plan of Merger entered into by Pharmasset and Gilead Sciences, Inc. on November 21, 2011 and does not alter either party's rights and obligations under the terms of the agreement. Pharmasset anticipates that the transaction announced on November 21, 2011 will conclude in the first quarter of 2012.


SOURCE Pharmasset, Inc.

URGENT ACTION REQUESTED: Syringe Exchange Federal Ban

The House Republican Leadership has released an appropriations omnibus bill that includes language banning the use of federal funding for syringe exchange programs.  This policy-rider is included in the bill, despite proven evidence that syringe exchange programs are a key tool in our viral hepatitis and HIV/AIDS prevention arsenal.  Additionally, this is particularly troubling in an era in which reducing new infections is a principle goal of the HHS Viral Hepatitis Action Plan. While the House bill has been released to the public, there remain opportunities to oppose this measure.

Viral hepatitis and HIV/AIDS community advocates continue a multi-pronged strategy to ensure this measure is not included in the final FY2012 appropriations bill, including reaching out to key House and Senate allies. While the House has made its bill public, there is an opportunity to weigh-in with the Senate (i.e., both your own U.S. Senators and key Senate Leadership negotiating the scope of the bill and any potential policy-riders). Calls on this issue to individual offices can make a difference. 

Please take a couple of minutes to call the White House, your Senator (click here to access the Senate directory) and Senate Leadership in this order:

Harry Reid, Senate Majority Leader - 202-224-3542

Dick Durbin, Senate Majority Whip - 202-224-2152 

Chuck Schumer, Democratic Policy Committee Chair - 202-224-6542 

Daniel Inouye, Appropriations Chairman - 202-224-3934 

Tom Harkin, HHS Appropriations Subcommittee Chair- 202-224-3254  

President Obama- 202-456-1414

YOUR SENATORS (click here to access the Senate directory)

Here is a script you can use for calls:

“My name is _______ and I’m from ______, __ (city, state). I support maintaining current language that allows local officials to make their own decisions to use federal and local Washington DC funds for syringe exchange.  This evidence-based prevention approach will reduce new HIV and viral hepatitis infections, which is a key goal of the National HIV/AIDS Strategy and the Viral Hepatitis Action Plan.  The House proposed bill includes a ban on the use of federal resources for these important programs, which will harm HIV and viral hepatitis prevention efforts. Please do not allow a change in the current law. Thank you.”

Please take the time to call and to pass this message on to your other contacts! Please contact Oscar Mairena if you have any questions.

Oscar Mairena

Senior Associate, Viral Hepatitis/Policy and Legislative Affairs

National Alliance of State & Territorial AIDS Directors (NASTAD)

444 North Capitol Street NW, Suite 339

Washington, DC  20001

Phone: (202) 434.8058      Fax: (202) 434.8092

omairena@NASTAD.org     www.NASTAD.org  

"Bridging Science, Policy, and Public Health"

Obesity and Diabetes Epidemics Spur Increase in Nonalcoholic Steatohepatitis

Liver Transplantations for NASH-Cirrhosis Grew More than 600% over Past Decade 

Nonalcoholic steatohepatitis (NASH) occurs when fat builds up in the liver. This accumulation of fat damages the liver and leads to cirrhosis. NASH is rapidly increasing in the U.S. mainly related to the epidemics of obesity and diabetes. As a result, the proportion of liver transplantations performed for NASH cirrhosis rose dramatically from roughly 1% in 1997-2003 to more than 7% in 2010. However, according to new research published in Liver Transplantation, a peer-reviewed journal of the American Association for the Study of Liver Diseases, post-transplantation survival for NASH patients is excellent, with one-year survival rates near 88%. 

Excessive fat in liver cells in the absence of alcohol is known as non-alcoholic fatty liver disease (NAFLD) and is the most common liver disease in the U.S., affecting nearly 30% of the general population experts say. Previous research found that 15% to 20% of those with NAFLD have NASH—the most severe form of fatty liver causing inflammation and fibrosis. Primary risk factors for both NAFLD and NASH are central obesity, insulin resistance, and diabetes, all of which are increasingly prevalent and could impact the future demand for liver transplantation. In fact, prior studies suggest that by 2025 more than 25 million Americans may have NASH, which may progress to cirrhosis, liver cancer, and liver failure in 20% of these cases. This influx of new cases has the potential to dramatically worsen the shortage of organs available for transplantation.  

In the current study, Dr. Anita Afzali and colleagues from the University of Washington in Seattle investigate the proportion of liver transplantations of NASH-related cirrhosis in the U.S. and estimate survival rates of those patients following transplantation. “With the epidemics of obesity and diabetes giving rise to cases of NAFLD and NASH, it is important to understand the impact of these metabolic conditions on the outcomes after liver transplantation,” says Dr. Afzali. 

The researchers used data collected by the United Network for Organ Sharing (UNOS) for all liver transplants performed in the U.S. from January 1, 1997 to October 31, 2010. A total of 53,738 transplant patients 18 years of age or older were included in the analysis. The team collected data on primary diagnosis for all study patients, categorizing those as NASH, cryptogenic cirrhosis, hepatitis C virus (HCV), alcohol-related cirrhosis, primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), hemochromatosis, autoimmune hepatitis, acute hepatic necrosis, and hepatocellular carcinoma (HCC). 

The research found that only 279 transplantations for NASH-cirrhosis (1.2%) were performed between 1997 and 2003, but increased dramatically to 1,531 (7.4%) between 2004 and 2010. The team found that by the end of the study period NASH was the fourth most common indication for transplantation behind HCC (34%), HCV (22%), and alcohol-related liver disease (11%). Survival was excellent among patients with NASH with 88% surviving at one year, 82% at three years, and 77% at five years following liver transplantation. 

Patients with NASH had higher survival rates than patients with HCC, HCV, alcoholic liver disease, acute hepatic necrosis, hemochromatosis and cryptogenic liver disease, but were lower than those with PBC, PSC, autoimmune hepatitis and HBV. Post-transplantation survival was similar in NASH patients compared to non-NASH patients, despite being older, more obese, and more likely to have diabetes. Their analysis shows deaths caused by recurrent disease occurred in roughly 9% of NASH patients compared to 17% of patients without NASH. The authors believe this is likely due to a greater frequency of recurrence of diseases such as HCV in those without NASH. 

“Our study confirms post-transplantation survival in recipients transplanted for NASH is excellent and comparable to patients with other liver diseases,” concludes Dr. Afzali. “With the shortage of available donor organs, appropriate allocation of livers is an important concern for transplant centers and our findings indicate NASH-cirrhosis patients are potentially good candidates for liver transplantation. However, careful screening for cardiovascular disease prior to transplantation and monitoring of underlying cardiac and metabolic conditions following transplantation is recommended to ensure optimal survival for patients with NASH.” 

Full citation: "Excellent Post-Transplantation Survival in Patients with Non-Alcoholic Steatohepatitis in the United States.” Anita Afzali, Kristin Berry, George N. Ioannou. Liver Transplantation; (DOI: 10.1002/lt.22435) Print Issue Date: January 2012. http://onlinelibrary.wiley.com/doi/10.1002/lt.22435/abstract. 

Author Contact:To arrange an interview with Dr. Afzali, please contact Carrie Silverman with the University of Washington at carries@medicine.washington.edu or at 206-235-3223.

About the Journal
Liver Transplantation. is published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society . Since the first application of liver transplantation in a clinical situation was reported more than twenty years ago, there has been a great deal of growth in this field and more is anticipated. As an official publication of the AALSD and the ILTS, Liver Transplantation. delivers current, peer-reviewed articles on surgical techniques, clinical investigations and drug research — the information necessary to keep abreast of this evolving specialty. For more information, please visit Liver Transplantation. 

About Wiley-Blackwell
Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world’s leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit www.wileyblackwell.com or our new online platform, Wiley Online Library (wileyonlinelibrary.com), one of the world’s most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.

Hepatitis B genotype B associated with poorer liver-related outcomes in Taiwanese patients co-infected with HIV and hepatitis B

Liver-related outcomes are poorer in HIV-positive patients who are co-infected with hepatitis B virus genotype B compared to co-infected patients with hepatitis B genotype C, Taiwanese investigators report in the online edition of Clinical Infectious Diseases.

The prospective, observational study involved individuals who commenced antiretroviral therapy containing 3TC (lamivudine, Epivir, also in the combination pill Combivir), a drug which has activity against both viruses. The patients were recruited between 1997 and 2008, and followed until 2010.

Read more....

Co-infection with hepatitis B worsens HIV-related outcomes

Co-infection with hepatitis B virus increases the risk of AIDS or death for patients newly diagnosed with HIV, investigators from the US military report in the online edition of the Journal of Infectious Diseases.

Individuals with chronic hepatitis B infection were twice as likely to progress to AIDS/death compared to patients who were only infected with HIV.

Read more.....

Important sign-on for viral hepatitis and HIV/AIDS organizations: Support a High National Standard for Essential Health Benefits

Note that sign-ons are needed by noon Eastern time this Wednesday, 12/14. To sign, email Ryan Clary at rclary@projectinform.org

Dear NVHR member: 

Reports are that the essential health benefits package rules may already be at the Office of Management and Budget(OMB) and may be issued as guidance rather than regulations.  Additionally - states will have significant flexibility in determining the benchmark for their EHB package (see clip below).

The HIV and viral hepatitis communities are circulating the attached letter to send to Secretary Sebelius and OMB calling for a robust national standard for people with HIV and viral hepatitis to reduce health disparities among these populations and improve our nation’s public health.  

To sign on – please email Ryan Clary at rclary@projectinform.org by noon on Wednesday (12/14). Apologies for the quick turnaround.

From InsideHealthPolicy:

Essential Health Benefits

Several sources confirmed last week to IHP's Rachana Dixit that the Office of Management and Budget had received paperwork on the health law's Essential Health Benefits package. The OMB hasn't posted information yet, leading many to believe that the paperwork is likely guidance rather than a proposed rule – which it would be required to post.

Meanwhile, as Dixit notes, business and insurance groups have been urging HHS in private discussions to craft an essential health benefits package that is not only affordable but also flexible in nature and are anxiously awaiting to see how specific the EHB regulation or guidance will be in terms of benefits and cost-sharing. Industry sources say they were encouraged by several of the recommendations in the highly anticipated Institute of Medicine report on essential health benefits, including that the initial EHB package should be guided by a national average premium target and it should be linked to the actuarial value of a typical small employer plan. Yet industry officials remain concerned that the rule will not provide the flexibility they seek, worrying that HHS may follow CMS' more rigid approach with Medicare benefits and that a recent decision with respect to preventive services coverage could serve as a signal for what direction the department will take with EHB, sources say.

Sign-on letter text:

December XX, 2011

The Honorable Kathleen Sebelius
Secretary
United States Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Secretary Sebelius:

We are writing on behalf of the more than 5 million people with hepatitis B or C (viral hepatitis) and 1.2 million with HIV/AIDS in the United States to express serious concerns regarding reports about the pending release of the federal standards for the EHB package. Specifically, we are concerned that the EHB package rules may be issued as guidance rather than regulations and that the guidance will offer significant flexibility to states in selecting the benchmark for their EHB package.  

The ACA offers unprecedented opportunity to ensure people with HIV/AIDS and viral hepatitis have affordable access to the medical care that they need to stay healthy and productive regardless of where they reside in the United States. In addition, the EHB package will apply to a wide range of populations – including newly-eligible Medicaid beneficiaries, those eligible for subsidized insurance in the Exchanges, and those eligible for coverage through Basic Health Plans – and the standard set by HHS must be able to meet the needs of these populations.  However, allowing considerable state and local discretion with regard to the EHB definition runs counter to the protections for vulnerable populations explicitly articulated in the ACA, including ensuring that the package is designed in ways that do not “discriminate against individuals because of their age, disability, or expected length of life” and ensuring that the package “take into account the health care needs of diverse segments of the population, including women, children, persons with disabilities, and other groups.” (§ 1302(b)(4). Setting a high national standard for the EHB package for benefits coverage and benefits design is critical to realizing the potential of the ACA and for ending the cruel disparities and gaps in coverage experienced by these populations due in part to the significant state variation in public and private health coverage programs and rules.

Many people with HIV/AIDS and viral hepatitis are currently uninsured or underinsured as a result of insurance practices that bar them from coverage entirely or policies that impede access to medically necessary care. These practices include unreasonable cost-sharing, limits on services or complex administrative and utilization management processes driven by reducing expenditures rather than promoting the standard of care. A failure to set a high national EHB standard will undermine the new insurer rules intended to end these discriminatory practices and increase state-based health disparities. 

The National HIV/AIDS Strategy and National Viral Hepatitis Plan were developed in recognition of our failure to adequately address the prevention and care needs of people with HIV and viral hepatitis in the United States.  A robust national EHB standard is critical to strengthen our response to these epidemics and to improving our nation’s public health. We strongly urge you to ensure people with HIV/AIDS and viral hepatitis gain meaningful health coverage by setting the highest possible EHB standard and issuing explicit regulations (as opposed to guidance) on how the EHB package is to be implemented so that there is a meaningful standard across the United States.

Respectfully submitted,

Doctors say they have no duty to lock up sedatives

DENVER (AP) — Denver doctors tell lawyers they don't have a duty to lock up surgery sedatives in a lawsuit over a surgery technician who infected patients with hepatitis C.

Dr. Sherry Gorman says she was not responsible after Joshua Kraft got infected by a dirty needle in 2009. Kristen Parker later pleaded guilty to several charges of tampering with a consumer product and illegally obtaining a controlled substance.

Read more...

Amick: The needle exchange debate

For those working to achieve sensible public-health policies in New Jersey, two important questions await answers in the waning days of 2011.

Question 1: The Legislature completed action last week on a bill to allow pharmacies to sell up to 10 hypodermic needles to adults without a prescription. By enabling intravenous drug addicts to obtain clean syringes, the measure would reduce the spread of HIV, hepatitis C and other blood-borne diseases. Will Gov. Chris Christie sign it into law? As of this writing, his administration says only that the bill “will get careful review and consideration.”

Read more....

Federal funding for syringe exchange is under attack!

Harm Reduction Coalition

Dear friends: 

Advocates went to the Senate this morning and we have heard that negotiations on the federal spending bills, including policy riders which would ban syringe exchange funding, are taking place at the highest levels.  Syringe exchange may be in danger.  We need to get calls to the offices below. Please take 5 minutes to make some calls ASAP while there is still time!! 

Please make 4 calls (in this order) TODAY to the President, Senate Majority Leader Reid, Senator negotiators and leadership from your state, and Speaker Pelosi. 

Calling the President:

Please call President Barack Obama: 202-456-1414

The message for the President is:  My name is _______.  I live in .  Thank you for your past support of syringe exchange.   I support maintaining current language that allows local officials to make their own decisions to use federal and local Washington DC funds for Syringe Exchange.    Please do not allow the Senate or House to change the current law in the Fiscal Year 2012 Appropriations negotiations.  Thank you

Calling Senate Majority Leader Reid and Other Senators:

*Harry Reid (D-NV) Majority Leader: 202-224-3542 

The Message for all of the Senators including Senator Reid is:

My name is _______.  I live in .  I support maintaining current language that allows local officials to make their own decisions to use federal and local Washington DC funds for Syringe Exchange.   Please do not change the current law in the Fiscal Year 2012 Appropriations negotiations.  Thank you

Alaska

Lisa Murkowski (R): 202-224-6665 

Arkansas

Mark Pryor (D) : 202-224-2353 

Hawaii

*Daniel Inouye (D) Appropriations Chairman: 202-224-3934 

Illinois

*Dick Durbin (D) Majority Whip, Financial Services Subcommittee Chair: 202-224-2152 

Mark Kirk (R): 202-224-2854 

Iowa

*Tom Harkin (D) Labor, HHS Subcommittee Chair: 202-224-3254 

Louisiana

Mary Landrieu (D): 202-224-5824 

Montana

Jon Tester (D): 202-224-2644   

Nebraska

Ben Nelson (D): 202-224-6551 

New York

*Chuck Schumer (D) Democratic Policy Committee Chair: 202-224-6542 

Kirsten Gillibrand (D): 202-224-4451   

--- (Note although not a negotiator or leadership, Sen. Gillibrand has been very responsive on HIV/AIDS issues ask her to weigh in with Schumer and her appropriations colleagues)

Rhode Island

Jack Reed (D-RI): 202-224-4642 

South Dakota

Tim Johnson (D-SD): 202-224-5842   

Vermont

Patrick Leahy (D-Vt.): 202-224-4242

Washington

Patty Murray (D-Wash): 202-224-2621

Calling Speaker Pelosi:

Please call Speaker Nancy Pelosi: 202-225-0100

The message for the Speaker is:  My name is _______.  I live in .  Thank you for your past support of syringe exchange.  I support maintaining current language that allows local officials to make their own decisions to use federal and local Washington DC funds for Syringe Exchange.    Please do not allow the Senate or House to change the current law in the Fiscal Year 2012 Appropriations negotiations.  Thank you

Thank you for your attention to this issue.  Please call now – Share with your friends.  We absolutely need to keep up the calls as long as we can.

You can also email a message to your Senators, telling them to refuse to compromise on syringe exchange.

Decisions are being made today - Monday, December 12th - so we have to act now!

Click here to send an email to your Senators. Feel free to customize the letter, telling your Senators why syringe exchange matters to you and your state.

Please take action today - time is critical

Please let Senate leadership and conferees know that these policy riders are unacceptable. HIV and hepatitis C prevention is too important to trade away.

Take action now

Thanks for your help - and please feel free to forward this message widely.

Sincerely,
Daniel Raymond

Hepatitis C cases drop in P.E.I. since opening of needle exchange

SUMMERSIDE, P.E.I. - The chief health officer in P.E.I. says there a fewer cases of hepatitis C in the province thanks in part to an expanding needle exchange program.

The program started in Charlottetown in 2009.

Read it on Global News: Hepatitis C cases drop in P.E.I. since opening of needle exchange

Patient Advocate Foundation Announces $9.3 Million Donation to their Co-Pay Relief (CPR) Program

-- Additional Funding to CPR Program Will Serve Nonsquamous Non-Small Cell Lung Cancer (NSCLC), Breast Cancer, Colon Cancer, Rheumatoid Arthritis, Hepatitis C Patients in Need of Financial Assistance--

WASHINGTON, Dec. 9, 2011 /PRNewswire-USNewswire/ -- Patient Advocate Foundation (PAF) is pleased to announce that it has received a $9.3 million contribution, from an existing partner, providing further support through its Co-Pay Relief Program (CPR) for patients suffering from nonsquamous non-small cell lung cancer (NSCLC), breast cancer, colon cancer, rheumatoid arthritis and hepatitis C who are unable to afford their medical co-payments. These funds are currently available to qualified patients.

PAF's CPR Program provides direct financial support for pharmaceutical co-payments to insured patients, including Medicare Part D beneficiaries, who financially and medically qualify. Since the program's inception in April 2004, CPR has distributed more than $130 million in assistance to more than 50,000 patients nationwide who were unable to afford their pharmaceutical co-payments.


Read more:

Hepatitis C Medicines Save Lives in Cambodia

Merck and AmeriCares Partner to Provide Treatment for Patients in Need

Tan Sou Chin, who suffers from Hepatitis C, did not have access to the treatment she needed for her life-threatening illness. Like many impoverished families in Cambodia, Mrs. Sou Chin, 54, and her husband, who recently lost his job as a fisherman, struggled daily to provide for their six children. Thanks to a hepatitis treatment program supported by AmeriCares and product donations from Merck (known as MSD outside the U.S.), she was able to get the treatment she needed to survive.

Nearly 10 percent of the population in Cambodia is infected with the Hepatitis C virus, but few have access to treatment. Merck’s donations have allowed physicians to effectively treat the disease for those in need, reducing the risk of liver cirrhosis, liver cancer and liver failure.


Read more....

Boehringer Ingelheim completes patient entry for Phase III trial programme in Hepatitis C

INGELHEIM, Germany, December 9th, 2011 – Boehringer Ingelheim today announced that the final patient has been randomised to treatment in the large-scale Phase III clinical trial programme for BI 201335, its investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV).

The extensive study programme is underway at more than 350 sites in 15 countries and together encompasses nearly 2,000 treatment-experienced as well as treatment-naïve patients. Key regions in the programme include the European Union, Japan, U.S., Canada, Taiwan, Korea and Russia.

The programme consists of three Phase III trials, that will be conducted to evaluate BI 201335 plus the standard backbone treatment, pegylated interferon (pegIFN) and ribavirin (RBV) in patients with chronic genotype-1 HCV. Most HCV patients are infected with genotype-1 virus and belong to the most challenging HCV group to treat. The study programme evaluates “sustained viral response” (SVR) as the primary clinical endpoint, which is considered viral cure. Results from the Phase III studies are expected in the first half of 2013.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the entire BI 201335 programme. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.

“We are progressing our BI 201335 programme with a high priority to leverage its potential to improve cure rates in HCV treatment,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. “We believe our HCV-pipeline may become an important tool to fight a chronic disease that affects over 170 million people worldwide.”

Phase IIb results presented last month showed that the interferon-free combination of BI 201335, with Boehringer Ingelheim’s polymerase inhibitor BI 207127 (SOUND-C2), led to 76% of patients achieving a virological response at week 12, with 63% achieving SVR12 (undetectable virus, 12 weeks post-treatment) with 16 weeks treatment. These results were presented at the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, USA, alongside SILEN-C1 and SILEN-C3 study results which showed the potential for BI 201335/ PegIFN/RBV to shorten treatment duration and improve the likelihood of viral cure (SVR). These Phase IIb results provide a strong basis for further development as BI 201335 progresses through Phase III.

SOUND-C2
SOUND-C2 is an open-label, randomised, Phase IIb study where 362 treatment-naïve GT1 HCV patients were randomised into five interferon-free treatment groups, each with 120mg BI 201335 once daily but with different dosing of BI 207127 and treatment durations as follows:

• BI 201335 120mg QD + BI 207127 600mg TID + RBV for 16 weeks;
• BI 201335 120mg QD + BI 207127 600mg TID + RBV for 28 weeks;
• BI 201335 120mg QD + BI 207127 600mg TID + RBV for 40 weeks;
• BI 201335 120mg QD + BI 207127 600mg BID + RBV for 28 weeks; or
• BI 201335 120mg QD + BI 207127 600mg TID without RBV for 28 weeks.

SILEN-C1 SILEN-C1 is a double-blind, placebo-controlled trial, that randomised 429 treatment-naïve GT1 HCV patients (1:1:2:2) to receive either placebo or
BI 201335 120 mg with three days Lead-in (LI) of PegIFN/RBV, BI 201335 240 mg QD with three days LI or BI 201335 mg 240mg QD without LI. In each treatment group, BI 201335 was given for 24 weeks together with PegIFN/RBV for 24 or 48 weeks. Patients were evaluated for SVR according to various baseline characteristics.

SILEN-C3 In this open-label Phase II trial, 159 treatment-naïve GT1 HCV patients were randomised to receive 120 mg QD BI 201335 for 12 or 24 weeks, each after three days lead-in (LI) with pegylated interferon and ribavirin (PegIFN/RBV). In both groups, PegIFN/RBV was given for 24 weeks. Patients who did not achieve an eRVR, continued PegIFN/RBV to week 48. eRVR was defined as viral load less than 25 IU/mL at week 4 and undetectable at weeks 8-18. 

BI 201335 is an investigational oral HCV NS3/4A protease inhibitor, discovered from Boehringer Ingelheim’s own research and development, which has completed clinical trials through Phase IIb (SILEN-C studies). This Phase II programme supports the investigation of BI 201335 in Phase III trials currently ongoing. Boehringer Ingelheim is also developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has completed Phase I clinical trials. Phase II trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, both with and without ribavirin, are currently underway.

Read complete release here

Vertex and Alios BioPharma Begin Clinical Studies of Nucleotide Drug Candidates ALS-2200 and ALS-2158 for the Treatment of Hepatitis C

Studies to evaluate safety and effects on viral kinetics in people with chronic genotype-1 hepatitis C-

-Data expected in second quarter of 2012 could enable initiation of interferon-free, nucleotide-based combination studies in the second half of 2012-

 

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Alios BioPharma, Inc. today announced the initiation of two clinical studies for the nucleotide analogues ALS-2200 and ALS-2158, which are inhibitors of the hepatitis C NS5B polymerase. The studies will evaluate the safety and tolerability of ALS-2200 and ALS-2158 in healthy volunteers followed by a seven-day evaluation to observe the effects on viral kinetics in people with chronic genotype-1 hepatitis C. Data are expected in the second quarter of 2012, which could enable the initiation of studies to evaluate multiple all-oral, interferon-free combination regimens for chronic hepatitis C in the second half of 2012. Vertex has worldwide development and commercialization rights for ALS-2200 and ALS-2158, which were discovered by Alios BioPharma. Alios and Vertex are jointly conducting the Phase 1 studies announced today.

"These studies are an important step in our ongoing efforts to strengthen our leadership position in hepatitis C by developing all-oral regimens that could further improve the future treatment of this disease," said Peter Mueller, Ph.D., Executive Vice President, Global Research and Development, and Chief Scientific Officer for Vertex. "The studies of ALS-2200 and ALS-2158 announced today are designed to generate data that may provide the opportunity to rapidly advance into Phase 2 development where we could evaluate a number of nucleotide-based regimens beginning in the second half of next year, including regimens with INCIVEK or VX-222."

Study Design
The two Phase 1 studies announced today will be randomized, double-blind, placebo-controlled studies. The primary goals are to evaluate the safety and tolerability of single ascending doses of ALS-2200 and ALS-2158 in healthy volunteers and of multiple ascending doses in people with chronic genotype-1 hepatitis C. A secondary objective will be to evaluate the effects on viral kinetics of ALS-2200 and ALS-2158 during seven days of dosing in people with hepatitis C.

Dosing is now underway for the study of ALS-2200, and dosing is expected to begin next week for the study of ALS-2158. Vertex and Alios BioPharma expect to have complete data, including seven-day viral kinetic data, from each trial in the second quarter of 2012, which could enable the initiation of all-oral, interferon-free Phase 2 combination studies in the second half of 2012. These Phase 2 studies are expected to evaluate combination regimens of ALS-2200 or ALS-2158 with INCIVEK (telaprevir) or VX-222, potential dual nucleotide regimens and other interferon-free combination regimens that may also include ribavirin. INCIVEK is Vertex's FDA-approved protease inhibitor for chronic genotype-1 hepatitis C, and VX-222 is Vertex's investigational hepatitis C non-nucleoside polymerase inhibitor. The combination studies will be designed to generate sustained viral response (SVR or viral cure) data.

About ALS-2200 and ALS-2158
ALS-2200 and ALS-2158 are highly potent pan-genotypic nucleotide analogues that appear in in vitro and non-clinical studies to have a high barrier to drug resistance and the potential to be dosed orally once-daily. Both compounds are designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase. Each compound is structurally distinct and has its own unique mechanism of action, which supports the potential for developing these compounds together as a dual nucleotide regimen and as part of combination therapy regimens, including regimens with INCIVEK^TM (telaprevir) and VX-222. Data from in vitro studies showed that both ALS-2200 and ALS-2158 had a synergistic effect when combined together and with INCIVEK and VX-222. Additionally, in those in vitro studies, both compounds showed antiviral activity across all genotypes, or forms, of the hepatitis C virus, including genotypes more prevalent outside of the United States.

Vertex gained worldwide rights to ALS-2200 and ALS-2158 through an exclusive worldwide licensing agreement signed with Alios BioPharma, Inc. in June 2011. The agreement also includes a research program that will focus on the discovery of additional nucleotide analogues that act on hepatitis C polymerase. Vertex has the option to select additional compounds for development emerging from the research program.

About Vertex
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada. Today, Vertex has more than 1,900 employees around the world, and Science magazine named Vertex number one on its 2011 list of Top Employers in the life sciences.

About Alios BioPharma
Alios BioPharma is a biotechnology company located in South San Francisco, California, that is developing novel medicines aimed at the treatment of viral diseases. Alios has an innovative team of highly experienced scientists and clinical researchers who are developing direct acting antiviral agents against several human viral pathogens of public health importance including, hepatotropic and respiratory viruses and other chronic, acute and emerging viral diseases. The overall goal for the Alios therapeutic platform is to maximize patient benefits in areas of high unmet medical need through optimization of potency, safety and tolerability. Alios is the recipient of the 2011 BayBio Pantheon Outstanding Partnering Award.


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