• Maraviroc approved by the FDA - The Food and Drug Administration (FDA) approved Selzentry (maraviroc) 150 mg and 300 mg tablets, a CCR5 co-receptor antagonist. The drug, taken twice a day at 150, 300 or 600 mg depending on what other drugs it is taken in combination with is approved for the treatment of adults infected with CCR5-tropic HIV-1. It requires at least one test to determine if someone has CCR5-tropic HIV-1. The drug should be available in the US in September 2007. The test can be ordered by any authorized health care provider.


• Action Alert Issued - Urge Your Representative and Senators To Cosponsor The Early Treatment for HIV Act. The Early Treatment for HIV Act (ETHA) has been introduced in the House of Representatives and the Senate. ETHA would allow states to extend Medicaid coverage to include low-income people with HIV who have not yet become disabled by AIDS. This would help people with HIV get early access to care and treatment. It would also help relieve the financial burden on other programs, such as the AIDS Drug Assistance Program. ETHA would save lives. One study shows that if passed and implemented, ETHA would reduce by 50% the death rate for people with HIV on Medicaid.


• Support Improvements to Medicare Part D, Medicaid and Children's Health With One Toll-Free Phone Call.


• Sign on to New Advocacy Group's call for full funding for ADAP in Fiscal Year 2008.


• The Hepatitis C Appropriations Partnership


• Education and Training Section added to The Access Project. Each state or territory will begin to list training and educational meetings,fact sheets, reports, resources and internet links to inform, educate, and encourage collaboration and networking among communities and providers.

Maraviroc approved by the FDA

"On August 6, 2007, the Food and Drug Administration (FDA) approved Selzentry (maraviroc) 150 mg and 300 mg tablets, a CCR5 co-receptor antagonist used in combination with other antiretroviral products for the treatment of adults infected with CCR5-tropic HIV-1.

Maraviroc received a priority review by the FDA and is the first drug approved in the new class of anti-HIV medications called CCR-5 co-receptor antagonist.

Rather than fighting HIV inside white blood cells, like most antiretrovirals used to treat infection with HIV, maraviroc prevents the virus from entering uninfected cells by blocking the predominant route of entry, the CCR5 co-receptor, a protein on the surface of immune cells affected by HIV. Among patients who have previously received HIV medications, approximately 50 percent to 60 percent have circulating CCR5-tropic HIV.

Maraviroc, in combination with other antiretroviral agents, is indicated for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable virus, who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

The approval of maraviroc is based on analyses of plasma HIV-1 RNA levels in two controlled studies each of 24 weeks duration with over 1000 clinical trial participants of which 840 received maraviroc. Both studies were conducted in clinically advanced, 3-class antiretroviral (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitor, protease inhibitors or fusion inhibitor, specifically enfuvirtide) treatment-experienced adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The following points should be considered when initiating therapy with maraviroc

• Tropism testing and treatment history should guide the use of maraviroc


• Use of maraviroc is not recommended in patients with dual/mixed or CXCR4-tropic HIV-1 as efficacy was not demonstrated in a phase 2 study of this patient group


• The safety and efficacy of maraviroc have not been established in treatment-na•ve adult patients or pediatric patients

The recommended dose of maraviroc differs based on concomitant medications due to drug interactions (See attached pdf label (300KB), Section 2, Dosage and Administration).

Maraviroc can be taken with or without food.

The product label includes a boxed warning about liver toxicity (hepatoxicity) and a statement in the Warnings/Precautions section about the possibility of increased risk for cardiovascular events such as heart attack or symptomatic postural hypotension (dizziness upon quickly standing). The most common adverse events reported with maraviroc were cough, fever, upper respiratory tract infections, rash, musculoskeletal symptoms, abdominal pain, and dizziness.

Maraviroc has not been tested or studied in pregnant women. The FDA recommends HIV positive women should not breast feed, whether or not they are on antiretroviral medications.

Maraviroc is distributed by Pfizer Inc., of New York and is available as 150 mg or 300 mg tablets.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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Support Improvements to Medicare Part D, Medicaid and Children's Health With One Phone Call

Call your Representative toll-free at 1-800-614-2803 You will get the Capitol switchboard. Ask to be connected to your Representative's office.Tell whoever answers the phone:

" My name is _________ and I live in (your city). I urge Representative ____________ to support the Children's Health and Medicare Protection Act. This legislation would provide many needed protections and expand important health care programs for the most vulnerable Americans, including children, people with disabilities and seniors."

Background:

Representatives John Dingell (D-MI), Charles Rangel (D-NY), Frank Pallone, Jr. (D-NJ), and Pete Stark (D-CA) recently introduced the Children's Health and Medicare Protection (CHAMP) Act . This legislation commits $50 billion to reauthorize and improve the Children's Health Insurance Program (CHIP) to protect the healthcare coverage of the six million children it covers today, and to assure coverage for as many other eligible, uninsured, children as possible.

It also includes provisions that are very important to people living with HIV/AIDS throughout the country including:

• Would allow AIDS Drug Assistance Programs (ADAPs) and Indian Health Service payments to count toward an individual's cost sharing in Medicare Part D (the new prescription drug benefit)
• Would make it law that all Medicare Part D plans must cover all (or substantially all) of six classes of drugs, including anti-retrovirals, anti-psychotics and anti-depressants
• Would create cost-sharing protections for Medicare low-income subsidy-eligible individuals
• Would permit mid-year changes in Medicare Part D plans if the formulary changes and the individual is negatively impacted
• Would allow benzodiazepines to be covered under the Medicare prescription drug program
• Would reduce Medicare's discriminatory 50% co-payment on mental health outpatient services

As you know, ADAP, funded under Part B of the Ryan White Program, provides access to treatment for low-income people living with HIV/AIDS who are uninsured or lack adequate prescription drug coverage. It is the final safety net for Americans who have no other means of accessing HIV medications, and a lifeline for the approximately 100,000 people who depend on it.

However, many state ADAPs are facing financial difficulties and are unable to meet the needs of those who depend on the program. According to the National Alliance of State and Territorial AIDS Directors (NASTAD), as of May 2007, there are over 500 people on ADAP waiting lists in four states. Two other states have been forced to implement other cost-containment strategies, and another state expects to do the same in the next year.

The medications received from the AIDS Drug Assistance Program allow many patients to remain in the workforce and contribute to society. Without access to these important medications, many more would be unable to work and therefore reliant on public assistance. A woman in South Carolina, for example, recently reported that because of ADAP she was able to become healthy enough to return to work. She was then covered under an employer's heath plan, which negated her reliance on ADAP for medications. Furthermore, the medications she received under ADAP enabled her to have a healthy baby. That baby is now over a year old and remains HIV negative, while the mother remains healthy enough to care for her family.

Since ADAP received no increase last year and only a nominal increase the year before, thirty one jurisdictions have experienced decreases in ADAP funding in Fiscal Year 2007. Meanwhile, some states that have struggled to provide adequate service to their ADAP clients have stepped up and contributed significant state funding for their programs. For example, South Carolina recently increased its contribution to ADAP by $3.5 million, which will help to greatly reduce its ongoing wait list. Across the nation, states contributed over $300 million in FY 2006. However, without adequate ongoing federal funding, many states will be unable to sustain a minimal level of service to those who need it. ADAP needs regular and substantial increases to be a true sustainable safety net program.

Fully funding HIV/AIDS care now will save in both financial and human costs by helping to decrease HIV transmission, increasing healthy participants in our workforce and helping to ease the strain on overburdened hospital emergency rooms. Please support the full need funding level of an additional $232.9 million funding for the AIDS Drug Assistance Program earmark.

The Hepatitis C Appropriations Partnership (HCAP) was formed in June 2004 as a coalition of hepatitis C community-based organizations, public health and provider associations, national HIV and HCV organizations, and members of the diagnostics and pharmaceutical industry. We work with policy makers and public health officials to increase federal support for hepatitis C prevention, testing, education, research, and treatment.

An estimated 3 to 5 million Americans have been infected with the hepatitis C virus (HCV). At least 2.7 million people in the U.S. are chronically infected with HCV, 3-times the number of Americans living with HIV/AIDS. The most recent data available from the Centers for Disease Control and Prevention (CDC) indicate that at least 30,000 new cases of HCV occur annually. Many people with chronic hepatitis C are unaware that they are infected because HCV is often asymptomatic until advanced liver damage develops.

CDC estimates at least 25% of people living with HIV/AIDS are also infected with HCV. HIV accelerates HCV disease progression, and HIV/HCV coinfected persons have twice the risk of cirrhosis and a six-fold increased risk of liver failure compared to people with HCV alone. HCV-related liver disease is now the leading cause of death among people with HIV/AIDS in many communities.

Chronic liver disease is among the top ten killers of Americans 25 years of age and older. Hepatitis C is the most common cause of chronic liver disease in the U.S. accounting for 40-60% of all cases. HCV is also the leading indication for adult liver transplantation in the U.S. Without increased resources for counseling, testing, and medical referral services, HCV-related deaths and long-term complications are projected to increase dramatically by the year 2020: liver failure by 106%, liver cancer by 81%, and liver-related deaths by 180%.

Critical funding needs to adequately address the HCV epidemic include:

• Increase funding for CDC's Division of Viral Hepatitis to: increase the ability of state and local health departments to provide HCV services; implement chronic hepatitis B and C surveillance systems, and; educate the public and medical providers about HCV.


• Increase funding under the Ryan White CARE Act to expand the capacity of programs to: provide HCV counseling and testing; improve provider education on HCV medical management; expand case management for patients undergoing treatment, and; enable states to add HCV viral load testing and HCV treatments to the AIDS Drug Assistance Plan (ADAP) formularies.


• Increase funding for the consolidated community health centers to expand grantees' capacity to provide hepatitis C prevention and medical management services.


• Increase NIH funding to support the implementation of the Action Plan for Liver Disease Research.


• Provide the Substance Abuse and Mental Health Services Administration with additional resources to address HCV within the context of substance abuse, and mental health treatment and prevention.


• Support the Veterans Health Administration in providing HCV care and treatment.

Participating Organizations

• The AIDS Institute
• AIDS Treatment Data Network
• American Academy of HIV Medicine
• American Association for the Study of Liver Disease
• American College of Gastroenterology
• American Gastroenterological Association
• American Liver Foundation
• American Social Health Association
• Association of State and Territorial Health Officials
• Bayer HealthCare LLC
• Beth Israel Deaconess Medical Center
• Harm Reduction Coalition
• Hepatitis C Advocate Network, Inc.
• Hepatitis C Caring Ambassadors Program
• Hepatitis C Coordinator Liaisons
• Hepatitis Foundation International
• Gilead Sciences, Inc.
• GlaxoSmithKline
• National AIDS Treatment Advocacy Project
• National Alliance of State and Territorial AIDS Directors
• National Association of Community Health Centers
• National Association of People with AIDS
• National Coalition of STD Directors
• National Hepatitis C Advocacy Council
• National Minority AIDS Council
• National Viral Hepatitis Roundtable
• OraSure Technologies, Inc.
• Positive Health Project
• Roche Pharmaceuticals
• Roche Diagnostics
• Schering-Plough Corporation
• Spears Hepatitis C Foundation
• Title II Community AIDS National Network
• Treatment Action Group
• Treatment Access Expansion Project
• Valeant Pharmaceuticals

Access Resources

• The Access Project
• State by State Access Programs Search
• Patient Assistance Programs
• Hepatitis Care and Treatments
• The Access Project News
• Treatment Information Notes
• Education and Training

Contact The Network for help getting drugs or services. Our national toll-free phone number is (800) 734-7104. We'll help explain what your options are and assist you in creating a plan. We'll describe programs like Medicaid, Medicare, Medicare Part D, ADAP, Clinical Trials, Patient Assistance Programs and more. Back to The Access Project

The Early Treatment for HIV Act (ETHA) has been introduced in the House of Representatives and the Senate. The House bill is H.R. 3326 and the Senate bill is S. 860.

ETHA would allow states to extend Medicaid coverage to include low-income people with HIV who have not yet become disabled by AIDS. This would help people with HIV get early access to care and treatment. It would also help relieve the financial burden on other programs, such as the AIDS Drug Assistance Program.

ETHA would save lives. One study shows that if passed and implemented, ETHA would reduce by 50% the death rate for people with HIV on Medicaid.

Now that the both bills have been introduced, we need as many House and Senate cosponsors as possible. The more cosponsors, (and the more bipartisan the list), the better the chance of passing this bill into law.

Please take a few minutes to call your House Representative and your two U.S. Senators and ask them to cosponsor ETHA!

How you can help:

Congress is on recess during August and most Members are back in their home district. This is a great opportunity to contact them in their district offices and urge them to cosponsor ETHA.

Please make three calls during August.

First, call your two U.S. Senators in their district office. Tell whoever answers the phone that you are a constituent and you urge the Senator to cosponsor S. 860, the Early Treatment for HIV Act. If your Senator is a Republican, they should contact Senator Gordon Smith's office to sign. If they are a Democrat, they should contact Senator Hillary Clinton's office.

Then, call your U.S. Representative in his/her district office. Tell whoever answers the phone that you are a constituent and you urge the Representative to cosponsor H.R. 3326, the Early Treatment for HIV Act. If your Representative is a Republican, she/he should contact Representative Ileana Ros-Lehtinen's office to sign. If your Representative is a Democrat, she/he should contact Representative Eliot Engel's office.

If your Senator/Representative is on the following list, they have already cosponsored ETHA. Please take a minute to call and thank them for their leadership!

(as of August 13, 2007)

Senate:

Lead authors:
Senator Hillary Clinton (D-New York)
Senator Gordon Smith (R-Oregon)

Cosponsors:
Senator Evan Bayh (D-Indiana)
Senator Jeff Bingaman (D-New Mexico)
Senator Barbara Boxer (D-California)
Senator Sherrod Brown (D-Ohio)
Senator Maria Cantwell (D-Washington)
Senator Benjamin Cardin (D-Maryland)
Senator Norm Coleman (R-Minnesota)
Senator Susan Collins (R-Maine)
Senator Christopher Dodd (D-Connecticut)
Senator Richard Durbin (D-Illinois)
Senator Russell Feingold (D-Wisconsin)
Senator Dianne Feinstein (D-California)
Senator Daniel Inouye (D-Hawaii)
Senator Tim Johnson (D-South Dakota)
Senator Edward Kennedy (D-Massachusetts)
Senator Frank Lautenberg (D-New Jersey)
Senator Patrick Leahy (D-Vermont)
Senator Carl Levin (D-Michigan)
Senator Blanche Lincoln (D-Arkansas)
Senator Robert Menendez (D-New Jersey)
Senator Patty Murray (D-Washington)
Senator Bill Nelson (D-Florida)
Senator Barack Obama (D-Illinois)
Senator Jack Reed (D-Rhode Island)
Senator Bernard Sanders (I-Vermont)
Senator Charles Schumer (D-New York)
Senator Olympia Snowe (R-Maine)
Senator Arlen Specter (R-Pennsylvania)
Senator Debbie Stabenow (D-Michigan)
Senator Ron Wyden (D-Oregon)

House of Representatives:

Lead authors:
Representative Eliot Engel (D-New York)
Speaker Nancy Pelosi (D-California)
Representative Ileana Ros-Lehtinen (R-Florida)

Cosponsors:
Representative Tom Allen (D-Maine)
Representative Tammy Baldwin (D-Wisconsin)
Representative Mary Bono (R-CA)
Representative Lois Capps (D-California)
Representative Michael Castle (R-Delaware)
Representative Donna Christensen (D-Virgin Islands)
Representative James Clyburn (D-South Carolina)
Representative Diana DeGette (D-Colorado)
Representative Charles Dent (R-Pennsylvania)
Representative Lincoln Diaz-Balart (R-Florida)
Representative Mario Diaz-Balart (R-Florida)
Representative Mike Doyle (D-Pennsylvania)
Representative Rahm Emanuel (D-Illinois)
Representative Anna Eshoo (D-California)
Representative Michael Ferguson (R-New Jersey)
Representative Luis Fortu–o (R-Puerto Rico)
Representative Vito Fossella (R-New York)
Representative Rodney Frelinghuysen (R-New Jersey)
Representative Gene Green (D-Texas)
Representative Raul Grijalva Š (D-Arizona)
Representative Maurice Hinchey (D-New York)
Representative Darlene Hooley (D-Oregon)
Representative Jay Inslee (D-Washington)
Representative Pete King (R-New York)
Representative Mark Kirk (R-Illinois)
Representative Jim Langevin (D-Rhode Island)
Representative Barbara Lee (D-California)
Representative Frank LoBiondo (R-New Jersey)
Representative Ed Markey (D-Massachusetts)
Representative Jim Matheson (D-Utah)
Representative Thaddeus McCotter (R-Minnesota)
Representative Jim McDermott (D-Washington)
Representative John McHugh (R-New York)
Representative Eleanor Holmes Norton (D-Washington, DC)
Representative Ron Paul (R-TX)
Representative Charles Pickering (R-Mississippi)
Representative Jon Porter (R-Nevada)
Representative Jim Ramstad (R-Minnesota)
Representative Charles Rangel (D-NY
Representative Bobby Rush (D-Illinois)
Representative Jim Saxton (R-New Jersey)
Representative Jan Schakowsky (D-Illinois)
Representative Pete Sessions (R-Texas)
Representative Christopher Shays (R-Connecticut)
Representative Chris Smith (R-New Jersey)
Representative Hilda Solis (D-California)
Representative Edolphus Towns (D-New York)
Representative Fred Upton (R-MI)
Representative Jim Walsh (R-New York)
Representative Henry Waxman (D-California)
Representative Anthony Weiner (D-New York)
Representative Jerry Weller (R-Illinois)
Representative Heather Wilson (R-New Mexico)
Representative Albert Wynn (D-Maryland)

For more information about ETHA, go to www.taepusa.org. You can also read the bill text, and follow its status, at http://thomas.loc.gov (enter the bill number, S. 860 and H.R. 3326)

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