Friday, September 13, 2013

Combatting HIV/HCV Co-Infection

Earlier this year on March 19th when the ADAP Advocacy Association and Community Access National Network (CANN) announced that they were co-hosting an HIV/HCV Co-Infection ADAP Summit, Bill Arnold said, "CANN has long been recognized for its commitment to promoting patient access to timely care and treatment, and we need to educate consumers, community partners, as well as congressional staff here in Washington, DC about the fastest growing public health epidemic since AIDS: Viral Hepatitis C infection. We have learned many valuable lessons from the HIV/AIDS advocacy community over the last three decades, and CANN will now apply those lessons to ensuring access to effective HCV treatments."

The Summit convened in Las Vegas, NV on April 25th-26th and various stakeholder groups participated in the conversation (only the federal government agencies were not represented because Sequestration restricted agency travel budgets). By all accounts the Summit achieved the objective laid out in Arnold's statement, but unfortunately there are some very sobering statistics behind the need for the event being held in the first place, among them:
  • About 25% of people infected with HIV in the U.S. are also infected with HCV.
  • About 80% of injection drug users (IDUs) with HIV infection also have HCV.
  • HIV/HCV co-infection more than triples the risk for liver disease, liver failure, and liver-related death from HCV.
  • Compared with other age groups, a greater proportion (about 1 in 33) of people aged 46–64 years are infected with HCV.
  • Chronic HCV is often "silent," and many people can have the infection for 20 to 30 years without having symptoms or feeling sick.
  • In the U.S., HCV is twice as prevalent among blacks as among whites.
  • New data suggest that sexual transmission of HCV between MSM living with HIV occurs more commonly than previously believed and that sexual transmission can occur undetected between HIV-infected MSM in the absence of injection drug use.[1]
Some public health experts predict that the HIV/AIDS epidemic of the 1980s will pale in comparison to what is likely to happen with the onslaught of new HCV infections. Fortunately, there is a cure for HCV infection.

Several pharmaceutical companies -- including AbbVie, Boehringer-Ingelheim, Bristol-Myers Squibb, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen Therapeutics, Merck, and Vertex -- have numerous new HCV treatments on the market, or in the pipeline, which are much improved over the initial treatments that won approval by the U.S. Food & Drug Administration (FDA). The marvels of modern medicine means that many of these new treatments come with far fewer side effects, better resistance profiles, and in some cases, patients will be on the treatments for less time before achieving optimal results. But at what cost?

According to the Fair Pricing Coalition (FPC), FDA-approved HCV treatments have been extremely expensive, coupled with double digit price increases accompanying some of these drugs since 2011. The FPC has released statements on the cost of the new drugs. The debate over drug pricing will surely continue to ignite emotions once the newer treatments gain FDA approval, and at a much higher cost. In all fairness to the pharmaceutical companies, they have also expanded access...or plan to expand their patient assistance and co-payment assistance programs.

The aforementioned discussion led to what amounted to be the most interesting idea accepted at the Summit: A Pharmaceutical Industry Access to Care Report Card. The "report card" idea was among the recommendations included in the HIV/HCV Co-Infection ADAP Summit Final Report, which was released last week and included both short-term and long-term recommendations.

The short-term recommendations included:

  1. Identify national coalitions (i.e., Federal AIDS Policy Partnership, National ADAP Working Group, HCV Coalition for the Cure) and their respective partners, and develop strategic objectives to advance the treatment of HIV/HCV Co-Infection, as well as access to them.
  2. Develop universal messaging campaign surrounding access to care under the AIDS Drug Assistance Programs, using “success stories” from co-infected patients. (Editor’s Note: Some of this is already being done by the Campaign to End AIDS).
  3. Analyze existing ADAPs covering HCV treatments to determine the pros/cons of recommending other ADAPs covering HCV treatments for co-infected patients. Using a mathematical model, establish guidelines and tiers for co-infected treatment options.
  4. Determine feasibility of ADAPs purchasing insurance continuation plans that cover HCV treatments.
  5. Ensure that ACA Essential Health Benefits include benchmarks for treatment guidelines, as well as sufficient appeals process.
  6. Establish emerging treatment guidelines using existing medical data and consumer experience. It is premature to evaluate “gold standard” for treatment because too many HCV treatments are in the development pipeline, including some already being evaluated by the Food & Drug Administration (FDA).
  7. Develop “Fact Sheets” on existing plans for treatment for co-infected patients, including “navigator” information and resources.
  8. Expand testing.

The long-term recommendations included:

  1. Commission study to identify the potential treatment gaps for HIV/HCV Co-Infection.
  2. Develop pharmaceutical industry “Report Card” to evaluate access to timely and appropriate care of people living with HIV/HCV Co-Infection; grading new should take into consideration drug pricing, patient assistance programs, drug rebates (if available), community education/participation initiatives, and accessibility of user-friendly product information (aside from what is legally required by the FDA).
  3. Implement “Common Portal” for ADAP.
  4. Evaluate adding a new Part under the Ryan White CARE Act, specifically addressing HIV/HCV Co-Infection modeling after the Minority AIDS Initiative.

Whereas the Summit's Final Report is not necessary endorsed by the HIV/HCV Co-Infection ADAP Summit’s sponsors, panelists or participating organizations, it does represent a significant step in ensuring that the effort to combat HCV infections learns from the ongoing struggle against HIV infections.

CLICK HERE to download the HIV/HCV Co-Infection ADAP Summit Final Report.

[1] Centers for Disease Control & Prevention, HIV and Viral Hepatitis Fact Sheet, November 2011.

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