Print this page    •   Back to Web version of article

Hepatitis C: New Treatments in the Pipeline

By Tracy Swan

April 2008

Table of Contents

Inside Cover: Thanks to the TAG board, staff, and generous donors. This work is possible because of your support.

Thanks to Andrea Benzacar for editing; Lei Chou for designing the cover, graphics, figures, and tables; Catherine Coleman for proofreading; Adam Fredericks for additional design and layout; and to Lynda Dee for her Foreword.

Dedicated to: Phyllis Beck
and
Narelle Ellendon, Shari Foster, Ronni Marks, Sharon Phillips, Lorren Sandt, Sue Simon and Andi Thomas


Foreword

I became an AIDS activist in 1986, when my husband was diagnosed with AIDS. He died from AIDS-related complications in 1987. While I’m very grateful I am not HIV-positive, last year I was diagnosed with hepatitis C. Just because I don’t now present as a party girl doesn’t mean I don’t have such risk factors in my background. In fact, the insidious hepatitis C virus has apparently been lounging in my liver for many years.

I am also a cancer chemotherapy and radiation survivor who is older and frailer than in days gone by. I know that I could never tolerate 48 weeks of pegylated interferon and ribavirin. Moreover, like most of us, I cannot afford to be unemployed for any great length of time. Many HCV patients are in my age range and have other health issues. We need more effective, better-tolerated, and more easily administered treatments.

By 2007, we thought we had finally reached a turning point; we believed we had found a new paradigm for HCV treatment. If only that were the case. Although effective drugs are on the horizon, interferon and ribavirin are still the mainstay of HCV treatment, and the community is rife with rumors that toxicities from some initially promising new drugs may outweigh their benefits.

Where do we go from here? The issues are both numerous and complex. Some patients are in a position to wait for new drugs, but many others are not. Many patients cannot tolerate the current standard of care. Those with poor prognostic factors, such as people with HCV genotype 1 and a high viral load; HIV-positive people; African Americans; and people who have already developed serious liver damage are in big trouble, since they are less likely to respond to currently marketed HCV treatment.

What about treatment-experienced patients who have already tried standard interferon, with or without ribavirin? While some of these patients do respond to pegylated interferon plus ribavirin, the data on re-treatment response rates are discouraging. There are currently no approved treatments for people who do not respond to pegylated interferon and ribavirin. Therapeutic vaccines for HCV, or improvements in interferon-based therapy, may offer some hope in the near future.

I believe that AIDS treatment activists have moved the field of HIV research forward swiftly, dramatically, and in a way that nothing else has. We can do the same for hepatitis C. We know that we need combinations of small molecules such as protease and polymerase inhibitors to replace interferon and/or ribavirin. Combination regimens targeting different areas of the HCV life cycle, with different mechanisms of action, are necessary to forestall resistance and effectively combat HCV. Until this is possible, we can at least hope that new drugs will boost response rates, and decrease the amount of time people must spend on these poorly tolerated treatments.

HCV researchers would do well to reflect on, and apply scientific and pragmatic lessons from, HIV research. As an advocate for people with HIV, I can't even utter the word resistance without acknowledging the harm done to so many people by poorly designed clinical trials, and from non-strategic prescribing of HIV antiviral therapy over the years. We will be working to remedy the misuse of effective treatment for years to come. We sincerely hope that HCV researchers and clinicians can learn from and avoid such mistakes.

We can also learn from the successes in HIV research and treatment. The development of more effective treatments for HIV, including once-daily and one-pill regimens, speaks volumes about the resounding success of well-funded modern medical research, and the contribution of AIDS activists. We have brought a fresh perspective to the field by speaking out at conferences and meetings without fear of losing grant funding or tenure as a result of our criticisms. We have worked successfully to ensure that crucial funding is available to support successful research efforts. In the United States, we continue to work as federal watchdogs by helping to draft FDA accelerated-approval regulations and new drug-safety legislation. Activists continue to participate in the design and oversight of clinical trials, and to disseminate information directly to affected communities.

As advocates and activists, we clearly understand the ever-present tension between getting a drug approved and studying the most strategic use of new drugs. But no one benefits from badly designed studies that rush a drug to market, particularly those that exclude African Americans, HIV-positive people, prior drug users, or other patient groups among whom HCV is common -- and the unmet medical need is great. Such studies are impractical, counterproductive, and unacceptable, and will not be tolerated by the patient community or FDA. Remember, consumers are included in FDA Advisory Panels.

Companies need to be as forthcoming as possible with the patient and provider communities about incidence and management of long- and short-term side effects and other tolerability issues. Companies would do better to share such information honestly, and sooner rather than later. It’s not as if the facts don’t eventually surface. Building trust throughout the drug development process can only benefit sponsors, especially since FDA is now armed with new drug safety laws to more effectively address long-term patient safety issues.

Researchers and clinicians would also do well to remember the heavy toll interferon and ribavirin take on patients. Implying that patients are at fault for not being able to adhere to such a difficult regimen is misguided. Referring to such people as "noncompliant" is insensitive and insulting. Instead, companies should work with researchers and the community to provide reasonable support services for patients undergoing treatment with these difficult regimens.

Congress must also allocate new monies to assist patients, instead of pitting disease groups against each other to argue over insufficient federal funds. Medicine, especially medical research, is inextricably entwined with politics in the good old USA. Getting new money from Congress for what is essentially an unpopular, and often disenfranchised, population will undoubtedly be a daunting task. Our economy and our treasury leave a lot to be desired at this juncture. Hopefully, prioritization that puts people and life before war and death will be upon us after November 2008.

"Thank you" hardly reflects the appreciation I feel towards the Treatment Action Group (TAG), and my friend and colleague, Tracy Swan, the "Countess of Coinfection," for their work with other activists, members of the medical and research communities, drug companies, and regulatory agencies. My long career as an AIDS activist convinces me and if we work together, more effective, better-tolerated regimens will be available much more quickly. I wish you sweeping and swift future success.

Lynda Dee
Co-founder of AIDS Action Baltimore.




This article was provided by Treatment Action Group. You can find this article online by typing this address into your Web browser:
http://www.thebody.com/content/art46368.html

General Disclaimer: TheBody.com is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through TheBody.com should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.