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HEPATITIS/HIV PROJECT BACKGROUND

Viral hepatitis is a serious global public health threat. Worldwide, more than 2 billion people have been infected with hepatitis B virus (HBV); at least 350 million are chronically infected. An estimated 170 to 200 million people have been infected with hepatitis C virus (HCV); as many as 130 million are chronically infected. In the United States, up to 1.4 million are chronically infected with HBV, and at least four million Americans are chronically infected with HCV. As with HIV, viral hepatitis disproportionately affects people who often lack access to medical care: African Americans, prisoners, people who use drugs, immigrants, the poor, and people with psychiatric disorders.

Viral hepatitis can cause serious liver damage. Approximately 25% of people with chronic hepatitis C eventually develop cirrhosis of the liver. People with cirrhosis are at risk for life-threatening complications such as liver cancer and liver failure. While 15% - 40% of people with chronic HBV will develop serious liver disease, unlike HCV, 30% of liver cancer occurs without the development of cirrhosis in chronic HBV infection.

In the United States, about 4,000 to 5,000 people die from HBV-related cirrhosis or liver cancer each year.  Mortality from hepatitis C complications is projected to increase by 180% over the next two decades, unless care and treatment initiatives scale up to meet the demand.

Viral hepatitis coinfection is common among HIV-positive people. Worldwide, an estimated two to four million people are coinfected with HIV and HBV; and four to five million are coinfected with HIV and HCV. In the United States, up to 10% of HIV-positive people are coinfected with HBV, and 25% to 30% are coinfected with HCV.

Viral hepatitis coinfection significantly impacts an HIV-positive person’s health, quality of life, and long-term survival. HIV accelerates viral hepatitis disease progression. People with low CD4 cell counts are at greatest risk for severe liver damage from viral hepatitis. In places where antiretroviral therapy is available, end-stage liver disease from hepatitis B and hepatitis C coinfection is a leading cause of death among HIV-positive people

Hepatitis B and hepatitis C are both treatable, but treatment access is limited; the drugs are prohibitively expensive for the majority who need them, and reimbursement programs are woefully inadequate.

Hepatitis B Treatment

Several drugs are approved by the Food and Drug Administration to treat chronic HBV, but treatment guidelines are still evolving due to a lack of data from large clinical trials. Current debates include the use of a single drug or combination therapy, when to start treatment, and the use of pegylated interferon. Currently approved drugs cannot eradicate the virus; therefore lifelong suppressive therapy is needed for the majority of chronically HBV infected people. Drug resistance is a major issue with HBV treatment, but an insufficient understanding of the hepatitis B virus hampers development of new drugs.

Treating HIV/HBV coinfection is complicated, as several HBV drugs were originally approved to treat HIV, and therefore are active against both viruses. Severe liver enzyme flares can be fatal if the combination of drugs used to treat HIV and HBV are not carefully selected, especially when switching therapies due to toxicity issues. With HIV and HBV, drug resistance to a single agent—or an entire family of agents—can develop, making treatment less effective, limiting future options.

Hepatitis C Treatment

The current standard of care for hepatitis C is pegylated interferon and ribavirin, a combination that has profound limitations. Treatment is only effective for about half of the people who undergo it, and the drugs have serious, sometimes debilitating, side effects. Numerous studies have reported that hepatitis C treatment is more likely to be successful when medical and mental health care, education, peer support, and addiction treatment are provided together.

Hepatitis C is harder to treat in people who are HIV-positive. Coinfected people are far less likely to respond to HCV treatment than people with hepatitis C alone, and are more likely to experience severe, potentially treatment-limiting side effects. Thus, more effective and less toxic hepatitis C drugs are essential for coinfected people.

Many new hepatitis C treatments are currently in development, but coinfected people often wait for years before gaining access to promising new drugs. Traditionally, hepatitis C treatment trials in coinfected people are not launched until the drug has already been approved for use in people with hepatitis C alone, a process that can take years. Drug companies are not currently required to study experimental hepatitis C drugs in HIV-positive people, despite an urgent, unmet need for treatment.TAG’s Hepatitis/HIV Project collaborates with domestic and international activists, viral hepatitis and HIV community members, scientists, governments, regulators, policy makers, and drug companies to make lifesaving information, high-quality care, and better treatment available to all people who need it. The Project fights for publicly and privately funded research on new drugs and prevention and treatment strategies for viral hepatitis; policies to increase access to prevention, care and treatment; and initiatives to help health care providers serve people with viral hepatitis and HIV coinfection more effectively.