Hidden Epidemic / Researchers, Policymakers Debate Tactics in Battle Against Hepatitis C
 (WebMD), 8/2/01 10:47 p.m.

August 02, 2001

Dr. Karen Seal is at the vanguard of an unsung and perhaps unpopular public health crusade -- the battle to identify and treat injection drug users infected with hepatitis C.

"If we don't start treating this population, the epidemic is only going to get worse," said Seal, a University of California at San Francisco researcher who will speak at a four-day conference on hepatitis C that begins at San Francisco's Holiday Inn today.

Hepatitis C, or Hepatitis C Virus for short, afflicts an estimated 600,000 Californians, 4 million Americans and 170 million people worldwide. Some 20 biotech and drug firms, led by Emeryville's Chiron Corp., have targeted the market for Hepatitis C Virus remedies that is estimated at $900 million in the United States and $3 billion worldwide.

Hepatitis C Virus has been called the silent epidemic. The name stems from the nature of the disease. Hepatitis C Virus is a viral infection transmitted primarily by the needles injection drug users share while shooting up.

"This is a disease nobody wants to pay for because the people who have it are unattractive," said Joey Tranchina, executive director of Hepatitis C Virus Global Foundation, the Redwood City nonprofit group that organized the conference, which should draw several hundred researchers to San Francisco.

Hepatitis C Virus is as stealthy and invisible as the injection drug users it infects. Most people who contract Hepatitis C Virus never know they have it because their bodies fight off the infection naturally or because the virus works so slowly the person dies of other causes before the infection becomes fatal.

In about 15 to 20 percent of cases, however, Hepatitis C Virus works quickly and severely enough to instigate cirrhosis, liver cancer or related illnesses that result in 8,000 to 10,000 deaths in the United States each year.

Still, because it is far less deadly than HIV and is only rarely transmitted through sexual contact, Hepatitis C Virus poses a lesser risk to the general public and therefore has a tougher time winning support for testing and treatment.

Hepatitis C Virus fighters got a tiny boost last year when the California Legislature passed a bill by state Sen. Richard Polanco, D-Los Angeles, to fund education and testing about Hepatitis C Virus risks. The bill, which started out seeking $7 million, emerged from the Legislature with a $2 million appropriation that was reduced to $1.5 million by Gov. Gray Davis.

"We know it's only a start, but it still puts California ahead of what other states are doing about hepatitis C," said Polanco legislative aide Chris Flammer.

This year's Hepatitis C Virus conference will give Seal and her colleagues a forum to question the way public health officials treat -- or rather fail to treat -- injection drug users who comprise most Hepatitis C Virus cases.

TREATMENT WITHHELD

The background for this debate begins in 1997, when the National Institutes of Health recommended that public health officials not treat drug users infected with Hepatitis C Virus unless the patient had gone cold turkey for six months.

Health officials in Europe and Canada have made similar recommendations. Several rationales are offered for this approach.

For one thing, Hepatitis C Virus acts so slowly that health officials consider the short-term ills of drug addiction worse than the harm caused by the virus. Health official also note that patients could be reinfected if they continue using drugs and sharing needles.

For these and other reasons, public health officials have been slow to offer drug users access to Hepatitis C Virus drug treatments that can cost $10,000 to $15,000 and only succeed about 40 to 60 percent percent of the time.

In a July 19 article in the New England Journal of Medicine, Seal and her associates at UCSF's Urban Health Study, led by project director Brian Edlin, challenged the notion that treatment should be withheld if patients are still injecting drugs.

"A recommendation to withhold medical treatment from a stigmatized class of persons raises questions about fairness and discrimination," the article said.

Other sick people get help even if they don't change underlying behavior, the authors noted. "Smokers are not denied coronary-artery bypass surgery or treatment for emphysema."

The authors argued that it was particularly unfair to withhold treatment until people kick their drug habits when effective drug treatment programs are not widely available and suggested that reinfection risk could be curbed through needle exchanges.

In a counterpoint article in the journal, two public health experts from the University of Florida urged continued caution in treating Hepatitis C Virus among active drug users. They argued that drugs and alcohol "have been reported to suppress" the effects of the interferon drugs used to treat Hepatitis C Virus.

Interferons are the body's natural virus-fighting agents. They prevent Hepatitis C Virus from taking over our cells and using the body's machinery to spread the virus.

The Florida authors, noting that interferon treatment often provokes depression, cautioned against giving these medicines to drug users who often already suffer from psychiatric disorders.

NEW DRUGS ON TAP

While the policy debate rages, drug and biotech firms experiment with new approaches.

Chiron is in the early stages of developing an Hepatitis C Virus vaccine. Twenty other firms are working on medicines to treat Hepatitis C Virus. Current treatment relies on interferon drugs from Roche, Schering-Plough, Biogen and Amgen.

But interferon therapy is, at best, successful only 40 to 60 percent of the time. Clinicians believe they can boost the success rate by combining interferons with ribavirin, a medicine that tricks the virus into making defective copies of itself.

Several companies are trying to make interferons easier to take. Right now these medicines are given by injection, several times a week over a four- to six-month period. Schering-Plough and Roche have once-a-week injectable versions in the works. BioMedicines Inc., an Alameda biotech firm, is in the early stages of testing a tiny titanium dispenser that would sit under the patient's skin and dole out a constant dose of medicine.

"This would greatly improve patient compliance," said BioMedicines chief executive Mark Moran.

SciClone, a San Mateo biotech firm, is seeking U.S. approval to sell Zadaxin, an immune system booster, to help treat Hepatitis C Virus. It is already approved for such use in two dozen other countries.

Biotech observers expect the $3 billion world market for Hepatitis C Virus medicines to grow as public and private health officials acknowledge the extent of the infection and increase funds for treatment.

OTHERS AT RISK

"Insurance companies are quaking in their shoes because so many people are chronically infected and may not know it yet," said Dr. Alfred Rudolph, chief operating officer of SciClone.

He said insured patients at risk include Baby Boomers who may have injected drugs once or twice a long time ago, unaware that Hepatitis C Virus is often transmitted the very first time a person shares a needle. People who got blood transfusions before the early 1990s, when blood supply testing became commonplace, may also be Hepatitis C Virus infected.

Meanwhile, the epidemic continues to spread among drug users, who remain off-limits to most government-sponsored treatment programs, as public health workers try to win support for patients who don't evoke sympathy.

"Who cares about a virus which only affects drug users?" Australian scientist Nick Crofts asked rhetorically in an e-mail. "Many people, especially those in control of policy, not only don't care but are quite pleased to see drug users get what they see as their (just) deserts."