Hepatitis B may feature typical viral hepatitis symptoms like yellow skin, yellow eye-white “sclera” and dark urine. Alternatively, it may occur unnoticed with subtle fatigue and/ or muscle pain. This is why it is often missed.
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[HONG KONG] In what has become a cruel public health irony, not being HIV positive is a lethal disadvantage experienced by millions of people with chronic hepatitis and no access to life-saving drugs.
On Global Hepatitis Day last week [July 28], viral hepatitis surpassed HIV, malaria and tuberculosis as a leading cause of death from infectious disease. [1]
Asia bears the brunt of the burden with over one million viral hepatitis-related deaths each year and 70 per cent of the global death toll. In Asia, viral hepatitis is three times more deadly than HIV and nine times more so than malaria.
“For years, viral hepatitis has been largely neglected,” Margaret Chan, WHO director-general, acknowledged recently.
Charles Gore, president of the World Hepatitis Alliance, says viral hepatitis has been so chronically under-prioritised that there is little funding available in domestic budgets and none from international funders.
“The failure to include hepatitis in the Millennium Development Goals [MDGs] has been calamitous in this regard and this mistake is likely to be compounded by the failure to include hepatitis in the post-2015 Sustainable Development Agenda,” Gore says.
A fatal error
On 22 July, medical journal The Lancet reported on the triumph of MDG 6, which has seen the HIV death toll fall by almost one third, from a peak of 1.7 million in 2005 to 1.3 million in 2013. Mortality rates for tuberculosis have fallen to 1.4 million [or 1.3 million, if those who are also HIV-positive are excluded]. Annual malaria deaths peaked at 1.2 million in 2004, falling to about 855,000 in 2013. [2]
However, the WHO Global Burden of Disease 2010 study, published in December 2012 by The Lancet, put annual viral hepatitis related deaths at 1.44 million. [3] Experts suggest there has been no reduction since then.
Stephen Locarnini, director of the WHO Regional Reference Laboratory for Hepatitis B, says the decision to exclude hepatitis from MDG 6 was an epidemiological oversight based on flawed data.
Back in 2000, when governments worldwide adopted MDG 6, experts profoundly underestimated the hepatitis disease burden, he says. They only included mortality figures for acute hepatitis and left out those for hepatitis B and C related liver cancer and cirrhosis deaths — which actually account for about 80 per cent of the viral hepatitis mortality burden. The error persisted until the WHO Global Burden of Disease figures came out in December 2012.
Ben Cowie, an Australian infectious diseases physician and epidemiologist, and spokesperson for the Coalition to Eradicate Viral Hepatitis in Asia Pacific [CEVHAP], tells SciDev.Net the legacy error has led to a public health agenda that is terribly distorted and far from evidence based.
“Only looking at acute hepatitis mortality was clearly insane. It’s a bit like saying we’re only going to count HIV/AIDS deaths from seroconversion illness and not immune deficiency,” he says.
Haves and have nots
Existing hepatitis B drugs suppress viral replication, which stops progressive liver disease, allowing the liver to recover. The antiviral drugs can reverse cirrhosis, and reduce the incidence of liver cancer by 50-70 per cent. But the vast majority of the 350 million people worldwide with chronic hepatitis B do not receive treatment.
One of the antiviral drugs, tenofovir, is also used in the treatment of HIV, and funding support from international financing organisations such as the Global Fund and the US President's Emergency Plan for AIDS Relief has made it available for people living with HIV in extremely resource-challenged settings in the Asia-Pacific region.
“But the tragedy is that tenofovir is not made available for people living with hepatitis B. So, you can have the dichotomy whereby someone living with HIV is readily able to access free tenofovir for the treatment of their HIV, but his next-door neighbour who is dying of cirrhosis or has progressive liver disease and is at significant risk of liver cancer is unable to access the drug,” Cowie says.
India makes tenofovir generically for US$15-20 per month, but this is still well beyond the reach of most people living in the Asia-Pacific region, Cowie adds. Licensing deals further restrict the availability of generics.
“This inequitable situation can’t be allowed to continue. We really need to broaden the MDGs to include viral hepatitis as a matter of equity, and, especially in the Asia-Pacific region, as an urgent public health initiative,” he stresses.
Although the WHO is making inroads in responding to the hepatitis burden, Cowie says the international funding response continues to be woefully inadequate. He accuses the Global Fund of burying its head in the sand.
“We have the data, we’ve shifted the evidence base, but this is not going to translate into outcomes for people’s lives until we have a funding response,” he argues.
In reply, a Global Fund spokesperson tells SciDevNet: “The Global Fund has a clear mandate to support programmes that prevent, treat and care for people affected by AIDS, TB and malaria. We are committed to that mandate and do not plan to change it.”
Learning from HIV
There is no hepatitis C vaccine, and vaccine candidates are a long way off. Meanwhile, there are 185 million people living with chronic hepatitis C infection worldwide. But new oral drug treatments for hepatitis C promise greater than 90 per cent cure rates in 12 weeks — even in people with severe liver disease.
However, the revolutionary drug therapies are prohibitively expensive, costing US$84,000 for sofosbuvir and US$66,000 for simeprevir per person for a full course of treatment, according to an article published in Science last month.
But the authors’ analysis demonstrated that the drugs could be manufactured for as little as US$78 to US$166 per person, if the same methods used for mass-producing generic drugs for HIV/AIDS were applied. [4]
The US patents for the new hepatitis C drugs do not expire until the mid-to-late 2020s. To avoid an estimated 7.5 million hepatitis C deaths between now and then, the authors called on pharmaceutical companies to allow low-cost mass production of generics, with a small royalty paid back to them.
The authors also encouraged low-income countries to emulate the actions that once helped lead to affordable HIV treatment. “In some cases, countries overruled company patents on drugs and started importing generic drugs at lower costs — so-called compulsory licensing — which is permitted in cases of national medical emergencies,” they wrote.
In May, a US$15 million grant from the WHO-hosted UNITAID to the humanitarian nongovernment organisation Médecins Sans Frontières paved the way for the first major global scale-up of the new hepatitis C drugs. The goal is to reduce the cost of treatment to US$500-1,000 per patient for low and middle income countries. But there is a catch: the only beneficiaries will be people who are co-infected
with HIV. In the same round of UNITAID grants, TB received US$60.4 million worth of funding and malaria received US$67.4 million.
Prevention is better than cure
The WHA president urges governments not to let the new hepatitis C drugs distract them from the task of prevention.
“The new drugs could be game-changing, but we must see governments and the WHO emphasising prevention as a key part of healthcare systems if the drugs are going to make the global impact we’re hoping for,” he says.
Although hepatitis C infection rates are tapering off in some parts of the world, they continue to rise in Asia, where many hospitals use contaminated syringes, surgical instruments and blood products; and where harm reduction measures for people who inject drug are often inadequate. A person who has been cured of hepatitis C can easily become reinfected, because natural infection with hepatitis C does not induce immunity.
The single most important preventive strategy for mother-to-child transmission of hepatitis B is a dose of hepatitis B vaccine given in the first 24 hours of life. Without it, exposed newborns have a 90 per cent chance of going on to develop chronic infection. Most people with chronic hepatitis B were infected at birth. But coverage of the birth dose remains low in much of South-East Asia and in remote areas of the Western Pacific.
The GAVI Alliance, a global vaccines partnership, funds a three-dose course of hepatitis B vaccine for many Asian countries, commencing in six week old newborns. But the birth dose remains largely unfunded. Last month, the Médecins Sans Frontières Access Campaign wrote to GAVI, expressing their concern about the missed opportunity and urging GAVI to scale up birth dosing. [5]
While a new development agenda is currently being set in place of the MDGs, the question of who will pay for lifesaving viral hepatitis prevention and treatment remains unanswered. In the meantime, those with chronic infection continue to needlessly die.
This article has been produced by SciDev.Net's South-East Asia & Pacific desk.