06/16/2017 / By Tracey Watson
The word “hepatitis” refers to inflammation of the liver, and can have several causes, including heavy alcohol use, exposure to toxins, or a bacterial or viral infection. There are three different types of viral infections: hepatitis A, hepatitis B and hepatitis C, which are caused by different viruses, and have different methods of transmission. Among this family of viruses, hepatitis C is the most dangerous, and is spread through contact with the blood of an infected person. A hepatitis C infection can last a lifetime, and can cause serious damage to the liver, ultimately resulting in cirrhosis (scarring) or even liver cancer. Hepatitis C kills about 700,000 people globally each year.
It is understandable, therefore, that the announcement of the release of an antiviral drug marketed as a “miracle” cure for hep C was received with great joy by many. However, a damning new study by the Cochrane Collaboration in Copenhagen, Denmark, has found that this $40,000 “miracle” cure might not be quite so miraculous, after all.
Though the astronomical price tag might have been out of the reach of many, there were lots of other patients who were more than happy to pay to avoid the death sentence so often attached to a hep C diagnosis.
These direct-acting antiviral drugs (DAAs) promise to completely clear the virus from the blood within 12 weeks, and it would seem that they do successfully fulfill this specific obligation.
In assessing all the DAA drug company trials, however, the Danish researchers determined that while clearing the virus from the blood, there is no evidence that these treatments actually fully remove hep C from the body. Their concern is that the virus may continue to linger elsewhere in the body, and in the sickest, stage 3 or 4 patients, could return and cause end stage liver disease.
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The researchers also noted that according to the 138 clinical trials reviewed, there were few deaths in either the placebo group or among those actually taking the DAAs.
Since all the trials were conducted under funding from the drug companies themselves, the study authors also expressed concerns about the “high risk of bias.”
“It is never possible to show that something does not work, but there is no evidence [that they do],” said Janus Christian Jakobsen, chief physician at a clinical trial unit in Copenhagen and the deputy coordinating editor of the Cochrane Hepato-Biliary Group. “Our results indicate [the drugs] may have no clinical effect.”
The authors concluded that with the lack of evidence that these drugs even work, as well as the potential that they might harm people, healthcare providers should think carefully before administering DAAs for the treatment of chronic hepatitis C.
Of course, the pharmaceutical companies are refusing to accept the results of the report.
AbbVie, one of these manufacturers, doggedly insists that both “controlled trials and real world experience” contradict the findings of the report.
“A cure in [hepatitis C] is defined as undetectable virus in the blood 12 weeks after completing treatment and, in the U.K., fewer than 1% of people treated with AbbVie’s therapy did not achieve this,” a company representative told The Guardian.
While a 2015 report by Public Health England pointed to an 8 percent decrease in end-stage liver disease, along with a decrease in liver transplants after the introduction of DAAs, the Cochrane researchers are adamant that there is no evidence proving their efficacy. [Related: Natural bioflavonoids kill the hepatitis C virus.]
The jaw-dropping price tag of these drugs has also caused immense concern worldwide. The World Health Organization (WHO) warned in 2016 that no country in the world could afford to treat all its hep C patients with such expensive drugs. Of course, their pleas fell on deaf ears. Big Pharma is happy as long as it’s making a profit, no matter who gets hurt along the way.
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Tagged Under: DAAs, direct-acting antiviral, hepatitis C, Liver cancer, liver disease