NUH seeking suitable Hepatitis B patients for study into possible cure by stopping medication
Professor Lim Seng Gee, senior consultant at NUH's division of gastroenterology and hepatology, and Mr Arfan Awaloeddin, his patient, who has been cured of Hepatitis B by stopping treatment, after 27 years living with the condition and constant medication.
SINGAPORE — The National University Hospital (NUH) is seeking about 150 suitable Hepatitis B patients to take part in a study, which has achieved early success in exploring the possibility of a cure by stopping medication. However, this should only be done under advice by doctors.
Indonesian entrepreneur Mr Arfan Awaloeddin, who had Hepatitis B for 27 years, has been cured of the condition after his medication was stopped as part of the study, which started on Jan 30.
The 49-year-old is the first patient in Singapore to be cured of Hepatitis B by stopping treatment. He has been on Hepatitis B medications since he was about 22, and has spent about S$4,000 a year on medications and various medical tests.
But he has now been declared clear of the condition — though he will need monthly checks for one year. “After stopping the medication, my body feels free… Now I feel free,” he said at a media briefing at NUH on Wednesday (June 12).
At the briefing, NUH shared details of its ongoing medical study on Hepatitis B, which is a potentially deadly viral infection that affects the liver, and is the most common cause of liver diseases and liver cancer.
The study, known as HALT-NUC, has screened 38 patients with Hepatitis B and enrolled 23 of them.
PATIENTS ADVISED NOT TO STOP TREATMENT WITHOUT MEDICAL ADVICE
Despite the encouraging outcome with Mr Awaloeddin, Professor Lim Seng Gee, senior consultant at NUH’s gastroenterology and hepatology division, cautioned against Hepatitis B patients stopping medication of their own accord, emphasising that they should seek advice from their doctors.
“I think stopping treatment can be dangerous so it is not recommended that when patients hear this exciting result and just stop treatment on their own, because stopping treatment have been associated with hepatitis B flares, and in some cases, liver failure,” said Prof Lim.
As such, stopping medication is not suitable for all patients, as it is dependent on each patient’s medical condition. As a result, patients must be selected carefully for those "who can stop and who would not run into problems”, Prof Lim said.
To ensure the safety of the patients, a list of criteria for participation in the study was set out:
Must have been on oral medications (tablets) for at least a year.
No diagnosis of liver cirrhosis.
Low levels of Hepatitis B markers (below or equal to 100 international units per millilitre (iu/MI) — a commonly used medical measure)
Aged 21 to 75 years
The current available treatment for Hepatitis B includes the use of tablets, injections, a combination of tablets and injections, and now the possibility of stopping treatment.
When treatment is stopped, the body’s immune system likely recognises the virus as foreign and tries to clear the virus, Prof Lim said.
He explained that “liver function tests (can) become abnormal, and the virus becomes detectable”, so patients under the study may become anxious but he assures that “this is a typical response” and there are still chances for the virus to be cleared after.
The patients would therefore be monitored before their doctor decides to restart treatment or proceed with no treatment. Prof Lim also advised that it is not wise to immediately restart treatment upon such results.
CURED AFTER 27 YEARS
Mr Awaloeddin, who travels across Indonesia in his job, said he has had to take medication with him on his travels ever since he was diagnosed with Hepatitis B at the age of 22.
More than 10 years ago, Mr Awaloeddin stopped his medication of his own accord. After two to three months, a test found that the condition was still present and he resumed his medication.
In February this year, as part of the study, Mr Awaloeddin stopped the treatment upon the advice of Prof Lim, who has been his attending doctor since 2006.
Mr Awaloeddin said he felt good that he is free of the medication, but admitted he felt anxious when he was told to stop the medication.
“(Initially) I felt good, but after about two months (of stopping medication), I felt uncomfortable because I saw that the Hepatitis B marker has gone up. Maybe it was a psychological effect of uneasiness to not be on medication, based on my past experiences,” he said.
But eventually the marker came back down and Mr Awaloeddin’s liver is now functioning normally and he has been cleared of Hepatitis B in May. However, he will be monitored monthly for one year.
Mr Awaloeddin added: “Professor Lim reassured me that it is common and told me that he will continue to monitor my condition, and if I feel unwell, I can just come back to him.”
Prof Lim confirmed that Mr Awaloeddin has been cleared of Hepatitis B: “Mr Awaloeddin’s Hepatitis B test, HBsAg went from positive to negative, hence was considered cured.”
The burden of medication is a major concern for Hepatitis B sufferers.
In a study conducted by Prof Lim in 2012, when patients were asked: “Would you be willing to have lifelong treatment?”, the response was mixed: 36.3 per cent answered ‘no’, 43.5 per cent “yes’”and 20.2 per cent neutral.
Oral medications and injections are generally safe for patients with Hepatitis B, but there are potential side effects associated with injections, such as flu-like illness, tiredness, weight loss and appetite loss. As a result, many patients prefer not to be on long-term medication.
Hepatitis B has two types of diagnosis — acute and chronic. Acute usually resolves after a few weeks or months but chronic tends to be more severe, leading to liver inflammation, liver failure, liver cirrhosis or liver cancer. They are also the group of patients who may be on long-term medication for Hepatitis B.
Medical experts use technical markers to measure Hepatitis B. The lower the level of the marker, the greater the prospects that the condition could be cured without medication. But stopping the medication may also speed up the infection. This was why Prof Lim stressed the need to select suitable patients for stopping medication.
LONG-TERM MEDICATION CARRIES SIDE-EFFECTS
While the concept of stopping treatment for a cure is not new, Prof Lim explained that it is “the first in the world to test the cut-off level” for Hepatitis B marker at 100 iu/MI, which is considered a lower level of infection markers for Hepatitis B.
“In other studies, they just stopped (at) people who have been on long-term treatment and did not worry about level or quantitative HBsAg. This is the first time we know whether 100 iu/MI is the right level,” Prof Lim said.
As part of the control for the study, one out of every three patients will be placed on continued medication and the other two patients will have their medication stopped.
Prof Lim said the study will also eventually be starting in Singapore General Hospital, Tan Tock Seng Hospital and Changi General Hospital, but no timeline has been provided.
Patients who are interested in taking part in the study can contact NUH on 6772 4447.
