'Ivermectin not a miracle drug for Covid-19'

 

The principal investigator in the Health Ministry’s Ivermectin Treatment Efficacy in Covid-19 High-Risk Patients (i-Tech) study has stressed that the anti-parasitic medicine is not a miracle drug for the treatment of Covid-19.

Dr Steven Lim Chee Loon said that promoting it as such will only create a lot of false assurance among those taking it.

“It is highly irresponsible especially coming from a doctor because when you say miracle drug to laypeople, it means a miracle drug where you pop a tablet and you will not get the severe (version of the) disease.

“This is what is perceived by the layperson, especially those who are uneducated,” Lim said in a press briefing session on the results of the i-Tech study today.

He pointed out that there have been incidences of Covid-19 patients who have taken ivermectin and only later sought medical treatment at the hospital after they progressed to severe symptoms.

“When we asked why they came (to the hospital) late, they said that they had been taking ivermectin.

“So they only came when they found themselves in bad shape and required high-flow oxygen.

“We know ivermectin is a generally safe drug but when used in a disease that will have no effect at all, it will give false assurance and may be detrimental to them because they do not come to seek proper intervention,” Lim said.

The results of the i-Tech study were first reported on Nov 3, confirming that there is no benefit in repurposing ivermectin to treat Covid-19, in line with high-quality studies published on the matter.

Instead, study participants who received ivermectin were three times more likely to report side effects compared to participants who didn’t – usually cases of diarrhoea.

Lim emphasised that the study was designed to assess the efficacy of ivermectin in preventing the progression to severe disease in Covid-19.

He explained that the primary efficacy of any new antiviral must be measured against the prevention of progression to severe disease because severe disease directly impacts the hospital health care system.

The primary role of an antiviral is also to reduce viral load and prevent progression to severe disease, he added.

“Based on our primary analysis, ivermectin does not prevent severe disease when administered to high-risk Covid-19 patients during their first week of illness,” he said.

Low mortality not statistically significant

Despite that, Lim noted that proponents of ivermectin had latched onto the secondary outcome for mortality in the study to prove that the anti-parasitic drug is effective in treating Covid-19.

Those in the study who were given ivermectin on top of standard care according to the Health Ministry’s guidelines only recorded three deaths while those in the control group who received standard care recorded 10 deaths.

Lim explained that this secondary outcome is not statistically significant largely due to the small total number of deaths, that is 13 out of 490 subjects.

Not only that, he reiterated that the i-Tech study was not designed to assess ivermectin’s efficacy in preventing Covid-19 deaths.

He also noted that it is not uncommon for physicians to be less aggressive in their intervention for older patients who may not have a good prognosis, so that could have been a confounding factor for the mortality results.

“In research, we do not look at the numbers alone. We have to look at the whole picture and the subsequent analysis to know this is not by chance and that this is the true effect,” Lim said.

The study also analysed the patients who died and it was not able to find significant variables that can contribute to the difference in death numbers, he added.

“Again, this is because the number (of deaths) is very small.”

Institute of Clinical Research director Dr Kalaiarasu Peariasamy said the i-Tech study has also been listed on ClinicalTrials.gov, a database of privately and publicly funded clinical studies conducted around the world.

“The public has to be made aware, that is why we registered this study on (the site) where anyone can access the data there.

“Our team has been very transparent so that the rightful information can go out,” he said.

New ivermectin study 

When asked whether the Health Ministry will conduct further studies on the ivermectin drug, Kalaiarasu said they are in the process of getting the National Pharmaceutical Regulatory Agency’s (NPRA) approval for a “post-exposure prophylaxis” study.

This study will assess the efficacy of ivermectin in preventing one from contracting Covid-19.

He said the trial subjects will be adults 18 years old and above, who are close contacts with a confirmed Covid-19 patient.

Prophylaxis refers to measures taken to maintain health and prevent the spread of disease.

Health Ministry deputy director-general (Research and Technical Support) Dr Hishamshah Mohd Ibrahim noted during the briefing that there are hardly any drugs used as prophylaxis.

“It is only used for a very specialised group of people such as the anti-malarial drug which is a pre-exposure prophylaxis,” he said.

He added that even in those circumstances, it is usually short-term prophylaxis that has to be strictly monitored to ensure there are no side effects.

Ivermectin is normally used for treating parasitic diseases such as head lice, scabies and river blindness. However, it is only approved for animal use in Malaysia.

Nevertheless, various groups and even MPs have touted it as a cheap and effective treatment for Covid-19 based on a mix of misinformation and poorly conducted studies.

At least one major paper claiming to show the benefits of using ivermectin to treat Covid-19 has since been retracted after further analysis purportedly found irregularities that pointed to scientific fraud.

Since then, higher-quality studies have been conducted, which were largely either inconclusive or found no benefit in using ivermectin to treat Covid-19. - Mkini