Coronavirus hopes dashed as trial finds promising HIV drug have little effect on patients

Lopinavir/ritonavir, marketed under the brand names Kaletra and Aluvia, is an anti-HIV medicine

Hopes for a coronavirus cure were dealt a blow today after promising HIV and antiviral drugs were shown to have no effect on infected patients in China.

Patients given anti-HIV medication lopinavir/ritonavir or the flu tablets Arbidol did not improve any quicker than those treated without drugs in the study of 86 patients.

Sufferers given the antivirals also reported side effects including diarrhoea, nausea, and loss of appetite.

The researchers recommend for this reason they should not be used as COVID-19 therapies.

However, they only looked at patients with mild-to-moderate cases of the infection and say the outcome may be different for people with critical illness.

Lopinavir/ritonavir (LPV/r) was earmarked as one of the most promising treatments for coronavirus after lab studies showed it stopped coronavirus from replicating.

It is currently being tested on NHS patients in the UK as part of the biggest COVID-19 trial, called RECOVERY.

The study is being led by Oxford University and is trialling five existing drugs on more than 6,000 patients around the country.

Arbidol, generic name umifenovir, is a soviet-era flu and cold medication predominantly only used in Russia and China. 

Both drugs are protease inhibitors which stick to viral molecules and prevent them from multiplying and spreading. 

Arbidol, generic name umifenovir, is a soviet-era flu and cold medication predominantly only used in Russia and China

Arbidol, generic name umifenovir, is a soviet-era flu and cold medication predominantly only used in Russia and China

The latest research, by the Centre for Infectious Diseases of Guangzhou Eighth People’s Hospital in Guangzhou, split 86 patients into three groups.

Thirty-four volunteers were randomly assigned to get lopinavir/ritonavir, 35 were given Arbidol, and 17 received supportive care as a control.

All three groups showed similar outcomes after a week and 14 days. The study found no differences between groups in the rates of fever reduction, cough alleviation, or improvement of lung inflammation.

Co-lead author Linghua Li, vice director of the Centre for Infectious Diseases at the hospital, said: ‘We found that neither lopinavir/ritonavir nor Arbidol could benefit clinical outcomes for patients and that they might bring some side effects.

WHAT DRUGS DID THE STUDY LOOK AT?

Patients were given either the anti-HIV medication lopinavir/ritonavir or the flu tablets Arbidol/.

The former is an anti-HIV medicine given to people living with the virus to prevent it developing into AIDS. 

HIV patients were prescribed either Kaltra or ritonavir alone around 1,400 times in 2018.

Arbidol, generic name umifenovir, is a soviet-era flu and cold medication predominantly only used in Russia and China.

Both drugs are protease inhibitors, which essentially stick to an enzyme on a virus which is vital to the virus reproducing. 

By doing this it blocks the process the virus would normally use to clone itself and spread the infection further.

Lopinavir/ritonavir (LPV/r) was earmarked as one of the most promising treatments for coronavirus after lab studies showed it stopped coronavirus from replicating.

It is currently being tested on NHS patients in the UK as part of the biggest COVID-19 trial, called RECOVERY.

‘And although the sample size is small…our findings suggest that we need to cautiously consider before using these drugs.

‘Researchers need to keep working to find a really effective antiviral regimen against COVID-19, but meanwhile, any conclusions about antiviral regimens need strict and scientific clinical trials and appropriate caution.

‘The general public, however, shouldn’t panic just because currently there’s no specific antiviral medicine currently.

‘Quarantine and good personal health protection could help us prevent people from getting infected with COVID-19, and even in case of infection, the present comprehensive treatment can still enable the vast majority of patients to return to health.’  

Commenting on the findings, Ian Jones, a professor of virologist at University of Reading, described the results as ‘disappointing’.

He said: ‘We are beginning to see a number of early drug trial reports and, generally, the results are disappointing. In this case the drugs were a long shot as they were developed for different viruses, not specifically for coronaviruses.

‘But it should also be borne in mind that, for drugs that target the virus itself, the timing of any drug treatment is crucial. Antivirals have to be given as early as possible if their effect on the virus is to have any clinical effect.

‘Think “bull in a china shop”, if the bull is stopped as it leaves the shop the damage is already done but if it is stopped soon after entry, the damage is much reduced.

‘Ideally drug treatment would follow an early diagnosis when symptoms are hardly present. So it is too early to give up on Covid drug therapy yet. 

‘Given at the appropriate time they could still impact disease, improve recovery and limit virus spread. More trials, with drug given at earlier times, are needed.’

Results from the RECOVERY trial are expected in the next few months, which will give a better idea of how effective lopinavir-ritonavir is on COVID-19 patients.

Likely hundreds of sufferers in NHS hospitals with varying degrees of illness will be given the drugs, which will provide a larger sample size.

The trial will also look at the Donald Trump-touted hydroxychloroquine; the steroid dexamethasone; azithromycin, an antibiotic that may kill off viruses; and the arthritis drug Tocilizumab. 

WHAT IS THE RECOVERY TRIAL? 

More than 6,000 coronavirus patients in the UK have volunteered to take part in a drug trial run by the University of Oxford to find a treatment for COVID-19.

The programme is called the RECOVERY Trial (The Randomised Evaluation of COV-id19 thERapY) and is the world’s biggest single trial of drugs to treat the coronavirus.

The university got the support of Chief Medical Officer Professor Chris Whitty and put out a plea to doctors around the country to enrol patients in the voluntary trial.

Volunteers have since joined the trial from more than 160 NHS trusts around the country and scientists are hopeful more people will continue to sign up.

Medics have not put a number on the amount of people the trial needs in order to be successful but has said the more participants the trial has, the more likely it will be the team will find answers.

Participants will receive one of five drugs currently on the market — including the anti-malaria drug touted by Donald Trump, known as hydroxychloroquine.

The other drugs being looked at as a treatment for COVID-19 include a combination of Lopinavir and Ritonavir (known by the brand name Kaletra), which is used to treat HIV; low-dose Dexamethasone,a steroid used to reduce inflammation; azithromycin, a commonly used antibiotic which may have antiviral properties; and the steroid Tocilizumab.

Similar trials are being set up around the world, which run independently to the Recovery Trial, but none have garnered as many participants as the UK programme.

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