'Life-changing': Revolutionary new HIV drug approved for use in the UK

 A revolutionary HIV drug that reduces the need for a daily cocktail of drugs to half a dozen injections a year has just been approved in the UK.

By Euronews  with AP  •  Updated: 19/11/2021

For those suffering from the disease, the news of a long-acting treatment is "extraordinary" and "life-changing".

The injectable treatment is a combination of cabotegravir (also called vocabria) with rilpivirine (also called r_ekambys_) and is as effective as oral antiretrovirals at maintaining a low viral load in clinical trials, according to the National Institute for Health and Care Excellence (NICE).

Cabotegravir is the result of the FLAIR trial run by Professor Chloe Orkin at Queen Mary University of London. The results were first published in March 2019.

Now more than two years later, its supply has been scaled up and the drug is being made available freely to HIV patients throughout the UK.

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Charities have welcomed the move as it offers an alternative to taking daily antiretroviral drugs to suppress the virus.

An estimated 13,000 people will be eligible for the new treatment via the NHS.

The treatment is already being used in parts of Europe, the US, and Canada, with scientists saying it is highly effective.

Original Source

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‘Great step forward’ for HIV treatment as long-acting jabs to replace daily pills

Charities hail ‘incredible’ news as injectable treatment to be offered to 13,000 people on NHS

Ella Pickover   19 Nov 2021

A new injectable HIV treatment could replace daily pills

(Getty Images)

The NHS has been given the green light to offer people living with HIV the first "long-acting injectable" to keep the virus at bay.

Charities have hailed the "incredible news" which offers an alternative to adults living with HIV who have to take daily antiretroviral drugs.

Many people living with HIV can keep the virus at very low levels by taking antiretroviral tablets each day.

These drugs keep the number of virus particles in the blood - also known as the viral load - so low that it cannot be detected or transmitted between people.

But now an estimated 13,000 people will be eligible for the injectable treatment in England which means they no longer need daily treatment but will have two injections every two months.

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This means they can reduce the days they receive treatment from 365 to six per year.

The National Institute for Health and Care Excellence said that cabotegravir (also called vocabria and made by Viiv Healthcare) with rilpivirine (also called Rekambys and made by Janssen) can be offered to adults who have managed to keep HIV viral load to a low level through daily antiretroviral medicines.

Clinical trial results show that cabotegravir with rilpivirine is as effective as oral antiretrovirals at maintaining a low viral load, Nice said.

Meindert Boysen, deputy chief executive Nice, said: "Despite scientific advances HIV is still incurable, but the virus can be controlled by modern treatment.

"However, for some people, having to take daily multi-tablet regimens can be difficult because of drug-related side effects, toxicity, and other psychosocial issues such as stigma or changes in lifestyle.

"We're pleased therefore to be able to recommend cabotegravir with rilpivirine as a valuable treatment option for people who already have good levels of adherence to daily tablets, but who might prefer an injectable regimen with less frequent dosing."

Commenting on the news, Debbie Laycock, head of policy at Terrence Higgins Trust, said: "It's incredible news for people living with HIV in England and Wales that they will be able to access the first long-acting injectable treatment on the NHS as an additional treatment option.

"We have incredibly effective treatment which means HIV is now a manageable virus, however, it is lifelong so it is important that taking treatment is as easy as possible.

"HIV unfortunately remains a stigmatised condition. Although we're working hard to tackle the stigma surrounding HIV, this new injectable treatment option could help people in house-shares for example who do not wish to share their HIV status and will no longer have to worry about hiding their medication.

"Pill fatigue is also an issue for some people living with HIV who struggle with the idea of taking antiretroviral drugs every day.

"Long-acting injectable treatment is also a better option for those who have difficulty swallowing medication. Therefore, the institute's approval provides a welcome additional treatment option for people living with HIV across England and Wales.

'This is a great step forward as we work towards ending new cases of HIV by 2030. The institute's decision brings great potential for HIV prevention including long-lasting PrEP in the future."

Deborah Gold, chief executive of National Aids Trust, said the charity was "delighted" with the news, adding: "The voice of people living with HIV is clear: they want this technology available as part of a range of treatment options. It won't be right for everyone but, for some, monthly injections are highly preferable to daily pills.

"Innovations that can make it easier for people to stick to their treatment plans both improve the wellbeing of people living with HIV and bring us one step closer to the goal of ending transmissions by 2030."

Dr Jonathan Stoye, from the Francis Crick Institute, said: "Drug treatment of HIV-1 has been one of the great successes of modern medicine.

"While HIV-1 was once a virtual death sentence from Aids, combination therapy now allows an essentially normal life span.

"However, almost all treatments require taking medicines at least once a day. This is inconvenient and brings with it the risk of missing doses essential for virus control.

Original Source

Coronavirus: how will the vaccine advances of 2020 alter the pandemic path in 2021?

 

• The extreme lows brought by Covid-19 have sparked unprecedented speed in developing and approving vaccines and rolling them out
• A number of factors beyond the shots themselves will determine if and how transmissions are curbed

Josephine Ma

Published: 7:00am, 8 Jan, 2021

Illustration: Sierra Chiao

This is the latest story in 

our series on the Covid-19 pandemic

, a year after the first cases were reported in the mainland Chinese city of Wuhan. It explores how vaccines have advanced at unprecedented speed and what prospects they hold for the fight against the disease this year. Please 

support us

 in our mission to bring you quality journalism.

One year after a 

novel coronavirus

 caused the worst pandemic in a century, several vaccines have already been rolled out and others are expected to follow in the coming months.

It is a record. Before this, no vaccine had been developed in less than four years, sometimes taking decades.

The year 2020 was catastrophic for many people, but it was also a record-setting year in terms of vaccine research. Now the big question is: how will 

Covid-19 vaccines

 make a difference in 2021?

How history was made in 2020

The genome sequence of the new coronavirus was shared on a public platform on January 11, 2020, and thanks to the tireless work of the team led by Shanghai-based virologist 

Zhang Yongzhen

, scientists in various countries began to work on vaccines.

For example, on January 13 last year, US company Moderna and the National Institutes of Health had already finalised the sequence for an mRNA vaccine against the new virus and they soon began to make a clinical batch.

Oxford University also moved quickly to adapt its research on a Middle East respiratory syndrome vaccine using a chimpanzee virus as a vector to express Sars-CoV-2, the official name of the new coronavirus.

Despite the sprints made by vaccine developers, when 

World Health Organization

 (WHO) chief Tedros Adhanom Ghebreyesus said in February that a vaccine might be ready in 18 months, it appeared unrealistically ambitious because there had never been a successful vaccine against a coronavirus.

“If you asked in February and March [2020] whether we have a vaccine available in December, nobody would have said that is going to happen that quickly,” said John Moore, professor of microbiology and immunology at Weill Cornell Medical College in New York.

But scientific research in vaccines over the past decade laid the groundwork.

“You have to remember the programme did not start from nothing,” Moore said.

Inside China’s exhausting race to develop a coronavirus vaccine

5 Jan 2021

For example, even though there has never been an mRNA vaccine for humans, there has been research into the technology for about 10 years, including laboratory and early clinical tests to determine whether it might work to tackle diseases such as Ebola, Zika, influenza and cancer.

In the past, developers needed to make sure the vaccines worked before they could start manufacturing. But now, massive government funding allowed them to invest in manufacturing facilities before they had to prove the vaccines worked.

The 

Warp Speed programme

 under the administration of US President Donald Trump gave more than US$12 billion to vaccine makers such as 

Moderna

, AstraZeneca, Johnson & Johnson, Sanofi and Novavax. In return, the US government signed contracts with these companies so it could meet its goal of securing 300 million doses for Americans.

The vectored vaccine by Oxford-AstraZeneca has an efficacy rate of at least 70 per cent. Photo: Reuters

In contrast, the Chinese government set up a special task force in January to fund and coordinate vaccine and drug research after the Wuhan outbreak. By April, it had identified five different types of vaccine technologies it would pursue for the vaccine race, including the traditional 

inactivated vaccine technology

 that has long been shunned by the West.

“There are a couple of reasons that inactivated vaccines are not really pursued in the West. One, is it is an old technology and pharmaceutical companies have moved on to more modern methods,” Moore said.

“The second is that there is always a risk, going back decades ago, of not inactivating vaccines thoroughly enough and leaving some virus around,” he added, referring to an accident in the US in 1955 related to polio vaccines.

China’s diplomacy leans on vaccine outreach but beware soft power failure

5 Jan 2021

He said there was no longer a culture facility in the US suited to making – and inactivating – large amounts of live virus.

China’s approach, however, is paying off. China was never a global leader in vaccine research but it has emerged as a front runner in the Covid-19 vaccine race. This is despite not being the first country to cross the finishing line, hampered by too few local cases for efficacy analysis and forced to host the final phase of vaccine trials in other countries.

Trial and regulatory review procedures were compressed and held simultaneously to speed up the process, which analysts said could be an example for future research.

Stanley Plotkin, who invented the rubella vaccine in the 1960s and was an important player in the vaccine industry for decades, said the scientific events of last year were unprecedented and would change the playbook for vaccine research.

“Never before have so many developers … worked on a single vaccine using so many different platforms in so short a time. Yes, it will help in the future,” Plotkin said.

But the surprisingly fast progress also depends on a bit of luck, as the virus turns out to be less tricky than some other pathogens for vaccine development.

Most of the 63 vaccines now undergoing clinical trials target the spike protein of the coronavirus that binds to human cells. The target, which was identified based on past vaccine research for coronaviruses, turned out to be the right one.

John Moore said: “HIV, for example, is much harder to vaccinate against … Influenza is much harder to deal with than Sars-CoV-2. So Sars-CoV-2 looks like it is quite easy compared to some pathogens. It has the side of vulnerability that can be exploited – that does not apply as much to other viruses.”

What should we expect in 2021?

Uncertainties remain about whether and when the vaccines can bring an end to the pandemic, which infected over 87 million and killed at least 1.8 million people in roughly one year.

Efficacy data from the front-running vaccines are all far better than the benchmark of 50 per cent set by the WHO and regulators in many countries.

The two mRNA vaccines developed by Pfizer-BioNTech and Moderna achieved about 95 per cent respectively. The vectored vaccine by Oxford-AstraZeneca had an efficacy rate of at least 70 per cent, although it could be even higher after adjusting the dosing.

China says it can produce 1 billion doses of Sinopharm vaccine this year

6 Jan 2021

China also announced one of its inactivated vaccines had an efficacy of 79 per cent. The country gave conditional approval to the vaccine for market launch on December 31 and promised to offer free inoculations to the public. It also has an ambitious plan to vaccinate 50 million people in high-priority groups before the Lunar New Year travel peak in mid-February.

However, the efficacy rates of these vaccines – whose trials compare symptomatic infections in different groups – cannot show how effectively the vaccines stop transmission. There remains scant information about how well the vaccines stop asymptomatic infections. And not all vaccine trials show how well they can protect elderly or seriously ill patients.

Scientists, therefore, will closely monitor whether transmission rates drop in the new year, a factor closely linked to accessibility of the vaccines and the public’s willingness to take the jabs.

“[Experts will be looking for] decreasing hospitalisations, but also decreasing infections indicating decreased spread of the virus,” Plotkin said.

Michael Kinch, director of the Centre for Research Innovation in Biotechnology at Washington University in St Louis, said the duration of protection and virus mutation would determine if the vaccines could really end the pandemic.

“Evidence is mounting that natural infection – becoming sick from the virus – may not provide durable immunity in some. The key is whether a vaccine might overcome this limitation,” he said.

So far, the new variant discovered in London, although rendering the virus more transmissible, does not affect the spike protein targeted by the vaccines, but mutations that could potentially appear in the coming year will affect the success of inoculation programmes.

Safety issues – ranging from long-term and rare side effects, production quality and human errors in inoculation – can also pose challenges. Public confidence in the vaccines will be crucial to whether they will truly make a difference.

Singaporeans won’t be able to choose between Covid-19 vaccines

4 Jan 2021

For example, while many hailed the high efficacy of mRNA vaccines, George Gao Fu, head of the Chinese Centre for Disease Control and Prevention (CDC), has 

cautioned about unknown side effects

 because mRNA vaccines have never been used on healthy humans.

In addition to issues around supply shortage and access by developing countries to the vaccines, a concern raised by many organisations since early last year, large-scale and rapid inoculation can be messy.

Even a developed country such as Germany faces many bumps early in the roll-out, particularly because it is using 

Pfizer-BioNTech

 vaccines that require deep freezing. Eight workers at a care home were mistakenly given Pfizer-BioNTech doses five times the recommended dose. And 1,000 doses of the same vaccine were returned after being transported in a picnic hamper cool box instead of at the required minus 70 degrees Celsius (-94°F).

Chinese CDC chief George Gao Fu has cautioned about the unknown side effects of mRNA vaccines. Photo: AFP

Johnson & Johnson – which has taken up a significant percentage of the portfolio of the 

Covax Facility

, an international vaccine distribution mechanism led by the WHO – is likely to be next to finish its efficacy analysis.

Scientists are also pinning their hopes on protein subunit vaccines, a technology being used by US company Novavax and also by a team led by China CDC head Gao and Anhui Zhifei Longcom Biopharmaceutical. The technology is well proven and has been used in flu shots and hepatitis vaccines but such vaccines are difficult to design.

A candidate of a protein vaccine developed by pharmaceutical giant Sanofi and GSK must be delayed until late this year because of weak clinical data.

https://www.scmp.com/news/china/science/article/3116547/coronavirus-how-will-vaccine-advances-2020-alter-pandemic-path