This is how the company that cured hepatitis C seeks to end the HIV epidemic

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Curing HIV is for many experts the

.

Unlike what happens with other infections, without going any further than the SARS-CoV-2 coronavirus or the flu, the immune system does not eliminate HIV naturally, which is why it is so difficult to achieve it with drugs;

These control the virus and prevent the disease, but the pathogen settles in cells of the body called reservoirs where it remains, always with the risk that, without the brake of pharmacological therapy, it will reactivate and be transmitted.

That's

in the world.

The Gilead Sciences company picks up the challenge glove, with an extensive R&D program that ranges from prevention to cure.

This pharmaceutical company has been working on innovation in the field of HIV for 35 years, during which it has developed a dozen antiretroviral treatments, including the first regimen presented in a tablet and the first pre-exposure prophylaxis (PrEP) pill to reduce new transmissions in individuals at risk.

Beyond AIDS, Gilead also counts among its achievements the launch of the first drug that cured hepatitis C virus (HCV) infection, although its scientists acknowledge that replicating such a feat in HIV will be much more complicated.

On the occasion of the 24th International AIDS Conference (AIDS 2022), which is being held in Montreal (Canada) until August 2, Gilead has presented its strategy to end the HIV epidemic.

As

, vice president of HIV Clinical Development at the pharmaceutical company, says, "our goal is

HIV infections to zero."

Baeten, together with

, Senior Vice

of Virology Research, are responsible for the basic and clinical strategies to achieve this;

both break them down exclusively for this medium.

From San Francisco, Jared Baeten recalls that "in recent decades we have seen a transformation of HIV into a preventable and treatable condition, but we still have a long way to go, because the problem of HIV is not solved anywhere in the world. There are

, individuals who could benefit from preventive treatments, but are not taking the medication, and while we have made great strides, we still do not have the ability to completely block HIV infections."

To reduce new transmissions, he emphasizes, "we have to apply prevention and treatment strategies that work

. "

A daily pill is the ideal guideline for many people;

five-year data with Gilead's single tablet, presented at the AIDS 2022 meeting, confirm high efficacy and durable viral suppression in patients initiating treatment on this regimen, including those coinfected with hepatitis B virus (HBV).

Although for some the advantages offered by simplified treatments are sufficient, "there are also a

of one pill a day", explains Baeten on the importance of finding different options that cover the needs of everybody.

The company's way of working, describes this manager, consists of "placing the patient at the center of the drug development program even

".

" Cooperation

- made up of people living with HIV and socio-health workers, among other agents involved in prevention and treatment - determines the first steps of pharmacological research, so that the therapies that finally overcome the research phase "respond to the needs of people living with HIV or who require preventive strategies".

And this culminates in treatments that can be easily taken every day, as well as others that make adherence easier for those who should."

of stigma and discrimination.

prevention programs

These are well-known barriers for this HIV specialist who began his career in the mid-1990s - "we all remember then the handfuls of daily pills that the treatment involved" - and took him to different places in the United States and Africa.

Before starting his career at Gilead, Baeten has devoted much of his time to working to prevent infection, specifically through PrEP programs.

In this sense, one of the innovations promoted by Gilead are long

-

, drugs whose administration is spaced out as much as possible, in such a way that it barely interferes with daily life.

The pharmaceutical company is developing a drug in the clinical phase that will be the first of its kind.

Lenacapavir

;

"Given that it has a new mechanism of action, it can be useful in individuals who have developed resistance or intolerance to other drug families," says Baeten.

Almost 'a vaccine'

At the end of June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted, on the basis of the Capella international multicentre phase II/III study, a

for lenacapavir, in combination with another or other antiretrovirals, for adults with multidrug-resistant HIV-1 infection who are on a failed treatment regimen due to poor tolerability, emergence of resistance, or safety considerations.

The drug is also being tested -in the Calibrate study- as an option for those starting their HIV treatment, adds this specialist.

Notably, in addition to being the first in its family, it is a treatment that can be administered every six months as a subcutaneous injection.

There are two annual injections, Tomas Cihlar points out, "if we are successful,

.

The data from these and other ongoing studies show the high efficacy and safety of the treatment, adds Baeten, which encourages it to be explored in prevention programs as well.

"One of the reasons for working here is to be able to deliver medicines just as people need them," adds Baeten, so that they fit into their lives and contribute to the fight against AIDS in any corner of the world.

In 2011, Gilead was the first pharmaceutical company to donate all of its patents to the

, an organization supported by the United Nations (UN) to facilitate access to treatments.

Also, according to information from the company, the licensing agreements carried out have allowed more than 16.5 million people in developing countries to access their HIV treatments last year.

functional healing

Along with prevention and treatment, the third great leg to end the epidemic is, without a doubt, healing.

"Gilead has been working on it for years, with firm steps towards that goal," Cihlar points out, however, "we have to be realistic, curing HIV is a challenge that will take time. We see that over the years Only a few people around the world have been cured through hematopoietic cell transplantation, a procedure that is not suitable for most, due to the associated complications and because it is not reproducible on a large scale. HIV, and certainly no one alone is going to achieve it. It will take a lot of collaboration between pharmaceutical companies, biotech companies, scientists, academics, governments and the HIV community."

For this Czech biochemist, with an extensive scientific career in the development of antivirals for HIV and hepatitis B, and, recently, in that of remdesivir for covid-19, finding "the cure for HIV is the greatest current challenge of the Virology".

We are facing a virus totally different from others that have been cured.

"Without going any further Gilead has achieved it with HCV: with a specific antiviral treatment for about ten weeks you get it to disappear from the body".

Instead, HIV forms

that the immune system is unable to recognize or eliminate.

Even with all the difficulties on the table, Tomas Cihlar considers that achieving a cure must also be "the aspiration, the next frontier of innovation to head towards" and that is what he has been living for a decade.

The scientist states that they have "encouraging data in preclinical models of healing, where we have combined several agents: some to

the virus from the reservoirs and make it visible to the immune system, and others that act as an aid to the defenses to fight against the virus".

In this way, Cihlar points out, the functional cure is intended -the definitive cure would consist of the total elimination of the reservoirs and, therefore, of all traces of the pathogen-, for which the immune system is reinforced in order to control the virus by itself, without antiretroviral therapy.

Scientific teams around the world are testing

to achieve this goal, known as

(kick, to

the virus, and kill it).

Combination of molecules, useful in experimental model

The strategy explained by Cihlar uses a "combination of components to awaken the virus and agents that enhance the immune system's response against the virus.

," he says.

Achieving functional cure would be "a great advance, from there we could go to cure, with which the virus is completely eliminated."

To achieve this goal, Gilead collaborates with various companies;

one of them is AELIX Therapeutics, a biotechnology company based in Barcelona.

"We partnered with this biotechnology company focused on developing vaccines, with which we carried out a clinical study that uses the therapeutic vaccine that they have developed with vesatolimod [agonist of the TLR7 receptor that acts on the plasmacytoid dendritic cells of the immune system]. This drug

. We have seen that it works in preclinical models; we are now in full phase II trials and we will probably have results over the next year".

He also alludes, as a sign of his company's commitment to basic research, to the grants launched in 2016 to promote specific work on curing HIV.

Research is financed "to better understand the reservoirs, develop preclinical models and fine-tune potential pharmaceutical interventions, always in close collaboration with the community".

And in that enumeration of lines of research, he does not want to overlook proper management of expectations: "

, we have to make people understand that there is still a long way to go."

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