Health

New HIV treatment options to end AIDS


Lifesaving antiretroviral therapy stops HIV from multiplying and can stop HIV to undetectable levels in the blood, which allows the person’s immune system to recover and overcome infections and stop development of AIDS. The risk of transmitting the virus is also negligible if people with HIV are on antiretroviral therapy and are suppressing the virus. So treatment also acts as one of the preventive options.

But the war is far from over. About 36.3 million people have died from AIDS-related diseases since the outbreak began. There are 37.7 million people living with HIV globally. Of these 36 million are adults and 1.7 million children. More worrying is that 26% of adults and 46% of children with HIV still do not have access to life-saving drugs (ART).

While there are enormous challenges to ending AIDS by 2030, it is commendable to see the significant progress that has been made worldwide towards achieving this goal. For example, 28.2 million people were accessing ART as of June 30, 2021. Another good news is that new ART drugs are rewriting the scenario for HIV prevention and treatment. .

At the 29th Conference on Retroviruses and Opportunistic Infections (CROI 2022) just concluded by CNS (Citizen News Service), Dr. Chloe Orkin, Clinical Professor of HIV Medicine at Queen Mary University, London, has shared valuable information on new drugs being in different stages of clinical development for the treatment and prevention of HIV. Dr. Chloe Orkin led the first phase III study (clinical trial) of an injectable antiviral drug.

Highlights of new HIV treatment options

Antiretroviral therapy People living with HIV must take medication for the rest of their lives. Missing doses and stopping and restarting treatment can lead to drug resistance, which can allow HIV to multiply and progress to AIDS. That is why the ongoing research and development of long-acting antiretroviral therapy is so important that people with HIV may not have to take their daily pill at the same time. Instead, they have the option of taking long-acting antiviral drugs.

The most advanced HIV treatment available today is a two-drug long-acting injectable antiretroviral-based regimen including Rilpivirine and Cabotegravir that reduces the treatment burden to just six or twelve injections. each year. The long-acting antiviral drugs Cabotegravir and Rilpivirine are given as separate injections once a month or every two months. Adults living with HIV can use this regimen, who are already on oral antiretroviral therapy and have been virally suppressed for at least three months.

Two studies – ATLAS and FLAIR – compared if long-acting injectable antiviral drugs (Cabotegravir and Rilpivirine) had the same efficacy, safety, and tolerability as other antiviral drugs. -withdrawal of the daily intake that people living with HIV take. Both of these studies found that whether a person took the daily oral medication or the long-acting injection, efficacy, safety, and tolerability were similar (not inferior).

Data from the 252-week ATLAS 2M study, presented at CROI 2022, showed that efficacy, safety, and tolerability were similar between monthly and bimonthly injectable doses of Cabotegravir and Rilpivirine.

Suppression of viral load is an important indicator if antiretroviral therapy is providing the desired effect in HIV-infected persons. Virological failure occurs when ART fails to prevent and maintain a person’s viral load below 200 copies/mL. Viral failure rates are 1-1.5% with long-acting injectables, and 95% of drug-related side effects are mild to moderate. The most commonly reported adverse events were headache, fever, and/or injection site reaction. However, two percent of the participants withdrew due to adverse events. 98% of participants preferred the long-acting injectables over their previous daily oral antiviral medications. In addition, 90% of ATLAS 2M study participants preferred the two-month injection to the monthly injection.

In the FLAIR study, participants were selected to start with the oral formulation of Cabotegravir and Rilpivirine, then switch to the injectable form afterwards, or to start directly with the injection. There were no differences in the end results for either group in terms of efficacy or pharmacokinetics (defined as a study of drug absorption, distribution, metabolism, and excretion time).

Based on the positive results of the above studies, a long-acting injectable antiviral regimen (Cabotegravir and Rilpivirine) has been approved for use in the European Union, the United States and Canada. as a four-week or eight-week treatment. with or without leading into the original mouth.

Flexible dosing period of seven days

One of the important factors contributing to the effectiveness of antiretroviral drugs in prolonging life and saving lives is treatment adherence. Dr. Orkin further explains that these long-acting injectable drugs (Cabotegravir and Rilpivirine) “provide patients with a flexible dosing interval of seven days. So one can have their next dose.” the week before or the week after the prescribed date The patient should then return to the same day of the month for the remaining injections If for some reason one cannot get the injections they can use the pill oral (of Cabotegravir and Rilpivirine) to replace injections for up to two months.But if oral therapy requires treatment for more than two months, an alternative regimen is recommended.For missed injections. If it goes unplanned, one needs to evaluate the person to see if this is still the right treatment for them.”

Is there any difference between oral and injectable drugs?

There is an important study, called the MOCHA (More Choices for Children and Adolescents) study, which is currently underway in Botswana, South Africa, Thailand, Uganda and the United States. This study looked at the safety of oral Cabotegravir, long-acting injectable Cabotegravir, and long-acting injectable Rilpivirine in adolescents 12-18 years of age living with HIV (type-1) and viral suppression.

The first interim data (based on 23 US participants) presented at CROI 2022 showed that the drug was well tolerated and targeted pharmacokinetic concentrations were achieved and there were no new or unforeseen concerns. safety is determined in advance. The study will continue to evaluate the safety, tolerability, acceptability, and pharmacokinetics of long-acting oral and injectable regimens, and is expected to expand treatment options. treatment for children and adolescents living with HIV-1, while improving adherence and treatment satisfaction.

New options for HIV prevention

Two studies show that Pre-Exposure Prophylaxis (PrEP), which is used to prevent a person from getting HIV, works better if it is based on a long-acting injectable antiretroviral drug (Cabotegravir), than Oral PrEP is based on Tenofovir Disoproxil Fumarate (TDF) and the antiviral drug Emtricitabine (FTC).

These two studies are HPTN-083 for HIV-negative transgender men who have sex with men and transgender women who have sex with men; and HPTN-084 for HIV-negative transgender women. Both studies showed that long-acting Cabotegravir-based PrEP was superior to oral (TDF/FTC-based) PrEP in preventing HIV infection.

Among transgender men who have sex with men and transgender women who have sex with men, the rate of HIV infection is 68% less frequent among long-term injectable users of Cabotegravir PrEP, and the rate of infection in women is 68% lower. trans women are 89% lower.

Vaginal ring

And let’s not forget the once-monthly dapivirine intravaginal ring (a controlled prevention option for women) offers a discreet and effective long-term alternative to daily oral PrEP. It has been recommended by WHO as an additional choice for women at high risk of HIV infection. It has also been approved by the European Medicines Agency and is under review in many African countries.

New drugs to treat and prevent HIV

Several drugs such as Lenacapavir and Islatravir are being developed to treat and prevent HIV both orally and by injection.

Lenacapavir, a first-class capsid inhibitor, shows multistage activity in the early and late viral life cycles. It can be taken orally or injected under the skin. Its pharmacokinetics support six-month dosing.

Phase 3 studies of six-month injectable Lenacapavir (in combination with an optimized background regimen) are underway: The CAPELLA study for highly treatment-experienced subjects with multidrug resistance and the CALIBRATE study for people on first-line treatment. To date this drug has been shown to be non-inferior at 26 weeks in both studies.

Two Phase 3 studies – PURPOSE-1 (in high-risk adolescent girls and young women) and PURPOSE-2 (in high-risk transgender men, transgender women, transgender men and heterosexual men who have sex with men) – are examining six-month injectable Lenacapavir for PrEP.

However, currently all studies on Lenacapavir (for treatment as well as PrEP) have been halted in part by the US Food and Drug Administration (FDA) due to concerns about borosilicate vial compatibility. with drug solution.

Islatravir is being developed as a daily oral therapy in combination with doravirine; once-weekly oral therapy in combination with MK-8507 (a non-nucleoside reverse transcriptase inhibitor); long-acting oral and injectable therapy in combination with Lenacapavir; as well as once a month oral and yearly PrEP implants. To date, however, the FDA has withheld all or part of the Islatravir programs due to several dose-related immunological concerns.

A new class of drugs known as maturation inhibitors – oral MI-254 and long-acting injectable MI-937 – are in different stages of clinical development. Maturation inhibitors block protein processing in the late stages of the viral life cycle.

Widespread neutralizing antibodies, which have become a household name in COVID-19, are also being studied for treatment and prevention.

“We want options for everyone”

Dr. Orkin said nothing about the future of HIV treatment: “We want options for everyone. We need treatments that work for everyone; that are safe for all. everyone, including pregnant and lactating mothers and children; it’s affordable and it’s easy to manage”.

In most countries, new treatment/prevention protocols are not available and so they remain a distant dream for those who need them. Availability and affordability are major obstacles preventing the results of science from reaching the people they want it to. And while products are targeted at pathogens, programs should be designed with people affected by pathogens in mind. Only then can no one be left out.

Source: Shobha Shukla, Citizen News Service – CNS



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