First Injectable Drug Regimen for Adults Living with HIV Approved by FDA

Cabenuva Approved by the FDA

Cabenuva has received approval by the FDA or Food and Drug Administration. Cabenuva is an injectable form of (Endurant) rilpivirine and (Vocabria) cabotegravir for adults with HIV-1 infections. This is the first adult injectable regimen approved by the FDA administered once per month. Cabenuva is intended to be a replacement for the antiretroviral regimes necessary for virologically suppressed adults. The condition of these individuals is either unknown or they are suspected of having a resistance to rilpivirine or cabotegravir with no history of treatment failure.

According to a news release from the Office of Infectious Diseases, the standard of care for all people with HIV includes those taking pills daily for the management of their condition. Due to the new approval, certain patients will have the option of having an injection monthly as opposed to taking pills orally every day. The ability to have this type of treatment is a beneficial alternative for certain patients currently responsible for the management of a chronic condition.

Cabotegravir Approved by the FDA

Vocabria or cabotegravir tablets have also received approval from the FDA. These tablets are meant to be taken along with oral rilpivirine for a one-month period prior to starting Cabenuva treatment. This is to make certain the medications are tolerated well before using the injectable, extended-release formula. Two controlled, open-label, randomized clinical trials were conducted. The results showed Cabenuva was an effective and safe treatment for adults infected with HIV with a virologically suppressed condition.

The participants in both trials showed virologic suppression when the studies ended. According to the FDA, there were no clinically relevant changes observed for baseline in CD4+ cell counts. The most common Cabenuva reactions included a reaction at the injection site, fatigue, musculoskeletal pain, nausea, dizziness, fever, headache, rash and sleep disorders. If the individual has had a hypersensitivity reaction in the past to either rilpivirine or cabotegravir or does not have a virally suppressed condition, Cabenuva is not a viable option.

Advancement in HIV Treatment

According to a professor at the Institute of Global Health and Infectious Diseases in North Carolina, the new development is a significant advancement in HIV treatment. One of the Cabenuva clinical trial investigators stated the new advancement is a reflection of the progress occurring during the last few years. During the initial AIDS crisis, people had no choice other than to make antiretrovirals in their own bathtubs. Everything has changed due to notable improvements in research and advancements for inclusive care.

Individuals diagnosed with HIV are now able to live healthy and long lives due to the new medications available. Provided these individuals maintain their standard antiretroviral treatments, the levels of the HIV viral load within the blood will remain low enough where the virus becomes undetectable. According to the CDC, once the level is undetectable the virus is not transferable to sexual partners.

The HIV Stigma

The HIV virus is unique. When a person is diabetic and takes a pill, nobody thinks twice. When the person has HIV, a stigma has been attached regarding living with the disease. Part of this stigma is external simply because certain individuals do not want anyone to know what is inside of their medicine cabinets, backpacks or purses. Unfortunately, there is an internal stigma as well. Living with HIV on a daily basis is extremely difficult. This is compounded when the person has to take a pill each and every day.

Many people are forced to develop stigmas against themselves. Some people begin to feel dirty, guilty or bad simply because they have a disease. There has been a significant amount of research showing taking a pill reminds people they have HIV. When the person receives an injection once per month, the pills are eliminated. This means the person does not have to think about it constantly. Receiving a monthly shot enables the person to live as normal of a life as possible. When considered on a psychological basis, many people will regard this as an important benefit.

One of Cleveland Clinic’s infectious disease experts made a statement. He said the published results of the study were initially surprising. This was due to the number of participants that preferred an injectable medication as opposed to a pill. Millions of people all over the country take pills for a wide range of medical issues every day. When a person is younger, remembering to take their pills is often harder. When the person is older, they have a tendency to begin to forget things. The studies do not mean the drug will be used by the majority of people with HIV. This is dependent on storage and supply.

The drug requires storage at a lower temperature. Each facility must have the capacity and enough space for storing the correct amount of supplies. There are also typical medication concerns such as how much of the drug will be covered by insurance and how much these individuals can afford to pay. The fact some people do not like or are not interested in injections must also be considered. In the future, monthly injections may become an accessible option. If this happens, those living with HIV will have a choice between the new injection and traditional types of medications.

According to a representative for ViiV, in February shipping of the drug will begin for specialty distributors and wholesalers. After that, the drug will become available for the correct channel order so it can be made available. Many of the people taking pills for HIV believe the fewer pills they have to take the better. The fact people do not like taking drugs is not a secret. There is the possibility that in the future these types of drugs will be replaced with injectables. If this ever becomes standard, it means people will finally have a choice.