Cabotegravir

Cabotegravir is an investigational drug being studied for both HIV prevention and treatment. Clinical trials are evaluating its effectiveness and safety when given as long-acting injections or oral tablets. This article summarizes key findings from recent cabotegravir clinical trials, including its potential as a pre-exposure prophylaxis (PrEP) option and treatment for people living with HIV.

Table of Contents

What is Cabotegravir?

Cabotegravir is a medication used in the treatment and prevention of Human Immunodeficiency Virus (HIV) infection. It’s also known by its brand name Apretude and the abbreviations CAB or GSK1265744[1][2][3]. HIV is a virus that attacks the body’s immune system, making it difficult to fight off infections and diseases.

How Cabotegravir Works

Cabotegravir belongs to a class of drugs called integrase strand-transfer inhibitors (INSTIs). These drugs work by blocking an enzyme called integrase, which the HIV virus needs to multiply in your body. By stopping the virus from reproducing, cabotegravir helps to lower the amount of HIV in your blood and prevent it from damaging your immune system[2].

Uses of Cabotegravir

Cabotegravir is used for two main purposes:

  1. HIV Treatment: It’s used as part of a combination therapy to treat HIV infection in adults[1].
  2. HIV Prevention (PrEP): It’s also used as a pre-exposure prophylaxis (PrEP) to prevent HIV infection in adults and adolescents who are at risk of getting HIV through sex[5].

Forms and Administration

Cabotegravir comes in two main forms:

  1. Oral tablets: These are usually used for a short period before starting the injectable form. They come in 30mg strength and are taken once daily[3][7].
  2. Long-acting injectable: This is the main form used for both treatment and prevention. It’s given as an injection into the muscle of your buttocks by a healthcare professional. For HIV prevention, it’s typically given once every two months after initial doses[2][5].

Effectiveness

Clinical trials have shown cabotegravir to be highly effective:

  • For HIV treatment, when used in combination with other antiretroviral drugs, it can significantly reduce the amount of HIV in the blood (viral load)[1].
  • For HIV prevention, studies have shown it to be more effective than daily oral PrEP pills. In one large study, it reduced the risk of getting HIV by 69% compared to daily oral PrEP[2].

Safety and Side Effects

Cabotegravir is generally well-tolerated, but like all medications, it can cause side effects. Common side effects may include:

  • Injection site reactions (pain, swelling, redness)
  • Headache
  • Fever
  • Fatigue
  • Muscle pain
  • Nausea

Serious side effects are rare but can occur. These may include liver problems or allergic reactions. It’s important to discuss all potential side effects with your healthcare provider[3].

Special Considerations

There are some important things to consider when using cabotegravir:

  • HIV Testing: Before starting cabotegravir for prevention, you must be tested to ensure you don’t already have HIV[5].
  • Adherence: For the injectable form, it’s crucial to stick to the scheduled injection appointments to maintain protection against HIV[5].
  • Drug Interactions: Cabotegravir may interact with other medications. Always inform your healthcare provider about all medicines you’re taking[3].
  • Pregnancy: If you’re pregnant or planning to become pregnant, discuss this with your doctor before using cabotegravir[2].

Ongoing Research

Research on cabotegravir is ongoing to further understand its long-term effects and optimal use. Current studies are looking at:

  • Its use in different populations, including young adults and transgender individuals[2][5].
  • Different formulations and dosing schedules[6].
  • Its effectiveness in real-world settings outside of clinical trials[5].

Cabotegravir represents a significant advance in HIV treatment and prevention. Its long-acting formulation offers a convenient alternative to daily pills, which may improve adherence and effectiveness for some people. However, like all medical decisions, the choice to use cabotegravir should be made in consultation with a healthcare provider, taking into account individual circumstances and preferences.

Aspect Details
Formulations Long-acting injectable, oral tablets
Dosing frequency Injectable: Every 8 weeks after initial doses; Oral: Daily
Key trials HPTN 083, HPTN 084, CAPRISA 014
Efficacy for prevention Superior to daily oral PrEP in clinical trials
Safety profile Generally well-tolerated; injection site reactions common
Populations studied MSM, transgender women, cisgender women
Implementation challenges HIV testing strategies, adherence to injection schedule
Regulatory status FDA approved for prevention; approvals pending in other countries

Ongoing Clinical Trials on Cabotegravir

  • Study on the Effectiveness of Cabotegravir and Rilpivirine for People with HIV-1 Who Have Not Responded Well to Oral Treatment

    Recruiting

    3 1 1 1
    Investigated drugs:
    Belgium Germany Italy Portugal Spain
  • Study of Long-Acting Cabotegravir and Rilpivirine for People Aged 60 and Over Living with HIV-1

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Spain
  • Study on Long-Acting Cabotegravir and Lenacapavir for HIV Patients: Evaluating Dual Antiretroviral Therapy

    Not recruiting

    3 1 1 1
    Investigated diseases:
    France
  • Study of Injectable Cabotegravir Compared to Oral Emtricitabine/Tenofovir for HIV Prevention in Men Who Have Sex with Men

    Not recruiting

    3 1 1 1
    Investigated diseases:
    France
  • Study on the Effectiveness and Safety of Lamivudine, Dolutegravir Sodium, Cabotegravir, and Rilpivirine for Adults with HIV-1 Who Have Not Taken Antiretroviral Therapy

    Not recruiting

    3 1 1 1
    France Germany Italy Spain
  • Study on Long-Acting Cabotegravir and Rilpivirine for HIV Patients in Spain: Evaluating Out-of-Hospital Treatment Options

    Not recruiting

    3 1 1 1
    Spain
  • Study on the Effects of Abacavir Sulfate and Etravirine in Pregnant Women with HIV

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Belgium Germany Ireland The Netherlands Spain

Glossary

  • Cabotegravir: An investigational integrase strand transfer inhibitor (INSTI) drug being studied for HIV prevention and treatment, available as long-acting injections or oral tablets.
  • Pre-exposure prophylaxis (PrEP): The use of antiretroviral medications by HIV-negative individuals to reduce their risk of acquiring HIV infection.
  • Integrase strand transfer inhibitor (INSTI): A class of antiretroviral drugs that work by blocking the HIV integrase enzyme, preventing the virus from inserting its genetic material into human cells.
  • Long-acting injectable: A medication formulation that is injected and remains active in the body for an extended period, allowing for less frequent dosing.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body over time.
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and is able to have an active effect.
  • HIV incidence: The rate of new HIV infections in a population over a specific period of time.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure.

References

  1. https://clinicaltrials.gov/study/NCT03462810
  2. https://clinicaltrials.gov/study/NCT02462772
  3. https://clinicaltrials.gov/study/NCT00920426
  4. https://clinicaltrials.gov/study/NCT00812318
  5. https://clinicaltrials.gov/study/NCT05515770
  6. https://clinicaltrials.gov/study/NCT06033547
  7. https://clinicaltrials.gov/study/NCT02354950