Lenacapavir (Sunlenca®) as HIV Treatment & Injectable HIV PrEP

An Overview of Lenacapavir (Sunlenca®)

Lenacapavir is a drug that the FDA has approved for treating HIV. It can be administered through injections or tablets and has a long-acting effect. It belongs to a group of HIV capsid inhibitors that target the structure of the virus. When prescribed, Lenacapavir is typically combined with other antiretroviral drugs that are taken daily as tablets. The specific combination of drugs is carefully selected based on the individual's HIV resistance to ensure the most effective treatment.

Lenacapavir is currently being investigated as an experimental antiretroviral (ARV) drug for pre-exposure prophylaxis (PrEP), which aims to prevent HIV transmission. Ongoing clinical trials are evaluating the effectiveness of Lenacapavir in this regard, assessing its potential as a preventive option.

New HIV Medication: Lenacapavir (Sunlenca®)

Lenacapavir is a medication used to treat HIV, and it is sold under the brand name Sunlenca. It is specifically designed for people who have developed resistance to other HIV antiretroviral medications.

Lenacapavir is a long-acting medication that is given through injections or tablets. It belongs to a class of drugs called HIV capsid inhibitors. Your doctor will prescribe Lenacapavir and other antiretroviral drugs, usually taken as daily tablets. The combination of drugs is carefully chosen based on your HIV resistance to ensure the most effective treatment.

Taking Lenacapavir and other HIV medications as prescribed is crucial. Each drug class works in different ways to fight HIV. The goal of HIV treatment is to lower the level of HIV in your body, known as the viral load, to an undetectable level (usually less than 50 copies of the virus per ml of blood). Adhering to treatment and achieving an undetectable viral load can protect your immune system and prevent you from transmitting HIV to others during sexual activities.

Lenacapavir, also known as GS-6207, is a type of medication that inhibits the capsid of the HIV-1 virus. In lab tests with MT-4 cells, lenacapavir was shown to be anti-HIV, with an EC50 (effective concentration that stops 50% of viral replication) of 100 pM. Also, when tested against 23 different HIV-1 clinical isolates from different subtypes in peripheral blood mononuclear cells (PBMCs), lenacapavir showed a mean EC50 of 50 pM, ranging from 20 to 160 pM. These findings highlight the potent anti-HIV effects of lenacapavir against various HIV-1 strains in different cell types.

What is Injectable PrEP?

Injectable pre-exposure prophylaxis (PrEP) refers to a form of HIV prevention that involves the use of injectable medications to reduce the risk of acquiring HIV. People who are at a high risk of contracting HIV, such as those who have multiple sexual partners or are in serodiscordant relationships (where one partner is HIV-positive and the other is not), typically use PrEP.

Lenacapavir is on trial for HIV PrEP injection

Lenacapavir is an experimental antiretroviral (ARV) drug currently being investigated as a potential product for pre-exposure prophylaxis (PrEP). It is being studied in clinical trials to assess its effectiveness in preventing HIV transmission.

Lenacapavir is the second injectable ARV being tested in late-stage efficacy trials for PrEP, with the first one, Cabotegravir for PrEP, receiving approval from the FDA in December 2021.

Cabotegravir & Lenacapavir for PrEP

One significant difference between lenacapavir and injectable Cabotegravir for PrEP (CAB for PrEP) is the method of administration. 

Lenacapavir is being studied as a subcutaneous injection, allowing for self-injection. In contrast, CAB for PrEP is administered as an intramuscular injection in the buttocks and requires privacy. Gilead, the pharmaceutical company, is conducting two Phase III trials to evaluate the efficacy of lenacapavir as a six-month injection for PrEP.

Lenacapavir is the second injectable ARV to be tested in late-phase efficacy trials for PrEP. In December 2021, the FDA approved the first,Cabotegravir for PrEP.

The pharmaceutical company Gilead is currently conducting two Phase III clinical trials to assess the efficacy of lenacapavir as a six-month injection for HIV prevention. These studies aim to determine the safety and effectiveness of lenacapavir as a new pre-exposure prophylaxis (PrEP) option to prevent HIV transmission.

The clinical trial that aims to assess the effectiveness and safety of subcutaneous (under the skin) injections of long-acting lenacapavir as pre-exposure prophylaxis (PrEP) for HIV prevention. It includes cisgender men, transgender women, transgender men, and gender nonbinary individuals aged 16 years and older who engage in sexual activities with male partners and are at risk of HIV infection.

The study started on June 28, 2021, and is estimated to have its primary completion in January 2024. The overall completion of the study is projected to be in April 2027. The trial is designed as a double-blind, multicenter, and randomized study, meaning that participants and researchers are unaware of the treatment assignment, and the study takes place across multiple locations. The objective is to gather robust data on the efficacy and safety of lenacapavir as a long-acting HIV prevention option

Conclusion

In conclusion, LENACAPAVIR has shown great potential as both an HIV treatment and an injectable option for pre-exposure prophylaxis (PrEP). Its ability to inhibit the HIV-1 virus by targeting the capsid has demonstrated strong anti-HIV activity in laboratory tests using different cell types.

For HIV treatment, LENACAPAVIR has received FDA approval for use in heavily treatment-experienced adults with multidrug-resistant HIV, providing an additional treatment option for individuals who have developed resistance to other antiretroviral drugs.

As an injectable PrEP, LENACAPAVIR is being investigated as a potential alternative for preventing HIV transmission. Its subcutaneous administration allows for self-injection, distinguishing it from other injectable PrEP options that require intramuscular injections and more privacy. Ongoing Phase III clinical trials are assessing the effectiveness of LENACAPAVIR as a six-month injection for PrEP.

Overall, LENACAPAVIR presents a novel approach to both HIV treatment and prevention. Its potent antiretroviral properties and long-acting injectable formulation make it a promising choice for individuals living with HIV and those at risk of HIV infection. Further research and clinical studies will provide additional information on its effectiveness and safety in diverse populations.

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