According to the World Health Organization, around 37 million people worldwide are living with HIV, and 1.7 million of them were newly infected in 2019 alone.

Antiretroviral therapy (ART) is the current standard of care to manage HIV infection, but it requires lifelong medication and does not provide a cure. However, a new pill called lenacapavir (LCV) may change that.

What is Lenacapavir?

Lenacapavir is an investigational long-acting HIV-1 capsid inhibitor developed by Gilead Sciences. It works by inhibiting the capsid protein, which plays a critical role in HIV replication.

The capsid protein is a shell that protects the virus’s genetic material and helps it infect immune cells. By inhibiting the capsid protein, lenacapavir prevents viral replication, reducing the viral load in the body.

How Does Lenacapavir Work?

Lenacapavir is unique in its mechanism of action. Unlike other HIV medications, such as protease inhibitors and reverse transcriptase inhibitors, lenacapavir targets the capsid protein.

This means that even HIV strains resistant to other drugs may still be susceptible to lenacapavir’s inhibition of viral replication.

Lenacapavir is administered through subcutaneous injection, meaning it is injected into the fatty layer just below the skin’s surface.

It has a half-life of approximately two weeks, meaning it can provide continuous viral suppression with less frequent dosing than traditional ART medications.

What are the Clinical Trial Results for Lenacapavir?

Lenacapavir has undergone several clinical trials, with promising results. In a phase 2a study, lenacapavir was tested in people living with HIV who were already virally suppressed with traditional ART medication.

The study found that lenacapavir was safe and well-tolerated, with no significant adverse events reported. Additionally, 89% of participants who received the highest dose of lenacapavir achieved viral suppression, compared to only 33% of participants who received a placebo.

Gilead Sciences has also initiated a phase 2b/3 clinical trial called CAPELLA to evaluate the safety and efficacy of lenacapavir as a maintenance therapy for people living with HIV who have already achieved viral suppression with traditional ART medication. The study plans to enroll approximately 780 participants and will compare lenacapavir to traditional ART medication. The primary endpoint of the study is the proportion of participants who maintain viral suppression over 26 weeks.

What are the Potential Benefits of Lenacapavir?

The potential benefits of lenacapavir are significant. If approved, lenacapavir could provide an alternative to traditional ART medication, which requires daily dosing and may have side effects.

Additionally, lenacapavir’s subcutaneous injection may be more convenient than daily pill-taking for some people living with HIV. Furthermore, lenacapavir may be an effective treatment option for people with HIV strains that are resistant to other drugs.

What are the Potential Side Effects of Lenacapavir?

Like all medications, lenacapavir may cause side effects. In the phase 2a clinical trial, the most common side effect was injection site reactions, such as pain and swelling.

However, these side effects were generally mild and did not require the discontinuation of lenacapavir. Additionally, lenacapavir was not associated with any significant laboratory abnormalities or changes in renal function, liver function, or lipid levels.

When Will Lenacapavir be Available?

Lenacapavir is an investigational medication and is not currently approved for use. Gilead Sciences is still conducting clinical trials to evaluate the safety and efficacy of lenacapavir.

However, the results from these trials are promising, and lenacapavir may be approved in the near future to treat people living with HIV who have already achieved viral suppression with traditional ART medication.

Conclusion

Lenacapavir is a new investigational medication developed by Gilead Sciences that may provide an alternative to traditional ART medication for people living with HIV.

It has a unique mechanism of action and may be effective in treating HIV strains that are resistant to other drugs. Additionally, lenacapavir’s subcutaneous injection delivery may be more convenient than daily pill-taking for some people living with HIV.

Although lenacapavir is still undergoing clinical trials, the results are promising, and it may be approved in the near future to help people living with HIV maintain viral suppression.