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What is the schedule for lenacapavir? A comprehensive guide

3 min read

Lenacapavir offers a groundbreaking schedule for HIV management, with maintenance injections required only twice a year, representing a significant shift from daily oral medications. So, what is the schedule for lenacapavir for both heavily treatment-experienced patients and those using it for pre-exposure prophylaxis (PrEP)?

Quick Summary

Lenacapavir, a long-acting capsid inhibitor, uses a two-phase dosing schedule. It begins with an oral and subcutaneous injection phase, followed by maintenance subcutaneous injections every six months for both HIV treatment and prevention options.

Key Points

  • Initial Dosage: The lenacapavir schedule always starts with a short oral tablet phase and an initial injection to build up drug levels quickly.

  • Bi-Annual Injections: Following the initial period, maintenance involves subcutaneous injections administered every 6 months (26 weeks) by a healthcare provider.

  • Treatment vs. PrEP: While the maintenance schedule is the same, the specific initiation timeline differs slightly for HIV treatment (Sunlenca) and prevention (Yeztugo).

  • Oral Bridging: For planned injection delays over two weeks, a weekly oral tablet regimen can be used temporarily to maintain drug levels.

  • Missed Injections: An unplanned delay of more than 28 weeks since the last injection requires restarting the full initiation schedule to restore effectiveness.

  • Long-Acting Mechanism: The infrequent dosing is possible due to lenacapavir's prolonged half-life as a capsid inhibitor, which is stored and slowly released from the injection site.

  • HIV Test Required for PrEP: Individuals must test negative for HIV before starting lenacapavir for PrEP and before every subsequent maintenance injection.

In This Article

Understanding the Lenacapavir Dosing Schedule

Lenacapavir, marketed as Sunlenca for HIV treatment and Yeztugo for PrEP, features a long-acting dosing schedule with an initiation and a maintenance phase. The initial phase uses both oral tablets and subcutaneous injections to achieve therapeutic drug levels, while the maintenance phase consists of bi-annual subcutaneous injections. The specific initiation schedule varies based on whether it is for treatment or prevention.

Lenacapavir for HIV-1 Treatment (Sunlenca)

For adults with multidrug-resistant HIV, two initiation options are available for Sunlenca before the bi-annual maintenance schedule. Detailed information on the specific schedules can be found on the {Link: SUNLENCA® (lenacapavir) Dosing Information website https://www.sunlenca.com/dosing} and {Link: SUNLENCA® (lenacapavir) Dosing and Administration website https://www.sunlencahcp.com/dosing-and-administration/sunlenca-dosing/}.

Lenacapavir for HIV-1 Pre-Exposure Prophylaxis (PrEP) (Yeztugo)

For HIV prevention, the Yeztugo schedule is standardized. The initiation phase involves doses on Day 1 and Day 2. The maintenance phase follows, with injections given every 6 months (26 weeks) ±2 weeks. More details can be found on the {Link: Lenacapavir for PrEP | Dosing & Administration Gilead ... website https://www.askgileadmedical.com/len4prep/dosing-admin/} and {Link: Interim Guideline on the Use of Twice-Yearly Lenacapavir for ... website https://www.hivguidelines.org/guideline/hiv-prep-len/}.

Comparison of Lenacapavir Schedules

Feature HIV-1 Treatment (Sunlenca) HIV-1 PrEP (Yeztugo)
Indication Heavily treatment-experienced adults with multidrug-resistant HIV-1 Adults and adolescents (>35 kg) at risk for sexually acquired HIV-1
Initiation Two options: a 2-day or a 15-day regimen involving oral tablets and one initial SC injection. A 2-day regimen involving oral tablets and one initial SC injection.
Maintenance SC injection every 6 months (26 weeks ± 2 weeks). SC injection every 6 months (26 weeks ± 2 weeks).
Use of other meds Must be used with other antiretroviral(s). Used alone for prevention.

What to do if you miss a dose

Missing a dose can impact effectiveness and increase the risk of resistance. Consult a healthcare provider if a maintenance injection is missed. For information on planned delays with oral bridging or unplanned/prolonged delays, refer to the {Link: SUNLENCA® (lenacapavir) Dosing and Administration website https://www.sunlencahcp.com/dosing-and-administration/sunlenca-dosing/}.

How Lenacapavir's Long-Acting Schedule Works

As a first-in-class HIV-1 capsid inhibitor, lenacapavir targets the virus's outer shell. Its long half-life and mechanism allow for infrequent dosing. The subcutaneous injection creates a depot that slowly releases the drug over six months, maintaining therapeutic levels for viral suppression or protection.

Important Considerations for the Lenacapavir Schedule

  • Prior HIV Test: Before starting lenacapavir for PrEP, a negative HIV-1 test, including testing for acute or primary infection, is required.
  • Other Medications: For treatment, lenacapavir must be used with other antiretroviral drugs. For PrEP, it's used alone but doesn't prevent other STIs.
  • Drug-Drug Interactions: Lenacapavir can interact with other medications, particularly strong or moderate CYP3A inducers. A healthcare provider should review all current medications.
  • Healthcare Administration: All subcutaneous injections must be given by a healthcare provider.

Conclusion: The Impact of a Bi-Annual Schedule

The twice-yearly injection schedule of lenacapavir offers a significant advantage in HIV management by improving adherence compared to daily oral medications. This has the potential to enhance outcomes for those with multidrug-resistant HIV and increase PrEP uptake. However, consistent adherence, proper handling of missed doses, and regular consultation with a healthcare provider are vital for effectiveness and preventing resistance.

Frequently Asked Questions

Following an initial oral and injectable phase, lenacapavir is administered via subcutaneous injections every six months (26 weeks ± 2 weeks) for maintenance.

The initiation schedule differs, with treatment having two options (a 2-day or a 15-day startup). However, the maintenance phase for both HIV treatment (Sunlenca) and prevention (Yeztugo) involves injections every six months.

If you miss an injection, contact your healthcare provider immediately. For a planned delay of more than two weeks, you may temporarily switch to weekly oral tablets. For longer, unplanned delays (over 28 weeks), you will need to restart the full initiation schedule.

For HIV-1 treatment (Sunlenca), the initiation phase is either 2 days or 15 days, depending on the regimen chosen by your healthcare provider.

No, the oral tablets are for the short-term initiation phase and for temporary 'oral bridging' in case of a missed injection. They are not a permanent substitute for the long-acting injections.

Oral bridging is a temporary regimen of weekly lenacapavir tablets used to maintain drug levels if a scheduled 6-month injection is going to be delayed by more than two weeks. This can be done for up to 6 months.

Lenacapavir injections are administered subcutaneously (under the skin) into the abdomen or upper thigh by a healthcare professional.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.