A method of treating HIV in pediatric patients using rilpivirine.

Abstract

This provides a method for treating children infected with the HIV virus. [Solution] A method comprising administering to a child infected with the HIV virus 25 mg or less of a rilpivirine non-nucleoside reverse transcriptase inhibitor or an equivalent amount of a pharmaceutically acceptable salt of rilpivirine once daily.

Claims

1. A method for treating children infected with the HIV virus, wherein the subject is given once a day, A non-nucleoside reverse transcriptase inhibitor, rilpivirine, in an amount of 25 mg or less, or an equivalent amount of rilpivirine. This includes administering a pharmaceutically acceptable salt of pibirine, The subjects mentioned above are those weighing 11 kg or more, who have experienced treatment, and whose first antibiotic treatment has been discontinued. He is being treated with a retroviral regimen. The subject is the drug of rilpivirine or an equivalent amount of rilpivirine for at least 24 weeks. After the aforementioned once-daily administration of a scientifically acceptable salt, the number of copies per 1 mL of plasma should be 50 or less (≤50). A method for indicating the viral load of HIV virus particles at c / mL.

2. The subject is administered a pharmaceutically acceptable salt of rilpivirine, as described in claim 1. Law.

3. Claim 1: The pharmaceutically acceptable salt of rilpivirine is rilpivirine hydrochloride. Or the method described in 2.

4. For the aforementioned pediatric subjects, dolutegravir, tenofovir, tenofovir disoproxil fumarate, Administer tenofovir alafenamide, emtricitabine, or a combination thereof. The method according to any one of claims 1 to 3.

5. The method according to any one of claims 1 to 4, wherein the pediatric subject is ≥2 to <12 years old.

6. The aforementioned child subject is a person having a weight of <25 kg as described in any one of claims 1 to 5. Law.

7. The aforementioned child subject is a person who has a weight of ≤70 kg as described in any one of claims 1 to 6. Law.

8. The aforementioned pediatric subjects are rilpivirine or an equivalent amount of rilpivirine that is pharmaceutically acceptable. Before administering the salt once daily, a concentration of 50 copies or less (≤50 c / mL) per 1 mL of plasma is used. The method according to any one of claims 1 to 7, which indicates the viral load of HIV virus particles.

9. The method according to any one of claims 1 to 8, wherein the HIV virus is HIV-1. 。

10. The aforementioned non-nucleoside reverse transcriptase inhibitors, such as rilpivirine, in doses of 25 mg or less, or the aforementioned etc. The amount of the pharmaceutically acceptable salt of rilpivirine is administered as a single-dose dosage form. The method described in any one of the requests 1 to 9.

11. The aforementioned non-nucleoside reverse transcriptase inhibitors, such as rilpivirine, in doses of 25 mg or less, or the aforementioned etc. A quantity of the pharmaceutically acceptable salt of rilpivirine is administered in multiple single-dose dosage forms. The method according to any one of claims 1 to 8.

12. The subject is rilpivirine or rilpivirine pharmaceutically... After once-daily administration of an acceptable salt, the number of copies per mL of plasma should be less than 50 (≤50 c / mL). The viral load of HIV-1 virus particles as described in any one of claims 1 to 11. method.

Images