Program Schedule

1617
Safety, Tolerability, and Antiretroviral Activity of Raltegravir in HIV-1 Infected Russian Children and Adolescents a 24 Week Study

Session: Poster Abstract Session: HIV: Pediatric
Saturday, October 11, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • IDWeek_Poster1617_Final.pdf (333.0 kB)
  • Background: Raltegravir (RAL) is indicated in combination with other antiretroviral therapies (ARTs) for the treatment of HIV-1 infection in pediatric patients (pts) 2-18 years old (yo) in the US and elsewhere.

    Methods: This was a multicenter, open-label, noncomparative, 24-week study of 2 oral formulations of RAL in Russian children and adolescents with HIV-1 infection. Pts 12 to <18 yo received the film-coated tablet (400 mg bid). Pts 2 to <12 yo (weight [wt] ≥7 to <25 kg) received the chewable tablet (wt-based dose of ~6 mg/kg, maximum 300 mg bid). Pts 6 to <12 yo (wt ≥25 kg) could receive either formulation. Safety was the primary endpoint and included all enrolled pts who received at least one dose of RAL. For efficacy, missing HIV RNA (vRNA) values were handled with the Observed Failure approach.

    Results:  Thirty-two pts were enrolled; 4 received the film-coated tablet (median age 10.5 y) and 28 received the chewable tablet (median age 7 y), in addition to background ART chosen by the investigator. The majority were white (97%) and treatment naïve (81%). At baseline, median vRNA was 4.6 (range 3-6) log10 copies(c)/mL, and median CD4 count was 518 (range 22-1295) cells/mm3. Twenty-nine pts (91%) completed the study. Clinical adverse events (AEs) were reported by 12 pts (37.5%), all on the chewable tablet; 4 (12.5%) had AEs that were considered drug-related: diarrhea, vomiting, abdominal pain/nausea, and somnambulism; all resolved and none led to discontinuation. One pt (3%), who received the chewable tablet, had a laboratory AE (decreased platelet count), which was considered drug-related and resolved after 84 days. No serious AEs were reported. At week 24, 86.2% of pts achieved ≥1 log10 decline from baseline vRNA or vRNA <200 c/mL, and 44.8% and 72.4% had vRNA <40 and <200 c/mL, respectively. The mean increase from baseline in CD4 count was 267 cells/mm3.  Virologic failure occurred in 4 pts; post-baseline RAL resistance mutations were identified in 2 of the 3 pts with genotype data available: L74I + N155H, and L74I alone.

    Conclusion: In HIV-infected Russian children and adolescents 2 to <18 yo, RAL given as the 400-mg film-coated tablet or the pediatric chewable tablet, in combination with other ARTs for up to 24 weeks, was generally safe and well tolerated, had a favorable antiretroviral effect, and demonstrated immunological benefit.

    Hedy Teppler, MD1, Andrey Shuldyakov, MD2, Natalia Gankina, PhD3, Valeriy Kulagin, PhD4, Firaya Nagimova, PhD5, Tatiana Shimonova, PhD6, Dmitriy Sonin, PhD7, Vladimir Sotnikov, MD8, Natalia Zakharova, MD9, Brenda Homony, MS1, Deng Wang, PhD1 and Grigoriy Moshkovich, MD10, (1)Merck & Co., Inc., Whitehouse Station, NJ, (2)Regional Center for Prevention & Control of AIDS & Infectious Diseases, Saratov, Russia, (3)Regional Center for Prevention & Control of AIDS & Infectious Diseases, Krasnoyarsk, Russia, (4)Clinical Center for Prevention & Control of AIDS & Infectious Diseases, Krasnodar, Russia, (5)Republican Center for Prevention & Control of AIDS & Infectious Diseases, Kazan, Russia, (6)Infectious Clinical Hospital #2 of Moscow city Healthcare Department, Moscow, Russia, (7)Regional Clinical Dermatovenerologic Dispensary, Ryazan, Russia, (8)Regional Center for Prophylaxis & Control of AIDS & Infectious Diseases, Kaluga, Russia, (9)Centre for Prophylaxis & Control of AIDS & Infectious Diseases, St. Petersburg, Russia, (10)Regional Centre for Prevention & Control of AIDS & Infectious Diseases, Nizhniy Novgorod, Russia

    Disclosures:

    H. Teppler, Merck & Co., Inc.: Employee, Salary

    A. Shuldyakov, Merck: Investigator, Research grant and Research support

    N. Gankina, Merck: Investigator, Research grant and Research support

    V. Kulagin, Merck: Investigator, Research grant and Research support

    F. Nagimova, Merck: Investigator, Research grant and Research support

    T. Shimonova, Merck: Investigator, Research grant and Research support

    D. Sonin, Merck: Investigator, Research grant and Research support

    V. Sotnikov, Merck: Investigator, Research grant and Research support

    N. Zakharova, Merck: Investigator, Research grant and Research support

    B. Homony, Merck: Employee, Salary

    D. Wang, Merck: Employee, Salary

    G. Moshkovich, Merck: Investigator, Research grant and Research support

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