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E. Gotuzzo 1 , B.-Y. Nguyen 2 , M. Markowitz 3 ,

Sustained Efficacy and Tolerability of Raltegravir after 240 Weeks of Combination ART in Treatment-Naive HIV-1 Infected Patients: Final Analysis of Protocol 004. E. Gotuzzo 1 , B.-Y. Nguyen 2 , M. Markowitz 3 , F. Mendo 4 , W. Ratanasuwan 5 , C. Lu 2 , S. Bhanja 2 ,

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E. Gotuzzo 1 , B.-Y. Nguyen 2 , M. Markowitz 3 ,

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  1. Sustained Efficacy and Tolerability of Raltegravir after 240 Weeks of Combination ART in Treatment-Naive HIV-1 Infected Patients: Final Analysis of Protocol 004 E. Gotuzzo1, B.-Y. Nguyen2, M. Markowitz3, F. Mendo4, W. Ratanasuwan5, C. Lu2, S. Bhanja2, H. Teppler2, and the Protocol 004 Part II Study Team 1Hospital Nacional Cayetano Heredia, Lima, Peru; 2Merck Research Labs, North Wales, PA, United States; 3Aaron Diamond AIDS Research Center, New York, NY, United States; 4Hospital Nacional Edgardo Rebagliati, Lima, Peru; 5Siriraj Hospital, Bangkok, Thailand

  2. 301.7 275.6 68.8% 63.2% Virologic and Immunologic Responses • Percentage of Patients with HIV RNA < 50 copies/mL (NC=F) • Change from Baseline in CD4 Cell Counts (OF) Week 240 (OF approach): RAL89% EFV 77% Raltegravir

  3. Safety Summary: Week 240 • Overall adverse event (AE) profiles, all causality • Generally similar for RAL and EFV (other than neuropsychiatric AEs) • Similar frequencies reported at Weeks 192 and 240 • Drug-related clinical AEs • Less common with RAL than EFV: 55% vs 76% (p=0.017) • Neuropsychiatric symptoms* • Most occurred by Week 48 • At Week 240: 38% for RAL vs 63% for EFV • Malignancies† • 3.1% (5/160 pts) in RAL group, none considered drug-related • 2.6% (1/38 pts) in EFV group, 1 event (GI carcinoma) possibly drug-related • Grade 3 / 4 lab abnormalities uncommon • Similar frequencies reported at Weeks 192 and 240 • Minimal effect of RAL on serum lipids *Abnormal dreams, adjustment disorder with depressed mood, depressed mood, depression, dizziness, insomnia, nightmare, psychotic disorder, somnolence, suicidal ideation, suicide attempt. † Cases included: in RAL group: 1 pt with B-cell lymphoma, 2 pts with Kaposi’s sarcoma, 1 pt with basal cell carcinoma and squamous cell carcinoma (SC), and 1 pt with non-small cell lung carcinoma; in EFV group: 1 pt with gastrointestinal carcinoma (possibly drug-related) and SC.

  4. Exploratory Analysis: Prognostic Factors Associated With CD4 Cell Count at Yearly Time Points Significant predictors for CD4 cell count (at 0.05 critical value) at each time point were: (1) baseline CD4 count and (2) log HIV RNA decline at week 8.

  5. CONCLUSIONS • RAL + TDF/3TC demonstrated sustained antiretroviral efficacy through 5 years, similar to EFV + TDF/3TC: • HIV RNA <50 copies/mL in 69% of RAL patients vs 63% of EFV patients • CD4 counts continued to increase through 5 years in both groups • RAL was generally well tolerated over 5 years: • Safety profile similar to Week 144 (3 years) and Week 192 (4 years) • Drug-related AEs less frequent with RAL than EFV • RAL has minimal effect on LDL-cholesterol and triglycerides • In an exploratory analysis, statistically significant predictors for CD4 cell count at each yearly time point were baseline CD4 count and early (week 8) log HIV RNA decline.

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