Etravirine in Treatment Experienced DUET-2 (TMC125-C216)

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Presentation transcript:

Etravirine in Treatment Experienced DUET-2 (TMC125-C216)

Etravirine in Treatment Experienced DUET-2: Study Design Study Design: DUET-2 Background: Randomized, controlled, double- blind, placebo-controlled phase 3 trial evaluating the long-term efficacy, tolerability, and safety of etravirine in treatment-experienced patients with HIV infection Inclusion Criteria (n = 591) - Age ≥18 - On stable ARV regimen for ≥8 weeks - HIV RNA >5000 copies/mL - ≥3 primary PI mutations - ≥1 NNRTI resistance-associated mutation Treatment Arms - Etravirine 200 mg BID + OBT* - Placebo + OBT* Etravirine 200mg bid + OBT (n = 295) Placebo + OBT (n = 296) *OBT = NRTIs, Darunavir/r, +/- Enfuvirtide Source: Lazzarin A, et al. Lancet. 2007;370:39-48.

Etravirine in Treatment Experienced DUET-2: Results Week 24: Virologic Response ( ITT-TLOVR*) 221/295 159/296 183/295 129/296 *ITT-TLOVR = Intention to Treat-Time to Loss of Virologic Response. Source: Lazzarin A, et al. Lancet. 2007;370:39-48.

Etravirine in Treatment Experienced DUET-2: Results Week 24: Virologic Response ( ITT-TLOVR*) 19/43 3/45 58/94 40116 67/82 45/64 39/49 37/51 *ITT-TLOVR = Intention to Treat-Time to Loss of Virologic Response. Source: Lazzarin A, et al. Lancet. 2007;370:39-48.

Etravirine in Treatment Experienced DUET-2: Results Week 24: Virologic Response ( ITT-TLOVR*) in Patients Re-using or Not Using Enfuvirtide *ITT-TLOVR = Intention to Treat-Time to Loss of Virologic Response. Source: Lazzarin A, et al. Lancet. 2007;370:39-48.

Etravirine in Treatment Experienced DUET-2: Conclusions Interpretation: “In treatment-experienced patients, treatment with TMC125 (etravirine) led to better virological suppression at week 24 than did placebo. The safety and tolerability profile of TMC125 (etravirine) was generally comparable with placebo.” Source: Lazzarin A, et al. Lancet. 2007;370:39-48.

Etravirine in Treatment Experienced DUET-1 and DUET-2 (Pooled Analysis)

Etravirine in Treatment Experienced DUET-1 and DUET-2 Pooled Analysis: Study Design Study Design: DUET-1 and DUET-2 Background: Pooled analysis of 2 randomized, controlled, double-blind, placebo-controlled phase 3 trial evaluating the long-term efficacy, tolerability, and safety of etravirine in treatment-experienced patients with HIV infection Inclusion Criteria (n = 1203) - Age ≥18 - On stable ARV regimen for ≥8 weeks - HIV RNA >5000 copies/mL - ≥3 primary PI mutations and ≥1NNRTI resistance-associated mutation Treatment Arms - Etravirine 200 mg BID + OBT* - Placebo + OBT* Etravirine 200mg bid + OBT (n = 599) Placebo + OBT (n = 604) *OBT = NRTIs, Darunavir/r, +/- Enfuvirtide Source: Lazzarin A, et al. Lancet. 2007;370:39-48.

Etravirine in Treatment Experienced DUET-1 and DUET-2 Pooled Analysis: Results Week 48: Virologic Response ( ITT-TLOVR*) 365/599 242/604 *ITT-TLOVR = Intention to Treat-Time to Loss of Virologic Response. Source: Katlama C, et al. AIDS. 2009;23:2289-300.

Etravirine in Treatment Experienced DUET-1 and DUET-2 Pooled Analysis: Results Week 48: Virologic Response ( ITT-TLOVR*), by Number of Active ARVs *ITT-TLOVR = Intention to Treat-Time to Loss of Virologic Response. Source: Katlama C, et al. AIDS. 2009;23:2289-300.

Etravirine in Treatment Experienced DUET-1 and DUET-2: Pooled Analysis Week 48: Virologic Response in Etravirine Group, by Weighted Genotypic Score Source: Katlama C, et al. AIDS. 2009;23:2289-300.

Etravirine in Treatment Experienced DUET-1 and DUET-2 Pooled Analysis: Conclusions Conclusion: “At 48 weeks, treatment-experienced patients receiving etravirine plus background regimen had statistically superior and durable virologic responses (viral load less than 50 copies/ml) than those receiving placebo plus background regimen, with comparable tolerability and no new safety signals reported since week 24.” Source: Katlama C, et al. AIDS. 2009;23:2289-300.