In Treatment-Experienced Adult Patients* with NNRTI and PI Resistance
Virologic Response in Treatment-Experienced Adult Patients* with NNRTI and PI Resistance
Superior virologic response (<50 copies/mL) vs placebo + BR at Week 48
The BR for both arms consisted of darunavir/ritonavir + ≥2 other investigator-selected ARVs (N[t]RTIs ± ENF)§
Rates of virologic failure (HIV-1 RNA ≥50 copies/mL) at Week 48 for overall INTELENCE and placebo arms were 21% and 33%, respectively. Discontinuation rates before Week 48 were 10% and 18% due to virologic failure, 5% and 2% due to adverse events, and 3% and 5% due to other reasons, respectively.
Treatment Consideration
Use of INTELENCE in combination with other active agents can increase the likelihood of treatment response. In patients who have had virologic failure on an NNRTI-containing regimen, INTELENCE should not be used in combination with only N(t)RTIs.
- In a randomized, exploratory, open-label, Phase 2b trial (TMC 125-C227): treatment-experienced, PI-naïve patients with evidence of NNRTI resistance received 2 investigator-selected N(t)RTIs + either INTELENCE (n=59) or an investigator-selected PI (n=57). Patients taking INTELENCE, compared with control PI-treated patients, had lower antiviral responses associated with reduced susceptibility to the N(t)RTIs and INTELENCE
Selected Important Safety Information
- Severe Skin and Hypersensitivity Reactions:
- Severe, potentially life-threatening and fatal skin reactions have been reported in patients taking INTELENCE. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction, toxic epidermal necrolysis, and erythema multiforme
- Immediately discontinue treatment if severe hypersensitivity, severe rash or rash with systemic symptoms or liver transaminase elevations develops and monitor clinical status, including liver transaminases, and initiate appropriate therapy
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- Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral (ARV) therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established
Please see additional Important Safety Information.
Please see full description of study design and baseline characteristics.
*Treatment-experienced adult patients who had viral load (HIV-1 RNA) >5000 copies/mL, ≥1 NNRTI RAM (A98G, L100I, K101E/P/Q, K103H/N/S/T, V106A/M, V108I, E138G/K/Q, V179I/F/G, Y181C/I/V, Y188C/H/L, G190A/E/S, P225H, F227C, M230I/L, P236L, K238N/T, Y318F) at screening or from prior genotypic analysis, ≥3 primary PI mutations (D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, V82A/F/L/S/T, I84V, N88S, or L90M) at screening, and were on a stable ARV regimen for ≥8 weeks.²
†Based on intent-to-treat (ITT) analysis missing equals failure (M=F).
‡Represents the effect of the addition of INTELENCE vs placebo to the BR noting that the characteristics of the BR for the two arms were similar.
§In the INTELENCE arm (n=599), 25.5% of patients used ENF de novo and 20.0% reused ENF. In the placebo arm (n=604), 26.5% of patients used ENF de novo and 20.4% reused ENF.