Association between first-year virological response to raltegravir and long-term outcomes in treatment-experienced patients with HIV-1 infection

作者：Eron Joseph J; Cooper David A; Steigbigel Roy T; Clotet Bonaventura; Yeni Patrick; Strohmaier Kim M; Rodgers Anthony J; Barnard Richard J; Nguyen Bach Yen T; Teppler Hedy^*

来源：Antiviral Therapy, 2015, 20(3): 307-315.

DOI：10.3851/IMP2912

Background: We explored the relationship between virological response in the first year of treatment and long-term outcomes in the BENCHMRK studies.
Methods: Patients failing antiretroviral treatment with 3-class resistant HIV-1 received double-blinded raltegravir (or placebo) with optimized background therapy (OBT) until week 156, followed by open-label raltegravir with OBT up to week 240. In this exploratory analysis of patients randomized to raltegravir, virological response over weeks 16-48 was categorized as continuous suppression (CS; viral RNA [vRNA] always < 50 copies/ml), low-level viraemia (LLV; vRNA always < 400 copies/ml, > 50 copies/ml at least once), or not suppressed (NS; vRNA > 400 copies/ml at least once). The association between these first-year vRNA response categories and baseline factors was analysed with univariate and multivariate models. Virological and immunological outcomes for years 2-5 were assessed by first-year vRNA response category (observed failure approach).
Results: Baseline vRNA, baseline CD4(+) T-cell count and rapid viral decay (vRNA < 50 copies/ml between weeks 2-12) correlated with first-year vRNA response (P< 0.001); only rapid viral decay remained significant by multiple regression. Virological response rates were similar in the LLV and CS groups and lowest in the NS group. CD4(+) T-cell count increased through week 240 in the CS and LLV groups. Time to loss of virological response (confirmed vRNA >= 400 copies/ml) through week 240 did not support as strong a difference between the LLV and CS groups (log-rank P= 0.11) as previously reported through weeks 156 and 192 (P<0.05).
Conclusions: Treatment-experienced patients on a raltegravir-based regimen with early LLV may have long-term virological and immunological benefit when their therapy is maintained.

• 出版日期2015