Background: Nucleos(t)ide reverse transcriptase inhibitors (NRTI) toxicity may represent a threat for long-term success of combined antiretroviral therapy. Some studies have suggested a possible improvement of NRTI-related toxicity after switching to NRTI-sparing regimens. Objectives: We aimed to explore the efficacy and tolerability of switching to darunavir/ritonavir (DRV/r) plus raltegravir (RAL) while having a viral load (VL) â¤50 copies/mL in the clinical setting. Study design: Treatment-experienced HIV 1-infected patients enrolled in the ICONA Foundation Study cohort were included if they switched their current regimen to DRV/rÂ +Â RAL with a HIV-RNA â¤50Â copies/mL. Different definitions of virological failure (VF) and treatment failure (TF) were employed. KaplanâMeier curves and Cox regression models were performed to estimate time to event probability. Results: We included 72 HIV-infected patients, 22 (31%) of these were female, 31 (43%) men who have sex with men (MSM) amd 15 (21%) had hepatitis co-infections. Median age was 44 (IQR: 35-50) years amd CD4 count was 389 (IQR 283-606) cells/mmc. Median follow-up time for TF was 24 (IQR 9â31)Â months. Twenty-five discontinuations occurred (60% simplifications); only 2 (8%) were toxicity-driven (lipid elevations). The probability of VF (confirmed VL >50 copies/mL) was estimated at 7% [95% confidence interval (CI) 1â13%] by 12 and 9% (95% CI 2â16%) by 24Â months. When considering TF, we found a probability of stop/intensification/single VLÂ >Â 200 copies/mL of 13% (95% CI 1â17%) and 22% (95% CI 11â33%) by 12 and 24Â months. Female gender (adjusted relative hazard, ARHÂ =Â 0.10; 95% CI 0.01â0.74; pÂ =Â 0.024) and older age (AHRÂ =Â 0.50 per 10Â years older; 95% CI 0.25â0.99; pÂ =Â 0.045) were associated with a lower risk of TF. A previous PI failure was strongly associated with TF (AHRÂ =Â 52.6, 95% CI 3.6â779; pÂ =Â 0.004). Conclusions: DRV/rÂ +Â RAL is a valuable NRTI-sparing option, especially in female and older patients, with a relatively low risk of VF and good tolerability after 2Â years since start in an ART-experienced population. However, previous PI-failure should be a limiting factor for this strategy.
|Number of pages||8|
|Publication status||Published - 2017|
All Science Journal Classification (ASJC) codes
- Microbiology (medical)
- Infectious Diseases