Abstract
BackgroundRaltegravir (RAL) has favorable tolerability and safety profile, with few and manageable drug interactions. The use of RAL 1200 mg once daily (qd) for first-line therapy is well established. We assessed efficacy and safety of RAL 1200 mg qd, as part of triple combined antiretroviral therapy (cART), for maintenance strategy.MethodsThe QDISS trial (NCT03195452) was a 48-week multicenter, single-arm, open-label study designed to evaluate the ability of 2 NRTIs + RAL 1200 mg qd to maintain virological suppression in HIV-1 infected subjects on a stable cART with 2 NRTIs and a third agent for at least 6 months. The primary endpoint was the proportion of participants with HIV-1 RNA < 50 copies/mL at week 24, by the FDA snapshot algorithm.ResultsOf 100 participants 91% maintained viral suppression (95% CI: 83.6–95.8) at week 24 and 89% (81.2–94.4) at week 48. At week 24, there was one virological failure, without emergence of resistance-associated mutation and 10 participants had discontinued, 4 because of adverse events (AEs). Over 48 weeks, 7 AEs of grade 3–4 were reported, one possibly study-drug related (spontaneous abortion). BMI remained stable regardless of previous therapy or baseline BMI category. Over 48 weeks, total cholesterol (p = 0.023) and LDL-cholesterol (p = 0.009) decreased, lifestyle and ease subscale significantly improved (p = 0.04). The quality of life and Patients Reported Outcomes (PROs) also improved at W12 (p = 0.007).ConclusionRAL 1200 mg qd as part of a maintenance triple therapy showed a high efficacy in virologically suppressed HIV-1 infected subjects, with good safety profile and improved lipid profile and patient reported outcomes.Trial registration: Clinical trials.gov NCT03195452 and EudraCT 2016-003702-13.
Highlights
Raltegravir (RAL) has favorable tolerability and safety profile, with few and manageable drug interac‐ tions
As viral suppression is achieved in most people living with HIV (PLWHIV) with currently recommended regimens, HIV treatment goals has shifted towards a durable viral suppression and an optimal long-term tolerability of combined antiretroviral therapy (cART) with regimens that are life-style compatible [1]
As no study has yet assessed the efficacy of a switch to RAL 1200 mg qd in patients virologically suppressed, we aimed, in this open-label, single-arm study, to assess the capacity of RAL 1200 mg qd combined with 2 nucleoside reverse transcriptase inhibitors (NRTIs) to maintain virological success in patients virologically suppressed
Summary
Raltegravir (RAL) has favorable tolerability and safety profile, with few and manageable drug interac‐ tions. As viral suppression is achieved in most people living with HIV (PLWHIV) with currently recommended regimens, HIV treatment goals has shifted towards a durable viral suppression and an optimal long-term tolerability of cART with regimens that are life-style compatible [1]. This is even more relevant in the context of. Integrase strand transfer inhibitors (INSTIs), given their high antiviral potency and their favorable safety profile are recommended, as the cornerstone of cART, in all HIV infected individuals [3]. As no study has yet assessed the efficacy of a switch to RAL 1200 mg qd in patients virologically suppressed, we aimed, in this open-label, single-arm study, to assess the capacity of RAL 1200 mg qd combined with 2 nucleoside reverse transcriptase inhibitors (NRTIs) to maintain virological success in patients virologically suppressed
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