Five years’ real-life experience with raltegravir in a large HIV centre

Abstract

Raltegravir was the first licensed integrase inhibitor. Real-life experience is informative and complements trial data. We therefore evaluated raltegravir use in adults in a large HIV treatment centre. From pharmacy and departmental HIV database records, we identified all adults taking ≥1 dose of raltegravir from first availability to the end of November 2012. Data were collected using a standardised case report form. Two hundred and fifteen individuals provided 502 patient-years (median 2.6 years/person) of raltegravir use. Of 215 individuals, 166 (77%) were male, median age 43 years; 189 (88%) were antiretroviral therapy (ART)-experienced and 26 (12%) ART-naive, with median baseline CD4 counts of 324 and 54 cells/µL, respectively. Of ten individuals using once-daily raltegravir, four, with good adherence remained virologically suppressed after a median 28 months, four stopped against medical advice, one stopped to simplify and one failed virologically. In hepatitis co-infection, 35 individuals (92 patient-years) took raltegravir without evidence of hepatotoxicity. Six women started raltegravir during pregnancy for intensification (5/6) or switch for tolerability without complications. Of ten individuals stopping raltegravir after virological failure, 2/4 with successful sequencing showed resistance. Raltegravir appears safe and effective, without evidence of toxicity above that in published trials, including in pregnancy and co-infections. Once-daily dosing seems effective where adherence is good.

First-line HIV treatment outcomes following the introduction of integrase inhibitors in UK guidelines

“…Overall, 38% of participants had a regimen change, and this was more common in the protease inhibitor group and less common in the INSTI group. This is higher than observed in most RCTs, but similar to the rate of third agent change of 28 per 100 person-years (95% CI [26][27][28][29][30][31] found by a review of aggregate data from 1949 patients at eight UK centres from 2012 to 2015 [26]. It was decided to censor follow-up at a regimen change in the current study as this indicated the treatment group had changed, which may have been for economic, simplification or tolerability reasons, rather than lack of virological effectiveness.…”

Integrase inhibitors in late pregnancy and rapid HIV viral load reduction

“…This study supports previously published case reports of rapid decline in HIV-1 viral load after treatment with INSTI-containing regimens. 8,9,11,12 All of the observed ART regimens were effective in decreasing HIV viral load in a relatively short time period, but the addition of an integrase inhibitor suppressed viral load more quickly. This is consistent with prior literature describing the effect of INSTI-based ART in pregnancy, however, a strength of our study is that we compared INSTI- and non-INSTI-containing ART directly.…”

“…This is consistent with prior literature describing the effect of INSTI-based ART in pregnancy, however, a strength of our study is that we compared INSTI- and non-INSTI-containing ART directly. 8,9,11–14 Additionally, we describe the clinical practice of using regimens that did not fall under 1 st line recommended maternal treatment at the time of the study. 1 According to these data, pregnant HIV-infected women are prescribed newer potent ART options or regimens that are convenient once-a-day options, likely in order to promote adherence.…”

Tratamiento anti-retroviral conteniendo raltegravir en mujeres gestantes con infección por VIH: Revisión sistemática

“…Con posterioridad a la lectura a texto completo se eliminaron 10 artículos [17][18][19][20][21][22][23][24][25][26] , por no cumplir con alguno de los criterios establecidos previamente. Finalmente, se seleccionaron 14 estudios 27-40 que cumplieron con los criterios establecidos inicialmente (Figura 1).…”