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.

Keywords

HAART (Highly Active Antiretroviral Therapy)treatment HIV (Human immunodeficiency virus)AIDS raltegravir integrase inhibitor viral disease antiviral toxicity

Get full access to this article

View all access options for this article.

References

Merck Sharp & Dohme Limited. Summary of product characteristics Isentress 400 mg film-coated tablets, 2013. Available at: http://www.medicines.org.uk/emc/medicine/20484/SPC/ (accessed 17 April 2015).

Lennox

Dejesus

Berger

et al.

Raltegravir versus efavirenz regimens in treatment-naïve HIV-1 infected patients: 96-week efficacy, durability, subgroup, safety and metabolic analyses. J Acquir Immune Defic Syndr 2010; 55: 39–48.

Eron

Cooper

Steigbigel

et al.

Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials. Lancet Infect Dis 2013; 13: 587–596.

Gazzard

Anderson

Babiker

et al.

British HIV Association guidelines for the treatment of HIV-1-infected adults with antiretroviral therapy 2008. HIV Med 2008; 9: 563–608.

Williams

Churchill

Anderson

et al.

British HIV Association guidelines for the treatment of HIV-1 positive adults with antiretroviral therapy 2012 (Update November 2013). HIV Med 2014; 15(suppl 1): 101–185.

Adeyemo

Wood

Govind

. Achieving rapid reduction of HIV-1 viral load in HIV-positive pregnant women close to term – an obstetric/medical emergency: a review of three cases. Int J STD AIDS 2013; 24: 691–692.

De Hoffer

DiBiagio

Bruzzone

et al.

Use of raltegravir in a late presented HIV-1 woman in advanced gestational age: case report and literature review. J Chemother 2013; 25: 181–183.

Nobrega

Travassos

Haguihara

et al.

Short communication: use of raltegravir in late-presenting HIV-infected pregnant women. AIDS Res Hum Retroviruses 2013; 29: 1451–1454.

Cha

Shaikh

Williams

et al.

Rapid reduction in HIV viral load in late pregnancy with raltegravir: a case report. J Int Assoc Provid AIDS Care 2013; 12: 312–314.

10.

Taylor

Touzeau

Geit

et al.

Raltegravir in pregnancy: a case series presentation. Int J STD AIDS 2011; 22: 358–360.

11.

Taylor

Clayden

Dhar

et al.

British HIV Association guidelines for the management of HIV infection in pregnant women 2012. HIV Med 2012; 13(suppl 2): 87–157.

12.

Asboe

Aitken

Boffito

et al.

British HIV Association guidelines for the routine investigation and monitoring of adult HIV-1 infected individuals 2011. HIV Med 2012; 13: 1–44.