Research Article: Raltegravir plus abacavir/lamivudine in virologically suppressed HIV-1-infected patients: 48-week results of the KIRAL study

Date Published: June 14, 2018

Publisher: Public Library of Science

Author(s): Jesús Troya, Rocio Montejano, Pablo Ryan, Cristina Gómez, Mariano Matarranz, Alfonso Cabello, Francisco Vera, María Antonia Sepúlveda, Ignacio Santos, Gloria Samperiz, Pablo Bachiller, Vicente Boix, Pilar Barrufet, Miguel Cervero, José Sanz, Javier Solís, María Yllescas, Eulalia Valencia, Giuseppe Vittorio De Socio.


Long-term combination antiretroviral therapy often results in toxicity/tolerability problems, which are one of the main reasons for switching treatment. Despite the favorable profile of raltegravir (RAL), data on its combination with abacavir/lamivudine (ABC/3TC) are scarce. Based on clinical data, we evaluated this regimen as a switching strategy.

Multicenter, non-controlled, retrospective study including all virologically suppressed HIV-1-infected patients who had switched to RAL+ABC/3TC.

We evaluated effectiveness (defined as maintenance of HIV-1-RNA <50 copies/mL at 48 weeks) safety, tolerability, laboratory data, and CD4+ count at week 48 of this switching strategy. The study population comprised 467 patients. Median age was 49 years (IQR: 45–53). Males accounted for 75.4%. Median CD4+ count at baseline was 580 cells/μL (IQR, 409). The main reasons for switching were toxicity/tolerability problems (197; 42.2%) and physician’s criteria (133; 28.5%). At week 48, HIV-1 RNA remained at <50 copies/mL in 371/380 (97.6%; 95%CI: 96.4–99.0) when non-virological failure was censured. Virological failure was recorded in 1.9% patients and treatment failure in 20.5% of patients (96/467 [95%CI, 16.9–24.2]). The main reasons for treatment failure included switch to fixed-dose combination regimens (31; 6.6%), toxicity/poor tolerability (27; 5.8%), and physician’s decision (17; 3.6%). A total of 73 adverse events were detected in 64 patients (13.7%). These resolved in 43 patients (67.2%). Of the 33 cases related or likely related to treatment, 30 were Grade-1 (90.9%). CD4+ count and renal, hepatic, and lipid profiles remained clinically stable over the 48 weeks. Our findings suggest that RAL+ABC/3TC could be an effective, safe/tolerable, and low-toxicity option for virologically suppressed HIV-1-infected patients.

Partial Text

The availability of highly effective combination antiretroviral therapy (cART) over the last 2 decades has made HIV-1 infection a treatable chronic disease. However, the need for continued use of cART has generated problems such as toxicity, lack of tolerability, and drug interactions, which have forced clinicians to seek new treatment regimens. These regimens are not always adequately represented in clinical trials or observational studies [1,2].

Although RAL+FTC/TDF has been shown to be highly efficacious and safe as a switching strategy in clinical trials and cohort studies [15,16], equivalent data for RAL+ABC/3TC are scarce, even though this regimen has been used in clinical practice [18]. Therefore, we provide, to our knowledge, data from the largest cohort to date of patients switching to RAL+ABC/3TC based on real-world data.




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