Raltegravir and Abacavir/Lamivudine in Japanese Treatment-Naïve and Treatment-Experienced Patients with HIV Infection: a 48-Week Retrospective Pilot Analysis

Abstract

SUMMARY: Abacavir/lamivudine (ABC/3TC) is a nucleoside reverse transcriptase inhibitor used for treating human immunodeficiency viral (HIV) infections. Hypersensitivity reactions such as skin eruptions caused by ABC are well-known, but rarely occur in Asians. Raltegravir (RAL) is an integrase strand transfer inhibitor, that is now increasingly, used for treating HIV infections because it has few adverse effects. This retrospective analysis assessed the efficacy and safety of combined ABC/3TC and RAL in both treatment-naä ƒve and -experienced Japanese patients with HIV infections. In all 11 treatment-naä ƒve patients (100z), virological suppression to undetectable level was achieved. Liver transaminases, renal function, and serum lipid profiles showed no exacerbations up to 48 weeks of treatment. In 12 patients who were switched from previous regimens to ABC/3TC and RAL, HIV viral load was undetectable in 11 patients (91.6z), but remained detectable in 1 patient with poor adherence. Major reasons for switching regimens to ABC/3TC and RAL were hyperlipidemia and nausea. After switching, these adverse effects improved, and no new adverse effects were observed. Despite the small number of participants in this study, the results support the combination of ABC/3TC and RAL as a possible treatment choice in Japanese individuals with HIV-infection.

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

“…Abundant data from clinical trials and some real-life cohort studies in naïve patients indicate that the combination of RAL with FTC/TDF, and to a lesser extent with ABC/3TC, is highly efficacious and safe [ 12 – 14 ]. As a switching option, RAL has been studied mostly in combination with FTC/TDF [ 15 , 16 ], and available data associated with ABC/3TC are scarce [ 17 , 18 ], even though this regimen has been widely used in clinical practice.…”

Efficacy and safety of abacavir/lamivudine with raltegravir in treatment-experienced and treatment-naïve patients with HIV-1 infection: an observational, retrospective, multi-centre study

“…13 Similarly, Suzuki et al and Kang et al, already mentioned with regard to treatment-experienced subjects, showed in their abovementioned studies optimal therapeutic effect of ABC/3TC plus RAL also in treatment-naı¨ve patients, even with pre-treatment viral loads >100,000 copies/mL. 6,7 As regards the safety of ABC/3TC þ RAL in treatment-naı¨ve patients, we did not observe any significant alteration in lipid profile, liver and renal function, in accordance with Suzuki et al 6…”

“…Similarly to our study, in other studies the switch to ABC/3TC plus RAL led to an improvement in lipid levels and liver function, particularly if the previous regimen contained a PI. 6,7,10,11 In the treatment-naı¨ve group, all five patients achieved viral suppression at the latest measurement, suggesting the efficacy of ABC/3TC plus RAL among treatment-naı¨ve patients. Three patients had pretreatment viral loads > 100,000 copies/mL, and all of them achieved viral suppression.…”

“…A limited number of other small-scale studies have investigated the efficacy of ABC/3TC plus RAL in treatment-experienced patients. Suzuki et al observed viral suppression at 48 weeks in 91.6% of the treatment-experienced subjects, who switched from a PI-based or NNRTI-based regimen to ABC/ 3TC plus RAL 6 ; Kang et al, in their study, assessed the efficacy of ABC/3TC plus RAL in treatmentexperienced patients, with 93% achieving viral suppression after the switch from PI-based or NNRTIbased regimens to RAL plus ABC/3TC or ZDV/ 3TC. 7 Similarly, the ORALSWIRAL study showed the efficacy of ABC/3TC plus RAL in treatmentexperienced patients with virological suppression, with 95% achieving viral suppression at 96 weeks.…”

“…Similarly to our study, in other studies the switch to ABC/3TC plus RAL led to an improvement in lipid levels and liver function, particularly if the previous regimen contained a PI. 6,7,10,11…”