Integrase Inhibitor-Based Regimen Shows Promise in Treating HIV-2
An integrase inhibitor-based regimen to treat human immunodeficiency virus-2 (HIV-2) has shown good safety, efficacy, and tolerability in a small clinical trial conducted in Senegal, West Africa. HIV-2 is rare, particularly in areas outside of West Africa. In the United States, only 166 cases of HIV-2 were documented between 1988 and 2010. Subsequently, HIV-2 has received relatively little attention, with infected individuals often having suboptimal outcomes despite HIV-2 generally having a less aggressive disease course with slower deterioration of immune function.
The 48-week open-label study included 30 HIV-2-positive, antiretroviral-therapy naïve individuals with World Health Organization stage 3 or 4 disease or CD4 counts <750 cells/mm3. Of these individuals, 29 completed the study, during which they were treated with a single-tablet regimen containing elvitegravir-cobicistat-emtricitabine-tenofovir disoproxil fumarate (E/C/F/TDF; Stribild®).
Efficacy findings were as follows at week 48:
- No deaths and no new AIDS-associated clinical events.
- Increase in median baseline CD4 count of 408 cells/mm3 (range, 34-747/mm3) by a median +161 cells/mm3 (range, 27-547/mm3) at week 48.
- 25 patients had baseline HIV-2 viral loads <50 copies/mL of plasma.
- Patients with detectable HIV-2 viral loads had a median of 41 copies/mL of plasma (range, 10-6135 copies/mL).
- Using a mITT analysis (FDA Snapshot method), 28 of 30 (93.3%; 95% confidence interval, 77.9%-99.2%) had viral suppression at 48 weeks.
- 1 patient had virologic failure; patient was found to have multidrug resistant HIV-2 (reverse transcriptase mutation: K65R; integrase mutations: G140S and Q148R).
There were 8 grade 3-4 adverse events but none were deemed study related. Patient adherence and acceptability were good.
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Reference
Ba S, Raugi DN, Smith RA, et al; University of Washington–Dakar HIV-2 Study Group. A trial of a single tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate for the initial treatment of HIV-2 infection in a resource-limited setting: 48 week results from Senegal, West Africa. Clin Infect Dis. 2018 Apr 17. doi: 10.1093/cid/ciy324.
