Date Published: April 5, 2019
Publisher: BioMed Central
Author(s): Sivaporn Gatechompol, Anchalee Avihingsanon, Tanakorn Apornpong, Win Min Han, Stephen J. Kerr, Kiat Ruxrungtham.
Long-term success of cART is possible if the regimen is convenient and less-toxic. This study assessed the efficacy and safety of switching from a first-line NNRTI or boosted PI-based regimens to RPV-based regimens among virologically suppressed participants in resource-limited setting (RLS).
This is a prospective cohort study. Participants with plasma HIV-RNA < 50 copies/mL receiving cART were switched from a PI- or NNRTI-based, to a RPV-based regimen between January 2011 and April 2018. The primary endpoint was the proportion of patients with plasma HIV-1 RNA level < 50 copies/mL after 12 months of RPV. The secondary endpoint was the virological response at 24 months and safety endpoint (change in lipid profiles and kidney function from baseline to 12 months). A total of 320 participants were enrolled into the study. The rationale for switching to RPV was based on toxicity of the current regimen (57%) or desire to simplify cART (41%). Totally, 177 (55%) and 143 (45%) participants were on NNRTI and boosted PI, respectively, prior to switching to RPV. After 12 months, 298 (93%) participants maintained virological suppression. There were significant improvements in the lipid parameters: TC (− 21 (IQR − 47 to 1) mg/dL; p < 0.001), LDL (− 14 (IQR − 37 to 11) mg/dL; p < 0.001) and TG (− 22 (IQR − 74 to 10) mg/dL; p < 0.001). Also, there was a small but statistically significant decrease in eGFR (− 4.3 (IQR − 12 to 1.1) mL/min per 1.73m2; p < 0.001). In RLS where integrase inhibitors are not affordable, RPV-based regimens are a good alternative option for PLHIV who cannot tolerate first-line NNRTI or boosted PI regimen, without prior NNRTI/PI resistance.
For the past decade, combined antiretroviral therapy (cART) has led to a marked reduction in mortality and morbidity among Human immunodeficiency virus (HIV)—infected participants worldwide [1, 2]. The participants on antiretroviral therapy can have life expectancy close to the general population . However, life-long suppressive therapy is required. Currently, rapid cART initiation is recommended and thus, numbers of people living with HIV (PLHIV) on cART is on the rise . Treatment fatigue and long-term adverse-effects.
Total of 362 participants were invited to the study but only 320 participants were enrolled. The reasons for not enrolling included having detectable viral load at baseline > 50 copies/mL (n = 22) and using previous regimens other than NNRTI and PI (n = 20). The enrollment period is between January 2011 and April 2017 but the follow up period up to April 2018. The majority of the participants were males (56%) and the median age was 46 (interquartile range (IQR) 41–50) years. Median duration of ART was 12 (IQR 8–16) years. Baseline median CD4 cell count was 674 (IQR 522–851) cells/mm3. Forty-five percent of all participants had viral load > 100,000 copies/mL before starting ART. TDF was used as Nucleoside reverse transcriptase inhibitors (NRTI) backbone component in 95% of participants and 6% of participants used ABC.
This study demonstrated the efficacy and safety of switching from first line NNRTI- or PI- based to RPV-based regimen among HIV-1-infected Thai participants who had been virologically suppressed with no previous antiretroviral treatment failure. The overall virological suppression at 12 months was 93% among participants who switched to RPV-based regimens, with low rates of virological failure (2.2%) which was similar to previous study reports [14, 15, 17–19]. The randomized SPIRIT study, showed that 89.3% of treatment experienced participants who switched from ritonavir-boosted PI (PI/r)-based regimen to RPV/FTC/TDF were able to maintain viral suppression at week 48 compared to those who continued treatment with a PI/r regimen; indicating a low risk for virological failure . Another study showed that switching from EFV/FTC/TDF to RPV/FTC/TDF a was safe and efficacious option for virologically suppressed HIV-infected participants who cannot tolerate EFV .
In many resource-limited settings (RLS), that integrase inhibitors is not affordable, RPV-based regimen would be a good alternative option for PLHIV with first line NNRTI or boosted PI intolerance and without prior NNRTI/PI resistance.