Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression (STEREOS)

Mahidol University

Status: Completed

Conditions: HIV-1-infection; Efavirenz; Dyslipidemias; Rilpivirine; Sustained Virologic Response; Anti-Retroviral Agents

Treatments: Drug: Tenofovir/Emtricitabine/Rilpivirine; Drug: Tenofovir/Emtricitabine/Efavirenz

Study type: Interventional

Funder types: Other

Identifiers

NCT03251690

ID09-59-06

Details and patient eligibility

About

According to the Thai National Guidelines for Treatment of HIV/AIDS 2014, the recommended first line ART regimen was 2 NRTIs backbone, TDF and FTC; plus 1 NNRTI, EFV, with RPV as an alternative one. Most of the randomized-controlled studies, including ECHO and THRIVE, showed the non-inferiority of RPV compared with EFV in naive cases. But there were not much randomized-controlled trials for changing from other NRTI to RPV in patients who currently on another ART, especially in Thailand. Moreover, the concerned adverse effects of dyslipidemia and neurological symptoms were better in RPV-based than EFV-based regimen. Finally, the cost-effectiveness and universal coverage are also the benefit of RPV over EFV in term of economics.

Full description

According to the Thai National Guidelines for Treatment of HIV/AIDS 2014, the recommended first line ART (Anti-retroviral therapy) regimen was 2 NRTIs (nucleoside reverse transcriptase inhibitors) backbone, which are TDF (Tenofovir) and FTC (Emtricitabine); plus 1 NNRTI (non-nucleoside reverse transcriptase inhibitor), which is EFV (Efavirenz), with RPV (Rilpivirine) as an alternative in this class of drug.

Most of the randomized-controlled studies, including ECHO (Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1) and THRIVE (Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1), the major trials about RPV, showed the non-inferiority in efficacy of RPV compared with that of EFV in treatment-naive cases with blood HIV viral load less than 500,000 copies/mL. But there were not many trials focusing on changing the ART-regimens from other NRTI to RPV in patients who currently on another ART, especially in randomized-controlled design. There were some studies comparing continuing current regimens versus changing to Rilpivirine-based regimens, but they didn't exclusively select the homogeneous drug components. In Thailand, study of changing to Rilpivirine-based regimens was primarily designed to evaluate the adverse outcome about dyslipidemia, whereas efficacy was a secondary outcome. Most studies, the concerned adverse effects of dyslipidemia and neurological symptoms were better in RPV-based than EFV-based regimen. Finally, the cost-effectiveness and universal coverage are also the benefit of RPV over EFV in term of economics.

Therefore, we design this study to evaluate the efficacy; in term of non-inferiority, of the newer, safer, and cheaper drug, Rilpivirine, to Efavirenz, the general-use drug with acceptable efficacy, in the virological-suppressed patients currently on ART. Besides, we also assess the adverse outcomes and factors associated with successful or failure of treatment. In addition, we can have more backup data in term of national economics.

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• on TDF/FTC/EFV for more than 3 months
• Blood HIV RNA viral load <50 copies/mL
• CD4+ count >200 cells/mm3
• eligible to sign the informed consent

Exclusion criteria

• history of NRTI resistance
• on medication that potentially interact with study drug
• denied to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 2 patient groups

Switching TDF/FTC/EFV to TDF/FTC/RPV

Experimental group

Description:

Switching from Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Efavirenz 600 mg/day (once daily) to Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Rilpivirine 25 mg/day (once daily) Intervention: Tenofovir/Emtricitabine/Rilpivirine

Treatment:

Drug: Tenofovir/Emtricitabine/Rilpivirine

Continuing TDF/FTC/EFV

Active Comparator group

Description:

Continuing Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Efavirenz 600 mg/day Intervention: Tenofovir/Emtricitabine/Efavirenz

Treatment:

Drug: Tenofovir/Emtricitabine/Efavirenz