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Review

Triple-combination rilpivirine, emtricitabine, and tenofovir (Complera™/Eviplera™) in the treatment of HIV infection

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Pages 531-542 | Published online: 19 Jun 2013

Figures & data

Table 1 Recommended and alternative initial antiretroviral regimens, including strength of recommendations and quality of evidence

Figure 1 Efficacy of oral rilpivirine as a component of combination therapy in antiretroviral-naïve patients with HIV infection.

Notes: Response rates (A) in the full modified intent-to-treat populations (primary end point) and (B) in descriptive subgroup analyses according to baseline HIV-RNA level. Results are from the randomized, double-blind, double-dummy, multinational ECHO (n = 690)Citation24 and THRIVE (n = 678)Citation25 trials, which compared rilpivirine 25 mg once daily with efavirenz 600 mg once daily, plus background regimens. For the primary analysis, the noninferiority margin (rilpivirine vs efavirenz) for the lower bound of the 95% CI was −12%. In the ECHO and THRIVE trials, 344 and 354, 265 and 254, and 81 and 70 patients, respectively, had baseline HIV-RNA levels of ≤100,000, 100,000–500,000, and >500,000 copies/mL.
Abbreviations: BR, background regimen; BVL, baseline viral load; CI, confidence interval; EFV, efavirenz; RPV, rilpivirine; RNA, ribonucleic acid.
Figure 1 Efficacy of oral rilpivirine as a component of combination therapy in antiretroviral-naïve patients with HIV infection.

Figure 2 Resistance-associated mutations occurring in ≥2 patients at time of virological failure with (A) once-daily oral rilpivirine 25 mg plus a background regimen or (B) efavirenz 600 mg plus a background regimen.

Notes: Data are from a pooled analysisCitation26 of the Phase III ECHOCitation24 and THRIVECitation25 trials. Patients with evaluable post-baseline resistance data at 48 weeks were included and the data are presented according to baseline HIV viral load.
Abbreviations: NNRTI, nonnucleoside reverse-transcriptase inhibitor; NRTI, nucleoside/nucleotide-reverse transcriptase inhibitor; RNA, ribonucleic acid.
Figure 2 Resistance-associated mutations occurring in ≥2 patients at time of virological failure with (A) once-daily oral rilpivirine 25 mg plus a background regimen or (B) efavirenz 600 mg plus a background regimen.

Figure 3 Virological response in antiretroviral-naïve patients with HIV infection receiving oral rilpivirine plus emtricitabine/tenofovir.

Notes: Proportion of patients with confirmed HIV-RNA levels <50 copies/mL at 48 weeks (intent-to-treat time-to-loss-of-virological-response analysis) and 96 weeks (intent-to-treat snapshot analysis) in all patients stratified according to baseline HIV-RNA levels. Results are shown for patients receiving rilpivirine plus emtricitabine/tenofovir (n = 550) or efavirenz plus emtricitabine/tenofovir (n = 546) in pooled subset analysesCitation29 of the ECHOCitation24 and THRIVECitation25 trials.
Abbreviations: BVL, baseline viral load; EFV, efavirenz; FTC/TDF, emtricitabine/tenofovir; pts, patients; RPV, rilpivirine; RNA, ribonucleic acid.
Figure 3 Virological response in antiretroviral-naïve patients with HIV infection receiving oral rilpivirine plus emtricitabine/tenofovir.

Figure 4 Tolerability of oral rilpivirine as a component of combination therapy in antiretroviral-naïve patients with HIV infection.

Notes: Pooled descriptive dataCitation10 from the ECHOCitation24 and THRIVECitation25 trials, which compared rilpivirine 25 mg once daily with efavirenz 600 mg/day, plus background regimens. Adverse events (grade ≥ 2 level of severity) occurring in ≥2% of patients in at least one group during 48 weeks of treatment.
Abbreviations: BR, background regimen; EFV, efavirenz; RPV, rilpivirine.
Figure 4 Tolerability of oral rilpivirine as a component of combination therapy in antiretroviral-naïve patients with HIV infection.

Figure 5 Laboratory abnormalities and changes in blood lipids associated with oral rilpivirine as a component of combination therapy in antiretroviral-naïve patients with HIV infection.

Notes: Pooled descriptive dataCitation10 from the ECHOCitation24 and THRIVE trialsCitation25 are for severity-level grades 2–4 laboratory abnormalities or changes in blood lipids occurring in ≥2% of patients in at least one group after 48 weeks of treatment. Values shown as <1 at a particular grade level of severity in the original reference were rounded up to 1 when summing to obtain totals for grade 2–4 levels.
Abbreviations: BR, background regimen; EFV, efavirenz; LDL, low-density lipoprotein; RPV, rilpivirine; AST, aspartate aminotransferase; ALT, alanine aminotransferase.
Figure 5 Laboratory abnormalities and changes in blood lipids associated with oral rilpivirine as a component of combination therapy in antiretroviral-naïve patients with HIV infection.