Emtricitabine, rilpivirine, tenofovir disoproxil fumarate

(Complera®)

Complera®

Drug updated on 11/1/2024

Dosage FormTablet (oral; 200 mg of emtricitabine, 25 mg of rilpivirine, and 300 mg of tenofovir disoproxil fumarate)
Drug ClassNucleoside analog HIV-1 reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for use as a complete regimen for the treatment of HIV-1 infection in patients weighing at least 35 kg (1) as initial therapy in those with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, or (2) or to replace a stable antiretroviral regiment in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of COMPLERA.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • CAB-LA (long-acting cabotegravir) significantly reduced HIV-1 infection rates (0.33%) compared to tenofovir disoproxil fumarate-emtricitabine (1.46%), with a risk ratio of 0.21 (95% CI (confidence interval) 0.07-0.61).
  • CAB-LA+RPV-LA (long-acting rilpivirine) maintained high virological suppression at 48 and 96 weeks (80.9% at 5 years), with similar efficacy in treatment-naive (93.2%) and treatment-experienced (94%) patients.
  • More than 85% of people living with HIV preferred long-acting antiretrovirals (LA-ARVs).
  • Higher incidence of drug-related adverse events was observed with CAB-LA+RPV-LA (81.6%) compared to placebo (6.2%), with the most common adverse event being mild or moderate injection site reactions, which decreased over time.
  • The safety profile of CAB-LA+RPV-LA was comparable to placebo in terms of adverse event-related withdrawals.
  • There is no population types or subgroups information available in the reviewed studies.