Last reviewed 2026-04-20 · How we verify

COMPLERA

Complera, marketed by Bayer, is a combination therapy that interacts with specific biological pathways to treat its primary indication, though the exact indication and revenue figures are not specified. The key strength of Complera lies in its key composition patent, which is set to expire in 2028, providing a period of market exclusivity. The primary risk for Complera is the potential increase in competition following the patent expiry in 2028.

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), two of the components of COMPLERA. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue COMPLERA

Common side effects

• Diarrhea
• Nausea
• Fatigue
• Headache
• Dizziness
• Depression
• Insomnia
• Abnormal Dreams
• Rash
• Abdominal Pain
• Dyspepsia
• Vomiting

Serious adverse events

• Glomerulonephritis Membranous
• Glomerulonephritis Mesangioproliferative
• Nephrolithiasis
• Cholecystitis
• Cholelithiasis
• Peripheral Neuropathy
• Psychiatric Disorders
• Anxiety

Key clinical trials

• FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir (PHASE4)
• Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir (PHASE2,PHASE3)
• Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) (PHASE3)
• Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis (PHASE2)
• Interaction With HIV Antiretroviral Agents (PHASE1)
• Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera (PHASE4)
• A Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration in Healthy Japanese Adult Male Participants (PHASE4)
• Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• COMPLERA CI brief — competitive landscape report
• COMPLERA updates RSS · CI watch RSS
• Bayer portfolio CI