Complera

Indicated For

HIV-1

About This Medication

# Gilead Advancing Access Patient Assistance Program Patient Guide: How to Get Complera at Low or No Cost Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is a prescription medication used to treat HIV-1 infection in adults and children who weigh at least 77 lbs (35 kg). This **patient-friendly guide** explains the Gilead Advancing Access Patient Assistance Program (PAP/MAP), which may provide Complera **free of charge** to eligible uninsured patients meeting specific criteria, including income and residency requirements. Note: As of March 2026, following the program's update effective May 5, 2025, to a mail order delivery model, eligible patients receive shipments directly.[1][7][10] ## About Complera **Complera** combines three antiretroviral medications—emtricitabine (200 mg), rilpivirine (25 mg), and tenofovir disoproxil fumarate (300 mg)—in one tablet taken once daily. It helps control HIV by reducing the amount of virus in your blood (viral load) and increasing CD4 cell counts, but it does not cure HIV or prevent transmission. Common side effects include nausea, headache, trouble sleeping, and dizziness; serious risks involve liver problems, kidney issues, bone density loss, and lactic acidosis. Always take as prescribed with food, and discuss with your doctor if you have hepatitis B, kidney/liver disease, or are pregnant/breastfeeding. Complera is for treatment-experienced patients with no history of resistance to its components.[1][2] ## Who Qualifies for the Program? The Gilead Advancing Access PAP/MAP is designed for **uninsured** U.S. residents (including Puerto Rico) who cannot afford their Gilead HIV medications like Complera. Key qualifications include: - **Residency**: Must live in the U.S. or Puerto Rico. - **Insurance Status**: No private/commercial insurance, Medicaid, Medicare, ADAP, VA/TRICARE, or other government programs. Underinsured patients may qualify if they lack coverage for this medication.[1][7] - **Prescription**: Valid prescription for an FDA-approved use from a U.S.-licensed provider. - **Income**: Based on household income and program criteria (specific Federal Poverty Level (FPL) not publicly detailed; typically up to 400-500% FPL for similar programs, but call for exacts). Income is verified and rechecked during the 12-month enrollment.[7] - **Other**: Age 18+ or with parental consent; not incarcerated. **Important Update**: Due to low utilization and generic availability, free medication provision for Complera ended for new enrollments after January 31, 2025, but existing enrollees continued until supplies ran out. However, as of May 5, 2025, the program shifted to mail order for eligible cases—confirm current status by calling.[10][7] ## Income Eligibility Breakdown Specific income thresholds are not publicly listed online and depend on household size, location, and annual review. The program uses program-specific criteria, often aligned with FPL. Here's a general table based on standard PAP structures (contact program for precise 2026 figures): | Household Size | Estimated Max Annual Income (e.g., ~400% FPL) | Notes | |---------------|-----------------------------------------------|-------| | 1 (Individual) | ~$60,000 | Subject to verification; recent pay stubs required. | | 2 (Couple) | ~$81,000 | Includes all household income sources. | | 3 | ~$102,000 | Ongoing checks during enrollment. | | 4 | ~$123,000 | Add ~$21,000 per additional member. | *Table is illustrative; actual eligibility requires application review. Proof of income (tax returns, W-2s, pay stubs) mandatory.*[7] ## Insurance Requirements This program is **strictly for patients without insurance coverage** for Complera. You are **ineligible** if enrolled in: - Medicaid or ADAP. - Medicare (Parts A/B/D). - VA/TRICARE, Federal Employee Health, or state plans. Commercially insured patients should use the separate Co-pay Savings Program (up to $8,000/year assistance, as low as $0 copay). If insurance changes, the program helps navigate appeals or alternatives.[1][5][8] ## Step-by-Step Application Process 1. **Confirm Eligibility**: Call 1-800-226-2056 (Mon-Fri, 9 AM-8 PM ET) or visit gileadadvancingaccess.com/patient to speak with a specialist.[1][3] 2. **Gather Documents**: Prescription, proof of residency (utility bill/ID), income proof (last 30 days pay stubs, tax return), and insurance denial (if applicable).[7] 3. **Enroll**: Options include: - **Online**: advancingaccessconsent.iassist.com for immediate decision.[6][7] - **Fax**: HCP faxes form + docs to 1-800-216-6857; reviewed in 2 business days.[7] - **Phone**: Call 800-226-2056 to start.[1] 4. **Doctor Involvement**: Your prescriber completes/signs the enrollment form. 5. **Approval Notification**: Program notifies you and your doctor via mail/email/phone. 6. **Receive Medication**: Shipped free to your home (mail order model since May 5, 2025).[7][10] Enrollment lasts up to **12 months** with **reauthorization required** annually or upon changes.[1] ## Timeline and Delivery - **Processing**: Online—instant; Fax—2 business days; Phone—immediate guidance.[6] - **Approval to Delivery**: 1-4 weeks typically, depending on docs. - **Delivery**: Free mail order directly to patient (updated May 5, 2025); 1-3 month supply per shipment. - **Refills**: Automatic for approved patients; reauthorized yearly. If delayed, call the program.[3] ## Alternatives if Denied - **Co-pay Program**: For commercial insurance (gileadcopay.com).[2][5] - **State ADAPs**: HIV-specific aid; check nadap.org. - **Other PAPs**: NeedyMeds.org or RxAssist.org for generics/alternatives. - **Patient Access Network (PAN) Foundation** or HealthWell Foundation grants. - **Generic Options**: Since Complera has equivalents, discuss with doctor. - **Appeals**: Program assists with insurance denials.[1][8] No biosimilars listed for Complera. ## Disclaimer This guide is for informational purposes only and not medical/financial advice. Eligibility, availability (especially post-2025 changes for Complera), and terms can change—**always verify with Gilead Advancing Access at 1-800-226-2056**. Consult your healthcare provider for treatment decisions. Program not available in all states; void where prohibited. Word count: ~950.

Program information last verified: March 30, 2026