If you’re concerned about how you will pay for your HIV-1 treatment, start by talking to your healthcare provider. He or she may be able to help you apply for assistance. Gilead also has or supports several programs that can help.
Also check with your insurance company as most HIV-1 treatments are covered.
For insured patients
The Gilead Co-pay Coupon Card. Insured patients may be able to save up to $400 off their monthly co-pay for COMPLERA with the Gilead Co-pay Coupon Card.*
There are 2 ways to sign up:
Visit www.GileadCoPay.com to enroll for, activate, or replace your Gilead Co-pay Coupon Card.
Over the phone
Call 1-877-505-6986 to speak to a representative directly.
Options for uninsured patients
Gilead’s U.S. Advancing Access® program provides assistance to patients in the United States who do not have insurance or who need financial assistance. As part of this program, Gilead provides assistance for people who cannot afford to pay for COMPLERA.
To learn about eligibility, contact Advancing Access® at 1-800-226-2056. You can also download the enrollment form to be completed by you and your healthcare provider.
The Partnership for Prescription Assistance (PPA) program is designed to help uninsured Americans get the prescription medicines they need at no or low cost. To find out if you qualify, here’s all you need to do:
- Call toll-free 1-888-4PPA-NOW (1-888-477-2669).
- Know the names of the medicines you take.
- A trained specialist will answer your questions and help you apply.
The call center accepts calls in English, Spanish, and approximately 150 other languages. You can also visit the Web site at www.pparx.org.
Government programs. If you do not have insurance, help may be available through:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about COMPLERA?
COMPLERA can cause serious side effects:
- Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak or tired, unusual (not normal) muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold especially in your arms and legs, feeling dizzy or lightheaded, and/or a fast or irregular heartbeat.
- Serious liver problems. The liver may become large (hepatomegaly) and fatty (steatosis). Symptoms of liver problems include your skin or the white part of your eyes turns yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements (stools), loss of appetite for several days or longer, nausea, and/or stomach pain.
- You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking COMPLERA for a long time. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.
- Worsening of hepatitis B (HBV) infection. If you also have HBV and stop taking COMPLERA, your hepatitis may suddenly get worse. Do not stop taking COMPLERA without first talking to your healthcare provider, as they will need to monitor your health. COMPLERA is not approved for the treatment of HBV.
Who should not take COMPLERA?
Do not take COMPLERA if you:
- Take a medicine that contains: carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol), oxcarbazepine (Trileptal), phenobarbital (Luminal), phenytoin (Dilantin, Dilantin-125, Phenytek), rifabutin (Mycobutin), rifampin (Rifater, Rifamate, Rimactane, Rifadin), rifapentine (Priftin), dexlansoprazole (Dexilant), esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole sodium (Protonix), rabeprazole (Aciphex), more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate, or the herbal supplement St. John’s wort.
- Take any other medicines to treat HIV-1 infection, or the medicine adefovir (Hepsera).
What are the other possible side effects of COMPLERA?
Serious side effects of COMPLERA may also include:
- New or worse kidney problems, including kidney failure. Your healthcare provider should do blood tests to check your kidneys before starting treatment with COMPLERA. If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider may also check your kidneys during treatment with COMPLERA.
- Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, have thoughts of hurting yourself (suicide) or have tried to hurt yourself.
- Changes in liver enzymes: People who have had hepatitis B or C, or who have had changes in their liver function tests in the past may have an increased risk for liver problems while taking COMPLERA. Some people without prior liver disease may also be at risk. Your healthcare provider may do tests to check your liver enzymes before and during treatment with COMPLERA.
- Bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones.
- Changes in body fat can happen in people taking HIV-1 medicines.
- Changes in your immune system. Your immune system may get stronger and begin to fight infections. Tell your healthcare provider if you have any new symptoms after you start taking COMPLERA.
The most common side effects of COMPLERA include trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, nausea, rash, tiredness, and depression. Other common side effects include vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles), and pain. Tell your healthcare provider if you have any side effects that bother you or do not go away.
What should I tell my healthcare provider before taking COMPLERA?
- All your health problems. Be sure to tell your healthcare provider if you have or had any kidney, mental health, bone, or liver problems, including hepatitis virus infection.
- All the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start any new medicines while taking COMPLERA without first talking with your healthcare provider.
- If you take antacids. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA.
- If you take stomach acid blockers. Take acid blockers at least 12 hours before or at least 4 hours after you take COMPLERA. Ask your healthcare provider if your acid blocker is okay to take, as some acid blockers should never be taken with COMPLERA.
- If you are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking COMPLERA.
- If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk. Also, some medicines in COMPLERA can pass into breast milk, and it is not known if this can harm the baby.
What is COMPLERA?
COMPLERA (emtricitabine 200 mg, rilpivirine 25 mg, tenofovir disoproxil fumarate 300 mg) is a prescription medicine used as a complete HIV-1 treatment in one pill a day. COMPLERA is for adults who have never taken HIV-1 medicines before and who have no more than 100,000 copies/mL of virus in their blood (this is called ‘viral load’). COMPLERA can also replace current HIV-1 medicines for some adults who have an undetectable viral load (less than 50 copies/mL) and whose healthcare provider determines that they meet certain other requirements.
COMPLERA combines 3 medicines into 1 pill to be taken once a day with food. COMPLERA is a complete single tablet regimen and should not be used with other HIV-1 medicines. It is not known if COMPLERA is safe and effective in children under the age of 18 years.
COMPLERA does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses you must keep taking COMPLERA. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For more information about COMPLERA, please see , including Patient Information with important warnings.