Juluca

Approved Uses

Juluca is a combination of two antiretroviral medicines, dolutegravir and rilpivirine. It is used to treat HIV-1 infection in adults. Unlike many other HIV treatments that require multiple pills, Juluca is intended to be a complete regimen on its own.

Switching to Juluca

This medication is specifically for adults who are already taking HIV medications and meet the following conditions:

• Their viral load is currently suppressed (less than 50 copies of HIV-1 RNA per mL).
• They have been on a stable antiretroviral regimen for at least six months.
• They have no history of treatment failure with previous HIV medications.
• There is no known resistance to either of the individual drugs in Juluca (dolutegravir or rilpivirine).

Juluca helps control HIV infection but is not a cure for HIV or AIDS. It works by decreasing the amount of HIV in the blood and increasing the number of immune cells that help fight infections.

Juluca contains two active ingredients, dolutegravir and rilpivirine, which belong to different classes of antiretroviral drugs. These medications work by interfering with the enzymes HIV uses to make copies of itself within the body.

• Dolutegravir is an integrase strand transfer inhibitor (INSTI). It blocks an enzyme called integrase. HIV needs this enzyme to insert its genetic material into the DNA of human immune cells.
• Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It works by binding to and blocking an enzyme called reverse transcriptase. This enzyme is necessary for the virus to convert its genetic code into a form that can be integrated into human cells.

By targeting these two separate stages of the viral life cycle, Juluca helps keep the amount of HIV in the blood at a very low level. This helps protect the immune system and prevents the virus from spreading to new cells, although it does not cure the infection.

Common Side Effects

Some people may experience mild side effects while taking Juluca. These often include:

• Diarrhea
• Headache
• Nausea
• Trouble sleeping
• Dizziness
• Tiredness

Serious Side Effects

Juluca can cause serious side effects that require immediate medical attention. Contact a healthcare provider right away if you experience any of the following:

• Liver problems: Symptoms include yellowing of the skin or the whites of the eyes (jaundice), dark-colored urine, light-colored stools, loss of appetite, nausea, or pain on the right side of the stomach area.
• Mental health changes: New or worsening depression, anxiety, or thoughts of hurting yourself.
• Severe allergic reactions: Signs may include a skin rash, fever, general ill feeling, extreme tiredness, muscle or joint aches, blisters, or swelling of the face, lips, tongue, or mouth.
• Kidney problems: Changes in how much or how often you urinate.

This is not a complete list of side effects. Always consult with a healthcare professional about any new or worsening symptoms while taking this medication.

Hypersensitivity Reactions

Serious and sometimes fatal allergic reactions have been reported. Symptoms may include a severe rash, fever, general ill feeling, fatigue, muscle or joint aches, blisters, or swelling of the face. If a hypersensitivity reaction is suspected, the medication is typically stopped immediately to prevent organ damage.

Liver Health

Liver toxicity has occurred in patients taking components of Juluca, even those without a history of liver disease. People with hepatitis B or C may be at a higher risk for liver enzyme elevations. Monitoring liver function through blood tests is common during treatment.

Pregnancy and Birth Defects

There is a potential risk of neural tube defects in infants born to individuals using dolutegravir, one of the active ingredients in Juluca, at the time of conception or during the first trimester of pregnancy. Healthcare providers usually discuss these risks and the use of effective contraception before starting treatment.

Depressive Disorders

Some individuals taking this medication have experienced depression, anxiety, or suicidal thoughts and behaviors. Immediate medical attention is necessary if mood changes or self-harm thoughts occur.

Drug Interactions

Juluca interacts with many other medications, which can make it less effective or increase side effects. It is not used with:

• Proton pump inhibitors (such as omeprazole or lansoprazole)
• Certain anti-seizure medications (such as carbamazepine or phenytoin)
• Rifampin or rifapentine
• St. John's wort

Other medications, like antacids or H2 blockers, require specific timing for doses to ensure proper absorption.

Immune Reconstitution Syndrome

As the immune system strengthens, it may react strongly to previously hidden infections, such as pneumonia or tuberculosis. This can cause new symptoms shortly after starting HIV treatment.

Pregnancy

If you are pregnant or planning to become pregnant, discuss the risks and benefits of Juluca with your healthcare provider. One of the medicines in Juluca, dolutegravir, may increase the risk of neural tube defects (birth defects of the brain or spine) if taken at the time of conception or during the first few weeks of pregnancy.

Your doctor may perform a pregnancy test before you start treatment. If you are able to become pregnant, you should use effective contraception while taking Juluca. If you become pregnant while taking this medication, do not stop taking it without talking to your doctor first, as stopping HIV medication can allow the virus level to increase in your body.

There is a pregnancy registry that monitors health outcomes in individuals who take HIV medicines during pregnancy. Healthcare providers are encouraged to register patients to help collect information about the safety of these drugs.

Breastfeeding

Health experts recommend that individuals with HIV-1 do not breastfeed their infants. This is to prevent the risk of transmitting the virus to the baby through breast milk. It is also unknown if the components of Juluca pass into human breast milk or if they could cause side effects in a nursing infant. Talk to your healthcare provider about the safest way to feed your baby.

Available Forms

Juluca is supplied as a film-coated tablet. This medication is a combination of antiretroviral drugs provided in a tablet for oral administration.

FDA Approval and Indications

Juluca was approved by the U.S. Food and Drug Administration (FDA) in November 2017. It is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace their current antiretroviral regimen. To be eligible for this switch, patients must meet specific criteria:

• They must be virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months.
• They must have no history of treatment failure.
• They must have no known resistance to either dolutegravir or rilpivirine.

Regulatory History and Safety Monitoring

Juluca represented a significant regulatory milestone as the first two-drug, fixed-dose complete regimen approved for HIV maintenance therapy, intended to reduce the number of antiretroviral drugs patients need to take daily. Unlike many other HIV medications, Juluca does not carry a Boxed Warning.

The FDA has issued safety communications regarding one of its active ingredients, dolutegravir. In 2018, the FDA alerted the public to a potential risk of neural tube birth defects in infants born to individuals using dolutegravir at the time of conception. This led to updated labeling regarding the use of the medication during pregnancy and for those of childbearing potential.

There is currently no Risk Evaluation and Mitigation Strategy (REMS) required for Juluca.

Insurance and Out-of-Pocket Costs

The amount a patient pays for Juluca depends largely on their insurance plan. Most commercial insurance, Medicare Part D, and Medicaid plans provide coverage for this medication, but the specific copayment or coinsurance amount is determined by the plan's formulary. Patients with high deductibles may face higher initial costs until their deductible is met.

Generic Availability

Juluca is a brand-name medication containing dolutegravir and rilpivirine. Currently, there is no generic version of this specific combination tablet available. Brand-name medications typically cost more than generic alternatives because they are protected by patents that prevent other companies from manufacturing the same drug for a set period.

Financial Assistance Programs

For individuals who have difficulty affording their medication, several options may be available:

• Manufacturer Savings Cards: Patients with private or commercial insurance may be eligible for savings cards provided by the manufacturer to reduce monthly copayments.
• Patient Assistance Programs: Uninsured or underinsured individuals may qualify for programs that provide the medication at little or no cost based on financial need.
• Non-Profit Organizations: Various foundations offer grants or assistance to help patients cover the costs of HIV treatments.

It is recommended that patients consult with their pharmacist or healthcare provider to explore available cost-saving options and verify coverage with their insurance provider.