Stribild

HIV-1 Infection

Stribild is indicated for the treatment of HIV-1 infection. While it does not cure HIV or AIDS, it works by decreasing the amount of the virus in the blood, which helps the immune system function better and reduces the risk of HIV-related complications.

Approved Patient Groups

This medication is used for:

• Adults: Men and women diagnosed with HIV-1.
• Children: Pediatric patients who weigh at least 35 kg (approximately 77 pounds).

Usage Scenarios

Healthcare providers may prescribe Stribild in the following situations:

• New Treatment: For individuals who have never received antiretroviral therapy before.
• Treatment Switch: To replace a current HIV treatment regimen in patients who have been virologically suppressed (meaning their viral load is very low) on a stable regimen for at least six months. This switch is only appropriate for those with no history of treatment failure and no known resistance to the specific drugs contained in Stribild.

Stribild is a complete treatment regimen and is not meant to be taken with other antiretroviral drugs used to treat HIV-1.

How Stribild Works

Stribild is a combination medication used to treat HIV-1 infection. It works by using four different active ingredients to interfere with the way the virus replicates and spreads in the body.

• Elvitegravir: This is an integrase strand transfer inhibitor (INSTI). It works by blocking an enzyme called integrase, which the virus uses to insert its genetic material into healthy human cells.
• Emtricitabine and Tenofovir Disoproxil Fumarate: These are nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). They interfere with an enzyme called reverse transcriptase, which HIV needs to convert its RNA into DNA so it can replicate.
• Cobicistat: This component does not treat HIV directly. Instead, it is a pharmacokinetic enhancer that blocks a specific enzyme in the body that breaks down elvitegravir. This keeps the levels of elvitegravir high enough to remain effective against the virus.

By combining these mechanisms, Stribild helps lower the amount of HIV in the blood (viral load) and allows the immune system's CD4 cells to recover. While it helps manage the virus and reduces the risk of complications, it is not a cure for HIV.

Common Side Effects

Many people taking Stribild experience mild side effects that may go away as their body adjusts to the medication. Common side effects include:

• Nausea and diarrhea
• Headache
• Fatigue or tiredness
• Dizziness
• Abnormal dreams or trouble sleeping
• Skin rash
• Changes in skin color on the palms of the hands or soles of the feet

Serious Side Effects

Some side effects can be severe and require immediate medical evaluation. Seek help if you notice symptoms of the following conditions:

• Kidney problems: New or worsening kidney impairment, which may cause swelling in the feet or ankles, shortness of breath, or changes in how much you urinate.
• Lactic acidosis: A dangerous buildup of lactic acid in the blood. Symptoms include unusual muscle pain, stomach pain with nausea and vomiting, cold arms and legs, or feeling very weak and tired.
• Liver problems: Signs include yellowing of the skin or eyes (jaundice), dark urine, light-colored stools, or pain in the upper right stomach area.
• Bone issues: Thinning of the bones (osteopenia) or bone pain, which may increase the risk of fractures.
• Immune system changes: Also known as immune reconstitution syndrome, this occurs when the immune system becomes more active and reacts to past or hidden infections.
• Body fat redistribution: Changes in where fat is stored on the body, such as an increase in fat in the upper back, neck, or trunk, and loss of fat from the legs, arms, or face.

Boxed Warnings

Stribild has boxed warnings for two life-threatening conditions. Some individuals taking this medication have developed lactic acidosis (a buildup of acid in the blood) and severe liver enlargement with fat (steatosis). Additionally, for people who have both HIV-1 and hepatitis B virus (HBV), the hepatitis B infection may become much worse if Stribild is discontinued. Liver function should be monitored closely for several months if treatment is stopped.

Kidney Impairment

This medication can cause new or worsening kidney problems, including kidney failure. Healthcare providers typically assess kidney function and monitor urine protein and glucose levels before and during treatment. Stribild is generally not started in patients with a creatinine clearance below 70 mL/min and is usually discontinued if it drops below 50 mL/min. It should not be used with other medications that can harm the kidneys.

Drug Interactions

Stribild contains cobicistat, which significantly affects how the body processes many other medications. Taking Stribild with certain drugs can lead to dangerous, life-threatening side effects or cause the HIV treatment to be less effective. It is contraindicated with several classes of drugs, including certain sedatives, heart medications, and herbal products like St. John's wort.

Bone Health

Decreases in bone mineral density have been observed in patients taking the components of Stribild. This may increase the risk of bone fractures. In some cases, kidney issues caused by the medication can lead to osteomalacia, which is a softening of the bones.

Immune Reconstitution Syndrome

As the immune system becomes stronger during treatment, it may react to hidden or previous infections that were already in the body, such as tuberculosis or fungal infections. This inflammatory response may require additional medical evaluation and treatment.

Fat Redistribution

Changes in body fat, such as increased fat in the upper back and neck (buffalo hump), breast, and trunk, or loss of fat from the arms and legs, may occur in people receiving antiretroviral therapy.

Pregnancy

Stribild is generally not recommended for use during pregnancy. Clinical data indicates that the levels of elvitegravir and cobicistat in the blood decrease significantly during the second and third trimesters. This reduction in drug levels can lead to virologic failure, meaning the medication may stop controlling the virus effectively, which increases the risk of transmitting HIV to the baby.

If you become pregnant while taking Stribild, you should speak with your healthcare provider right away about switching to a different antiretroviral regimen. Individuals who are pregnant are encouraged to enroll in the Antiretroviral Pregnancy Registry to help monitor the safety of HIV medications during pregnancy.

Breastfeeding

The Centers for Disease Control and Prevention (CDC) and other health authorities recommend that mothers with HIV do not breastfeed their infants. This recommendation is intended to eliminate the risk of postnatal HIV transmission through breast milk. It is also not fully known how Stribild affects a nursing infant or if all its active ingredients are present in breast milk in significant amounts.

Dosage Forms

Stribild is available as a film-coated tablet. It is a fixed-dose combination product, which means it contains multiple active ingredients in one pill.

Tablet Appearance and Strength

Each tablet contains a combination of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate. The tablets are green, capsule-shaped, and debossed with identifying marks on one side to ensure the medication is correctly identified.

FDA Approval

Stribild was approved by the U.S. Food and Drug Administration (FDA) in August 2012. It was the first once-daily single-tablet regimen containing an integrase inhibitor to be approved for adults who have not previously received HIV treatment.

Approved Indications

Stribild is indicated for use in adults and pediatric patients weighing at least 35 kg. It is used for patients who have no prior antiretroviral treatment history or to replace a current stable regimen in patients who are virologically suppressed and meet specific clinical criteria.

Boxed Warnings

The FDA requires a boxed warning for Stribild due to the following safety concerns:

• Exacerbation of Hepatitis B: Patients with both HIV-1 and hepatitis B virus (HBV) may experience severe worsening of hepatitis B if they stop taking Stribild. Liver function should be monitored closely if treatment is discontinued.
• Lactic Acidosis and Hepatomegaly: There is a risk of lactic acidosis and severe liver problems, including hepatomegaly with steatosis. These conditions can be life-threatening.

Insurance and Out-of-Pocket Costs

The price of Stribild is primarily determined by your health insurance plan. Most commercial insurance and Medicare Part D plans cover the medication, but it is often placed on a higher cost-sharing tier. This means your out-of-pocket expenses, such as copays or coinsurance, may vary depending on your specific plan benefits and whether you have met your deductible.

Generic Availability

Stribild is a brand-name drug that combines four active ingredients into one tablet. Currently, there is no generic version of this specific combination available. Brand-name medications typically cost more than generic alternatives.

Financial Assistance Options

Several options may help reduce the cost of Stribild for eligible patients:

• Copay Coupons: The manufacturer may offer savings cards for patients with commercial insurance to help lower monthly out-of-pocket costs.
• Patient Assistance Programs: Programs are often available for individuals who are uninsured or have limited income to help them access the medication at a lower cost.
• Pharmacy Discounts: Some pharmacies may offer different pricing or discount programs that can affect the final cost.