BICTEGRAVIR, EMTRICITABINE & TENOFOVIR ALAFENAMIDE (50 mg/200 mg/25 mg)
Product Code: PR02193021
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
What Is This Drug?
It is an oral tablet containing a combination of three drugs for the treatment of human immunodeficiency virus type-1 (HIV-1) infection in adults. It can either be used in individuals with no history of any anti-retroviral therapy or to change the current treatment regimen in virologically suppressed individuals on stable antiretroviral therapy for a minimum of three months with no history of resistance to any of the drugs in It or treatment failure due to any of the drugs in It. The active ingredients of It are bictegravir, emtricitabine, and tenofovir alafenamide. 
Classification and Mechanism of Action
Bictegravir: The enzyme HIV-1 integrase in the HIV-1 virus is necessary for the replication of the virus. The integrase inhibitor, bictegravir, inhibits HIV-1 integrase and prevents the replication of viral DNA. 
Emtricitabine: This is a reverse transcriptase inhibitor. The cellular enzymes in your body convert emtricitabine to emtricitabine‑5'‑phosphate. It incorporates itself in the viral DNA and causes chain growth termination. 
Tenofovir alafenamide: This HIV-1 reverse transcriptase inhibitor gets converted to tenofovir diphosphate inside the body through a series of steps. Tenofovir diphosphate incorporates itself into the DNA of the virus through an enzyme known as HIV reverse transcriptase and inhibits the replication of the HIV-1 virus. This leads to the DNA chain termination in the virus. 
Looking After Your Drug
Store the drug in a cool place. Protect it from moisture, direct sunlight, and heat. Do not freeze. Keep it away from children. Store below 30°C. Close the container tightly after use. 
Dosage Form And Strength
It is available in the tablet form, which contains 50 mg bictegravir, equivalent to 52.5 mg of bictegravir sodium, 200 mg emtricitabine, and 25 mg of tenofovir alafenamide (which is equivalent to 28 mg of tenofovir alafenamide fumarate). 
One It tablet should be taken by mouth once a day, with or without food. There should be a gap of 24 hours between two consecutive doses. Take It tablet as directed by the physician. Do not take more or fewer doses of It than prescribed by your doctor. 
How to Take the Medication?
This drug should only be taken if prescribed by a registered medical practitioner. It should be taken with water, before or after meals. It must not be used in individuals under 18 years of age as the safety and effectiveness in this population is not established. [1, 2]
The data regarding overdose of It is not available. If overdose occurs, seek medical help and evaluate the individual for signs of toxicity. The treatment of It overdose includes supportive treatment and clinical monitoring. The exact treatment for overdose depends on the clinical status of the patient. Hemodialysis treatment helps in the elimination of about 30% of emtricitabine in a 3‑hour dialysis period. Emtricitabine removal by peritoneal dialysis has not been studied. Tenofovir can also be removed by means of hemodialysis. 
Warnings and Precautions
It should be avoided in pregnant women and breastfeeding mothers. It should not be used in people with severe hepatic or renal impairment. It must be avoided in individuals with hepatitis B infection. It must be avoided in individuals below 18 years of age as no data is available on the effects of the drug on that age group. It must also be avoided in the elderly above 65 years of age as not enough data is available about the safety and efficacy of the drug in this age group. Do not use any other medication in combination with It without consulting your doctor. 
Possible Side Effects
It is an oral therapy for the treatment of HIV-1 infection in adults. Before using It, individuals should consult a physician.  Some of the side effects that can be experienced by the individual on It therapy are: 
- New kidney problems or worsening of existing kidney problems: Your doctor will recommend urine and blood examinations to check the functioning of your kidney. The tests will be needed in the beginning as well as during the entire therapy period.
- Modifications in your immune response: Your immune system may get stronger with It therapy, and your body may start fighting against the hidden infections in your body. Inform the doctor if you experience new signs and symptoms after the initiation of It therapy.
- High amount of lactic acid in the blood: Also called lactic acidosis, this is a serious and rare condition that may even lead to death. Symptoms such as fatigue, difficulty breathing, muscle pain, stomach pain, tiredness, dizziness, cold hands and feet, abnormal and increased heart rate can be seen with lactic acidosis.
- Severe problems in the liver: Liver problems may lead to death; hence you should consult your physician immediately if you observe dark colored urine, yellowing of the eyes, light-colored stools, nausea, loss of appetite for several days, and stomach pain.
Consult a physician if any of the side effects of It are observed. The other commonly occurring side effects of It are nausea, headache, and diarrhea. 
When the Drug Should Not Be Used?
Before beginning the therapy, the medical history of the patient should be studied thoroughly. The doctor must be informed regarding any liver or kidney conditions, hepatitis B infection, current or future pregnancy plans, and breastfeeding. The doctor must also be informed about prescription or over-the-counter medicines including herbal or nutritional supplements taken by the individual. 
- Highlights of prescribing information [Internet] [Updated Feb 2018]. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210251s000lbl.pdf. Accessed on Oct 16, 2018.
- Bictegravir/emtricitabine/tenofovir AF (Rx) [Internet]. Available at: https://reference.medscape.com/drug/It-bictegravir-emtricitabine-tenofovir-af-1000199. Accessed on Oct 16, 2018.