56245
Buy Biktarvy (Bictegravir/ emtricitabine/ tenofovir alafenamide) online and deliver to Australia (Sydney, Melbourne, Queensland, Perth, Brisbane)
If you are looking for a genuine original / generic Biktarvy, email us at info.bkk@pulse-clinic.com or have a chat with us on your preferred platform.
+66-84-226-2569 @442yeswp PulseClinic
Written by Dr.Deyn on 28 June 2020, last Reviewed and updated by Dr. Deyn, on 30 October 2021
The newest once-daily, all-in-one HIV combination pills can maintain undetectable viral load for two years and counting, according to a set of studies presented at ID WEEK 2018 in October 2018 in San Francisco.
Two phase 3 clinical trials showed that most people who took the Bicctegravir-based co-formulation or the doravirine-based DELSTRIGO pill for first-line therapy continued to have undetectable viral load at 96 weeks.
David Wohl of the University of North Carolina presented the latest results from a head-to-head comparison of the Biktarvy and Triumeq single-tablet regimens in 629 study participants in Europe and North America who were starting HIV treatment for the first time. The primary 48-week results were presented at the International AIDS Society Conference on HIV Science (IAS 2017) last summer.
Biktarvy contains the next-generation integrase inhibitor bictegravir, emtricitabine (FTC) and tenofovir alafenamide (TAF), a newer formulation that causes less kidney and bone toxicity than the older tenofovir disoproxil fumarate (TDF). Triumeq consists of the integrase inhibitor dolutegravir plus abacavir and lamivudine (3TC).
Most study participants (90%) were men and the median age was approximately 32 years. The median CD4 count was about 450 cells/mm3, but 10% had less than 200 cells/mm3, indicating substantial immune damage. Because they could be randomised to either regimen, they had to be HLA B*5701 negative to guard against abacavir hypersensitivity and could not have hepatitis B virus (HBV) co-infection, as Biktarvy but not Triumeq includes drugs that are active against HBV.
At 96 weeks, 87.9% of Biktarvy recipients and 89.8% of Triumeq recipients had HIV RNA below 50 copies/ml, demonstrating that Biktarvy remained non-inferior to Triumeq. The two regimens worked about equally well in people who started with high or low viral load, Wohl said. Virological failure was rare (0.6% and 2.2%, respectively) and no new resistance mutations were seen in either treatment group. Follow-up will continue to 144 weeks.
Treatment was safe and well tolerated. No one stopped treatment due to adverse events in the Biktarvy arm and five did so in the Triumeq arm. There were two deaths in the Biktarvy arm (a drug overdose and a suicide).
Drug-related adverse events were reported significantly less often in the Biktarvy group (28% vs 40%, respectively). The most common adverse events in both groups were diarrhoea, headache, nausea and upper respiratory infections. Side-effects were generally similar, except nausea was about twice as likely among those taking Triumeq (11% vs 24%).
Estimated glomerular filtration rate (eGFR), a measure of kidney function, declined by a similar amount in both arms – changes Wohl said were probably clinically irrelevant. No Biktarvy recipients developed proximal tubulopathy, a type of kidney damage sometimes associated with the older version of tenofovir. Decreases in bone density after starting treatment were small and similar in both groups. Total and LDL cholesterol levels rose significantly more in the Biktarvy arm, but only about 4% in each arm were put on lipid-lowering drugs.
"These results provide further evidence of longer-term safety, efficacy, and high barrier to resistance of [Biktarvy] in people living with HIV-1," the researchers concluded.
Biktarvy in Australia (Sydney, Melbourne, Queensland, Perth, Brisbane) costs: 5590THB/30 tablets/bottle/month
Availability: Prescription only. Contact PULSE CLINIC.
.
BIKTARVY tablets consist of the following medicines:
Bictegravir belongs to a group of antiretroviral medicines known as integrase strand transfer inhibitors (INSTI).
Emtricitabine and tenofovir alafenamide belong to a group of antiviral medicines known as nucleoside and nucleotide reverse transcriptase inhibitors (NRTI) and (NtRTI) respectively.
These are combined in one tablet to help control Human Immunodeficiency Virus 1 (HIV-1) infection in adults and children weighing at least 25 kg.
When used to treat HIV-1 infection
BIKTARVY lowers the amount of HIV in the blood (viral load). BIKTARVY may also help to increase the number of T cells (CD4+ cells), allowing your immune system to improve. Lowering the amount of HIV in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections).
HIV infection destroys CD4+ T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) may develop.
BIKTARVY is for people who do not have a HIV virus resistant to BIKTARVY.
Emtricitabine and tenofovir alafenamide are also components of DESCOVY, GENVOYA, ODEFSEY tablets. VEMLIDY tablets contain tenofovir alafenamide.
BIKTARVY is used to treat HIV-1 infection in adults and children weighing at least 25 kg.
The use of BIKTARVY in children and adolescents under 18 years of age has not yet been established.
BIKTARVY does not cure HIV infection, AIDS or HBV infection.
The long-term effects of BIKTARVY are not known at this time.
People taking BIKTARVY or any other medication for HIV may still get opportunistic infections or other conditions that happen with HIV infection.
Opportunistic infections are infections that develop because the immune system is weakened. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection.
This medicine is only available from a pharmacist after it has been prescribed by a doctor who specialises in the treatment of HIV infection.
If you wish to continue receiving treatment with BIKTARVY it is important you remain under the care of a hospital or doctor who specialises in the treatment of HIV infection.
Effective viral suppression with BIKTARVY will substantially reduce the risk of passing HIV to others. However, a residual risk cannot be excluded.
Discuss with your doctor the precautions needed to avoid infecting other people.
For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier to lower the chance of sexual contact with semen, vaginal secretions, or blood.
Never re-use or share needles.
Together with your doctor, you need to decide whether BIKTARVY is right for you.
Do not take BIKTARVY if you are allergic to:
The ingredients of BIKTARVY are listed in the product description section of this leaflet.
Do not take BIKTARVY if you are already taking any other medicines that contain the same active ingredients.
Do not take BIKTARVY if you are taking other medicines that contain:
Do not take BIKTARVY to treat your HIV infection if you are also taking dofetilide to treat heart conditions.
Do not take BIKTARVY to treat your HIV infection if you are also taking rifampicin to treat infections.
Do not take BIKTARVY to treat your HIV infection if you are also taking adefovir dipivoxil to treat your hepatitis B virus (HBV) infection.
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have, or have had, any of the following medical conditions:
Tell your doctor if you are pregnant, or likely to become pregnant during your course of medication. We do not know if BIKTARVY can harm your unborn child. You and your doctor will need to decide if BIKTARVY is right for you.
Tell your doctor if you are breastfeeding, or likely to breastfeed during your course of medication. You should not breastfeed if you are HIV-positive because of the chance of passing the HIV virus to your baby. At least one of the active substances in this medicine (emtricitabine) has been found in breast milk at low concentrations. Talk with your doctor about the best way to feed your baby.
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and BIKTARVY may interfere with each other. These include:
This is not a complete list of medicines that you should tell your doctor about.
These medicines may be affected by BIKTARVY or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
For this reason, it is very important to let your doctor or pharmacist know what medications, herbal supplements, or vitamins you are taking.
Know the medicines you take. Keep a list of medicines and show it to your doctor and pharmacist when you get a new medicine.
Do not start any new medicines while you are taking BIKTARVY without first talking with your doctor or pharmacist.
Take the exact amount of BIKTARVY your doctor has prescribed for you.
Never change the dose on your own.
Do not stop this medicine unless your healthcare provider tells you to stop.
The usual dose is one BIKTARVY tablet orally, once daily.
Take BIKTARVY with or without food.
Do not chew, crush or split the tablet.
If you are taking an antacid (such as aluminium/magnesium hydroxide), a mineral supplement or vitamin (containing calcium or iron), ulcer-healing medication (such as sucralfate), or a buffered medication (containing calcium carbonate), take BIKTARVY at least 2 hours before taking these medications.
Alternatively, you can take the medication and BIKTARVY together with food.
Do not miss a dose of BIKTARVY.
If you forget to take BIKTARVY, take your missed dose right away unless it is almost time for your next dose.
Do not take a double dose to make up for a forgotten dose. Continue with your regular dosing schedule.
When your BIKTARVY supply starts to run low, get more from your doctor or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to BIKTARVY and become harder to treat. Contact our staff scan this QR code
Immediately telephone your doctor or Poisons Information Centre: 131126 (Australia) and 0800 764 766 (New Zealand) or go to the Accident and Emergency department at your nearest hospital if you think you or anyone else may have taken too many BIKTARVY tablets. Do this even if there are no signs of discomfort or poisoning. This may need urgent medical attention.
Do not breastfeed. See “Before you start to take it”
Avoid doing things that can spread HIV infection.
Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood.
Do not take BIKTARVY after the expiry or “use by” date (EXP) printed on the bottle. If you take it after the expiry date has passed, it may not work as well.
Do not take BIKTARVY if the packaging is torn or shows signs of tampering.
Be careful driving or operating machinery until you know how BIKTARVY affects you. If you are dizzy, have trouble concentrating, or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.
Like all medicines, BIKTARVY can have side effects, although not everybody gets them. Some may be serious and need medical attention.
Check with your doctor as soon as possible if you have any problems while taking BIKTARVY, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Hepatic Flares
If you have both HIV infection and HBV infection you should not stop your BIKTARVY treatment without first discussing this with your doctor. Your HBV may get worse (flare-up) if you stop taking BIKTARVY. A “flare-up” or “hepatic flare” is when your HBV infection suddenly returns in a worse way than before. You may require medical exams and blood tests for several months after stopping treatment.
Signs and symptoms of inflammation
In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, which lets the body fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please tell your doctor immediately.
Allergy
Some people are allergic to medicines. If you have any of the following symptoms soon after taking your medicine, DO NOT TAKE ANY MORE BIKTARVY and tell your doctor IMMEDIATELY or go to the accident and emergency department at your nearest hospital:
These are very serious effects. If you have them, you may have a serious allergic reaction. You may need urgent medical attention or hospitalisation. Hypersensitivity reactions are very rare.
The most common side effects of BIKTARVY are diarrhoea and headache.
Other side effects include:
Talk to your doctor or pharmacist if you don’t understand anything in this list.
This is not a complete list of side effects possible with BIKTARVY.
Ask your doctor or pharmacist for a more complete list of side effects of BIKTARVY and all the medicines you will take.
Keep BIKTARVY tablets where children cannot reach them. A locked cupboard at least one-and-a half metres above the ground is a good place to store them.
Keep BIKTARVY tablets in a cool, dry place where it stays below 30 °C.
Do not store BIKTARVY or any other medicine in a bathroom or near a sink.
Do not leave BIKTARVY in the car or on a window sill. Heat and dampness can destroy some medicines.
Keep your BIKTARVY tablets in the bottle with the cap tightly closed until you take them. If you take BIKTARVY tablets out of their pack they may not keep well.
The 50/200/25 mg BIKTARVY tablets are capsule-shaped, purplish-brown in colour and film-coated.
Each tablet is debossed with “GSI” on one side and the number “9883” on the other side.
BIKTARVY tablets are supplied in bottles containing 30 tablets.
Each BIKTARVY tablet contains the active ingredients:
Each BIKTARVY tablet also contains the following inactive ingredients:
Film-coating
If you are looking for a genuine original / generic Biktarvy, email us at info.bkk@pulse-clinic.com or have a chat with us on your preferred platform.
+66-84-226-2569 @442yeswp PulseClinic
References:
Wohl D et al. A phase 3, randomized, controlled clinical trial of bictegravir in a fixed-dose combination, B/F/TAF, vs ABC/DTG/3TC in treatment-naïve adults at week 96. IDWeek, abstract LB4, 2018.
https://idsa.confex.com/idsa/2018/webprogram/Paper74246.html
Orkin C et al (Squires K presenting). Doravirine/lamivudine/tenofovir DF continues to be non-inferior to efavirenz/emtricitabine/tenofovir DF in treatment-naive adults with HIV-1 infection: week 96 results of the DRIVE-AHEAD trial. IDWeek, abstract LB1, 2018.
https://idsa.confex.com/idsa/2018/webprogram/Paper73851.html
Update: Following the conference presentation, this study was published in a peer-reviewed journal:
Orkin C et al. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF) Versus Efavirenz/Emtricitabine/TDF in Treatment-naive Adults With Human Immunodeficiency Virus Type 1 Infection: Week 96 Results of the Randomized, Double-blind, Phase 3 DRIVE-AHEAD Noninferiority Trial. Clinical Infectious Diseases, ciaa822, December 2020 (open access).
https://doi.org/10.1093/cid/ciaa822
Eron J et al. Efficacy and safety of switching from boosted-protease inhibitors (bPI) plus emtricitabine/tenofovir disoproxil fumarate (F/TDF) regimens to the once daily (QD), single-tablet regimen (STR) of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in virologically-suppressed, hiv-1-infected adults: week 96 results of the phase 3, randomized, non-inferiority EMERALD trial. IDWeek, abstract 1768, 2018.
https://idsa.confex.com/idsa/2018/webprogram/Paper72755.html
Chat with PULSE CLINIC ONLINE Department