#bictegravir emtricitabine tenofovir alafenamide

[mollyleonaa]

Biktarvy - Bictegravir-Tenofovir alafenamide-Emtricitabine

[mcatmemoranda]

Gonorrhea: ceftriaxone 500 mg IM

Chlamydia: doxycycline 100 mg bid x7 days (do a pregnancy test first); alternative: azithromycin 1g x1

Syphilis: penicillin

Trichomonas: metronidazole 500 mg bid x7 days (intravaginal metronidazole is not effective); males: single dose oral metronidazole or tinidazole 2g

HIV/AIDS complications: CMV, MAC, PCP

HIV tx: dual NRTI + 3rd agent from a different class (INSTI, PI); dulategravir + tenofovir and either emtricitabine or lamivudine

Biktarvy = Bictegravir-tenofovir alafenamide-emtricitabine

Ritonavir-boosted darunavir + tenofovir and either emtricitabine or lamivudine

PrEP: tenofovir disoproxil fumarate-emtricitabine 300-200 mg qd (Truvada); tenofovir-emtricitabine 25-200 mg (Descovy).

On demand 2-1-1 dosing: loading dose of TDF-FTC 2 tabs 2-24 hours before sexual activity, one tab 24 hours later, one tab 48 hours later (reduces transmission by 86%)

Long-acting cabotegravir is an integrase inhibitor that can be injected q8 weeks

Before starting PrEP: HIV test, BMP, other STIs, HCV/HBV

Contraindications to PrEP: HBV/HCV, CrCl< 60%

Post exposure prophylaxis: TDF-emtricitabine + integrase inhibitor (dolutegravir 50 mg) x28 days; should be started within 72 hours of exposure

Granite State PrEP Connect: resource for pts and providers

[pozmagazine]

Health Canada has approved Gilead Sciences’ new integrase-inhibitor-based single-tablet antiretroviral regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) for the treatment of HIV among those who lack viral mutations associated with resistance to any of the three medications included in the tablet.

The bictegravir component of the tablet is an integrase inhibitor while the components of Descovy (emtricitabine/tenofovir alafenamide) serve as a nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) backbone in Biktarvy.

[healthcare-market]

Antiviral Combination Therapies Market : Global Market Revenue and Share by Manufacturers

Antiviral Combination Therapies Market: Introduction

According to the report, the global antiviral combination therapies market was valued at US$ 40.4 Bn in 2019 and is projected to expand at a high CAGR from 2020 to 2030. Antiviral combination therapies are drugs developed using a combination of two or more drugs for the treatment of various viral diseases, including chronic hepatitis B, hepatitis C, and HIV. Combination antiretroviral therapy aids in stopping the virus from making multiple copies of itself in the body.     The growth of the global antiviral combination therapies market can be attributed to the increase in investment in research & development for the development of combination medications that aid in fighting antiviral resistance, surge in demand for antiviral combinations for the treatment of HIV, rise in prevalence of viral diseases, and increase in focus on the development of vaccines for fighting the pandemic of COVID-19.

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North America dominated the global antiviral combination therapies market in terms of revenue in 2019 and the trend is anticipated to continue during the forecast period. The market in the region is expected to expand at a high CAGR from 2020 to 2030. The growth of the market in North America can be attributed to rise in prevalence of HIV and hepatitis infections among people. Additionally, strong sales of branded drugs for the treatment of HIV contributed to the high revenue generated from the region in 2019. Furthermore, patent protection of the drugs is likely to contribute to the growth of the market during the forecast period.

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Product Approvals Received by Companies Boost Market Growth

Leading players, such as Celltrion and Gilead, focus on enhancing their market presence through product approvals. This, in turn, will enable them to cater to the rise in demand and consolidate their positions in the antiviral combination therapies market. In September 2019, Celltrion received the U.S. FDA approval for its Temixys, a once-daily combination of two nucleoside reverse transcriptase inhibitors, for the treatment of HIV. In March 2019, Gilead received approval for its Biktarvy (Bictegravir, Emtricitabine and Tenofovir Alafenamide) for the treatment of HIV-1 infection from the Japanese Ministry of Health, Labour and Welfare (MHLW).

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Integrase Inhibitor/NRTI Drug Combination Dominated Global Market

In terms of drug combination, the integrase inhibitor/NRTI segment is projected to account for a major share of the global antiviral combination therapies market during the forecast period. This can be attributed to increase in usage of this drug combination in the treatment of HIV. Additionally, patent exclusivity of these drugs drives the segment.

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Antiviral Combination Therapies Market: Prominent Regions

The global antiviral combination therapies market has been segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global antiviral combination therapies market in 2019. The U.S. was a major market for antiviral combination therapies in the region in 2019. The expansion of the market in the country can be attributed to the presence of leading players, rise in usage of antiviral combination therapies for treating viral diseases, strong pipeline of drugs, and increase in research on the development of antiviral combination drugs for treatment of COVID-19.

The antiviral combination therapies market in Asia Pacific is expected to expand at a high CAGR from 2020 to 2030 driven by developing countries such as China and India. The growth of the market in the region can be attributed to rise in prevalence of HIV in India and other countries in Asia. Additionally, increase in trials on combining antiviral drugs with HIV drugs for the treatment of patients with COVID-19 contributes to the growth of the market in the region.

Focus on Strategic Acquisitions and Partnerships by Key Players to Propel Global Market

The global antiviral combination therapies market is fragmented in terms of number of players. Key players operating in the global antiviral combination therapies market are Celltrion, Inc., GlaxoSmithKline plc, Gilead Sciences, Inc., AbbVie, Inc., Bristol-Myers Squibb Company, Janssen Global Services, LLC (pharmaceutical companies of Johnson & Johnson), Cipla, Inc., Mylan N.V., Merck & Co., Inc., and F. Hoffmann-La Roche Ltd.

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[pharmaphorumuk]

ViiV gets FDA nod for Rukobia drug for older HIV patients

The FDA has approved Rukobia, a first-in-class drug from ViiV Healthcare intended for older people with HIV, who have been on antiretroviral therapy (ART) for so long it is starting to fail.

When the HIV epidemic started more than 30 years ago, patients could only expect to live for one to two years from diagnosis but the introduction of increasingly effective combination ART regimens has since restored the life expectancy of people with HIV to near normal levels.

The trouble is, there is an increasing population of people with HIV who have been on ART for so long that it is starting to lose its efficacy. In fact, more than a third (36%) of the US HIV-positive population – some 400,000 people – were aged over 55 in 2018.

HIV specialist ViiV – which is majority-owned by GlaxoSmithKline – has claimed approval from the US regulator for Rukobia (fostemsavir) as a rescue therapy for heavily pre-treated adults in whom the virus has developed resistance to multiple ARTs.

The clearance is based on the phase 3 BRIGHTE study, which showed that fostemsavir was significantly better than placebo when added on to current therapy at reducing viral load in this hard-to-treat patient population. 

Rukobia is the lead drug in a new class of HIV attachment inhibitors, which bind to a glycoprotein (gp120) on the envelope of HIV and prevent the virus binding to host cells. Its mechanism of action means there is no cross-resistance to other classes of anti-retroviral drugs, according to ViiV.

The drugmaker estimates that around 6% of all adults with HIV in the US have been heavily pre-treated and so are at greater risk of progressing to AIDS.

That’s a relatively small but growing group of patients, and analysts have predicted that sales of Rukobia will be modest at around $400 million, much smaller than ViiV’s other new products – like Juluca (dolutegravir/rilpivirine) and Dovato (dolutegravir/lamivudine) – which some analysts think could garner $1 billion-plus revenues.

Nevertheless, it’s another addition to ViiV’s product range as it tries to wrest market share from Gilead Sciences, its arch-rival in the HIV market.

Gilead has been growing at a phenomenal rate thanks to new drugs like triple therapy Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). Meanwhile, ViiV has been trying to convince doctors that its two-drug regimens are safer and more cost-effective, although at the moment Gilead seems to be in the ascendency.

Sales of Biktarvy more than doubled in the first quarter of this year to $1.7 billion, while during the same period Juluca grew 71% to $150 million and Dovato added another $82 million.

ViiV suffered a setback in its HIV franchise at the end of 2019 however when the FDA rejected its once-monthly injectable Cabenuva (cabotegravir/rilpivirine), after finding fault with manufacturing data for the drug. Fostemsavir has also been submitted for approval in other markets, including Europe.

The post ViiV gets FDA nod for Rukobia drug for older HIV patients appeared first on .

from https://pharmaphorum.com/news/viiv-gets-fda-nod-for-rukobia-drug-for-older-hiv-patients/

[emedkitmedicine]

[hivforum]

sorry Dr I need new glasses. I actually meant study 1489. Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults and I do agree with you I wish I could switch Drs but sort of stuck in a study for now.

In amendment 2 the duration of the 1489 study was extended from 96 to 144 weeks.  

It’s concerning that you don’t feel like you know this information. The doctor or study coordinator should be going over the consent forms with you very carefully. For reconsents (amendments) you should be made aware of what’s new in the protocol.  

You’re never “stuck” in a study. As the consent form says, you can drop out of a study at any time or for any reason. Of course we prefer that you remain in a study for the duration because it makes the study stronger, but it’s not an obligation.

[mikemortgage]

Ontario Provides Access to Biktarvy® for the Treatment of HIV

MISSISSAUGA, Ontario -- Gilead Sciences Canada, Inc. (Gilead Canada) today announced that effective July 31, the Ontario Drug Benefit Program will provide eligible patients with access to Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) tablets, a once-daily single tablet and complete regimen for the treatment of HIV-1 infection in adults. Health Canada granted a Notice of Compliance for BIKTARVY in July 2018. Read More from Financial Post https://ift.tt/2OKI7Ia via IFTTT Blogger Mortgage Tumblr Mortgage Evernote Mortgage Wordpress Mortgage href="https://www.diigo.com/user/gelsi11">Diigo Mortgage

[siglerprescriptiondrugcards]

Bictegravir, emtricitabine, and tenofovir alafenamide

Brand Name: Biktarvy.

Common Dosage Forms:

Tablets: Each tablet contains 50 mg of bictegravir, 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide.

FDA Indications/Dosages:

For the treatment of HIV-1 infection in adults with no history of antiretroviral treatment or to replace their current regimen in those who are virologically-suppressed on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to any component of Biktarvy: One tablet daily with or without food.

Monitor: CrCl, urine glucose, urine protein, BMD, LFT, CD4+ cell count.

Pharmacology/Pharmacokinetics: Biktarvy is a fixed dose combination of the antiviral drugs bictegravir, emtricitabine, and tenofovir alafenamide. Bictegravir inhibits the strand transfer activity of HIV-1 DNA into host genomic DNA. This inhibition blocks the formation of the HIV-1 provirus and propagation of the viral infection. Emtricitabine undergoes phosphorylation by cellular enzymes to form emtricitabine 5′-triphosphate. This metabolite inhibits the activity of HIV-1 RT by competing with the natural substrate deoxycytidine 5′ triphosphate.Incorporation of emtricitabine 5′-triphosphate into the viral DNA results in chain termination. Tenofovir alafenamide is the phosphoramidate prodrug of tenofovir. Tenofovir is metabolized to the active metabolite tenofovir diphosphate when it inhibits the activity of HIV-1 RT by competing with deoxyadenosine 5′-triphosphate for incorporation into DNA. It ultimately causes chain termination. Peak plasma levels in the fasted state are different for each ingredient and range from 1 to 4 hours. Tenofovir and emtricitabine are primarily excreted as unchanged drug in the urine. Bictegravir is metabolized primarily via the CYP3A isoenzyme.

Drug Interactions: Antacids, calcium or iron supplements, CARBAMAZEPINE, RIFAMPIN, or PHENOBARBITAL may decrease bictegravir concentrations. May increase concentrations of DOFETILIDE. Drugs that reduce kidney function or compete with active tubular secretion may increase concentrations of emtricitabine and tenofovir. ST. JOHN’S WORT may decrease concentrations. May increase the concentrations of metformin.

Contraindicated/Precautions: Coadministration is contraindicated with dofetilide or rifampin. Severe acute exacerbations of hepatitis B may occur therefore patients should be tested for hepatitis B before initiating treatment. Not recommended in patients with CrCl below 30 mL/min. Monitor renal function throughout therapy. Use is not recommended in patients with severe hepatic impairment. Avoid use with other antiviral medications. May decrease bone mineral density therefore monitoring is suggested.Cases of lactic acidosis and severe hepatomegaly have occurred in patients taking tenofovir with other antiretrovirals.

Adverse Effects: The most common adverse effects are diarrhea, nausea, fatigue, headache, dizziness, insomnia, and abnormal dreams. Rare but potentially severe adverse effects include lactic acidosis, severe hepatomegaly, hepatitis B exacerbations, renal impairment, and decreased bone mineral density.

Patient Consultation:

May be taken without regard to meals.

If you miss a dose, take it as soon as you remember. If it is close to the time of your next dose, skip the missed dose and carry on with your normal dosing schedule. Do not double doses.

Call your healthcare provider if you experience any symptoms of lactic acidosis (very weak, unusual muscle pain, breathing trouble, stomach pain with nausea or vomiting, fast or irregular heartbeat, dizziness, coldness in extremities).

Call your healthcare provider if you experience any symptoms of liver dysfunction (yellow eyes or skin, dark urine, light colored stools, anorexia, stomach pain or nausea).

This medication does not prevent you from transmitting HIv-1 to other people. Do not share needles, personal items that have blood or body fluids on them, and use barrier protection (condom) during sex.

Do not take St. John’s Wort with this medication.

[pozmagazine]

The once-daily regimen includes the integrase inhibitor bictegravir plus the contents of Descovy (emtricitabine/tenofovir alafenamide). Epzicom

[daniablub]

Bictegravir-Based Regimen Noninferior to Dolutegravir-Based Regimens for HIV Treatment

A single-tablet regimen of bictegravir, emtricitabine and tenofovir alafenamide is noninferior to regimens of dolutegravir coformulated with emtricitabine and tenofovir alafenamide or with abacavir and lamivudine for the initial treatment of HIV-1 infection, according to results from two randomized phase 3 trials. Reuters Health Information from Medscape Medical News Headlines https://wb.md/2F0hwQa via IFTTT

[inpatientdrugrehabohio]

Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-infe… https://t.co/kk4b0dc7J1

Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-infe… https://t.co/kk4b0dc7J1

— IDRO (@IDROOhio) May 6, 2019

from Twitter https://twitter.com/IDROOhio May 05, 2019 at 10:04PM http://twitter.com/IDROOhio/status/1125295132566331392

[pharmamktnet]

Gilead Presents Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) in Virologically Suppressed Adults, Including Those With Pre-Existing NRTI Resistance

Gilead Presents Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) in Virologically Suppressed Adults, Including Those With Pre-Existing NRTI Resistance

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) today announced data from two studies evaluating the resistance profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, BIC/FTC/TAF) in virologically suppressed adults switching from dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) or a boosted protease inhibitor (PI)-based regimen for…

[pharmaphorumuk]

ViiV’s two-drug HIV therapy Dovato gets Japanese approval

One of ViiV Healthcare’s two-drug HIV therapies – Dovato – has been approved in Japan, providing a new treatment option for the country’s 30,000 or so people with HIV.

Dovato (dolutegravir/lamivudine), a once-daily, single-pill antiretroviral therapy (ART), has been cleared by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40kg.

The drug – which is already available in the US and Europe – is one of a clutch of two-drug HIV therapies that ViiV is counting on to try to wrest market share from Gilead Sciences, which currently dominates HIV treatment with a share of around 73%, compared to ViiV’s 16%, according to Credit Suisse figures.

The Japanese approval is backed up by data from two trials, GEMINI 1 and 2, which involved 1,400 HIV-infected people worldwide.

The studies showed that Dovato was as effective as a combination of ViiV’s integrase inhibitor dolutegravir plus Gilead’s two-drug combination therapy Truvada (emtricitabine/tenofovir disoproxil fumarate) at suppressing HIV levels in previously-untreated patients.

Dolutegravir is the active ingredient in ViiV’s already-marketed HIV drug Tivicay, and is usually taken in combination with another “backbone” pill like Truvada.

Dovato does away with the need for two pills, and using only two active ingredients could also help to limit side effects, according to ViiV, which is majority owned by GlaxoSmithKline.

HIV medicines have for years been based on three-drug regimens based on an integrase inhibitor such as dolutegravir, and two nucleoside reverse transcriptase inhibitors (NRTIs).

The challenge for Dovato – as well as ViiV’s other two-drug HIV therapies like Juluca (dolutegravir/rilpivirine) – is to supplant Gilead’s newer HIV drug Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), which has emerged as the dominant triple regimen.

Biktarvy is leading the charge in Gilead’s HIV franchise, with sales approaching $3.2 billion in the first nine months of 2019, although analysts have suggested a lot of the gains have come from patients switching for Gilead’s older HIV therapies.

The Japanese approval of Dovato is a boost to those ambitions, although ViiV still has a long way to go with its new drugs – combined sales of Dovato and Juluca were around $260 million in the first nine months of 2019.

“In Japan, the standard of care for treatment-naïve people living with HIV has been for many years with a three-drug regimen,” commented Dustin Haines, ViiV’s Japanese head, who says the GEMINI data has challenged this approach.

“With the authorisation of Dovato, people living with HIV in Japan can – for the first time – start treatment on a once-daily, single-pill, two-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen,” he added.

ViiV suffered a setback last month when the FDA rejected its once-monthly injectable Cabenuva (cabotegravir/rilpivirine) – another highly-touted new product – after finding fault with manufacturing data for the drug.

The post ViiV’s two-drug HIV therapy Dovato gets Japanese approval appeared first on .

from https://pharmaphorum.com/news/viivs-two-drug-hiv-therapy-dovato-gets-japanese-approval/