#Descovy

[ipconsultinggroup-1]

Gilead Sciences and U.S. Government Resolve Patent Dispute Over HIV Prevention Drugs

Gilead Sciences and the U.S. government have resolved a high-profile patent dispute over the HIV prevention drugs Truvada and Descovy. The settlement comes after Gilead's 2023 jury trial win against the government’s claims of patent infringement.

The dispute stemmed from the government's assertion that Gilead failed to compensate the CDC for its role in discovering Truvada’s potential for HIV prevention. Gilead had argued that the CDC exaggerated its contributions and improperly patented the drug's regimen without proper notice.

Gilead's General Counsel, Deborah Telman, emphasized the settlement allows the company to focus on developing innovative therapies. Meanwhile, the government had sought over $1 billion in damages, citing significant earnings from the drugs. Further details of the agreement were not disclosed.

Contact Us DC: +1 (202) 666-8377 MD: +1 (240) 477-6361 FL +1 (239) 292–6789 Website: https://www.ipconsultinggroups.com/ Mail: protect@ipconsultinggroups.com Headquarters: 9009 Shady Grove Ct. Gaithersburg, MD 20877 Branch Office: 7734 16th St, NW Washington DC 20012 Branch Office: Vanderbilt Dr, Bonita Spring, FL 34134

[angelmotifs]

these tubi ads... ENOUGH!

[reasonsforhope]

"A large clinical trial in South Africa and Uganda has shown that a twice-yearly injection of a new pre-exposure prophylaxis drug gives young women total protection from HIV infection.

The trial tested whether the six-month injection of lenacapavir would provide better protection against HIV infection than two other drugs, both daily pills. All three medications are pre-exposure prophylaxis (or PrEP) drugs.

Physician-scientist Linda-Gail Bekker, principal investigator for the South African part of the study, tells Nadine Dreyer what makes this breakthough so significant and what to expect next.

Tell us about the trial and what it set out to achieve

The Purpose 1 trial with 5,000 participants took place at three sites in Uganda and 25 sites in South Africa to test the efficacy of lenacapavir and two other drugs.

Lenacapavir (Len LA) is a fusion capside inhibitor. It interferes with the HIV capsid, a protein shell that protects HIV’s genetic material and enzymes needed for replication. It is administered just under the skin, once every six months.

The randomised controlled trial, sponsored by the drug developers Gilead Sciences, tested several things.

The first was whether a six-monthly injection of lenacapavir was safe and would provide better protection against HIV infection as PrEP for women between the ages of 16 and 25 years than Truvada F/TDF, a daily PrEP pill in wide use that has been available for more than a decade.

Secondly, the trial also tested whether Descovy F/TAF, a newer daily pill, was as effective as F/TDF...

The trial had three arms. Young women were randomly assigned to one of the arms in a 2:2:1 ratio (Len LA: F/TAF oral: F/TDF oral) in a double blinded fashion. This means neither the participants nor the researchers knew which treatment participants were receiving until the clinical trial was over.

In eastern and southern Africa, young women are the population who bear the brunt of new HIV infections. They also find a daily PrEP regimen challenging to maintain, for a number of social and structural reasons.

During the randomised phase of the trial none of the 2,134 women who received lenacapavir contracted HIV. There was 100 percent efficiency.

By comparison, 16 of the 1,068 women (or 1.5%) who took Truvada (F/TDF) and 39 of 2,136 (1.8%) who received Descovy (F/TAF) contracted the HIV virus...

What is the significance of these trials?

This breakthrough gives great hope that we have a proven, highly effective prevention tool to protect people from HIV.

There were 1.3 million new HIV infections globally in the past year. Although that’s fewer than the 2 million infections seen in 2010, it is clear that at this rate we are not going to meet the HIV new infection target that UNAIDS set for 2025 (fewer than 500,000 globally) or potentially even the goal to end Aids by 2030...

For young people, the daily decision to take a pill or use a condom or take a pill at the time of sexual intercourse can be very challenging.

HIV scientists and activists hope that young people may find that having to make this “prevention decision” only twice a year may reduce unpredictability and barriers.

For a young woman who struggles to get to an appointment at a clinic in a town or who can’t keep pills without facing stigma or violence, an injection just twice a year is the option that could keep her free of HIV.

What happens now?

The plan is that the Purpose 1 trial will go on but now in an “open label” phase. This means that study participants will be “unblinded”: they will be told whether they have been in the “injectable” or oral TDF or oral TAF groups.

They will be offered the choice of PrEP they would prefer as the trial continues.

A sister trial is also under way: Purpose 2 is being conducted in a number of regions including some sites in Africa among cisgender men, and transgender and nonbinary people who have sex with men.

It’s important to conduct trials among different groups because we have seen differences in effectiveness. Whether the sex is anal or vaginal is important and may have an impact on effectiveness.

How long until the drug is rolled out?

We have read in a Gilead Sciences press statement that within the next couple of months [from July 2024] the company will submit the dossier with all the results to a number of country regulators, particularly the Ugandan and South African regulators.

The World Health Organization will also review the data and may issue recommendations.

We hope then that this new drug will be adopted into WHO and country guidelines.

We also hope we may begin to see the drug being tested in more studies to understand better how to incorporate it into real world settings.

Price is a critical factor to ensure access and distribution in the public sector where it is badly needed.

Gilead Sciences has said it will offer licences to companies that make generic drugs, which is another critical way to get prices down.

In an ideal world, governments will be able to purchase this affordably and it will be offered to all who want it and need protection against HIV."

-via The Conversation, July 3, 2024

[transfemme-shelterdog]

Master List of Trans Male/Transmasc Privileges:

The privilege to be forcibly married off

The privilege of being raped and impregnated to "correct" their gender

The privilege of not being treated like a rational human being that knows their body by doctors

The privilege of having your existence erased

The privilege to have little to no studies about trans people involve your voice

The privilege to not have access to domestic violence shelters due to being a man (and not allowed in women's shelters) and not having many, if any shelters for men

The privilege of having your transition treated like you're becoming a violent, disgusting, monster

The privilege of having any sort of hormonal transition impossible to be done DIY due to heavy restrictions on testosterone.

The privilege of increased risk of cervical cancer due to reduced access to pap smears

The privilege of having abortion rights not apply to you

The privilege of being over twice as likely to be raped, compared to cis women (51%/21.3%)

The privilege of having almost 5x the chance of being sexually abused as a child, compared to cis women (50%:11.1%)

The privilege that when you are assaulted, to not have access to rape kits

The privilege of not being able to report a hate crime due to barriers

The privilege of experiencing isolation, rejection and distrust due to now presenting masculine

The privilege to have your pregnancy treated as some sort of sick joke

The privilege of a lack of credible research about how to provide adequate healthcare to transgender men undergoing medical transition

The privilege of not being invited for ovarian cancer screenings due to your gender being listed as M

The privilege of doctors not knowing how to check for breast cancer if you've had top surgery

The privilege of an increased risk of AIDS due to the most common PrEP meds such as Descovy not working on AFAB individuals

Others feel free to chime in! The list is ever growing

[mrsterlingeverything]

Descovy is a beautiful name for a baby whatever

[benihana-circumcision]

descovy bottles are kinda extra with the childproofing im imagining the product packaging engineers like Oh man this is dangerous if a baby got access to this it could . . .

.... NOT ... get aids

[junglejim4322]

My beautiful twins named descovy and truvada

[warningsine]

A large clinical trial in South Africa and Uganda has shown that a twice-yearly injection of a new pre-exposure prophylaxis drug gives young women total protection from HIV infection.

The trial tested whether the six-month injection of lenacapavir would provide better protection against HIV infection than two other drugs, both daily pills. All three medications are pre-exposure prophylaxis (or PrEP) drugs.

Physician-scientist Linda-Gail Bekker, principal investigator for the South African part of the study, tells Nadine Dreyer what makes this breakthough so significant and what to expect next.

Tell us about the trial and what it set out to achieve

The Purpose 1 trial with 5,000 participants took place at three sites in Uganda and 25 sites in South Africa to test the efficacy of lenacapavir and two other drugs.

Lenacapavir (Len LA) is a fusion capside inhibitor. It interferes with the HIV capsid, a protein shell that protects HIV’s genetic material and enzymes needed for replication. It is administered just under the skin, once every six months.

The randomised controlled trial, sponsored by the drug developers Gilead Sciences, tested several things.

The first was whether a six-monthly injection of lenacapavir was safe and would provide better protection against HIV infection as PrEP for women between the ages of 16 and 25 years than Truvada F/TDF, a daily PrEP pill in wide use that has been available for more than a decade.

Secondly, the trial also tested whether Descovy F/TAF, a newer daily pill, was as effective as F/TDF. The newer F/TAF has superior pharmacokinetic properties to F/TDF. Pharmacokinetic refers to the movement of a drug into, through, and out of the body. F/TAF is a smaller pill and is in use among men and transgender women in high-income countries.

The trial had three arms. Young women were randomly assigned to one of the arms in a 2:2:1 ratio (Len LA: F/TAF oral: F/TDF oral) in a double blinded fashion. This means neither the participants nor the researchers knew which treatment participants were receiving until the clinical trial was over.

In eastern and southern Africa, young women are the population who bear the brunt of new HIV infections. They also find a daily PrEP regimen challenging to maintain, for a number of social and structural reasons.

During the randomised phase of the trial none of the 2,134 women who received lenacapavir contracted HIV. There was 100 percent efficiency.

By comparison, 16 of the 1,068 women (or 1.5%) who took Truvada (F/TDF) and 39 of 2,136 (1.8%) who received Descovy (F/TAF) contracted the HIV virus.

The results at a recent independent data safety monitoring board review led to the recommendation that the trial’s “blinded” phase should be stopped and all participants should be offered a choice of PrEP.

This board is an independent committee of experts who are put in place at the start of a clinical trial. They see the unblinded data at stipulated times during the trial to monitor progress and safety. They ensure that a trial does not continue if there is harm or a clear benefit in one arm over others.

What is the significance of these trials?

This breakthrough gives great hope that we have a proven, highly effective prevention tool to protect people from HIV.

There were 1.3 million new HIV infections globally in the past year. Although that’s fewer than the 2 million infections seen in 2010, it is clear that at this rate we are not going to meet the HIV new infection target that UNAIDS set for 2025 (fewer than 500,000 globally) or potentially even the goal to end Aids by 2030.

PrEP is not the only prevention tool.

PrEP should be provided alongside HIV self-testing, access to condoms, screening and treatment for sexually transmitted infections and access to contraception for women of childbearing potential.

In addition, young men should be offered medical male circumcision for health reasons.

But despite these options, we haven’t quite got to the point where we have been able to stop new infections, particularly among young people.

For young people, the daily decision to take a pill or use a condom or take a pill at the time of sexual intercourse can be very challenging.

HIV scientists and activists hope that young people may find that having to make this “prevention decision” only twice a year may reduce unpredictability and barriers.

For a young woman who struggles to get to an appointment at a clinic in a town or who can’t keep pills without facing stigma or violence, an injection just twice a year is the option that could keep her free of HIV.

What happens now?

The plan is that the Purpose 1 trial will go on but now in an “open label” phase. This means that study participants will be “unblinded”: they will be told whether they have been in the “injectable” or oral TDF or oral TAF groups.

They will be offered the choice of PrEP they would prefer as the trial continues.

A sister trial is also under way: Purpose 2 is being conducted in a number of regions including some sites in Africa among cisgender men, and transgender and nonbinary people who have sex with men.

It’s important to conduct trials among different groups because we have seen differences in effectiveness. Whether the sex is anal or vaginal is important and may have an impact on effectiveness.

How long until the drug is rolled out?

We have read in a Gilead Sciences press statement that within the next couple of months the company will submit the dossier with all the results to a number of country regulators, particularly the Ugandan and South African regulators.

The World Health Organization will also review the data and may issue recommendations.

We hope then that this new drug will be adopted into WHO and country guidelines.

We also hope we may begin to see the drug being tested in more studies to understand better how to incorporate it into real world settings.

Price is a critical factor to ensure access and distribution in the public sector where it is badly needed.

Gilead Sciences has said it will offer licences to companies that make generic drugs, which is another critical way to get prices down.

In an ideal world, governments will be able to purchase this affordably and it will be offered to all who want it and need protection against HIV.

[woodsfae]

During the randomised phase of the trial none of the 2,134 women who received lenacapavir contracted HIV. There was 100 percent efficiency. By comparison, 16 of the 1,068 women (or 1.5%) who took Truvada (F/TDF) and 39 of 2,136 (1.8%) who received Descovy (F/TAF) contracted the HIV virus.

[log6]

anyone else feel terrible when they started descovy?

[hasdrubal-gisco]

June 20, 2024 – Gilead Sciences, Inc. today announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women. [...] PURPOSE 1, a Phase 3, double-blind, randomized study, is evaluating the safety and efficacy of twice-yearly, subcutaneous lenacapavir for pre-exposure prophylaxis (PrEP) and once-daily oral Descovy® (emtricitabine 200mg and tenofovir alafenamide 25mg; F/TAF) in more than 5,300 cisgender women and adolescent girls aged 16-25 across 25 sites in South Africa and three sites in Uganda. The drugs are being tested in parallel, with one group receiving twice-yearly lenacapavir and one group taking once-daily oral Descovy. Additionally, a third group was assigned once-daily oral Truvada. Study participants were randomized in a 2:2:1 ratio to lenacapavir, Descovy and Truvada, respectively. Because effective PrEP options already exist, there is broad consensus in the PrEP field that a placebo group would be unethical; thus, the trial used bHIV as the primary comparator and Truvada as a secondary comparator. There were 0 incident cases of HIV infection among 2,134 women in the lenacapavir group (incidence 0.00 per 100 person-years). There were 16 incident cases among 1,068 women in the Truvada group (incidence 1.69 per 100 person-years). The results demonstrated superiority of twice-yearly lenacapavir over bHIV (primary endpoint, incidence 2.41 per 100 person-years) and superiority of twice-yearly lenacapavir over once-daily Truvada (secondary endpoint), with p<0.0001 for both endpoints. In the trial, lenacapavir was generally well-tolerated and no significant or new safety concerns were identified. HIV incidence in the Descovy group was numerically similar (39 incident cases among 2,136 women, incidence 2.02 per 100 person-years) to that in the Truvada group and was not statistically superior to bHIV. Previous clinical trials among cisgender women have commonly found challenges with adherence to daily oral pills for PrEP, and adherence analyses for Descovy and Truvada from PURPOSE 1 are ongoing. In the trial, both Descovy and Truvada were generally well-tolerated and no new safety concerns were identified. 

[danielwege-blog]

Nova injeção promete prevenir infecção pelo HIV com eficácia inovadora

News https://portal.esgagenda.com/nova-injecao-promete-prevenir-infeccao-pelo-hiv-com-eficacia-inovadora/

Nova injeção promete prevenir infecção pelo HIV com eficácia inovadora

Uma nova injeção semestral chamada Yeztugo, aprovada pela FDA, promete revolucionar a prevenção do HIV. Com um custo de U$ 14.109 por dose, a injeção visa facilitar o acesso à profilaxia pré-exposição (PrEP) para pessoas em risco de infecção. O medicamento, fabricado pela Gilead Sciences, foi aprovado na quarta-feira e é destinado a adultos e adolescentes com peso mínimo de 35 kg que não estejam infectados pelo vírus.

Os especialistas destacam que Yeztugo pode ser uma alternativa para aqueles que têm dificuldade em seguir o regime de comprimidos diários, como Truvada e Descovy. Raphael J. Landovitz, diretor do Centro de Pesquisa e Educação Clínica sobre AIDS da UCLA, afirma que a injeção é uma ferramenta poderosa para a prevenção do HIV. Eileen Scully, professora da Escola de Medicina Johns Hopkins, ressalta que a conscientização sobre o novo tratamento é crucial para sua adoção.

Eficácia e Estudos Clínicos

Os dados de dois ensaios clínicos apoiaram a aprovação do medicamento. Em um estudo com mais de 5.000 mulheres na África do Sul e Uganda, nenhuma contraiu HIV após receber Yeztugo. Em outro ensaio, houve apenas duas infecções entre os que receberam a injeção, em comparação com nove infecções no grupo que tomou Truvada. Os efeitos colaterais mais comuns incluem reações no local da injeção, como dor e inchaço.

Apesar da eficácia, o alto custo da injeção levanta preocupações sobre acessibilidade. Embora a maioria dos seguros de saúde nos EUA seja obrigada a cobrir serviços de PrEP sem copagamentos, o preço elevado pode ser um obstáculo. A versão genérica do Truvada custa cerca de U$ 30 por mês, enquanto Yeztugo representa um investimento anual de aproximadamente U$ 28.218.

Desafios na Adoção

Os especialistas alertam que, apesar das inovações, a adesão à PrEP ainda é desigual. Em 2022, apenas um terço das pessoas que poderiam se beneficiar do tratamento o receberam. Grupos minoritários, como negros e hispânicos, enfrentam barreiras adicionais, incluindo falta de informação e estigma associado ao HIV. A pesquisa contínua e a educação são essenciais para aumentar a conscientização e a aceitação de novas opções de prevenção.

A introdução de Yeztugo representa um avanço significativo na luta contra o HIV, mas a questão do custo e a necessidade de uma abordagem abrangente para a saúde pública permanecem desafios a serem enfrentados.

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[thestevenwickblog]

Health News

In one of the largest healthcare fraud settlements in recent years, pharmaceutical giant Gilead Sciences, Inc. has agreed to pay $202 million to resolve allegations that it paid illegal kickbacks to doctors to boost prescriptions of its lucrative HIV medications, including Biktarvy®, Descovy®, and Genvoya®. #healthnews #DOJ #HHS #medicare #TRICARE

[drabglam]

no but rly. Why is it so hard to refill a Descovy prescription?

[benihana-circumcision]

rhe doctor wasnt lying that descovy can gastrointestinal.distress

[healthcarercmservices]

What Medications Usually Require Prior Authorization?

Prior authorization services is a process in which a healthcare provider must obtain approval from an insurance company before prescribing certain medications. This requirement ensures that the prescribed drug is medically necessary, cost-effective, and appropriate for the patient’s condition.

Practolytics, a trusted leader in healthcare RCM  and prior authorization services, helps healthcare providers streamline this process, reducing administrative burdens and improving patient access to essential medications.

Below is a detailed breakdown of the types of medications that usually require prior authorization and how Practolytics can assist providers in navigating the approval process.

Types of Medications That Usually Require Prior Authorization

1. High-Cost Brand-Name Medications

Many brand-name drugs require prior authorization due to their high cost. Insurance providers may require patients to try lower-cost generic alternatives first.

Examples include:

Humira (adalimumab) – Used for autoimmune diseases like rheumatoid arthritis.

Enbrel (etanercept) – Treats rheumatoid arthritis and psoriasis.

Xeljanz (tofacitinib) – Used for rheumatoid arthritis and ulcerative colitis.

Dupixent (dupilumab) – Treats eczema and asthma.

Ozempic (semaglutide) – A diabetes drug also used for weight management.

With Practolytics, providers can reduce PA delays by ensuring all necessary documentation is submitted correctly and promptly.

2. Specialty Medications

Specialty drugs used for chronic or complex conditions are expensive and require extensive insurance review.

Examples include:

Cancer drugs (Keytruda, Opdivo, Revlimid)

Multiple sclerosis drugs (Ocrevus, Gilenya, Tecfidera)

HIV/AIDS treatments (Biktarvy, Descovy)

Cystic fibrosis medications (Trikafta, Kalydeco)

Since specialty drugs often require additional documentation, Practolytics assists in managing these requests efficiently, minimizing treatment delays.

3. Medications With High Potential for Abuse

To prevent misuse and addiction, controlled substances often require prior authorization.

Examples include:

Opioids (OxyContin, fentanyl, hydrocodone)

ADHD medications (Adderall, Ritalin, Vyvanse)

Benzodiazepines (Xanax, Ativan, Valium)

Sleep medications (Ambien, Lunesta)

By using Practolytics’ automated PA solutions, providers can ensure compliance with regulatory guidelines while expediting approvals.

4. Medications for Off-Label Use

Insurance companies often require PA for medications prescribed outside of their FDA-approved use.

Examples include:

Methotrexate – Used off-label for autoimmune diseases.

Ketamine – Used off-label for depression and pain management.

Low-dose naltrexone (LDN) – Prescribed for fibromyalgia and multiple sclerosis.

Practolytics assists providers in submitting the necessary medical justifications to secure approvals for off-label prescriptions.

5. Cosmetic and Lifestyle Medications

Drugs used for non-medically essential purposes often require PA.

Examples include:

Hair loss treatments (Propecia, Rogaine)

Weight loss medications (Wegovy, Saxenda)

Erectile dysfunction drugs (Viagra, Cialis)

Hormone therapy (testosterone replacement)

With Practolytics, healthcare providers can navigate these approvals by ensuring proper documentation is in place.

6. Biologics and Immunotherapy Drugs

Biologic medications are highly specialized and require thorough insurance approval.

Examples include:

Monoclonal antibodies (Rituxan, Herceptin)

Interleukin inhibitors (Cosentyx, Stelara)

Checkpoint inhibitors (Keytruda, Opdivo)

Practolytics’ dedicated team ensures that PA requests for biologics are processed quickly, preventing disruptions in patient care.

7. Preventive Medications With Limited Coverage

Some preventive medications require PA based on insurance policies.

Examples include:

Shingles vaccine (Shingrix)

HPV vaccine (Gardasil)

Malaria prevention drugs (Malarone, doxycycline)

Hepatitis B treatments (Viread)

Using Practolytics, providers can secure approvals by ensuring that preventive medication requests meet insurance guidelines.

8. Fertility and Reproductive Medications

Fertility treatments often require prior authorization due to their high cost.

Examples include:

Clomid (clomiphene citrate) – Induces ovulation.

Follistim and Gonal-F – Injectable fertility drugs.

IVF-related medications (Menopur, Lupron)

Practolytics simplifies the PA process for fertility drugs, ensuring faster approval times for patients undergoing treatment.

9. Combination Medications

Combination medications often require PA because insurers may prefer patients to take individual components separately.

Examples include:

Duexis (ibuprofen + famotidine)

Treximet (sumatriptan + naproxen)

Advair, Symbicort – Combination inhalers for asthma and COPD.

With Practolytics’ expertise, providers can justify the need for combination drugs and reduce approval wait times.

10. Step Therapy or Alternative Treatment Requirements

Many insurance plans require patients to try lower-cost drugs before approving a more expensive medication.

Examples include:

Metformin before Jardiance or Trulicity (for diabetes)

SSRIs before Spravato (esketamine) for depression

Practolytics helps providers navigate step therapy protocols to ensure patients receive the most effective treatment without unnecessary delays.

How Practolytics Helps Providers Navigate the Prior Authorization Process

Prior authorization can be time-consuming, but Practolytics offers streamlined solutions to reduce administrative burdens and speed up approvals. Here’s how:

1. Automated PA Submissions

Using advanced technology, Practolytics automates prior authorization requests, minimizing manual effort.

2. Real-Time Status Tracking

Providers can track the status of PA requests in real time, ensuring timely approvals.

3. Expert Documentation and Appeals

If a request is denied, Practolytics assists with appeals, providing necessary justifications to insurance companies.

4. Compliance and Insurance Coordination

Practolytics ensures all PA requests comply with payer policies, reducing the risk of claim denials.

Final Thoughts

Prior authorization is a necessary but complex process that can delay patient care if not managed efficiently. By partnering with Practolytics, healthcare providers can streamline PA approvals, reduce paperwork, and improve patient access to essential medications.

For more information on how Practolytics can optimize your prior authorization workflow, visit their website or contact their expert team today!