Monday, March 27, 2023

Truvada For Prevention Of Hiv Infection

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Prep Prevents Hiv So Why Arent More People Taking It

Insights: Using Truvada to Prevent HIV Infection

Each year, 1.7 million people globally are newly infected with HIV more than 38,000 in the United States alone. This year, President Trump announced a 10-year initiative aimed at reducing new HIV infections in the US, and ultimately ending an epidemic that has plagued this country, and the world, since HIV first emerged in the early 1980s. A key part of that plan is pre-exposure prophylaxis or PrEP, a daily medication to help prevent HIV that is recommended for people at high risk. Recently, the FDA approved a new formulation of PrEP for many but not all of those at risk.

Not Used With Other Drugs For Hiv Prep

Truvada is used alone when its prescribed for pre-exposure prophylaxis . Its not used with other drugs.

Drinking alcohol while taking Truvada might increase your risk of some side effects, such as:

Drinking too much alcohol and taking Truvada might also increase your risk of liver or kidney problems.

If you take Truvada, talk with your doctor about whether drinking alcohol is safe for you.

What Should I Tell My Health Care Provider Before Taking Truvada

Before taking Truvada, tell your health care provider:

Before taking Truvada for HIV PrEP, you must get tested to be sure you are HIV negative. Do not take Truvada for HIV PrEP unless you are confirmed to be HIV negative.

Before taking Truvada for PrEP, also tell your health care provider:

  • If you had a flu-like illness anytime in the month before starting Truvada or if you have a flu-like illness at any time while taking Truvada. Flu-like symptoms may be a sign that you could have recently gotten HIV. The flu-like symptoms of a new HIV infection may include: tiredness, fever, nighttime sweating, rash, vomiting, diarrhea, joint or muscle aches, headache, sore throat, or enlarged lymph nodes in the neck or groin.
  • If you think that you were exposed to HIV. Your health care provider may want to do more tests to be sure you are still HIV negative.

While taking Truvada for PrEP, you will get tested for HIV at least every 3 months.

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Niaid Study First To Establish Prep Efficacy

The NIAID-supported clinical trial called iPrEx was the first to establish the effectiveness of PrEP. In 2010, this randomized controlled trial found that daily Truvada reduced the risk of acquiring HIV among nearly 2,500 men who have sex with men . Since many study participants did not take the medication daily as prescribed, the reduction in risk for the whole study population was just 44 percent. However, those men who had detectable drug in their bloodindicating that they were taking Truvada regularlyhad a 92 percent lower risk of acquiring HIV than participants who received a placebo.

Recommended Dosage For Treatment Of Hiv

First Truvada Patient Tests Positive for HIV

The recommended oral dosage of Truvada for pediatric patients weighing at least 17 kg and who can swallow a tablet is presented in Table 1. Tablets should be taken once daily with or without food. Weight should be monitored periodically and the Truvada dose adjusted accordingly.

Table 1 Dosing for Treatment of HIV-1 Infection in Pediatric Patients Weighing 17 kg to less than 35 kg

Body Weight

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How Would I Pay For Prep

Most health insurance plans, including Medicaid, cover the cost of PrEP without co-pays. This includes the medication, medical appointments and lab tests associated with PrEP. Some health insurance plans may require prior approval. For people without access to health insurance with prescription drug coverage, a number of options for financial assistance are available. If you need information about financial assistance options for PrEP, visit the NYSDOH website at:

How Is Prep Taken

PrEP is currently one tablet of Truvada daily. It can be taken with food, or between meals.There is research ongoing to look at other medications for PrEP.

Truvada contains two medications, tenofovir and emtricitabine . Truvada is only available with a prescription.

PrEP is more than simply taking HIV pills. The US Centers for Disease Control and Prevention has issued guidelines for the use of PrEP. One set of guidelines is for men who have sex with men. Another is for heterosexuals.

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Nbc Out#breakthepatent: How Hiv Activists Are Going After Gilead’s Prep Patent

Cohens clinic has been on the forefront of a nationwide effort to promote and distribute PrEP to at-risk people. The clinic operates one of San Franciscos largest PrEP programs.

Cohen said the latest patient to contract HIV while on PrEP came to the clinic consistently for regular sexually transmitted infection testing and, after months with no issues, tested positive for HIV. But the patient insisted he had taken a Truvada tablet every day, as instructed. So Cohen and her team decided to dig in.

Just scientifically, we wanted to understand, Cohen said, how can this have occurred.

Using hair and blood samples, they determined the patient had indeed been adherent to the PrEP regiment and had taken Truvada consistently for at least three months. Testing of the mans HIV strain revealed that he had contracted a rare strain that is simultaneously resistant to both ingredients in Truvada. Including his case, four of the six confirmed PrEP failures have involved rare, resistant HIV strains.

There is only one confirmed PrEP failure, involving a man from Amsterdam, in which the HIV strain contracted was not resistant to any drugs. One of the six cases is disputed the patient may have had a very recent HIV infection before starting Truvada.

In all cases of PrEP failures thus far, the patients responded quickly to HIV treatment and became HIV-undetectable shortly after switching from Truvada to new medication.

The New Formulation Of Prep

The Complete Elimination of HIV: The Truvada Revolution (Full Length)

In August, an FDA advisory panel voted 16 to 2 to recommend a new formulation of PrEP for men who have sex with men and transgender women, while voting 8 to 10 against approval in cisgender women. The panel was presented with data from a single study sponsored by Gilead, the manufacturer of the drug, which is a combination of emtricitabine and tenofovir alafenamide . This new formulation is less likely to affect the kidneys and bones, yet is just as effective as Truvada in preventing HIV.

The DISCOVER trial enrolled 5,387 participants across 92 study sites. Nearly all were cisgender men. Less than 10% of the study participants were Black. Only 74 transgender women were enrolled, and the study explicitly excluded cisgender women.

The FDA panel members acknowledged these limitations. Dr. Lindsey Baden, an infectious disease physician at Brigham and Womens Hospital and the Dana-Farber Cancer Institute, noted weve failed women, and Dr. Roblena Walker, a consumer representative on the panel, voted against approval, citing the poor representation of Black men in the study, a lost opportunity to provide substantial data reflective of the community that is impacted by HIV.

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Truvada And Other Medications

Below is a list of medications that can interact with Truvada. This list does not contain all drugs that may interact with Truvada.

Before taking Truvada, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Drugs that can interact with Truvada

Below are examples of medications that can interact with Truvada. This list doesnt contain all drugs that may interact with Truvada.

  • Drugs that affect kidney function. Truvada is removed from your body by your kidneys. Taking Truvada with other drugs that are removed by your kidneys, or drugs that can damage your kidneys, can increase Truvada levels in your body and increase your risk of side effects. Examples of drugs that are removed by your kidneys or that can damage your kidneys include:
  • Atazanavir. Taking Truvada with atazanavir , which is another HIV drug, can decrease levels of atazanavir in your body. This can make atazanavir less effective.
  • Didanosine. Taking Truvada with didanosine can increase didanosine levels in your body and increase your risk of didanosine side effects.
  • Who Should Consider Taking Pep

    If you are HIV-negative and you think you may have been recently exposed to HIV, contact your health care provider immediately or go to an emergency room right away.

    You may be prescribed PEP if you are HIV negative or don’t know your HIV status, and in the last 72 hours you:

    • Think you may have been exposed to HIV during sex,
    • Shared needles or drug preparation equipment, OR
    • Were sexually assaulted

    Your health care provider or emergency room doctor will help to decide whether PEP is right for you.

    PEP may also be given to a health care worker after a possible exposure to HIV at work, for example, from a needlestick injury.

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    An Estimated 40 Million People Are Living With Hiv Worldwide About 10 Million Of Them Do Not Have Access To Treatment

    In an email, Dr. Robert Grant, the lead investigator for the iPrEx study, called the 99 percent figure our best estimate of the H.I.V. risk reduction when men and transgender women who have sex with men use PrEP daily. Dr. Grant, a top H.I.V. researcher at the Gladstone Institutes and University of California at San Francisco, noted that lower estimates, such as the 92 percent figure, include results for people who were not taking the drug daily.

    As such, Mr. Horn prefers to point to direct study findings, such as the 92 percent figure. Dr. Buchbinder uses qualitative descriptions, such as saying PrEP is highly effective and can drastically reduce infection risk if taken daily.

    How Much Does Prep Cost

    Truvada: Everything You Should Know

    Most health insurance plans, including Medicaid, cover PrEP. Check with your insurance company to see if PrEP is covered on your plan. You might also be able to get help with other expenses, like copays, coinsurance, and deductibles, through Gilead or patient advocacy groups like the Patient Advocate Foundation.

    If you dont have health insurance, you can still get help paying for PrEP. You can apply to get free PrEP through the Ready, Set, PrEP program. Gilead also has a medication assistance program that could make PrEP free for you, depending on your income. Your doctor or nurse will need to submit an application for you to find out if you qualify.

    The staff at your nearest Planned Parenthood health center can help you apply for health insurance or assistance programs that can make PrEP affordable for you.

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    Is The Prep Medication Effective For Treating Hiv Infection

    PrEP medications are not effective alone for treating HIV infection. If you acquire HIV infection while taking PrEP, the provider who conducted the HIV test should either provide HIV medical care or refer you to a healthcare provider who can provide HIV care. The HIV care provider will conduct lab tests and determine the most effective regimen to treat your HIV infection. There is no evidence that having taken PrEP will impact the effectiveness of your HIV treatment. People who acquire HIV while on PrEP can be successfully treated with HIV medications.

    Dosage Forms And Strengths

    Truvada tablets are available in four dose strengths.

    • 100 mg/150 mg Tablets: 100 mg of emtricitabine and 150 mg of tenofovir disoproxil fumarate : blue, oval shaped, film coated, debossed with “GSI” on one side and with “703” on the other side.
    • 133 mg/200 mg Tablets: 133 mg of FTC and 200 mg of TDF : blue, rectangular shaped, film coated, debossed with “GSI” on one side and with “704” on the other side.
    • 167 mg/250 mg Tablets: 167 mg of FTC and 250 mg of TDF : blue, modified capsule shaped, film coated, debossed with “GSI” on one side and with “705” on the other side.
    • 200 mg/300 mg Tablets: 200 mg of FTC and 300 mg of TDF : blue, capsule shaped, film coated, debossed with “GILEAD” on one side and with “701” on the other side.

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    Animal Toxicology And/or Pharmacology

    Tenofovir and TDF administered in toxicology studies to rats, dogs, and monkeys at exposures greater than or equal to 6-fold those observed in humans caused bone toxicity. In monkeys the bone toxicity was diagnosed as osteomalacia. Osteomalacia observed in monkeys appeared to be reversible upon dose reduction or discontinuation of tenofovir. In rats and dogs, the bone toxicity manifested as reduced bone mineral density. The mechanism underlying bone toxicity is unknown.

    Evidence of renal toxicity was noted in four animal species. Increases in serum creatinine, BUN, glycosuria, proteinuria, phosphaturia, and/or calciuria and decreases in serum phosphate were observed to varying degrees in these animals. These toxicities were noted at exposures 2â20 times higher than those observed in humans. The relationship of the renal abnormalities, particularly the phosphaturia, to the bone toxicity is not known.

    Is Truvada The Pill To Prevent Hiv 99 Percent Effective Dont Be So Sure

    HIV Pre-exposure Prophylaxis
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    By Josh Barro

    Truvada, the once-a-day pill to help keep people from contracting H.I.V., is on the cover of this weeks New York magazine, and Tim Murphys cover story focuses on how the pill is changing sex by drastically reducing gay mens fear of infection.

    Its not hard to see why: Mr. Murphy writes, When taken every day, its been shown in a major study to be up to 99 percent effective. This is a claim I hear thrown around a lot among gay men in New York. And its wrong. The 99 percent figure isnt a study finding its a statistical estimate, based on a number of assumptions that are reasonable, but debatable.

    Heres how the estimate was reached: A major study of men who have sex with men, called iPrEx, found that H.I.V.-negative men who were prescribed daily Truvada were 44 percent less likely to contract the virus than those who were given a placebo. But a great many of the subjects did not take their prescribed medication regularly, or at all. Of 48 iPrEx subjects who were assigned to take Truvada and contracted H.I.V. anyway, just four had any detectable level of the drug in their system when they were diagnosed, indicating a 92 percent reduction in risk for people who were actually taking the medicine.

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    Alternatives For Treating Hiv

    When used to treat HIV, Truvada is combined with other HIV antiviral medications. The most common Truvada combinations are Truvada plus Isentress , and Truvada plus Tivicay . These are considered first-choice treatment options for people who are starting HIV treatment.

    Examples of other first-choice HIV drug combinations that may be used to treat HIV include:

    First-choice drugs for HIV are medications that:

    • help reduce virus levels
    • have fewer side effects than other options
    • are easy to use

    There are many other drugs and drug combinations that are used to treat HIV in certain situations, but these are typically only used when first-choice drug combinations cant be used.

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    Hiv/aids Prevention With Truvada: How Pregnant Women And Others May Benefit

    Infection with AIDS Virus Need Not Spread to Uninfected Partners

    Truvada this week became the first drug approved by the U.S. Food and Drug Administration for the prevention of HIV infection and AIDS in individuals at high risk.

    The FDA evaluation relied heavily on two large studies. One was a UCSF-led study of men and transgender women who have sex with men, which found that Truvada reduced risk of infection by 42 percent. The second, Partners PrEP, was a study in Africa of HIV transmission in heterosexual couples. Researchers found that risk was reduced by 75 percent.

    Apart from the specific populations studied in these large-scale trials, others deemed to be at high risk also can lower their chances of becoming infected. For instance, Deborah Cohan, MD, MPH, a UCSF obstetrician and gynecologist who specializes in the care of pregnant women with HIV, has been evaluating the use of Truvada in pregnant women in the U.S. who are uninfected, but whose male partners have HIV.

    Deborah Cohan, MD

    There is a growing body of evidence to suggest that pregnancy increases the risk of HIV acquisition, she said.

    Additional large studies, including FEM-PrEP and TDF2, also have shed light on Truvada use in women. The data that support its use for women are for resource-limited settings outside the U.S., Cohan said. One of the things that was clear is that adherence to the treatment is key, and that perception of risk probably drives adherence.

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