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[text] => In order to avoid the “resource demands and uncertainty of a trial” Johnson & Johnson has agreed to pay counties Cuyahoga and Summit of Ohio $20.4 million to assist in opioid crisis recovery.
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[text] => With the two counties accepting settlements, Johnson & Johnson sidesteps the upcoming opioid trial that has been referred to as a bellwether for the thousands of pending opioid lawsuits. In an official statement, the pharmaceutical giant has stated openness to mass settlement while vehemently defending their practices both before and during the opioid crisis.
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[text] => Last Wednesday, the FDA approved Decsovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg), a pre-exposure prophylaxis (PrEP) medication that may prevent HIV. The drug produced by Truvada’s manufacturer, Gilead Sciences, has already been used to reduce HIV-1 viral levels for some time.
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[text] => According to Gilead’s CEO, Daniel O’Day, the addition of Descovy as an option for HIV prevention in certain populations can provide an HIV prevention drug that doesn’t have the renal or bone health risks associated with Truvada. In studies testing the efficacy of Descovy, one of the only significant adverse side effects noted was diarrhea.
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[text] => Last Friday, a jury delivered a verdict in favor of Phil and Nancy Cabibi. The judgment included $1.2 million in economic damages; $19.1 million for past and future damages, and $20 million for Phil Cabibi’s damages, which included lost marital relations, companionship, and love.
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[text] => Although Johnson & Johnson was fined by the jury, there were no punitive damages because neither the judge nor the jury believed that the company acted with malice, fraud, or negligence. Johnson & Johnson have announced immediate intent to appeal the verdict.
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[text] => The governors of Oregon and Washington state have recently urged their respective health agencies to take steps to prevent e-cigarette use after the CDC estimates a total of 800 citizens have been negatively affected by the epidemic. In Oregon, state officials have suggested a 6-month cessation of any e-cigarette products in the state. Meanwhile, Washington’s State Board of Health has announced intentions to use emergency rulemaking authority to ban all flavored vaping products, including THC products, at its next meeting on Oct 9.
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[text] => Overseas, the government of India has also issued a ban on importing vaping products last month and is now defending their actions in court. Solicitor general Aman Lekhi says the government was acting in reaction to the news of an e-cigarette epidemic. Last Monday also marked the surrender of JUUL Labs in their fight for Proposition C in San Francisco, a ballot measure aimed at overturning the city’s anti-vaping law. The e-cigarettes company announced that the move was sparked by efforts to “responsibly lead the industry.”
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[text] => New Zealand’s Breast Cancer Aotearoa Coalition chair, Dr. Libby Burgess has suggested last week that the New Zealand Health Ministry mirror Australia’s Therapeutic Goods Administration and ban eight models of breast implant that pose a health risk to women. Dr. Burgess stated that although the implants may not be used in the country, the ban could help protect women from unnecessary risk.
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[text] => Manufactured by Gilead Sciences Inc., Truvada is a prescription medication used in to reduce the risk of HIV infection in adults and adolescents who are HIV-negative and at risk of getting HIV. Truvada is also used in combination with other HIV medicines to treat HIV in adults and children to help them live longer, healthier lives and reduce the risk of transmission
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[text] => To take Truvada for PrEP, of which the dosage is one pill a day, patients must be HIV-negative and are advised to combine the medication with safe sex practices and regular testing to more effectively decrease their chances of contracting HIV. Patients should take the pill at the same time each day, not just on days they might be at risk of exposure.
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[text] => Truvada combines two HIV medicines in one pill: emtricitabine and tenofovir disoproxil fumarate, which belong to the group of HIV drugs called nucleoside reverse transcriptase inhibitors (NRTIs). They block an HIV enzyme called reverse transcriptase and prevent the disease from multiplying and can reduce the amount of HIV in the body. Research shows that proper use of Truvada can reduce the risk of infection by 92 percent and can be up to 99 percent effective when taken daily.
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[text] => In 2010, an iPrex study revealed that, overall, Truvada reduced the rate of new infections by 42 percent. In participants with monthly blood levels of the drug equal to 7 days of dosing per week, the efficacy was 99 percent, and in participants who reported taking Truvada more than 90 percent of the time, efficacy was 73 percent
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[text] => 2012 | FDA Approves Truvada
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[text] => The drug was first approved by the FDA as an HIV prevention method for adults in 2012. Truvada marks a new chapter for the LGBTQ community when it comes to safe sex and eradicating the fear surrounding HIV and AIDS. Access to and correct usage of the drug means a safer and healthier sex life for all.
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[text] => Photo by Sharon McCutcheon on Unsplash
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[text] => 2018 | FDA Expands Truvada Approval
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[text] => The FDA expanded its approval in 2018 to include at-risk adolescents weighing at least 77 pounds.
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[text] => 2018 | Lawsuits Filed for Truvada Bone Density Loss
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[text] => In May 2018, lawsuits were filed in California against Gilead, claiming the company refrained from releasing a safer HIV drug it had also been testing in the early 2000s in order to keep the multi-billion dollar patent for Truvada. The company was also accused of misinforming patients and physicians about possible side effects. Gilead continued to make money off of the drug as Truvada users suffered the consequences because they were simply unaware.
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[text] => Injury claims against Truvada include:
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[text] => As previously reported by MedTruth, Gilead was apparently aware from their own studies that Truvada was “highly toxic” and resulted in “possible fatal damage to the kidneys and bones.” In 2002 and 2003, the FDA issued warning letters to Gilead over its marketing practices for the drug stating representatives violated the law by giving doctors and patients false and misleading information regarding side effects.
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[text] => In January 2019, The New York Times reported that Massachusetts attorney general’s office filed allegations of discrimination against insurer Mutual of Omaha for denying policies to applicants, mostly gay men, who took Truvada. Some men said they even stopped taking Truvada, potentially endangering themselves, just to obtain insurance. At the same time, the company settled an LGBTQ Legal Advocates and Defenders (GLAD) lawsuit on behalf of an anonymous 61-year-old man who was allegedly one of those discriminated against for taking Truvada. The lawsuit was the first of its kind and alleged that Mutual of Omaha violated Massachusetts laws that prohibit discrimination on the basis of sexual orientation and disability.
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[text] => The company admitted no wrongdoing in the settlements but will pay $25,000 to the state and has agreed to provide insurance to people who use medication to prevent HIV infection. Per previous Medtruth reporting, the state of New York declared such insurer behavior unlawful.
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[text] => 2019 | DISCOVER Trial Results Show Similar Drug Descovy May Be Safer
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[text] => Gilead announced in March 2019 that results were in from the DISCOVER trial of Descovy, a drug similar to Truvada for PrEP. Descovy achieved a clinical profile similar to the high efficacy of Truvada but had a more favorable bone and renal safety profile, according to Gilead, who will file regulatory applications for Descovy for PrEP. In 2021, Truvada will come off patent, meaning other drugs may be produced.
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[text] => If Truvada is part of your daily routine, take the side effects seriously, as lactic acidosis and kidney failure can be life-threatening. As we near 2021 when the drug will come off patent, generic and potentially safer HIV drugs will begin to surface.
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[text] => Truvada insurance coverage is no longer denied by Massachusetts company Mutual of Omaha, though discrimination against Truvada users remains an industry-wide practice.
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[text] => On Jan. 8, in response to allegations of discrimination by the Massachusetts attorney general’s office, Mutual of Omaha insurance company agreed that it will no longer deny life, disability, accident or health insurance, including long-term care insurance, to an individual solely because the individual takes the prescription drug Truvada.
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[text] => Eighty percent of Truvada users are gay men, according to the New York Times.
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[text] => What is Truvada for HIV Prevention?
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[text] => Also known as PrEP (pre-exposure prophylaxis), Truvada is intended to prevent HIV in those who are not already infected but who are at risk of infection. Used daily, the little blue pill has been shown to be 92 to 99 percent effective at preventing the virus from taking hold in the body. First approved in 2012, Truvada is considered a significant milestone in the fight against HIV, according to the Boston Globe.
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[text] => Although the agreement is specific to Massachusetts, the company told the Boston Globe that their change in policy went into effect nationwide in July 2018. Mutual of Omaha also agreed to pay the state of Massachusetts $25,000.
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[text] => On the same day, Mutual of Omaha also announced the settlement of a LGBTQ Legal Advocates and Defenders (GLAD) lawsuit on behalf of a 61-year-old man, “John Doe,” who was allegedly denied long-term care insurance by Mutual of Omaha solely because he takes Truvada. Bennett Klein, GLAD’s AIDS law project director, represented the plaintiff in the 2014 lawsuit, the first of its kind.
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[text] => The suit alleged that Mutual of Omaha was violating Massachusetts laws that prohibit discrimination on the basis of sexual orientation and disability. GLAD argued that the company’s policies had no rational basis.
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[text] => On the one hand, Mutual of Omaha insures individuals who are at risk for HIV infection, Klein told the New York Times, because the insurer does not screen applicants for high-risk sexual behaviors. On the other hand, the insurer denies individuals who are taking a medication which is highly HIV-protective and who are thus at very low risk for infection.
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[text] => Unfortunately, Mutual of Omaha is apparently not unique in its discriminatory policies.
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[text] => Truvada, PrEP Medication for HIV, Linked to Side Effects
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[text] => Read about the potential for bone fractures and kidney issues.
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[text] => In an opinion piece in The Advocate, an LGBT-oriented publication, Klein and co-author Alex Weinstein asserted that insurance discrimination against Truvada users is an industry-wide practice.
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[text] => “Some of the largest insurance companies in the nation are engaging in this categorical exclusion of PrEP users. GLAD has heard directly about cases of discrimination by State Farm, Aetna, Metropolitan Life, John Hancock, Protective Life, Lincoln Financial, and many more,” Klein and Weinstein wrote.
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[text] => “This is an industry-wide policy and practice. Gay men can either get insurance or they can forgo taking the best biomedical HIV prevention method in the history of an epidemic that has claimed so many lives,” the authors continued.
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[text] => In 2018, the state of New York declared such insurer behavior unlawful, while officials from the state of California promised to investigate these practices, Klein told the Globe.
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[text] => Manufactured by California’s Gilead Sciences, Truvada is a combination of two drugs used to treat active HIV infection. Most health insurers and state Medicaid agencies cover the drug, which is a good thing because the list price is nearly $2,000 for a 30-day supply.
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[text] => Truvada Side Effects?
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[text] => When it comes to drug safety, government agencies offer conflicting information.
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[text] => The Center for Disease Control states on its PrEP Basics webpage that “No serious side effects have been observed, and these side effects aren’t life threatening.”
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[text] => The National Institutes of Health, on the other hand, warns users of potentially life-threatening side effects from Truvada, including liver problems and lactic acidosis (a build-up of lactic acid in the blood).
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[text] => Truvada, a popular HIV prevention medication, has been linked to issues with kidneys and bones, among other side effects.
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[text] => Pre-Exposure Prophylaxis or PrEP is taken by patients before coming into contact with HIV-1 in order to practice safe sex. TRUVADA is the actual medication taken by people, every day, to ensure safety from HIV. Patients must be HIV-negative before taking Truvada for PrEP, which is one pill a day. On top of the pill, condoms, conversations with partners, and regular testing can all decrease a person's chances of contracting HIV by 90 percent.
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[text] => In 2012, the FDA approved Truvada which includes “two medicines in one: Emtriva and Viread.” An iPrEx study found that PrEP is most effective for people who take seven pills a week, but even people who take two pills a week see 76 percent protection. For the LGBTQ community, PrEP has paved a new peace of mind when participating in responsible sex. Posters, fliers, pamphlets, commercials, etc., have all advertised PrEP as being revolutionary. And it is. Its success rate is exemplified in the numbers and people have come forward explaining that PrEP has eradicated anxieties and fears around HIV and AIDS.
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[text] => Truvada users must 1) be HIV negative; 2) take it every day, not just when you may have exposure; 3) if you do become HIV positive, you must take Truvada in combination with another drug.
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[text] => Other HIV drugs that are currently being studied for PrEP are Maraviroc, Rilpivirine, Dapivirine, and Tenofovir. In 2018, lawsuits were filed against Gilead Medicine, which focuses on antiviral drugs to treat HIV, hepatitis B, hepatitis C, and influenza. The lawsuits claimed that there is a safer HIV drug available but the drug company has refrained from releasing it in order to keep their multi-billion dollar patent. The most common side effects of PrEP drugs are headaches, stomach aches, and decreased weight. More serious issues are kidney problems, including kidney failure, too much lactic acid in the blood, serious liver problems, and bone pain, softening, and fractures.
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[text] => Almost 6,000 bone breaks have been linked to the drug. A study found that bone mineral density “declines by 2-6% in the first two years of Truvada treatment.”
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[text] => Gilead was apparently aware of the serious side effects of Truvada and tested a new formula of tenofovir alafenamide (TAF) that is not linked to the same kidney and bone risks. However, in the early 2000s, any development of this drug stopped until 2010. During this time, people were exposed to ten years of bone and kidney complications.
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[text] => The patent timespan and sales were extended and resulted in Gilead earning over 18 billion dollars in 2015. The so-called “miracle drug” has come with reparations and consequences in order to serve a long term profit.
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[text] => The company was aware from their own studies that the drug prescribed was “highly toxic” and resulted in “possible fatal damage to the kidneys and bones.” The injury claims include 1) Strict products liability—design defect and failure to warn; 2) Negligent products liability — design defect and failure to warn; 3) Breach of implied warranty, and; 4) Breach of express warranty.
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[text] => Tim Horn, MS, and deputy executive director of HIV and HCV programs at Treatment Action Group says, “When Truvada comes off patent in 2021, I think we can fully expect there to be a lot of competition,” as more generic brands will begin to surface.
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[text] => The drug company placed patients in a compromising condition. Options for many people were to participate in PrEP and reap the consequences or don’t participate and also reap health consequences as well as anxiety and stress. It is without a doubt that PrEP and the accompanying drugs are life changing — people have been relieved of any worry surrounding HIV and AIDS and can live a fulfilling and healthy sex life.
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[text] => Approximately 133 million people in the United States suffer from a chronic illness according to a report by the National Health Council. By 2020, that number is estimated to hit 157 million. Unfortunately, these large numbers don't mean chronic illness is largely understood or widely acknowledged.
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[meta_description] => Approximately 133 million people in the United States suffer from a chronic illness according to a report by the National Health Council. By 2020, that number is estimated to hit 157 million. Unfortunately, these large numbers don't mean chronic illness is largely understood or widely acknowledged.
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[text] => Approximately 133 million people in the United States suffer from a chronic illness according to a report by the National Health Council. By 2020, that number is estimated to hit 157 million.
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[text] => The council's report also noted that almost a third of the U.S. population is now living with multiple chronic conditions. Whether it's diabetes, heart disease, or depression, it isn't atypical for one chronic illness to be accompanied by another.
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[text] => Unfortunately for many sufferers, chronic illnesses are commonly left undiagnosed and untreated, sometimes significantly impacting a person's livelihood and quality of life.
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[text] => This may be attributed to the often debt-inducing costs of treatment - with treatment for heart disease, cancer, mental disorders, and pulmonary conditions topping the list as most expensive.
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[text] => The council reports that chronic illness costs impact the economy at a ringing number of $1.3 trillion a year.
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[text] => In addition to expenses, those who have chronic illnesses are often up against the challenge of living with an "invisible" affliction. Asking for help can be made harder when medical professionals and peers don't believe the sufferer's pain. Even in cases where someone struggling with chronic illness does speak up, they are often met with the disheartening phrase, "you don't look sick."
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[text] => While chronic illnesses are endured by a large number of Americans, the lack of dialogue about them continues to perpetuate social responses and financial circumstances that are ultimately detrimental to the sufferers. It's time to get informed.
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[text] => Mental Health
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[text] => Sometimes, mental health conditions may follow recent health diagnoses. They may also, however, accompany chronic illness sufferers for a sustained period of time as they cope with their condition(s).
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[text] => Managing mental obstacles can make struggling with a chronic illness even harder - with exacerbated feelings of stress, anxiety, and depression making once enjoyable activities unbearable. There may also be a a strong correlation between the incapacity of one coping with chronic illness to perform physical activities and decreased mental wellbeing.
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[text] => One of the most common mental illnesses among chronic illness sufferers is depression.
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[text] => Symptoms of depression can include: feeling empty, loss of pleasure, fatigue, trouble with concentration and memory, lack of sleep or too much sleep, thoughts of suicide, aches, headaches, and digestive problems. If symptoms last for more than a few weeks, it is best for those to seek a medical professional.
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[text] => And while the diagnosis of mental illness, like depression, can be closely linked to the diagnosis of a physical illness, the reverse is also true. Scientists still have much to learn about the complex ways that mental and physical health influence one another, but it's clear the two are greatly intertwined.
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[text] => Yana* who struggles with bipolar disorder and Poly Cystic Ovarian Syndrome said, “Being queer and being sick is exhausting.”
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[text] => Yana identifies as non-binary and says that at a young age they began to struggle with depression and anxiety. “Then my PCOS began to affect my adult life. I feel as if I’ll be sick forever,” they stated over email correspondence.
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[text] => Depression generally affects 10-25 percent of women and 5-12 percent of men. One in three who identify as LGBTQ struggle with some type of mental illness compared to one in five heterosexual people.
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[text] => According to the US Transgender Survey, 40 percent of transgender adults have attempted suicide in their life.
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[text] => “A way for me to find support is my LGBTQ community in my city. I am surrounded by peers who uplift me and who remind me that I am worthy,” explains Yana on the topic of their chronic depression.
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[text] => Lack of medical support is a huge concern for people like Yana who do not have the funds, nor the understanding, from healthcare providers that they deserve.
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[text] => “Suffering without the proper means to address my issue is always a constant worry for me. I’m always terrified that I won’t be able to treat my PCOS properly or that I’ll be diagnosed with another serious illness. It’s a cycle I can’t seem to break,” Yana adds.
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[text] => Pelvic Pain (Hernia Mesh + Transvaginal Mesh)
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[text] => Persistent pelvic pain after hernia or vaginal mesh surgery is a serious complication that is affecting people all over the world. Though mesh removal is possible, it does not always promise the cure of intense pelvic pain.
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[text] => Hernia meshes are implanted in the upper stomach, abdomen, or groin in order to support weak tissue. The mesh lowers the rate of hernias, however, it can also cause life-altering side effects. Bleeding, infections, debilitating pain, erectile dysfunction, and hernia recurrence are common side effects.
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[text] => In 2014, the U.S. Food and Drug Administration updated their warning labels on poor performance and adverse effects. Though not everyone has severe complications, the removal of a hernia mesh is recommended if any complications occur.
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[text] => In a documentary which covers the often life-altering consequences of medical devices, The Bleeding Truth, several women spoke on the suffering they endured because of side effects that followed their transvaginal mesh insertion.
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[text] => The synthetic materials in the mesh and improper placement of the device are what are thought to be causing the complications which leave patients immobile and unable to live a normal life. For the women in the documentary and countless others, the mesh has caused issues related to their sex life, physical capabilities, and mental wellbeing. To add to these afflictions, women who suffer with chronic pelvic pain often also face sexism within the medical community - often considered “hysterical or emotional” when confiding in a medical professional about pain.
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[text] => To bring light to these issues, MedTruth shared the stories of transvaginal mesh survivors for Pelvic Pain Awareness Month.
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[text] => With more than 500,00 being implanted a year after childbirth, hysterectomies, or menopause, it’s imperative that medical professionals warn women of the side effects.
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[text] => Truvada is a combination of antiviral drugs in order to treat HIV/AIDS, although it is not a cure. Combining two medicines in one pill to block the HIV enzyme and prevent "the disease from multiplying," and "reduce the amount of HIV in the body," this pill is to be taken once a day and accompanied by safe sex practices and regular testing.
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[text] => Though revolutionary, and 99 percent effective, Truvada has been linked to bone loss with nearly 6,000 bone breaks. Common side effects include: headaches, stomach aches, weight loss, jaundice, dizziness, muscle pain, abdominal pain, loss of appetite, bone pain, serious liver and kidney problems.
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[text] => The antiviral drug company, Gilead Medicine, has received numerous lawsuits as people demand a safe HIV drug that may be administered without invasive side effects. More studies and new formulas are underway to reduce kidney and bone risks associated with the drug.
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[text] => Truvada is also expensive—costing $2,000 for a 30 day supply. In addition, Mutual of Omaha, an insurance company, has a blanket policy of refusing long-term care insurance to anyone who takes Truvada, regardless of sexual orientation.
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[text] => According to Rewire News, opponents argue that because the policy disproportionately affects gay men, as 80 percent of Truvada users are gay men, the policy is a form of discrimination.
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[text] => “This is an industry-wide policy and practice. Gay men can either get insurance or they can forgo taking the best biomedical HIV prevention method in the history of an epidemic that has claimed so many lives,” wrote Ben Klein and Alex Weinstein in an Advocate article.
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[text] => What makes these chronic illnesses complicated is that they are seemingly invisible; They aren’t always apparent to the public at first glance. Physical ailments may vary from day-to-day.
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[text] => Some other “invisible illnesses” include Lyme Disease, lupus, fibromyalgia, and Crohn’s disease. The denial of these illnesses in those who suffer in silence can make coping with the illness even more challenging.
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[text] => To overcome stigmas associated with chronic illness, many turn to grassroots rallying for medical concerns that are ignored or written off as psychosomatic. Online forums have served as a huge resource for sufferers who find strength, support, understanding, and validation in having their stories heard by those who can, quite literally, feel their pain.
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[text] => Together, the advocates of these communities bring greater visibility and a voice to invisible illnesses that are too often silenced.
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[text] => As for those looking for help beyond peer-to-peer communities, it's best to keep track of symptoms and when they occur so that doctors can have a clearer insight when approached with the issues.
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[text] => *Yana has requested for her identity to remain anonymous.
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[text] => San Francisco governor Gavin Newsom signed a bill to grant California residents access to HIV-prevention drugs PrEP and PEP without the requirement of a prescription.
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[text] => With a groundbreaking stroke of his pen, California Governor Gavin Newsom signed California Senate Bill 159 into law on Monday, granting state residents access to two HIV-prevention drugs, PrEP and PEP, without the need for a physician’s prescription.
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[text] => The new law, which passed with overwhelming bipartisan support, authorizes pharmacists to dispense 30 to 60-day supplies of PrEP provided consumers have undergone an HIV test and received counseling on the effects of the medication. The law also prohibits health insurance companies from requiring prior authorizations for patients seeking insurance coverage for PrEP.
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[text] => Short for “pre-exposure prophylaxis,” PrEP refers to the name brand drug Truvada manufactured by Gilead Sciences. Clinical studies have demonstrated that PrEP is 99% effective at preventing the spread of HIV when an uninfected individual comes into contact with the HIV virus through sex or through the sharing of drug equipment such as needles.
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[text] => While the use of PrEP has increased dramatically in recent years among gay men overall, its use remains low in communities at greatest risk, particularly gay men of color and of lower income status. The hope is that passage of this bill will foster greater access to PrEP for those who face obstacles in seeing a doctor. A generic version of Truvada is expected to be made available later this year, further increasing accessibility.
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[text] => PEP, which stands for “post-exposure prophylaxis,” is a combination of antiretroviral drugs taken as an initial emergency measure within 72 hours of suspected exposure to the HIV virus and then taken once or twice daily for 28 days. Unfortunately, however, PEP is not always effective at preventing HIV infection, according to a National Institutes of Health website.
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[text] => “All Californians deserve access to PrEP and PEP, two treatments that have transformed our fight against HIV and AIDS. I applaud the Legislature for taking action to expand access to these treatments and getting us closer to ending HIV and AIDS for good,” Governor Newsom said in a statement.
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[text] => The goal of PrEP is to prevent HIV infection even if there is an accidental exposure. Tenofovir and emtricitabine are antiviral drugs that inhibit HIV’s ability to replicate and spread within the human body.
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[text] => PrEP, which stands for pre-exposure prophylaxis, is a medication regimen designed to reduce the chances of infection by the Human Immunodeficiency Virus (HIV) in at-risk patients. The most widely used PrEP medication is a combination of tenofovir disproxil fumarate (TDF) and emtricitabine. While generic versions of PrEP for HIV exist, in the United States, it is sold as "Truvada" by the pharmaceutical company Gilead Science.
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[text] => When used consistently with appropriate precautions and regular visits to a physician to test for HIV, PrEP can keep patients HIV-free for the duration of their lives.
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[text] => HIV spreads via blood, unprotected sex (vaginal, anal, and oral), or from mother to baby (pregnancy, labor, and breastfeeding). The virus cannot be spread through saliva, for instance, with kissing, but it could be spread via transmission of infected blood if there’s an open sore or cut in the mouth of an HIV-positive person or in the mouth of an HIV-negative person when they are kissing an HIV-positive person.
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[text] => Within two or four weeks of infection, a person with HIV may experience a flu-like illness that is indistinguishable from normal flu. Some people will not experience any symptoms at all. This stage is known as Acute HIV, and HIV levels will be very high as the virus spreads and infects the cells that make up the immune system. During the acute stage, a person is highly contagious.
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[text] => Following this brief period, a person with HIV will enter a longer latent period known as Chronic or Asymptomatic HIV. This chronic period can last for years or even over a decade without medications, and there might not be any symptoms or illness. HIV levels drop to very low amounts, but the virus is still active and reproducing. A person must take antiretroviral therapy (ART) during this period to keep virus levels down and reduce the chance of transmission to another person. ART can extend the chronic period for several decades.
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[text] => If a person with HIV does not maintain a consistent ART regimen, their chronic period will end and HIV levels will rise once again. This is when an HIV patient develops Acquired Immunodeficiency Syndrome (AIDS). As HIV finally overwhelms the immune system, a person with AIDS will lose the ability to fight off even minor infections. Something like normal skin bacteria, which would be harmless to a healthy person, may become lethal to a person with AIDS.
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[text] => The goal of PrEP is to prevent HIV infection even in cases of accidental exposure. Tenofovir and emtricitabine are antiviral drugs that inhibit HIV’s ability to replicate and spread within the human body. A patient at-risk for HIV infection takes PrEP daily to establish a baseline of protection that prevents HIV from gaining a foothold in the body, even if a patient is exposed to the virus.
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[text] => However, PrEP is not completely foolproof. While PrEP reduces the risk of contracting HIV from sexual activity by 99%, it does not offer any protection against other Sexually Transmitted Diseases (STDs). People using PrEP still need to utilize other methods to protect against STDs, especially regular use of condoms during sexual activity.
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[text] => People who have a partner who is HIV-positive but are considering getting pregnant can also take PrEP to prevent their baby from becoming infected with HIV.
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[text] => The CDC has provided online guidance so that those curious about whether PrEP is right for them may identify if they are at risk and whether they should consult their physician.
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[text] => Other drugs are currently under review as researchers aim to find more effective PrEP drug combinations with fewer side effects.
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[text] => Marviroc, which prevents HIV from entering and infecting cells, is being tested in combination with other PrEP drugs and as an intravaginal ring for HIV prevention.
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[text] => A combination of tenofovir alafenamide (TAF) and emtricitabine demonstrated non-inferiority to the Truvada combination, which uses TDF and emtricitabine. It was found that TAF lasted longer in the blood than TDF. While the TAF results are not definitively better than TDF, the findings show promise for longer lasting PrEP medications in the future.
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[text] => For the time being, PrEP using the TDF and emtricitabine combination remains the approved drug of choice by major public health organizations like the World Health Organization and the US Centers for Disease Control. The move towards generic versions of Truvada, which are expected to become available in September 2020, represent the next biggest hope for patients seeking vital HIV prevention methods without life-inhibiting costs, which can be thousands of dollars.
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[text] => For pharmaceutical companies, it takes billions of dollars to develop a new medication, along with years of research and revisions to achieve regulatory approval. Drug manufacturers want to maintain the profits and rights to their flagship medications, attempting to protect profits, patent products and block less expensive generic versions.
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[text] => That’s one of the reasons Americans pay the most for prescription drugs in the world.
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[text] => Congress passed a law requiring drug companies to provide samples of their products, which would allow for the development of generic equivalents. This intention is to increase competition and ultimately lower drug prices.
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[text] => Samples are required for bioequivalence testing, which is necessary for a generic drug to be approved. By refusing to provide samples, the companies are delaying the formulation and availability of cheaper options.
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[text] => Which companies are blocking generic drugs?
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[text] => The U.S. Food and Drug Administration (FDA) has publicly released a list of companies that may be intentionally delaying generic drugs. As part of the FDA’s Drug Competition Action Plan (DCAP) to support government efforts for affordable medications, the agency is focusing on transparency.
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[text] => The FDA has received more than 150 inquiries from generic drug makers looking to access samples from manufacturers. Some companies that have yet to comply include GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, BioMarin Pharmaceutical, Gilead Sciences and Novartis Pharmaceuticals.
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[text] => What drugs are being blocked from generic development?
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[text] => Many of the drugs manufactured by these companies are necessary or life-saving medications. One medication, Revlimid (lenalidomide), which treats multiple myeloma and other related diseases, currently costs $20,000 a month. Tracleer (bosentan), which is used to treat pulmonary arterial hypertension, costs $12,000 a month, according to GoodRx.
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[text] => Other drugs include Truvada, the blockbuster medication used to prevent HIV infection, and Clozaril, which is used to treat schizophrenia and suicidal thinking. Also listed is Accutane, a treatment for severe cystic acne.
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[text] => To urge compliance from manufacturers, the FDA has listed the companies who have yet to provide samples for generics:
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James Parker · October 7, 2019
Johnson & Johnson sidesteps opioid trials, agreeing to a settlement of $20.4 million for affected counties in Ohio. Meanwhile, Descovy has been approved by FDA for HIV prevention, a court verdict falls in favor of California couple affected by J& J talc powder, and more bans are proposed on e-cigarattes and breast implants.
NewsCarah Wertheimer · February 12, 2019
Truvada insurance coverage is no longer denied by Massachusetts company Mutual of Omaha, though discrimination against Truvada users remains an industry-wide practice.
News