6 Jan 2012 10:45 AM EST

-by Molly C. Braswell, Staff Writer; Image: Bryan Fischer (Image Source: Queerty)

The Focal Point host, Director of Issues Analysis for the American Family Association and conservative extremist Bryan Fischer said on his show that the Human Immunodeficiency Virus (HIV) is not the source of causing the Acquired Immune Deficiency Syndrome (AIDS).

“The reason that HIV was invented as the cause of AIDS was a way to get research money,” Fischer said. “That’s how you get big bucks. That’s how you get research grants to fund your laboratories and your research. if AIDS is caused by behavior, then there’s no money in that because you just tell people, ‘Hey, stop doing the behavior.’”

Fischer interviewed (via telephone) Peter H. Duesberg, Ph. D., of the University of California, Berkley, on his show Tuesday. Duesberg is the author of the book Inventing the AIDS Virus. He claims that recreational drug use by the homosexual male population is the cause of most AIDS symptoms.

“what I know as AIDS is what, like, abnormal diseases pneumonia, diarrhea and dementia in 20 to 30-year-old men and women in the U.S., in Europe, in Asia and even a few that fit that definition in Africa use recreational drugs like cocaine, heroin, amphetamines,” Duesberg said. “in the U.S., the CDC (Center for Disease Control and Prevention) even reports that intravenous drug use is half of all AIDS patients. The rest of the other half is male homosexuals… but it’s the ones who have… hundreds, thousands of sexual contacts in a short period of time.”

Fischer cited basketball star Magic Johnson as a prime example that HIV does not cause AIDS. He noted that Johnson has been living with the syndrome for more than 20 years after his diagnosis was “confirmed.”

Duesberg also mentioned on the program that he wasn’t talking about “you’re all-American male homosexuals from next door.”

Follow Molly on Twitter @Molly_AMNY

Press Release Source: Tibotec Therapeutics on Monday December 13, 2010, 6:37 pm EST

TITUSVILLE, N.J., Dec. 13, 2010 /PRNewswire/ — Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., announced today that the U.S. Food and Drug Administration (FDA) has approved a revision to the dosing recommendation to include once-daily dosing of PREZISTA® (darunavir) tablets in combination with ritonavir for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adult patients with no darunavir resistance-associated mutations (DRV RAMs).(1)  

The revised dosing recommendation extends the same dosing already approved for treatment-naive patients – PREZISTA, co-administered with ritonavir (in combination with other antiretroviral agents and with food, once-daily (800/100 mg) – to treatment-experienced patients with no DRV RAMs. the previously approved dosing recommendation for PREZISTA/ritonavir in treatment-experienced patients (patients who have taken HIV medications in the past) was PREZISTA/ritonavir 600/100 mg twice daily.  

For antiretroviral treatment-experienced patients, genotypic testing is recommended. However, when genotypic testing is not feasible, PREZISTA/ritonavir 600/100 mg twice daily dosing is recommended.

The approval of this revision is based on 48-week data from the ODIN (Once-daily Darunavir In treatment-experieNced patients) study. ODIN evaluated the efficacy and safety of PREZISTA/ritonavir once daily vs. PREZISTA/ritonavir twice daily for the treatment of HIV-1 in treatment-experienced adult patients with no DRV RAMs (i.e., V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, or L89V).

“With this once-daily dosing recommendation, boosted PREZISTA is now a viable option for more treatment-experienced patients,” said Glenn Mattes, president, Tibotec Therapeutics. “This approval reflects Tibotec’s ongoing commitment to optimizing dosing strategies for HIV patients.”  

Data from the Phase 3b ODIN study were presented earlier this year at CROI 2010, the 17th Conference on Retroviruses and Opportunistic Infections, in San Francisco. the study achieved its primary objective of demonstrating non-inferiority of PREZISTA/ritonavir once daily compared with twice daily.

PREZISTA Indication: Adults

PREZISTA, co-administered with ritonavir and with other antiretroviral agents, is indicated for the treatment of HIV-1 infection.

This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from two controlled, Phase 3 trials of 48 weeks duration in antiretroviral treatment-naïve and treatment-experienced patients, and two controlled, Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients.

In treatment-experienced adult patients, the following points should be considered when initiating therapy with PREZISTA/ritonavir:

• Treatment history and, when available, genotypic or phenotypic testing, should guide the use of PREZISTA/ritonavir.

• The use of other active agents with PREZISTA/ritonavir is associated with a greater likelihood of treatment response.

About the ODIN Study

ODIN is a Phase 3b, randomized, open-label study that compared the efficacy, safety, and tolerability of PREZISTA/ritonavir 800/100 mg once daily versus PREZISTA/ritonavir 600/100 mg twice daily at week 48 in 590 treatment-experienced HIV-1-infected adult patients with no DRV RAMs (V11I, V32I, L33F, I47V, I50V, I54L/M, T74P, L76V, I84V, L89V). Patients had HIV-1 RNA greater than 1,000 copies/mL and CD4 count greater than 50 cells/mm(3), and received a stable antiretroviral therapy regimen for greater than or equal to 12 weeks at screening. Patients received either once-daily (n=294) or twice-daily (n=296) PREZISTA/ritonavir plus optimized background regimen. the primary objective of the study was to demonstrate non-inferiority of PREZISTA/ritonavir 800/100 mg once daily versus PREZISTA/ritonavir 600/100 mg twice daily in confirmed virologic response (HIV-1 RNA less than 50 copies/mL [intent-to-treat/time-to-loss of virologic response; ITT-TLOVR]) at Week 48.

Important Safety Information

PREZISTA does not cure HIV-1 infection or AIDS, and does not prevent passing HIV-1 to others.

Drug Interactions

• Coadministration of PREZISTA/ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (e.g., alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, lovastatin, or simvastatin)

• Coadministration of PREZISTA/ritonavir is also contraindicated with rifampin and products containing St. John’s wort (Hypericum perforatum) because this may cause significant decrease in plasma concentration of darunavir, resulting in loss of therapeutic effect and development of resistance

• Coadministration is not recommended with indinavir, lopinavir/ritonavir, saquinavir, and pravastatin

• Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA/ritonavir.

• This list of potential drug interactions is not complete.

Warnings & Precautions

• PREZISTA must be coadministered with ritonavir and food to achieve the desired antiviral effect. Failure to administer PREZISTA with ritonavir and food may result in a loss of efficacy of darunavir. Please refer to ritonavir prescribing information for additional information on precautionary measures

• Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA/ritonavir. during the clinical development program (N=3063), hepatitis has been reported in 0.5% of patients receiving combination therapy with PREZISTA/ritonavir. Patients with preexisting liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse events

Post-marketing cases of liver injury, including some fatalities, have been reported. A causal relationship with PREZISTA/ritonavir therapy has not been established

Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of PREZISTA/ritonavir treatment. Evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA/ritonavir should prompt consideration of interruption or discontinuation of treatment

• Severe Skin Reactions:  Severe skin reactions (0.4%), accompanied by fever and/or elevations of transaminases in some cases, Stevens-Johnson Syndrome (
  ]]> http://symptomadvice.com/fda-approves-prezista%c2%aeritonavir-once-daily-dosing-for-hiv-1-treatment-experienced-adults-with-no-darunavir-resistance-associated-mutations/feed/ 0 http://symptomadvice.com/the-daily-tar-heel-got-tested-being-inspired/ http://symptomadvice.com/the-daily-tar-heel-got-tested-being-inspired/#comments Sun, 28 Nov 2010 08:17:09 +0000 Symptom Advice http://symptomadvice.com/the-daily-tar-heel-got-tested-being-inspired/

  

  This is the first in a series of guest columns by Wooten exploring the current state of HIV/AIDS, leading up to World Aids Day on Dec. 1.

  On a rare afternoon, I found myself watching “Jersey Shore.” The group was fist pumping in a club, as Mike “The Situation” was ready to smash with a young lady from the club. The next scene was The Situation walking into a bedroom.

  I shuddered and changed the channel to an episode of Maury. I braced myself for teen paternity tests. instead, I found a touching story about a mother who was infected with HIV. It struck me that these shows revealed a clear message on views about sex. The case of the woman with HIV led me to do more research.

  The Human Immunodeficiency Virus, or HIV, usually develops into Acquired Immune Deficiency Syndrome (AIDS). Commonly these two are referred to by the term, HIV/AIDS. Young people (15 to 24 years old), especially young women, are in the growing number of people affected by HIV/AIDS.

  The relevance of this is profoundly felt on college campuses as it is estimated that 1 out of 500 college students (0.2 percent) is infected with HIV/AIDS. This shows an alarming trend primarily fueled by three factors: high sexually transmitted disease rates, substance abuse and lack of awareness.

  Overall, the CDC estimates 19 million new sexually transmitted infections occur each year, almost half among 15- to 24-year-olds. The presence of an STD greatly increases a person’s likelihood of acquiring or transmitting HIV. It is estimated that one-in-four college students will contract an STD during their time at school. of people who have a sexually transmitted disease, 80 percent experience no noticeable symptoms, allowing them to unknowingly transmit the disease and compound the impact of HIV/AIDS.

  Young people in the United States also abuse substances such as alcohol, tobacco and other drugs at high rates. Users are more likely to engage in high-risk behaviors, such as unprotected sex, when they are under the influence of drugs or alcohol. Rounding out this trifecta of transmission is the lack of awareness. Research has shown a large proportion of young people are not concerned about becoming infected with HIV, as it is viewed as a problem of yesteryear. The population at large mirrors the high rate of transmission in youth.

  Currently, there are 1.2 million Americans that live with HIV/AIDS, and more than 36 million people worldwide that live with HIV/AIDS. Roughly 1 in 5 Americans infected with HIV do not know they have the virus. The majority of new sexually transmitted HIV infections are transmitted by those unaware of their infection.

  Even in the midst of these statistics, complacency about HIV has increased. a recent survey by the Kaiser Family Foundation found that the percentage of Americans who think HIV is a major health problem has declined precipitously over the past decade. with this trend, the best tool in the fight against HIV/AIDS is knowledge about the enemy.

  There are various ways a person can become infected with HIV: unprotected sexual intercourse with an infected person, contact with an infected person’s blood, and injecting drugs, as HIV can be passed on when injecting equipment that has been used by an infected person is used. The majority of young people are infected sexually. This indicates a prevention model is still vital to fighting HIV/AIDS.

  So after all these facts, how can one avoid contracting HIV? Abstinence is the only 100-percent effective method of avoiding sexual exposure to HIV. Traditionally, this method has had issues with adherence. other methods of risk reduction include reducing your number of sexual partners and using male or female condoms consistently and correctly during sex.

  It is important to know your status. The first symptom of HIV infection is often swollen lymph glands in the throat, armpit or groin. some other early symptoms include profuse night sweats, headaches, fatigue and muscle aches. They may only last for a few weeks. then there are usually no symptoms for many years. That’s why it is important to get tested as you may be positive and have no symptoms.

  Most college health centers, local clinics and hospitals can perform a test. Major health centers offer blood testing, which detect HIV antibodies and HIV antigen. Results usually take two to three weeks to return. Rapid oral testing is available, which tests fluid rubbed from the gums and cheeks for HIV antibodies, not the actual virus. The results of the oral test are available in about 20 minutes. Detection of HIV antibody or antigen is evidence of HIV infection.

  If you have AIDS or are HIV positive, you are legally obligated to disclose this status to future partner(s).

  Every 12 seconds another person is infected with HIV, and every 16 seconds another life is claimed by AIDS. We know more about HIV now than ever, giving us more weapons to fight this global threat. These statistics are life changing. Consider yourself inspi(red).

  Julian E. Wooten is a columnist from The Daily Tar Heel. He is a first year pharmacy graduate student. major from Fountain. Contact him at edu

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