Wednesday, October 22, 2014

Ibalizumab: First HIV Drug to Get Orphan Drug Status for Salvage Patients

Shares of TaiMed Biologics Inc, which manufactures drugs to treat AIDS, soared 12.93 percent yesterday after its new TMB-355 drug for intravenous injection was granted orphan drug status in the US.
The company’s shares closed at NT$151.2 yesterday, outperforming the over-the-counter benchmark index, which ended up 0.56 percent.
The granting of orphan status could shorten the time it takes for TMB-355 to enter the US market, TaiMed financial controller Jack Chen said over the telephone yesterday.
“By getting orphan status, we are able to negotiate with the US Food and Drug Administration to see if we can waive the phase-three clinical trials for the drug, or conduct them on a smaller scale,” Chen said.
An orphan drug is one that satisfies an unfilled medical need for a specific group of people numbering less than 200,000, TaiMed said, adding that as a result, clinical trials for such drugs do not require as many patients as those for other pharmaceuticals.

Sunday, October 19, 2014

Demystifying HIV Pre-Exposure Prophylaxis

Pre-Exposure Prophylaxis or PrEP is an HIV prevention strategy where an HIV negative person takes a daily pill to reduce their risk of contracting HIV. It's important to note that PrEP is not the same as PEP or Post-Exposure Prophylaxis, which HIV treatment given to individuals within 72 hours after exposure to HIV to prevent infection from taking hold.

The only currently approved PrEP regimen is Truvada, a two drug combo, which blocks an enzyme called HIV reverse transcriptase. HIV relies on this enzyme to make new copies of itself. So Truvada prevents the HIV virus from multiplying and establishing infection in the body. 

Because PrEP blocks an HIV enzyme, it protects against HIV infection, but it does not prevent against pregnancy or other sexually transmitted infections or STI's. Therefore, people taking PrEP should also get regular HIV testing, to make sure they haven't been recently infected. As well as STI testing and treatment if necessary. 

PrEP has been proven to reduce the risk of HIV infection in gay and bisexual men, transgender women and heterosexual men and women, as well as people who inject drugs. PrEP does not treat HIV. It's meant to prevent HIV from establishing infection so it should not be taken by someone who already has HIV. People who want to start PrEP must first be tested for HIV infection. 

PrEP has made a lot of headlines over the last two years, and the messages haven't always been clear. Let's look at three myths about PrEP, and see what the facts really are. 

Myth number one - PrEP doesn't work. In the large IPrEx study of PrEP in gay and bisexual men and transgender women, researchers found an overall 42% reduction in HIV transmission. However, when the researchers looked at levels of Truvada in the blood samples, they found that for people who took four PrEP pills per week, protection was approximately 96%. For people who took PrEP daily as recommended, protection was estimated at more than 99%. So the take home message - PrEP works if you take it as prescribed, every day. 

Myth number two - PrEP causes bad side effects. Some people in PrEP studies have reported side effects such as nausea, headaches, or weight loss in the first few weeks of taking PrEP. Most of these side effects went away on their own or when PrEP was stopped. And the majority of people didn't have them at all. For example, one clinical trial reported moderate nausea only 22 times among the 1251 people that started to take PrEP over a study period of more than two years. A recent analysis showed that some people taking PrEP can have a slight increase in serum creatinine, an indicator of reduced kidney function. But, these levels returned to normal after PrEP was stopped. Just to be safe, people who take PrEP should have regular monitoring for kidney health. Another analysis found a slight loss in bone and mineral density in study participants taking PrEP. Although this bone loss did not worsen with long term use. Truvada was chosen for use as PrEP, in part because it is safe and well tolerated. Like most drugs, some mild side effects are possible. But again, side effects reported with PrEP went away over time or when PrEP was stopped. Also, there are other drugs currently in clinical trials that may have fewer side effects.

Myth number three - PrEP is impossible to get. PrEP is available by prescription from doctors, nurse practitioners, and physicians assistants, and most health care plans cover PREP. Without insurance, Truvada PrEP can cost upwards of $1800 per month. But few people actually pay this full stickered price. There are medication assistance programs through Gilead Sciences that may be able to cover some or all of the cost of PrEP, whether or not you have insurance. Keep in mind that depending on how you are accessing PrEP, it may take several weeks to get your prescription filled the first time.

Of course, PrEP is not the only way to prevent HIV infection. When used correctly and consistently, condoms are an important tool for reducing HIV risk, as well as preventing against other STI's and pregnancy. For people who do not use condoms every time they have sex, PrEP provides effective protection against HIV. The choice to use PrEP, like the choice to use condoms is personal. The important thing is to find an HIV prevention strategy that works for you. 

This document is a transcription of a video ( ) provided  by Youreka Science in collaboration with Beta of the San Francisco AIDS Foundation. To learn more about HIV treatment and prevention, visit Beta at

Friday, October 17, 2014

Friday, October 10, 2014

The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.

For Immediate Release

October 10, 2014


The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.
“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”
Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.
Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.
Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured.
In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for eight weeks and 96 percent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants.
The most common side effects reported in clinical trial participants were fatigue and headache.
Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Harvoni and Sovaldi are marketed by Gilead, based in Foster City, California. Olysio is marketed by Janssen Pharmaceutical based in Raritan, New Jersey.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Wednesday, October 08, 2014

As PrEP Becomes More Available, Couples With One HIV + Partner Consider Treatment

It has been recommended that gay and bisexual men consider taking pre-exposure prophylaxis, or PrEP, for HIV prevention, but there is one demographic that, according to many health care professionals, is an ideal candidate for this treatment: HIV-negative men with HIV-positive male partners, relationships that are referred to as serodiscordant.
For many of these couples, PrEP may offer a security in intimacy among both partners that is beneficial to physically, mentally, and emotionally, where HIV is concerned. The fear of a condom breaking during sex or not being used properly can be alleviated with the knowledge that medication taken for PrEP, when administered properly, can reduce the risk of HIV infection by 96 to 99 percent.

Read more here

What You Should Know About Ebola

Important facts summarized in this great figure.

Tuesday, October 07, 2014

HIV Prevention Pill (Truvada) Patient Assistance Program Now Available

More Breaking from U.S. Conference on AIDS: Gilead is raising income levels for their Assistance Program to 500% of FPL (or approx $58,350). So you may be able to get PrEP paid for if you are making below that amount and can't afford the drug. Also being told that the Co-Pay Assistance program is expanding from $200 to $300 per month. This is an important breakthrough, for ‪#‎PrEP‬ consumers!

The Truvada® for PrEP Medication Assistance Program assists eligible HIV-negative adults in the United States who do not have insurance obtain access to Truvada (emtricitabine and tenofovir disoproxil fumarate) for PrEP (pre-exposure prophylaxis). To find out if you are eligible for this medication assistance program, call 1-855-330-5479, Monday through Friday between 9:00 a.m. and 8:00 p.m. (Eastern). 

Friday, July 11, 2014

Great video that explains how a DEXA scan works for measuring bone, body fat and muscle

This video about how a full body dual-energy x-ray absorptiometry (DEXA) scan works as the best way to measure body composition.  However, few clinics provide it since they only use DEXA to measure bone density in the lower back and pelvis. It required special calibration for a full body scan. Talk to your doctor is he can find a local clinic that can do a full body DEXA scan. Your insurance may not pay for it. Out of pocket cost may be close to $200.  You only need to do it every 2-3 years for bone density if you are over 50 and HIV+. If you are a bodybuilder that expects dramatic body changes in a few months, then every 6 months to a year would be OK. The amount of X ray radiation you are exposed to is equivalent to your exposure in a transatlantic flight.

Wednesday, July 09, 2014

Fwd: Hot Topics: Our Inner Demons; How Bad Is Smoking?; Once-Monthly Treatment?; and More

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July 9, 2014
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Living With HIV/AIDS

 Living With Our Doubts, and Our Inner Demons
To the person who wrote last week about trying to commit suicide: I think that you are right that we are suffering a sort of post-traumatic stress disorder, both from the past and from the present we live. This is not a question, just insight on how some of us are not doing well out here and not knowing how to do a thing about it.

Nelson Vergel responds in the "Aging With HIV" forum

 Is Smoking While HIV Positive Really So Bad?
I just tested positive for HIV, and I smoke one or two cigarettes a day, as well as some weed and the occasional electric cigar. How much will continuing like this worsen my situation or hurt my CD4 count?

David Fawcett, Ph.D., L.C.S.W., responds in the "Substance Use and HIV" forum

 Day One With HIV: Coping With an HIV Diagnosis While in College
thumbnail image for blurb"Needless to say, my life is a mess and the future that was once so clear seems so blurred and uncertain," Jason Q writes. "I am simply looking to my graduation day, and trying to overcome the depression I have been fighting since my day one.

HIV/AIDS Treatment

 How Soon Will We Have Once-a-Month HIV Meds?
Do you have any good guess as to when those injectable once-per-month medications I've read about will be available to treat HIV?

Benjamin Young, M.D., Ph.D., responds in the "Choosing Your Meds" forum

 Is It Wise to "Undo" a Regimen Switch?
I was on Atripla for four years -- viral load undetectable, no drug resistance, CD4 count of 600 -- but switched to Stribild last week upon my doctor's suggestion. I am having very hard time adjusting to it. Are my symptoms normal -- and even if they are, would it be OK to switch back to Atripla so quickly?

Keith Henry, M.D., responds in the "Managing Side Effects of HIV Treatment" forum

 Can One Missed Dose Spell Resistance?
I've been on Stribild for over four months and haven't missed a dose, but I'm scared that I'm going to miss one at some point. If I do, will it make me resistant?

Benjamin Young, M.D., Ph.D., responds in the "Choosing Your Meds" forum

 A Guide to Talking to Your Health Care Provider About HIV Treatment Issues
thumbnail image for blurbWe realize that, if you're doing things that hurt your ability to adhere to your HIV treatment, your HCP won't always feel like the easiest person to confide in. But if you want your treatment to work, you and your health care team have to work as partners. You don't have to do this alone.

Other Health Issues & HIV/AIDS

 How Do I Manage Heart Health When Statins Aren't an Option?
I have been HIV positive for 30 years, and have had great results with my meds. But my total cholesterol is over 225 (LDL 150) and my triglycerides are close to 300. I have horrible side effects when using statins. At what point should I consider switching HIV meds to lower cholesterol?

Keith Henry, M.D., responds in the "Managing Side Effects of HIV Treatment" forum

 Can I Do Anything About Itchy Skin Bumps?
When I started to take my antiretrovirals seven months ago, I developed very itchy pimple-like bumps on my scalp, face, neck, and all the way down to my legs. I always wear long sleeves or a jacket because I'm too shy too show off my arms. My doctor says it will go away, but I need help managing this now!

Keith Henry, M.D., responds in the "Managing Side Effects of HIV Treatment" forum

 Can Antibiotics Be Dangerous for People With HIV?
I've been on HIV treatment for two years, and have also been prescribed antibiotics throughout that time. My CD4 count is 230 and climbing slowly. However, I have heard many times that antibiotics should not be "overused" -- does that go for us HIV-positive people as well?

Benjamin Young, M.D., Ph.D., responds in the "Choosing Your Meds" forum

 Spotlight Series on Hepatitis C
thumbnail image for blurbWe're in the midst of a dramatic evolution in hepatitis C management.'s exclusive spotlight series on HCV captures the latest developments with a range of overviews, research updates, expert interviews, educational materials and new information.

how do you #LiveBold?

thumbnail image for blurbEach of us knows all too well how deeply stigma can affect the lives of people with HIV. We also know how much HIV-positive people do, day in and day out, to push back against that stigma.'s sister site, HealthCentral, is honoring that fight against stigma with a photo contest that gives you a chance to make a statement -- and potentially win some cash in the process.

The "Live Bold, Live Now" Photo Contest invites people who are living with a significant health issue to share their story by July 11; public voting will determine the winners of a $500 first prize, $250 second prize and $100 third prize.

Several HIV-positive people have already submitted their stories. Visit the photo contest entry post on HealthCentral's Facebook page to see them, and to submit your own story!

News & Opinion

 How Can I Support My Newly Diagnosed Friend?
Not even 24 hours ago I found out a very dear friend of mine is HIV positive. Is there anything I should know? Other than shock I don't see him any differently, but I just want to be educated in any way possible to be there for him.

David Fawcett, Ph.D., L.C.S.W., responds in the "Mental Health and HIV" forum

 Is HIV Treatment Truly a "Functional Cure"?
I disagree with the theory that people living with HIV are already "functionally cured" if they are on antiretroviral therapy. If that's true, then why must we disclose our status even if we are undetectable and practically unable to transmit the virus?

Benjamin Young, M.D., Ph.D., responds in the "Choosing Your Meds" forum

 HIV Management in Depth: Exploring Key Issues in HIV Care
thumbnail image for blurbOur flagship interview series on features important discussions with some of the brightest minds and most active figures in HIV treatment, research, prevention and activism. Browse our latest additions!

Understanding HIV/AIDS Labs

 19 vs. 56: Is There a Difference Between Extremely Low Viral Loads?
While I was volunteering for a study, I would consistently get viral load results back that were "less than 20." Most recently, though, my viral load was 56. My doctor doesn't seem concerned, but does suddenly becoming "detectable" mean I'm becoming resistant to my meds?

Mark Holodniy, M.D., F.A.C.P., C.I.C., responds in the "Understanding Your Labs" forum

 Can I Ever Fully Recover From a Super-Low CD4 Count?
I was diagnosed in June 2011 with CD4 count of 43. Since starting treatment, my CD4 slowly climbed to around 260, where it has hovered. Why won't it keep climbing?

Mark Holodniy, M.D., F.A.C.P., C.I.C., responds in the "Understanding Your Labs" forum

HIV Transmission

 What's the "Real" Risk of Heterosexual Transmission?
I'm HIV positive, but since I started meds I've always had an undetectable viral load. I'm also circumcised and have no other STDs. I'm wondering: What is the real percentage chance of transmitting HIV to my female partner if we don't use condoms?

Shannon R. Southall responds in the "Safe Sex and HIV Prevention" forum

 PEP Regimens: Do the Specific Drugs Matter?
I was abroad on vacation when my condom broke during sex with a stranger. Doctors prescribed me post-exposure prophylaxis (PEP) consisting of Truvada and Kaletra, but due to drug access problems with the Truvada, they said it'd be fine to just take the Kaletra alone if I need to. Are they right?

Benjamin Young, M.D., Ph.D., responds in the "Choosing Your Meds" forum

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