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.

Demystifying HIV Pre-Exposure Prophylaxis

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 ( https://www.youtube.com/watch?v=-Xx92whZS0o
) 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 BetaBlog.org.

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.

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

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).