October 12, 2012

AHF Advocacy Against Gilead’s Truvada as HIV Prevention Yields Stronger FDA Drug Warning Label


October 11, 2012 09:52 PM Eastern Daylight Time

New warning label is welcomed by AIDS advocates who were astounded by recommendation by an FDA Advisory Panel earlier this year to allow Gilead to market use of its blockbuster AIDS treatment as a form of HIV prevention in uninfected individuals without any HIV testing requirement whatsoever

AHF and other advocates strenuously opposed use of the AIDS treatment as a form of HIV prevention pill, concerned about efficacy, medication adherence issues among uninfected high-risk populations; ‘Black box warning’ label on Truvada for prevention now recommends HIV testing every three months

WASHINGTON--(BUSINESS WIRE)--AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS nonprofit medical provider, welcomed the news today the boxed warning label (also called the ‘black box warning’) on Gilead Sciences blockbuster AIDS treatment Truvada for use as a form of an HIV prevention pill appears much stronger than proposed versions of the label earlier this year. The new warning label is being welcomed by AIDS advocates from AHF and other organizations who were astounded by a recommendation by a Food and Drug Administration (FDA) Advisory Panel to allow Gilead to market use of Truvada as a form of HIV prevention in uninfected individuals, particularly when the panel—comprised of 23 physicians, scientists and members of the general public—also recommended that the FDA allow Gilead to market the drug for such use without any requirement for HIV testing whatsoever.

“From the beginning, AHF and many other advocates strenuously opposed use of this well-established AIDS treatment as a form of an HIV prevention pill, concerned about both the efficacy of the treatment as well as medication adherence issues among uninfected high-risk populations,” said Michael Weinstein, President of AIDS Healthcare Foundation. “It is difficult for many of those who are already infected with HIV to properly comply with daily drug regimens. Expecting uninfected people to remember to take a drug every day for a disease that they don’t have is an even more daunting challenge. At least now the ‘black box warning’ label on Truvada for prevention recommends HIV testing every three months. It is good to see that the FDA and Gilead have finally come to this realization. I believe it was in part because of our advocacy over the past year opposing the drug for this use that this warning label is now stronger.”

The FDA Advisory Panel took place in May in Silver Spring, MD, at FDA headquarters. Nearly 30 advocates from AHF and other groups spoke against use of the drug for HIV prevention to the panel, which nevertheless indicated it would give preliminary approval to Gilead for use as HIV prevention.

Later in the summer, at the ‘Controlling the HIV Epidemic with ARVs’Summit, held in London June 11-12, a Gilead official publicly disclosed in a plenary session in which he was participating that use of its blockbuster AIDS treatment Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to prevent possible HIV infection would have labeling indicating that a negative HIV test will be required before a prescription.

Following is what the Truvada packaging and printed drug warning inserts now state regarding use of the drug for pre-exposure prophylaxis (PrEP) for HIV prevention:

For PrEP:

"When prescribing TRUVADA for pre-exposure prophylaxis, healthcare providers must:

  • prescribe TRUVADA as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection [See Warnings and Precautions (5.9)];
  • counsel all uninfected individuals to strictly adhere to the recommended TRUVADA dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 was strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials [See Warnings and Precautions (5.9)];
  • confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication. If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. [See Warnings and Precautions (5.9)]; and
  • screen for HIV-1 infection at least once every 3 months while taking TRUVADA for PrEP."

About AIDS Healthcare Foundation

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 176,000 individuals in 27 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.


High testosterone may boost advanced liver disease risk

10/12/2012 02:10:00

By Jimmy Downs

Thursday Oct 11, 2012 (foodconsumer.org) -- High levels of testosterone in men may explain why men are more likely than women to develop advanced liver disease like hepatitis C virus related advanced liver disease, according to a study in Hepatology.

The study led by Donna L. White at Michael E. DeBakey Veterans Affairs Medical Center in Houston, TX and colleagues showed men with advanced fibrosis had significantly higher total serum testosterone, compared to controls with mild diseases.

The cross-sectional study involved 308 eligible male veterans with chronic hepatitis C virus whose blood samples were obtained to measure total serum testosterone. Of the subjects, 105 men were diagnosed with advanced fibrosis, 203 with mild fibrosis, 88 with advanced inflammatory activity and 220 with mild activity.

Mean total serum testosterone was found at 6.0 versus 5.3 ng/mL and 5.9 versus 5.4 ng/mL for men with advanced fibrosis, mild fibrosis, advanced inflammatory activity, and mild activity respectively.

Each 1-ng/mL increase in total serum testosterone was associated with 25 percent increased risk in advanced fibrosis and 15 percent increased risk in advanced inflammatory activity.

After adjustment for other risk factors, total testosterone in the upper tertile was correlated with 274 percent increased risk of advanced fibrosis and 123 percent increased risk for advanced inflammatory activity.

The researchers concluded "Total serum testosterone is associated with an increased risk of both advanced hepatic fibrosis and advanced hepatic inflammatory activity in HCV-infected men. Testosterone may be important in the pathogenesis of HCV-related advanced liver disease in males."

The study could not determine if having a high serum level of testosterone is a cause for or result from having advanced fibrosis or advanced inflammatory activity.


Indonesia acts to over-ride patents on HIV drugs

By Matthew Bigg

JAKARTA | Fri Oct 12, 2012 8:18am EDT

JAKARTA (Reuters) - Indonesia's government has taken steps to over-ride patents for HIV drugs, following the lead of other Asian states that have allowed the production of cheap generic drugs that cut into the sales of global pharmaceutical companies.

President Susilo Bambang Yudhoyono quietly issued a decree last month authorizing the use of patents for seven HIV/AIDS and hepatitis medicines held by the likes of Merck & Co, GlaxoSmithKline, Bristol-Myers Squibb, Abbott and Gilead.

The companies affected did not provide immediate comment.

The decree states Indonesia implemented the measures to "meet the urgent need for antiviral and antiretroviral treatments".

An estimated 310,000 people are living with HIV in Indonesia, Southeast Asia's largest economy. The prevalence rate among the 15 to 49-year-old population is 0.2 percent, according to 2009 statistics from the U.N. Aids website.

Unreported cases mean that the true figure could be higher.

Under World Trade Organization rules member countries are permitted to take measures to over-ride patents when it is deemed necessary to protect public health.

Yudhoyono signed the decree without fanfare on September 3 and it was only recently highlighted by Western groups campaigning for increased access to drugs in the developing world.

The issuing of the decree follows a decision by India in March to strip German drugmaker Bayer of its exclusive rights to a cancer drug.

India's highest court also heard final arguments last month in a landmark case over drug patents involving Novartis's leukaemia drug Glivec that could change the rules for the country's healthcare sector and potentially curb its global role as a supplier of cut-price generic medicines.

At the same time, China in June overhauled parts of its intellectual property laws to allow local production of patented medicines in another initiative likely to unnerve foreign pharmaceutical companies.

The amended patent law allows Beijing to issue compulsory licenses to eligible companies to produce generic versions of patented drugs during state emergencies, or unusual circumstances, or in the interests of the public.

If implemented to the full, the measure taken by Indonesia would introduce widespread generic competition and generate big cost savings in the world's fourth most populous country.

It is not the first time that Indonesia has made an order giving government control over HIV drugs but the latest decree goes further than earlier ones in 2004 and 2007.

"Indonesia has set an important precedent, not just for the people living with HIV within its country, who have been campaigning for this, but also for other developing countries," said Michelle Childs of Medecins Sans Frontieres.

"This is one of the widest licenses issued by a government and rightly reflects the reality that a range of treatment options are needed," Childs said.

(Additional reporting by Ben Hirschler in London; Editing by Jeremy Laurence)