December 14, 2010

Exploratory phase 2 trial in patients with HCV genotype 2 or 3 to receive PSI-7977 400mg QD and ribavirin, with 0-12 weeks of pegylated interferon

Interim data expected in first half of 2011

PRINCETON, N.J., Dec. 14, 2010 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that dosing has begun in an exploratory study of PSI-7977, a nucleotide analog polymerase inhibitor, for the treatment of chronic hepatitis C (HCV). The trial will evaluate PSI-7977 400mg QD in combination with ribavirin (RBV), with 0, 4, 8, or 12 weeks of pegylated interferon alfa 2a (Peg-IFN) in treatment-naive patients infected with HCV genotype 2 or 3.

"Based on the encouraging efficacy, safety and resistance data from the Phase 2a trial with PSI-7977 in combination with pegylated interferon and ribavirin, we initiated a study to explore shorter durations of interferon, including an interferon-free regimen in treatment naïve patients with HCV genotype 2 or 3," stated Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "An important limitation to the current treatment of HCV patients is the use of interferon with its associated side effect profile. We believe that PSI-7977's high barrier to resistance and the lack of a significant effect of IL28B genotype in the Phase 2a trial provide us an opportunity with PSI-7977 to explore shorter durations of interferon, and potentially even removing it from the treatment regimen altogether."

About the Trial

The trial is anticipated to enroll approximately 40 patients infected with HCV genotype 2 or 3 who have not previously been treated. The primary endpoint of the trial will be the assessment of safety and tolerability of PSI-7977 400mg QD and RBV for 12 weeks, administered with or without pegylated interferon (Peg-IFN) in treatment naïve patients with HCV genotypes 2 or 3. The trial will be conducted in New Zealand. Patients will be randomized into one of 4 arms:

-- PSI-7977 400mg QD in combination with RBV for 12 weeks (no interferon);

-- PSI-7977 400mg QD in combination with RBV for 12 weeks, with only 4 weeks of Peg-IFN;

-- PSI-7977 400mg QD in combination with RBV for 12 weeks, with only 8 weeks of Peg-IFN;

-- PSI-7977 400mg QD in combination with Peg-IFN and RBV for 12 weeks.

Patients will be stratified by HCV genotype and IL28B status to ensure balance across cohorts.

Pharmasset anticipates reporting interim data from this trial in the first half of 2011.

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus (HCV). Our research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have four clinical-stage product candidates. RG7128, a cytosine nucleoside analog for chronic HCV infection, is in two Phase 2b clinical studies in combination with Pegasys(R) plus Copegus(R) and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys(R) and Copegus(R) to treat chronic HCV. These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical stage HCV candidates include PSI-7977, an unpartnered uracil nucleotide analog that has recently initiated dosing in a Phase 2b study in patients with HCV genotypes 1, 2, or 3, and PSI-938, an unpartnered guanosine nucleotide analog which recently completed a 7-day monotherapy study. We also have in our pipeline an additional purine nucleotide analog, PSI-661, in advanced preclinical development.

Pegasys(R) and Copegus(R) are registered trademarks of Roche.

Forward-Looking Statements

Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2010 filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.

Contact
Richard E. T. Smith, Ph.D.
VP, Investor Relations and Corporate Communications
Office +1 (609) 613-4181

SOURCE Pharmasset, Inc.
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Reported by Jules Levin, AASLD Nov 2 2010

C. Stern1; M. Martinot-Peignoux1; M. Ripault1; N. Boyer1; A. Cardoso1; A. El Ray1; T. Asselah1; D. Valla1; P. Marcellin1 1. Service d'Hepatologie, Hôpital Beaujon, Clichy, France.

BACKGROUND/AIMS: Relapse after treatment of chronic hepatitis C (CHC) patients with the combination of pegylated interferon (PEG-IFN)-α and ribavirin (RBV) is observed in 30% of patients with end of therapy (EOT) response. Factors associated with relapse are not well known. The aim of this study was to evaluate the factors related to relapse in CHC patients, particularly in female patients, treated with PEG-IFN in combination with RBV.

METHODS: A total of 249 consecutive naive CHC patients treated with PEG-IFN-α-2a or -2b plus RBV (800 to 1200 mg/day) and with EOT response were included. Among these, 84 (34%) patients were female. Duration of therapy was defined according to the current guidelines. Clinical, biological, virological and histological data were collected. Type of PEG-IFN, initial doses and modifications of therapy were analyzed. The efficacy of treatment was evaluated with a sensitive qualitative HCV RNA assay (<15 IU/mL). Factors associated with relapse were analyzed.

RESULTS: Relapse was observed in 34% of patients; 50% received PEG-IFN-α2a. Overall population presented the following characteristics: mean age 47±11, obesity (BMI ≥30) in 10%, genotype 1 in 33%, advanced fibrosis (≥F3) in 24% and marked steatosis (≥30%) in 27%.

In the logistic regression, factors related to relapse in overall population were: obesity (p=0.011), genotype 1 (p=0.001), marked steatosis (p=0.006) and PEG-IFN dose reduction (p<0.001). In female patients, menopause was observed in 59% (mean age 48±6). Therefore, to confirm a possible impact of menopause on relapse in CHC female patients, we compared patients under and older than 50 years according to gender. In males (n=165), relapse was present in 22% and 28% of patients under 50 years and older than 50 years (p=0.38), respectively. When relapse rates were analyzed in females (n=84), a statistically difference related to age was observed (14% vs 37%, p=0.023). Among female patients, factors associated with relapse were: menopause (p=0.006), obesity (p=0.031), high viral load (≥400,000 IU/mL) (p=0.014), genotype 1 (p=0.034) and necro-inflammatory activity ≥A2 (p=0.043). In the logistic regression, only menopause was independently associated with relapse in CHC female patients (p=0.007, 95% CI 1.66 - 24.47).

CONCLUSION: CHC patients infected with genotype 1 and presenting obesity and marked steatosis have higher rates of relapse. PEG-IFN reduction, but not ribavirin reduction, is associated with relapse. In female patients, menopause has a negative impact on SVR rates.

Source
Reported by Jules Levin
AASLD Nov 2 2010 Boston
NATAP

Stephane Chevaliez1,2, Christophe Hezode1,3, Alexandre Soulier1,2, Bruno Costes2,4, Magali Bouvier-Alias1,2, Stephanie Rouanet5, Juliette Foucher6, Jean-Pierre Bronowicki7, Albert Tran8, Isabelle Rosa9, Philippe Mathurin10, Laurent Alric11, Vincent Leroy12, Victor De Ledinghen6, Ariane Mallat1,3, Mariem Charaf-Eddine5, Gerard Babany5, and Jean-Michel Pawlotsky1,2

1National Reference Center for Viral Hepatitis B, C and delta, Virology, Hôpital Henri Mondor, Creteil, France; 2INSERM U955, Creteil, France; 3Hepatology and Gastroenterology, Hôpital Henri Mondor, Creteil, France; 4 Biochemistry, Hôpital Henri Mondor, Creteil, France; 5Roche, Neuilly-Seine, France; 6Hepatology and Gastroenterology, Hôpital Haut-Levêque, Pessac, France; 7Hepatology and Gastroenterology, Hôpital de Brabois, Nancy, France; 8Hepatology and Gastroenterology, Hôpital de l'Archet, Nice, France; 9Hepatology and Gastroenterology, Centre Hospitalier Intercommunal, Creteil, France; 10Hepatology and Gastroenterology, Hôpital Claude Huriez, Lille, France; 11Internal Medicine, Hôpital Purpan, Toulouse, France; 12Hepatology and Gastroenterology, Hôpital de la Tronche, Grenoble, France

from Jules: we need to wait for the IL28B subanalyses from the telaprevir ADVANCE & boceprevir SPRINT2 studies in order to see how to use this information. Using double dose Pegasys in this study appeared to on average increase the virologic response quite a lot by weeks 4, 8 and 12 compared to prior use of the standard Pegasys dose for both TT and CT genotypes. CT genotype achieved better virologic response than TT genotype in this study, by week 24: 44% of TT and 70% of CT achieved >2 log viral load reduction. These data suggest that double-dose Pegasys 360 ug/week in combination with telaprevir or boceprevir may significantly increase virologic response and SVR. Conceivably, double-dose Pegasys during a lead-in and during therapy with telaprevir or boceprevir could increase SVR rates potentially quite a lot based on these data. There is a suggestion that an HCV protease resenesitizes the patient's internal interferon response so let's see how the TTs and CTs respond in the subanalyses from Advance & Sprint.

ABSTRACT:

Polymorphisms upstream of the region encoding IL28B have been shown to be associated with both natural and treatment-induced control of HCV infection. With new therapies using direct acting antiviral molecules, a null response to IFN is associated with treatment failure and selection of resistant viruses. Our goal was to assess, in null-responders to IFN-ribavirin therapy, whether the IL28B genotype has an influence and predictive value on the ability of high-dose pegylated IFN and ribavirin retreatment to induce a virological response.

METHODS:

83 genotype 1 null-responders received peg-IFN alpha-2a, 360 µg/week in one or two injections, plus ribavirin, 1000-1200 or 1200-1600 mg/d. Genotyping of the IL28B SNP rs12979860 was performed from host cell DNA by means of a real-time PCR method using minor groove binding probes. RESULTS: The IL28B genotype was determined in all 83 patients: 3 (3.6%) had a CC genotype and were removed to allow comparison between CT (n=55) and TT (n=25) patients. The difference between reductions in HCV RNA levels between TT and CT patients was significant at week 2 (<0.5 vs ≥0.5 Log, p=0.02), at week 4 (<1 vs ≥1 Log, p=0.008), and at weeks 12 and 24 (<2 vs ≥2 Log p=0.02). When comparing CT and TT patients, the odds ratio were 3.09 for a more than 0.5 Log drop at week 2; 3.86 for a more than 1 Log drop at week 4; 3.08 for a more than 2 Log drop at week 12; 3.10 for a more than 2 Log drop at week 24; and 3.57 for an undetectable HCV RNA at week 24.

CONCLUSIONS:

Most patients who fail to respond to pegylated IFN and ribavirin carry either TT or CT rs12979860 genotypes. CT patients are significantly more likely to respond to higher doses of IFN and the difference is significant at week 2. This indicates that the IL28B genotype is a marker of host cell responsiveness to IFN. These findings will have major implications in the treatment of HCV infection with higher peg-IFN doses in combination with ribavirin and direct acting antivirals.

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Doctors Claim HIV-Positive Man Cured by Stem Cell Transplant

Published December 14, 2010
FoxNews.com

There’s an estimated 33 million people worldwide living with HIV/AIDS, and now doctors believe one of them may have been cured of the virus after receiving a stem cell transplant in 2007, the medical journal Blood reported.

Timothy Ray Brown, an HIV-positive American living in Germany, had leukemia and was undergoing chemotherapy, when he received a transplant of stem cells from a donor carrying a rare, inherited gene mutation that seems to make carriers virtually immune to HIV infection.

The transplant appeared to wipe out both diseases, giving hope to doctors, but Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, who has been studying HIV/AIDS for almost 30 years, said while this is an interesting proof of concept, it’s absurdly impractical.

“It’s hard enough to get a good compatible match for a transplant like this,” Fauci told FoxNews.com, “But you also have to find compatible donor that has this genetic defect, and this defect is only found in 1 percent of the Caucasian population and zero percent of the black population. This is very rare.”

Fauci said while this patient is “functionally cured” this is not something you can do with every HIV-infected individual.

“This is not prime time to me at all,” he said. “This is a very unusual situation that has little practical application for a simple reason. This donor not only had to be a good compatible match, but the donor had to have a genetic defect of cells that do not express the receptor that the HIV virus needs to enter the cell.”

Fauci also pointed to the fact that this transplant process is not only expensive, it’s incredibly painful and complicated, and requires the patient to start a whole new regimen of drugs.

“This patient is trading one poison for another. He may not have to be on antiretroviral drugs anymore, but he has to take immunosuppressant drugs now to prevent the rejection of his transplant cells. Again, what this is, is an interesting proof of concept, but it’s absolutely impractical.”

Dr. Thomas Quinn, director of Johns Hopkins Center for Global Health told FoxNews.com that he is very familiar with the “Berlin patient” case.

“This was a new report that looked much deeper into whether HIV could still be present or lurking in the body in some way, not cured, and since the transplant he remains viral free and his cells appear to be resistant to infection,” he said.

Quinn said he agrees with the researchers on this case that it would be qualified as the first HIV cure, opening the door to alternative means of curing HIV.

“He [Brown] has been without therapy for three years and appears to be free of the virus,” he said. “It gives hope to the millions of people infected with HIV that cure is a feasible option in the future.”

Even though Brown’s procedure proved to be successful, Quinn also warns that this was a rare case and a bone marrow transplant is not a cure-all for other HIV patients.

“It is a near fatal procedure that he had to have done because of the leukemia, but this procedure is very expensive and you have to be transplanted with a donor who is shown to be already resistant to HIV,” Quinn said. “You’re asking for a tall order to replicate this in the future.”

Brown’s case was published in a February 2009 issue of the New England Journal of Medicine.

Click here to read more from the journal Blood (subscription is required).

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WASHINGTON, Dec. 14, 2010 /PRNewswire-USNewswire/ -- To improve the care for individuals infected with the hepatitis C virus, a major health problem and a leading cause of chronic liver disease around the world, nearly 200 international hepatitis experts have taken an important step in escalating the introduction of a new class of targeted therapies for HCV – direct-acting antivirals (DAAs).

December 6 at a major scientific meeting – Advancing HCV Drug Development: A Collaborative Approach – convened by the Forum for Collaborative HIV Research, researchers, hepatitis advocates, members of industry and representatives from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) created the roadmap for accelerating the development of DAAs, agreeing that this new class of drugs targeting specific hepatitis C virus proteins has the same potential to improve treatment outcomes for people with HCV as antiretroviral drugs changed the standard of care in HIV. Currently, two DAA compounds have advanced into phase 3 development in the United State and EU, and many more are in phase 2 trials and likely to advance to phase 3 research in the near future.

"If there was ever a time when we can change the course of HCV, it is now," said Veronica Miller, Ph.D., Director of the Forum. "We are now where we were with HIV more than a decade ago and can apply many of the lessons learned from HIV drug development to significantly accelerate the progress in bringing new and better HCV therapies to market."

DAAs directly attack the ability of the hepatitis C virus to replicate and can increase the cure rate in certain HCV patients to between 60 and 70 percent– a major advance over the 40 percent success rate associated with the currently recommended treatment for chronic HCV infection, the combination of pegylated interferon and ribavirin. Although the first DAAs still require concomitant use with current HCV medications, these new compounds will shorten the length of time on pegylated interferon and ribavirin therapy, which hepatitis specialists noted is often difficult to tolerate and has significant adverse event profiles that limit treatment in many patients. According to the latest data, between 15 and 30 percent of HCV patients started on current HCV therapy are unable to complete the year of treatment now required because they cannot tolerate the side effects.

Charting the future of HCV drug development, the meeting participants applied FDA's new guidance on conducting clinical trials on DAAs, which was issued in September 2010 in draft form and expected to be finalized in 2011. According to Jeffrey S. Murray, M.D., M.P.H., Deputy Director of the Division of Antiviral Drug Products in FDA's Center for Drug Evaluation and Research, the draft guidance follows the same approach FDA uses in developing HIV and oncology drugs. For early clinical testing, FDA recognizes that most if not all DAAs for HCV will be used in combination with other approved drug and therefore, recommends studies examining the relationship between the new DAA agent and both pegylated interferon and ribavirin as well as testing the combination antiviral activity. FDA's draft guidance also calls for using the results from proof-in-concept trials (meaning a study in HCV infected patients that demonstrates initial activity as measured by reductions in the HCV viral load) to guide dose selection for subsequent Phase 2 trials in which DAAs are studied for longer durations as part of a combination regimen. FDA is further encouraging drug sponsors to design development plans for combinations of two or more DAAs.

"The good news for the HCV community is that more drugs are coming," said Jur Strobos, MD, JD, FACEP, Deputy Director of the Forum. "The bad news is we don't know how to combine them and that is what we need to study."

With FDA's guidance as the framework, the hepatitis experts also identified the major factors researchers must take into account when designing clinical trials for DAAs and other new HCV therapies. Among the major issues cited are the emergence of resistant virus and its potential management, and including in future DAA clinical trials those special populations with significant unmet needs in HCV therapy. These patients include individuals co-infected with HIV, liver transplant recipients, patients with decompensated cirrhosis, opioid users and those on opiate substitution therapy, and children. According to the Centers for Disease Control and Prevention (CDC), between 5 and 6 percent of infants born to HCV infected women contract the infection from their mothers and the majority of those infants will develop a chronic infection.

Focusing on the special needs of pediatric patients, leaders from both FDA and EMA agreed that the time to start investigating DAAs in children is when sufficient safety data exist in adults. As explained by specialists in pediatric liver disease, children with HCV often tolerate drug therapy better than adults, which is why the ideal age to start children in pediatric trials for DAAs is when they are 3 years old. According to hepatitis experts, the beneficial impact of a 'cure' for children, preferably before they start school, cannot be overestimated.

Reducing Disparities in HCV Clinical Trials

Because identifying potential differences among groups treated with a therapeutic regimen is an important goal of human studies, the HCV community singled out the under-representation of women, older people and different ethnic subgroups in clinical trials as the problem requiring immediate attention and change at a systemic level. Although there is a higher prevalence of HCV in men than women, women metabolize HCV drugs differently and are more affected by autoimmune diseases, which share similar symptoms with HCV. Women also are twice as likely as men to suffer from depression, which is a common side effect of treatment with HCV medications.

Even more challenging for the HCV community is increasing the representation of older HCV-infected adults in HCV clinical trials, even though Baby Boomers constitute the majority of hepatitis C infections in the United States and are often less responsive than younger generations to antiviral treatment. Compounding the problem, older HCV patients are more difficult to treat, due to the increased prevalence of co-morbid conditions, such as diabetes, dyslipidemia, and other metabolic conditions that are correlated to chronic liver disease. Aging is also strongly associated with liver fibrosis progression, which means older HCV patients are likely to have advanced liver disease and a high risk for impending liver complications. But despite this reality, few studies have examined the age-specific factors of chronic HCV infection and the clinical management of the infection in this patient population.

More than an issue of fairness, HCV experts associate better designed clinical research studies with the increased ability of scientists to catalog and understand the influence of genetic and non-genetic factors on individual and group responses to new treatments. Findings from the large amount of genetic data generated to date show that more than 90 percent of the observed genetic variations occur within, rather than between groups. This underscores the fact that gender and ethnicity have biomedical consequences when evaluating patients with more resistant virus and with more severe disease.

Designing the Research Roadmap to Address a Growing Public Health Threat

Accelerating the development of DAAs to improve HCV treatment outcomes is especially warranted now that the hepatitis C virus has become the most common chronic blood borne infection in the U.S. According to new government estimates, approximately 4.1 million Americans are infected with HCV, of whom 60 to 70 percent will develop chronic liver disease. Currently, almost half of all liver transplants in the U.S. are performed for end-stage hepatitis C. Moreover, because liver disease is one of the leading causes of death in the U.S., the CDC predicts that deaths from chronic liver disease attributed to hepatitis C will double or triple over the next 15 to 20 years.

To change these statistics, hepatitis specialists focused on ways to advance HCV drug development so DAAs and other new classes of drugs for HCV can reach the market quickly. Here, the experts reached agreement on a number of issues:

• Exposure to new single agents – because HCV remains sensitive to ribavirin and pegylated interferon, longer initial studies may be recommended to evaluate single drugs and novel combinations of drugs

• Composition of patients in early studies (phase 1 and 2a) – early studies should be large enough so results with one type of virus or one group of patients can be easily discerned. Focusing on specific genetic sub-populations will also ensure that early studies do not produce confusing results

• Drug resistance in HCV patients – unlike HIV, drug resistance in HCV may not be as large a concern because HCV does not integrate into host DNA as HIV does. Thus, resistant strains are not archived and there is the potential that resistant patients can be retreated with different combinations regimens, as and when they become available

• Baseline parameters – there is the need to develop predictive algorithms based on baseline characteristics such as gender, body weight, HCV genotypes and subtypes

• Exclusion of former and current drug users in clinical trials – exclusion is unnecessary and does not serve the field well. Over 60 percent of patients with HCV are infected through drug use, indicating the need to have quality data to guide treatment decisions in this patient population

As a next step, the Forum for Collaborative HIV Research will publish the consensus of this scientific meeting to advance the research agenda. Once published, the report will be distributed widely to the Forum's many constituencies – government, industry, patient advocates, healthcare providers, foundations, health insurers and academia – with the goal of advancing research on HCV and driving public policy.

About the Forum for Collaborative HIV Research

Now part of the University of California (UC), Berkeley School of Public Health and based in Washington, DC, the Forum was founded in 1997 as the outgrowth of a White House initiative which called for an ongoing collaboration among stakeholders to address emerging issues in HIV/AIDS and set the research strategy. Representing government, industry, patient advocates, healthcare providers, foundations and academia, the Forum is a public/private partnership that is guided by an Executive Committee that sets the research agenda. The Forum organizes roundtables and issues reports on a range of global HIV/AIDS issues, including treatment-related toxicities, immune-based therapies, health services research, co-infections, prevention, and the transference of research results into care. Forum recommendations have changed how clinical trials are conducted, accelerated the delivery of new classes of drugs, heightened awareness of TB/HIV co-infection, and helped to spur national momentum toward universal testing for HIV. http://www.hivforum.org/

SOURCE Forum for Collaborative HIV Research

Source

Tips for the Media on How to Stop Screwing Up HIV/AIDS Coverage

Kellee Terrell
News Editor, TheBody.com
Posted: December 14, 2010 11:56 AM

This year, we saw a number of medical breakthroughs that made headlines: The discovery of two rare human antibodies that kill 90 percent of all HIV strains, which could provide the basis for a vaccine. The first-ever successful clinical trial of a microbicide, which could bring us one step closer to women being able to have more control over their sexual health. And the finding that pre-exposure prophylaxis can reduce HIV infections among gay men.

This year also brought major events that got heavy news coverage: The XVIII International AIDS Conference in Vienna. The first-ever national HIV/AIDS strategy for the U.S. The return of U.S. AIDS Drug Assistance Program (ADAP) waiting lists, which had been empty, but are now full again. A harsh reminder that you can be imprisoned and potentially executed for being gay in certain countries. And a confirmation that poverty is the top risk factor for HIV among heterosexuals living in inner cities.

On the pop culture end, HIV was also present. Part of the porn industry temporarily shut down when adult film actor Derrick Burts tested positive. Project Runway's Mondo Guerra disclosed his status on air. The Other City, a documentary about HIV/AIDS in Washington, D.C., debuted to rave reviews. And on World AIDS Day, celebrities "died" on social media, only to have some billionaire "resuscitate" them when it looked as if they might not be able to raise enough money to do so through smaller donations.

But even in the wake of all of this, the media still doesn't report enough about the global pandemic and, most importantly, there are not enough stories exploring the U.S. epidemic. (Newsflash: AIDS is still a huge problem here in the U.S.) And when the media does tackle AIDS in America, too many times it borrows from FOX News' playbook of sensationalism, fabrications and one-sided narratives.

Just how many down low and criminalization stories can a person take?

And this is where I come in. I looked over 2010's media coverage of HIV/AIDS and came up with some important lessons that journalists should keep in mind for next year:

Include More Voices of People Living With HIV: This is a "no duh" if we want to eliminate stigma. But minus the media frenzy around Project Runway's Mondo Guerra disclosing his HIV status on air, mainstream media almost never showcases the real voices of people living with HIV.

Wouldn't it be awesome if -- on a day other than World AIDS Day -- we could hear people living with HIV talk about love and marriage; stigma and discrimination; pregnancy and family; treatment and adhering to drugs; the trials and tribulations of being on an ADAP waiting list; disclosing to others; and all that other good stuff? Perhaps "reality" only works for the Kardashians.

Bigwigs Are Not the Only People You Should Pay Attention To: Did you know that, this summer at the XVIII International AIDS Conference in Vienna, sex workers from around the world had a major presence (including a huge rally)? Or that the same was true of drug users, who had an international declaration on their behalf signed by more than 18,000 people? Did you know that UNIFEM and the ATHENA Network released a comprehensive report that highlighted the lack of female leadership in HIV policymaking despite the fact that the global face of AIDS is more female than male?

Of course you did. But the rest of the world probably did not: All of those stories were overlooked, because journalists were more interested in writing about Bill Gates, Annie Lennox and other high-power players who were present at the conference. Please don't forget about the grassroots work that is being done to better the lives of people living with HIV. You might be missing out on a good story.

Teens and Seniors Have Sex Too: If it wasn't for the reality shows 16 and Pregnant and Sunset Daze, or the occasional sensationalized stories about "retirement homes gone wild" or "teen sex parties," one would think that these two groups never had sex. Oh, but they do -- and the media (along with most of society) needs to get over its hang-ups and begin exploring the alarming and rising rates of HIV and other sexually transmitted diseases among these demographics. This means fewer interviews with Bristol Palin and company, and more interviews with women such as Marvelyn Brown and Jane Fowler.

The Fight for LGBT Equality Is Connected to HIV Risk: While the media continues to improve its reporting on LGBT issues -- especially around bullying, homophobia, DADT (the U.S. military's "Don't Ask, Don't Tell" law), marriage equality and job discrimination -- more needs to be done to illustrate how these issues directly impact one's own HIV risk.

It may come as a surprise to some that there are still many cases (and many states) in which it is legal to fire someone based on their sexual orientation and gender identity and expression in the U.S. And if people can be fired from their job, that means they can lose their financial stability. They become less able to look after their health care, and in some cases may even become homeless. A slew of reasons begin to emerge that can make those individuals more vulnerable to HIV.

(Hint, hint: National LGBT organizations, perhaps now is the time to make HIV/AIDS a platform issue. If you do, the media might follow.)

Try Normalizing HIV; It's Not That Hard: HIV has always been the "cheese that stands alone" -- it's even classified separately from other sexually transmitted diseases. One way to help destigmatize the disease is to include a discussion about HIV into stories in which HIV is simply a fact to be noted, not the focus of the entire piece. For example, in a feature about people struggling to pay for their health care or the difficulties of adhering to daily medications, why not include a person living with HIV as one of the interviewees? Or in a story about Mother's Day, or Valentine's Day, or Veteran's Day, why not include the perspective of an HIV-positive person? HIV doesn't always have to exist outside the box.

Read the rest of the lessons here.

Want to learn more about the major HIV/AIDS developments, trends and advocates who rocked 2010? Take a look at TheBody.com's new series, HIV/AIDS Year in Review: Looking Back on 2010 (and Ahead to 2011).

Source
Dec 14, 2010 11:08 ET\

AMARILLO, TX--(Marketwire - December 14, 2010) - Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) today announced that enrollment in a Phase 2 clinical trial of 165 patients with chronic hepatitis C virus infection is now complete. The clinical trial is being conducted in Taiwan and funded by ABI's strategic partner, CytoPharm, Inc. The aim of the study is to reduce the virologic relapse rate for those patients who have successfully completed standard combination therapy for hepatitis C, which consists of injectable interferon alpha and Ribavirin.

Many patients with hepatitis C are found to be virus-free at the end of standard therapy, but up to half of those with certain viral genotypes relapse in the six months following treatment, once again becoming positive for hepatitis C virus. There are currently no FDA-approved medications shown to reduce the relapse rate for hepatitis C patients, so there is a clear medical need for effective new therapies.

All patients enrolled in this trial first completed standard therapy and were found to be negative for hepatitis C virus. The patients were then assigned to one of two different daily doses of ABI's human interferon alpha lozenges or placebo for 24 weeks, followed by untreated observation for 24 weeks to check for relapse. All patients are scheduled to complete the untreated observation phase by December 2011, and final results from this important study are expected to be available by the end of next year.

About Amarillo Biosciences

Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 5.4% of Amarillo Biosciences shares and has provided over $18 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including influenza, hepatitis C, chronic cough, and opportunistic infections in patients who are HIV positive. The Company has invested nearly $40 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the web at http://www.amarbio.com/.

Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" and "Item 7A. Qualitative and Quantitative Disclosures About Market Risk" of the Company's Form 10-K for the fiscal year ended December 31, 2009.

Investor Relations:

Philippe Niemetz
PAN Consultants, Ltd.
e-mail: p.niemetz@panconsultants.com
Tel: 800-477-7570; 212-344-6464
Fax: 212-618-1276

Joseph M. Cummins, DVM, PhD
Amarillo Biosciences, Inc.
e-mail: jcummins@amarbio.com
Tel: 806-376-1741 x 13
Fax: 806-376-9301

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