October 27, 2010

A Capital In Crisis: Showtime Documentary “The Other City” Explores The HIV/Aids Epidemic In Washington D.C.

By Bill Gorman – October 27, 2010


To Premiere In Honor of World AIDS Day

Wednesday, December 1st at 7:30 PM ET/PT

LOS ANGELES, CA – (October 27, 2010) – Washington D.C. is a place where power and policy intersect, yet in the shadows of the U.S. Capitol lies the reality of a very different city – a city visitors rarely see. Last year, it was reported that 3% ofWashington D.C.’s residents are living with HIV or AIDS. How does the capital of the most powerful country in the world become the home of the highest HIV/AIDS rate in the nation – rivaling some African countries? On Wednesday, December 1stat 7:30 PM ET/PT, in honor of World AIDS Day, SHOWTIME will premiere THE OTHER CITY, a documentary that believes politics, ideology, corruption and bureaucracy have led the HIV/AIDS epidemic to grow out of control in Washington D.C., the city that is supposed to represent the best ideals of the United States of America.

THE OTHER CITY tells the stories of Washington D.C. citizens who have taken matters into their own hands and have not let the lack of government assistance stop them from pursuing effective treatment or from fighting the spread of HIV/AIDS every day. The individuals profiled include: J’Mia Edwards, a woman living with AIDS and fighting desperately to keep herself and her three young children from being thrown out of their home; Jose Ramirez, a young man who contracted the disease from a boyfriend – who didn’t disclose he was infected – but now, devotes his life to promoting HIV awareness among Hispanic teens; a one-time addict now living with AIDS, Ron Daniels saves lives by providing clean needles and helping drug users receive treatment; and finally, the staff of the AIDS hospice Joseph’s House struggles to provide solace to terminal patients’ last days, to deal with their own sense of loss, and their constantly declining funding.

The film is directed by Emmy®-and Peabody-winning filmmaker Susan Koch (“Kicking It”) and produced by entrepreneur and philanthropist Sheila C. Johnson. The co-producer is award-winning journalist Jose Antonio Vargas.


Pharmasset to Webcast an Investor Event from the AASLD Meeting

PRINCETON, N.J., Oct. 27 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) today announced that it will webcast an investor event from the American Association for the Study of Liver Diseases (AASLD) on Sunday, October 31, 2010 starting at 7:00pm ET. During this webcast, management will review Pharmasset's progress on the programs that are the subject of presentations at AASLD.

To access a simultaneous webcast of this event via the internet, log on to the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events.cfm . Please connect to the website at least ten minutes prior to the start of the presentation to ensure adequate time for a reliable connection and any software download that may be necessary for the webcast.

The following abstracts are available on the AASLD website (AASLD.org).


Abstract 81

"High rates of early viral response, promising safety profile and lack of resistance related breakthrough in HCV GT 1/4 patients treated with RG7128 plus PegIFN alfa-2a (40KD)/RBV: Planned Week 12 interim analysis from the PROPEL study" will be presented in the HCV Clinical Trials session on Sunday October 31st at 5:15pm ET. Authors of the study are Jensen, D. M. et al.

Abstract 799

"No evidence of drug resistance or baseline S282T resistance mutation among GT1 and GT4 HCV infected patients on nucleoside polymerase inhibitor RG7128 and Peg-IFN/RBV combination treatment for up to 12 weeks: Interim analysis from the PROPEL study" will be presented in a poster session on Sunday October 31st. Authors of the study are Le Pogam, S. et al.


Abstract 806

"High Rapid Virologic Response (RVR) with PSI-7977 Daily Dosing plus PEG-IFN/RBV in a 28-day Phase 2a Trial" will be presented in a poster session on Sunday October 31st. Authors of the study are Lawitz, E. et al.

Abstract 1861

"Clinical synergy of an Anti-HCV Nucleotide Analog with SOC: Viral Kinetics of PSI-7977 with SOC" will be presented in a poster session on Tuesday November 2nd. Authors of the study are Lawitz E, et al.

Abstract 815

"IL28B SNP Geographical Distribution and Antiviral Responses in a 28-day Phase 2a Trial of PSI-7977 Daily Dosing plus PEG-IFN/RBV" will be presented in a poster session on Sunday October 31st. Authors of the study are McHutchison, J.G. et al.


Abstract 1890

"Pharmacokinetics, Safety, and Tolerability of PSI-938, a Novel Nucleotide Polymerase Inhibitor for HCV, Following Single Ascending Oral Doses in Healthy Subjects" will be presented in a poster session on Tuesday November 2nd. Authors of the study are Symonds, W. et al.

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 presently in a Phase 2b study, and PSI-938, an unpartnered guanosine nucleotide analog in a Phase 1 study. We also have in our pipeline an additional purine nucleotide analog, PSI-661, in advanced preclinical development. Racivir, for the treatment of HIV, has completed a Phase 2 clinical study.

Pegasys® and Copegus® are registered trademarks of Roche.

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

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, 2009 and our Quarterly Reports on Form 10-Q for the periods ended December 31, 2009, March 31, 2010 and June 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.

SOURCE Pharmasset, Inc.



Heavy Alcohol Consumption May Increase HIV Disease Progression

By Mariana Plazas-Mayorca and Courtney McQueen

Published: Oct 27, 2010 9:00 am

A new review of several studies has found some evidence linking heavy alcohol use to accelerated HIV disease progression. In particular, alcohol use influences how reliably people take their medication, which can affect HIV progression. However, it is still unclear whether alcohol affects progression independently of antiretroviral adherence.

“There is strong evidence that alcohol consumption interferes with antiretroviral therapy adherence. The more a person drinks alcohol, the more medication he/she misses,” said Professors Judith Hahn and Jeffrey Samet, the authors of the review, in correspondence with The AIDS Beacon.

“Suboptimal adherence to these medications can cause HIV to become resistant and for the treatment regimen to fail,” they added.

However, whether alcohol affects disease progression independently of missed antiretroviral drug doses is more controversial.

Scientists have long speculated that alcohol and drug use affects the rate of HIV progression. Alcohol is known to have suppressive effects on the immune system, and illegal drug use (particularly stimulant use) has been linked to faster progression (see related AIDS Beacon news).

However, the role of alcohol in HIV progression has remained elusive.

“While many studies conducted in the early 1990s found no link between alcohol consumption and HIV disease progression, more recent studies have suggested that there is such a link,” said the authors.

To better understand the connection between alcohol and disease progression, the authors of the review examined a number of studies from before and after the advent of antiretroviral therapy, as well as animal studies where alcohol use was more controlled.

Results showed that prior to the advent of highly active antiretroviral therapy (HAART), studies found no relationship between heavy alcohol consumption and HIV disease progression.

However, more recent studies from the post-HAART era have been inconclusive. Three of the six studies from the post-HAART era included in the review demonstrated an association between heavy alcohol use and at least one measure of HIV disease progression, such as higher viral load (amount of HIV in the blood), lower CD4 (white blood cell) count, opportunistic infections, or death.

The other three studies found no association between alcohol consumption and HIV progression, aside from alcohol’s impact on treatment adherence.

Since studies of alcohol consumption in people can be complicated by other factors – heavy drinkers may be more likely to be depressed, for example, and depression can affect HIV progression – the review authors also examined studies of alcohol use in monkeys.

Monkeys can be infected with simian immunodeficiency virus (SIV), the monkey version of HIV. Since both their alcohol intake and antiretroviral adherence can be carefully controlled, these studies can potentially illuminate purely biological effects of alcohol consumption on disease progression, rather than effects of behavior, such as treatment adherence.

Results of these studies suggest that there might in fact be a biological basis for alcohol’s effects on HIV progression. For example, several studies found higher viral loads in monkeys that drank heavily, and one study found that monkeys with high alcohol consumption progressed faster than monkeys that did not drink alcohol.

The authors speculated on a variety of reasons why alcohol might affect HIV progression. Alcohol is known to have detrimental effects on the immune system, for example, and can also lead to vitamin and mineral deficiencies.

In addition, there is evidence that alcohol may interfere with the body’s metabolism of antiretroviral medications. As a result, chronic alcohol users might be at higher risk for ineffective therapy due to low concentrations of antiretrovirals in the blood.

Aside from these potential biological factors, heavy drinkers may be less likely to receive HIV care and more likely to take illegal drugs, which are known to increase disease progression. HIV-positive individuals who suffer from other conditions, such as hepatitis C, should be particularly cautious when consuming alcohol.

“Many persons living with HIV are also infected with hepatitis C virus (HCV), and for those patients, using alcohol can speed HCV disease progression,” said Professors Hahn and Samet.

The authors suggested that people with HIV be cautious about alcohol consumption.

“All persons who are living with HIV and who drink alcohol should discuss their alcohol consumption with their physicians,” said the authors. “There are several effective methods to reduce or quit alcohol consumption; counseling, medications, and mutual support groups (e.g., Alcoholics Anonymous) are options that can help.”

“Even if they do not stop drinking, their physicians should know so that they can monitor their liver function,” the authors added. “Physicians treating those with HIV should be aware of the potential effects of alcohol on HIV disease progression and routinely screen all of their patients for alcohol consumption.”

They concluded that the evidence linking alcohol abuse to HIV progression is suggestive but not conclusive, and that further study is needed to elucidate the link.

Brown University announced earlier this month that a new research institute, the Brown Alcohol Research Center on HIV, will be devoted to studying the health effects of drinking in people with HIV. The institute will conduct studies on the effects of alcohol and HIV on metabolism and brain function, and the interaction between alcohol, HIV, and HCV, among others.

For more information, please see the review article in Current HIV/AIDS Reports. For more information on the Brown Alcohol Research Center on HIV, please see the Brown University website.


Also See: HIV, alcohol topic for Brown study

Few Veterans at US Government Care Facilities Receive Testing for HIV: Presented at IDSA

By Ed Susman

VANCOUVER -- October 26, 2010 -- The percentage of patients in the US government-run Veterans Affairs medical facilities who have been tested for HIV infection is less than 10%, despite government recommendations that patients receive routine HIV testing, researchers stated here at the 48th Annual Meeting of the Infectious Diseases Society of America (IDSA).

"We don't know why these testing levels are so low, but they are even low in areas where HIV has a large prevalence," said Meredith Welch, MD, Veterans Affairs Medical Center/George Washington University Medical Center, Washington, DC.

Dr. Welch noted that 5.7 million outpatients were seen in the Veterans Affairs system in 2009. In a detailed survey of that system, however, it appeared that, as of 2009, just 9.2% of these outpatients had been tested ever before for HIV, with 2.5% of these patients tested within that year.

In the District of Columbia, where HIV infection prevalence is just over 1,402/100,000 persons, about 21.6% of outpatients have ever been tested for HIV, Dr. Welch said here at her poster presentation on October 23.

In New York, where the prevalence of HIV is just over 777/100,000 persons, about 11.8% of people in the Veterans Affairs health system have ever been tested for HIV.

In places where prevalence of HIV is low, such as Utah with a prevalence of just over 105/100,000 persons, just 2.7% of outpatients in the Veterans Affairs facilities there have ever been tested for HIV.

"The Centers for Disease Control and Prevention has recommended HIV testing for all persons aged 13 to 64 or pregnant women since 2006," Dr. Welch said. "The federal law requiring written informed consent for HIV testing with pre- and post-test counselling within Veterans Affairs was repealed in 2008."

Despite removal of such barriers, there still appears to be a slow uptake of testing in the Veterans Affairs system. Dr. Welch suggested that her study could act as a baseline for future studies that will determine how well the Veterans Affairs health system is performing in testing for HIV.

"There may still be some stigma involved with HIV that prevents physicians from asking patients to undergo an HIV test," she speculated.

[Presentation title: Initial Assessment of HIV Testing Among Outpatient Veterans Compared With US Rates of HIV/AIDS. Abstract 1063]


Presidio Pharmaceuticals, Inc. to Present First Clinical Data for PPI-461, a New HCV NS5A inhibitor, at the American Association for the Study of Liver Diseases (AASLD) Meeting, Supporting Initiation of a Trial in Hepatitis C Patients

October 27, 2010 03:00 AM Eastern Daylight Time

SAN FRANCISCO--(BUSINESS WIRE)--Presidio Pharmaceuticals, Inc. announced today that Nathaniel Brown, M.D., Chief Medical Officer, will present a late-breaker poster, “Safety and Pharmacokinetics of PPI-461, a Potent New Hepatitis C virus (HCV) NS5A Inhibitor with Pan-Genotype Activity” at the 61st AASLD meeting in Boston, MA, on November 1, 2010. The presentation provides the results of the first clinical trial of PPI-461, and will be available for review from 8:00A to 5:00P (EDT) in Exhibit Hall C at the Hynes Convention Center.


PPI-461 is a novel and promising NS5A inhibitor that interferes with HCV replication. Discovered at Presidio, PPI-461 exhibits highly potent and selective activity against all seven major HCV genotypes in laboratory assays. Inhibitors of the HCV NS5A protein represent a promising new class of HCV antivirals that are mechanistically distinct from HCV agents that target the viral protease or replicase (polymerase). Laboratory data suggest that NS5A inhibitors can potentially be used in combination with any of these other HCV agents, to achieve better efficacy in hepatitis C patients and combat the emergence of antiviral resistance.

About the Phase 1a Trial Results

The data to be reported at the AASLD meeting are the results of a Phase 1a dose-ranging trial of PPI-461 in healthy volunteers completed this year. This trial assessed the safety and pharmacokinetics of five different oral dosing regimens for PPI-461: four single doses (20, 50, 100, and 200 mg), and a multi-dose regimen (200 mg daily for five days). A total of 40 subjects participated in the study, with eight subjects in each of the five dosing groups.

As indicated in the LB-12 abstract, now viewable on the AASLD meeting website (AASLD.org), all PPI-461 dose regimens were well tolerated. All subjects completed the study, and there were no patterns of clinical adverse events or laboratory abnormalities associated with administration of PPI-461. The pharmacokinetic results indicated that all subjects rapidly achieved substantial blood levels of PPI-461, which far exceeded the concentrations of PPI-461 needed to inhibit HCV (genotypes 1-7) in the laboratory. For PPI-461 doses of 50 mg or more, all subjects achieved blood levels of PPI-461 that would be expected to inhibit HCV replication for 24 hours or longer. This profile suggests that PPI-461 may be effective when administered to hepatitis C patients at relatively low oral doses on a once-daily dosing schedule, which would facilitate its convenient use in future co-formulated combination therapies. Additional details of the Phase 1a results will be given with the November 1 presentation at AASLD.

First Study of PPI-461 in Hepatitis C Patients Underway

Based on the encouraging Phase 1a results, Presidio has initiated a Phase 1b proof-of-concept clinical trial of PPI-461 in hepatitis C patients. This dose-ranging trial will evaluate the safety, pharmacokinetics and antiviral efficacy of PPI-461 in previously-untreated patients with HCV genotype-1 infection.

“We are pleased to begin initial assessments of the tolerance and antiviral efficacy of PPI-461 in patients with chronic hepatitis C, following the encouraging results of the recent Phase 1a study,” said Nathaniel Brown, M.D., Chief Medical Officer. “HCV-related mortality and severe debilitation are projected to increase continually in the coming years, so there is an urgent need for improved therapies for hepatitis C.”


Presidio Pharmaceuticals, Inc. is a San Francisco-based clinical stage specialty pharmaceutical company dedicated to the discovery and development of small-molecule antiviral therapeutics. For more information, please visit our website at: http://www.presidiopharma.com/.

Presidio Pharmaceuticals, Inc.
Omar K. Haffar, PhD, 415-655-7561


Hepatitis C increased risks for cerebrovascular-related death

Posted on October 27, 2010

Lee M. Stroke. 2010;doi:10.1161/STROKEAHA.110.598136.

Hepatitis C virus infection was an independent risk predictor of cerebrovascular deaths, indicating a biological gradient of cerebrovascular mortality with increasing serum hepatitis C virus RNA levels, researchers said.

The study included residents (n=23,665, aged 30 to 65 years) from a community-based prospective cohort who were enrolled from 1991 to 1992. Residents answered structured questionnaires and provided blood samples for various serological and biochemical tests at study entry. Researchers tested serum hepatitis C virus (HCV) RNA level and HCV genotype for participants seropositive for antibodies against HCV (anti-HCV).

During the 382,011 person-years of follow-up, researchers reported 255 cerebrovascular deaths, which translated into a cumulative risk for cerebrovascular deaths of 1% for seronegatives and 2.7% for seropositives of anti-HCV (P<.001). The corresponding multivariate-adjusted HR for cerebrovascular death was 2.18 (95% CI, 1.50-3.16) for anti-HCV seropositives.

In additional analysis, compared with patients seronegative for anti-HCV, the multivariate-adjusted HR for anti-HCV-seropositive participants with undetectable serum levels of HCV RNA was 1.40 (95% CI, 0.62-3.16), 2.36 (95% CI, 1.42-3.93) for low serum levels and 2.82 (95% CI, 1.25-6.37) for high serum levels (P<.001 for trend).

“HCV infection is associated with an increased risk of cerebrovascular mortality, particularly for those with elevated serum HCV RNA levels,” the researchers concluded. “If future additional studies confirm the role of HCV infection and the development of cerebrovascular disease, it may be possible to prevent cerebrovascular disease by using specific antiviral strategies.”


Idenix Pharmaceuticals to Hold an Investor/Analyst Day Event on October 30, 2010

CAMBRIDGE, Mass., Oct. 27 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX) announced today that the Company will hold an Analyst Day event during the upcoming 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) on Saturday, October 30, 2010 from 9:00 a.m. to 12:00 p.m. ET at the Mandarin Oriental, Boston.

The live and archived webcast of the presentation can be accessed under "Calendar of Events" in the Idenix Investor Center at www.idenix.com. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived replays will be available on the Idenix website for two weeks following the event.

About Idenix

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of infections caused by the hepatitis C virus. For further information about Idenix, please refer to http://www.idenix.com/.

Idenix Pharmaceuticals' Contacts:
Jonae Barnes (617) 224-4485 (investors)
Kelly Barry (617) 995-9033 (media)

SOURCE Idenix Pharmaceuticals, Inc.