The Forum for Collaborative HIV Research - Advancing HCV Drug Development: A Collaborative Approach

Announcements

CDC Update to Interim Guidance for PrEP: PrEP for Injecting Drug Users

JUN-13-13 The Thailand Ministry of Health and CDC published results from a randomized controlled trial of a daily oral dose of 300 mg of tenofovir disoproxil fumarate (TDF) that showed efficacy in reducing the acquisition of HIV infection among injecting drug users. Based on these findings, CDC recommends that preexposure prophylaxis (PrEP) be considered as one of several prevention options for persons at very high risk for HIV acquisition through the injection of illicit drugs. Click here to view the updated guidance in the MMWR and click here to view the Lancet article .

On Behalf of IDSA: Urge Lawmakers to Protect PEPFAR Funding

MAY-22-13 IDSA is asking for you to join them and lend your name to a letter in support of PEPFAR funding for the next fiscal year. Click here to read the letter and sign by Monday, June 3-Noon Eastern time.

Renewal of the National Viral Hepatitis Action Plan, 2014-2016

MAY-20-13 Dr. Ronald Valdiserri writes to recognize the second anniversary of Combating the Silent Epidemic of Viral Hepatitis: Action Plan for the Prevention, Care & Treatment of Viral Hepatitis and to share an important announcement from Dr. Howard Koh about plans to update and renew the existing plan through 2014-2016.

MAY-17-13 Please join the Forum in congratulating Nina Mani on an exciting new career move. Nina is leaving the Forum, but she is not going far – starting June 3 she will join the FDA Center for Drug Evaluation Research, Division of Antiviral Products. That we will miss her is the understatement of the century. But the offer to join our colleagues at the FDA as a project manager presented a phenomenal opportunity – an excellent fit for her career path. We congratulate Jeff, Kim, Jules and Patrick on an excellent choice! We imagine that many of you will have the pleasure of interacting with her in her new capacity.

National Viral Hepatitis Action Plan to Be Renewed

MAY-16-13 Dr. Howard Koh, the Assistant Secretary for Health, announced on May 16 that the partner agencies are committed and dedicated to renewing the Action Plan for another three years and are currently working on their vision and priorities for 2014-2016.

Upcoming Events

29-Jun-13

IAS 2013 Towards an HIV Cure Symposium

04-Jun-13

International Workshop on HIV & Hepatitis Virus Drug Resistance and Curative Strategies

23-May-13

Hepatitis B and C Testing and Awareness Day in House of Representatives

Advancing HCV Drug Development: A Collaborative Approach

DEC-06-10 A public meeting on HCV drug development was held Monday, December 6, 2010, in Washington, DC.

Materials and Links

Agenda
Partcipant Survey Responses

Presentations:
Veronica Miller
Jeff Murray
Leonard Seef
Ann Kwong
Filip Josephson
Peyton Meyers
Ira Jacobson
Jean-Michel Pawlotsky

Click here to view the meeting webcast

The Forum sponsored a Public Meeting to discuss HCV drug development. New trial information presented at AASLD, draft FDA guidance and recent opinions from EMA have provided the necessary background to discuss trial designs with direct acting antivirals (DAAs) for treatment of chronic HCV infection.

The Forum held this meeting to obtain public comments regarding future trial designs and endpoints, including evaluation of interferon and/or ribavirin sparing regimens and the use of two or more DAAs in treatment-naïve and treatment-experienced trials and in special populations. Additional issues encountered during the drug development process were also discussed.

The Forum brought together stakeholders from industry, patient advocates, academia, and regulators to discuss issues in clinical development of DAAs.

The Steering Committee for this project includes:

Ann Kwong - Vertex
Dale Kempf - Abbott
Filip Josephson - EMA
Ira Jacobson - Cornell University, School of Medicine
Isabel Najera - Roche
Jean-Michel Pawlotsky - Henri Mondor Hospital
Jules O'Rear - FDA
Jur Strobos - Forum for Collaborative HIV Research
Kimberly Struble - FDA
Nina Mani -Forum for Collaborative HIV Research
Stuart Ray - Johns Hopkins University, School of Medicine
Tracy Swan - Treatment Action Group
Veronica Miller - Forum for Collaborative HIV Research