FDA Issues New Guidance on New HIV Antiretroviral Drugs

Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.

Nov. 2 — Antiretroviral drugs to treat HIV no longer need to follow a pathway of accelerated approval followed by traditional approval by the FDA, “[g]iven that HIV-RNA is a validated surrogate for predicting efficacy of antiretrovirals,” according to agency guidance issued Nov. 2.

The guidance document “Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment” is designed to help sponsors in all phases of drug development to treat patients who already have HIV, including clinical trial designs for HIV patients who are taking multiple drug combinations and have few remaining treatment options. The Food and Drug Administration said the guidance doesn't address drugs that are designed to prevent the transmission of HIV-1 infection, nor does it address the development of therapeutics intended to mitigate or reverse clinical or pathophysiological outcomes of immunologic suppression caused by HIV-1 infection.

“[A] paradigm of accelerated approval (based on viral load changes at 24 weeks) followed by traditional approval (based on viral load changes at 48 weeks) is no longer needed for the development of antiretrovirals. Instead traditional approval can be the initial approval for all antiretroviral drugs, with the duration of viral load assessments dependent on the population studied, as will be described in this guidance,” the guidance said.

The guidance finalizes a draft version issued in June 2013 (7 LSLR 649, 6/14/13). According to a Federal Register notice set to be published Nov. 3, the FDA said it made changes from the draft version to:

• clarify definitions of treatment-naïve and treatment-experienced patient categories with respect to both drug susceptibility and clinical history;

• add recommendations for trial designs that investigate switching treatment regimens in patients who are suppressed on current therapy; and

• briefly discuss recommendations for labeling claims for safety endpoints.


The new guidance also replaces an October 2002 document, “Antiretroviral Drugs Using Plasma HIV RNA Measurements—Clinical Considerations for Accelerated and Traditional Approval.” When issuing the draft version of the guidance two years ago, the FDA said it was updating its guidance to place a greater emphasis on recommended trial designs for HIV-1 infected heavily treatment-experienced patients, among other changes, and provide more details on nonclinical development of these drugs.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bna.com

To contact the editor responsible for this story: Nancy Simmons at nsimmons@bna.com

The new guidance is available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm355128.pdf.

The Federal Register notice is at http://src.bna.com/RL.

Request Health Care on Bloomberg Law