Long-Term Data Reinforce Safety and Efficacy Profile of Pfizer's New HIV Drug

PfizerNearly three times as many patients receiving Selzentry, in addition to an optimized background regimen, achieved undetectable levels of HIV virus compared with those receiving an optimized regimen alone, according to 48 week data presented today in late-breaking sessions at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting. This newly approved CCR5 antagonist - the first new class of oral HIV medicines introduced in more than ten years - is now available throughout the U.S.

"These data continue to demonstrate that Selzentry provides significant benefit to certain treatment-experienced patients," said Dr. Jacob Lalezari, director, Quest Clinical Research and Assistant Clinical Professor of Medicine, University of California, San Francisco. "The safety and durability of response seen with Selzentry out to one year in our study is reassuring. This drug is an important new weapon for clinicians who treat HIV."

Results from the planned 48-week analysis also demonstrated that Selzentry, along with an optimized background regimen, significantly increased CD4 cells, as compared to patients receiving an optimized regimen alone. The adverse event profile observed in this analysis in patients receiving Selzentry was similar to those receiving an optimized regimen alone. The most common adverse events reported included diarrhea, nausea, fatigue and headache.

This longer-term analysis is consistent with the pre-planned 24-week analyses that formed the basis of Selzentry’s accelerated U.S. approval in August for CCR5-tropic treatment-experienced patients. The 48-week data are under review by the U.S. Food and Drug Administration (FDA) for consideration of full approval of Selzentry for these patients.

Selzentry is now available in the U.S., and Pfizer is working with private and public payors to secure coverage and reimbursement for this novel and potentially life-saving medicine. Pfizer has also recently included Selzentry as part of a robust patient-assistance program to help patients who may experience difficulties accessing this medicine. For patients who qualify, the program offers a range of services, such as benefits verification and reimbursement case management, designed to meet the unique needs of those taking specialty products.

Selzentry is the first in a class of drugs known as CCR5 antagonists, which block the CCR5 co-receptor, the virus' predominant entry route into T-cells. Selzentry stops the R5 virus on the outside surface of the cells before it enters, rather than fighting the virus inside as do all other classes of oral HIV medicines. In the U.S., Selzentry is indicated for combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1 detectable, who have evidence of viral replication and have HIV-1 strains resistant to multiple antiretroviral agents. A diagnostic test confirms whether a patient is infected with CCR5-tropic HIV-1, which is also known as, "R5-virus."

The company is currently submitting marketing applications around the world and recently received a positive opinion from the CHMP in the EU. Pfizer intends to commercialize the product with the name Celsentri outside of the U.S.

Pfizer is committed to bringing meaningful improvement to the lives of people living with HIV/AIDS. In April 2007, Pfizer launched ConnectHIV, a three-year initiative that will provide $7.5 million in grants and capacity building to twenty community-based AIDS Service Organizations in communities of greatest need in the U.S. ConnectHIV grantee organizations were chosen based on a demonstrated commitment to comprehensive approaches to improving HIV prevention efforts in underserved populations.

For full prescribing information for Selzentry, including boxed warning, go to www.Selzentry.com.

For more information on Pfizer's patient assistance program, visit the RSVP section of www.PfizerHelpfulAnswers.com.

Most Popular Now

Most popular vitamin and mineral supplements provi…

The most commonly consumed vitamin and mineral supplements provide no consistent health benefit or harm, suggests a new study led by researchers at St. Michael's Hospital...

AstraZeneca heads to 2018 ASCO Annual Meeting with…

AstraZeneca and MedImmune, its global biologics research and development arm, head to the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US...

Tiny particles could help fight brain cancer

Glioblastoma multiforme, a type of brain tumor, is one of the most difficult-to-treat cancers. Only a handful of drugs are approved to treat glioblastoma, and the median ...

New approach to immunotherapy leads to complete re…

A novel approach to immunotherapy developed by researchers at the National Cancer Institute (NCI) has led to the complete regression of breast cancer in a patient who was...

Spiolto® Respimat® enables greater physical activi…

Boehringer Ingelheim announced data which add to the growing body of evidence that show Spiolto® (tiotropium/olodaterol) Respimat® enables greater physical activity in pa...

Amgen Foundation and Harvard team up to offer free…

The Amgen Foundation and Harvard University today announced plans to launch a free online science education platform uniquely designed to level the playing field for aspi...

The Pfizer Foundation announces $5 million in gran…

The Pfizer Foundation announced a new $5 million grant commitment to initiatives in low- and middle-income countries that provide family planning access and education for...

Study finds antioxidant-enriched vitamin reduces r…

Researchers at Children's Hospital Colorado (Children's Colorado) and the University of Colorado School of Medicine have found that taking a specially formulated antioxid...

New drugs could also be deployed against lung and …

A new anti-cancer drug may be effective against a wider range of cancers than previously thought. Using a mouse model and samples taken from cancer patients, a team from ...

What would help or hinder patient participation in…

As clinical trials gear up with the aim of attaining the first FDA-approved treatments for mitochondrial disease, a new study reports for the first time what patients and...

Pfizer to expand venture investing with $600 milli…

Pfizer Inc. (NYSE:PFE) today announced it plans to invest $600 million in biotechnology and other emerging growth companies through Pfizer Ventures, the company’s venture...

Update on Phase III clinical trials of lanabecesta…

AstraZeneca and Eli Lilly and Company (Lilly) are discontinuing the global Phase III clinical trials of lanabecestat, an oral beta secretase cleaving enzyme (BACE) inhibi...