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The Antiretroviral Pregnancy Registry THE ANTIRETROVIRAL PREGNANCY REGISTRY Interim Report For ABACAVIR (ZIAGEN ®, ABC) ABACAVIR+LAMIVUDINE (EPZICOM ®, EPZ) ABACAVIR+LAMIVUDINE+ZIDOVUDINE (TRIZIVIR ®, TZV) ADEFOVIR DIPIVOXIL (HEPSERA ®, ADV) AMPRENAVIR (AGENERASE®, APV) ATAZANAVIR SULFATE (REYATAZ ®, ATV) DARUNAVIR (PREZISTA™, DRV) DELAVIRDINE MESYLATE (RESCRIPTOR ®, DLV) DIDANOSINE (VIDEX ®, VIDEX ® EC, ddI) EFAVIRENZ (SUSTIVA ®, STOCRIN ®, EFV) EFAVIRENZ+EMTRICITABINE+TENOFOVIR DISOPROXIL FUMARATE (ATRIPLA™, ATR) EMTRICITABINE (EMTRIVA ®, FTC) ENFUVIRTIDE (FUZEON ®, T-20) ENTECAVIR (BARACLUDE ®, ETV) ETRAVIRINE (INTELENCE TM , ETR) FOSAMPRENAVIR CALCIUM (LEXIVA ®, FOS) INDINAVIR (CRIXIVAN ®, IDV) LAMIVUDINE (EPIVIR ®, 3TC) LAMIVUDINE+ZIDOVUDINE (COMBIVIR ®, ZDV+3TC) LOPINAVIR+RITONAVIR (KALETRA ®, ALUVIA ®, LPV/r) MARAVIROC (SELZENTRY TM, CELSENTRI™, MVC) NELFINAVIR (VIRACEPT ®, NFV) NEVIRAPINE (VIRAMUNE ®, NVP) RALTEGRAVIR (ISENTRESS TM , RAL) RITONAVIR (NORVIR ®, RTV) SAQUINAVIR (FORTOVASE®, SQV-SGC) (FORTOVASE NO LONGER MANUFACTURED AS OF 6 JULY 06) SAQUINAVIR MESYLATE (INVIRASE ®, SQV-HGC) STAVUDINE (ZERIT ®, d4T) TELBIVUDINE (SEBIVO ®, TYZEKA ®, LdT) TENOFOVIR DISOPROXIL FUMARATE (VIREAD ®, TDF) TENOFOVIR DISOPROXIL FUMARATE+EMTRICITABINE (TRUVADA®, TVD) TIPRANAVIR (APTIVUS ®, TPV) ZALCITABINE (HIVID ®, ddC) (HIVID NO LONGER MANUFACTURED AS OF 12 DEC 06) ZIDOVUDINE (RETROVIR ®, ZDV) 1 JANUARY 1989 THROUGH 31 JANUARY 2008 (Issued: June 2008) A Collaborative Project Managed by Kendle International Inc for: Abbott Laboratories, Agouron Pharmaceuticals/Pfizer Inc, Aurobindo Pharma Ltd, Barr Laboratories Inc, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Cipla Ltd, Gilead Sciences Inc, GlaxoSmithKline, Hetero USA, Merck & Company Inc, Mylan Laboratories, Novartis Pharmaceuticals, Ranbaxy Inc, Roche, Tibotec BVBA POLICY FOR PRESENTATION OF DATA The sponsors encourage the responsible sharing of the information contained in this report with health professionals who might benefit. In an attempt to standardize dissemination and interpretation of the data, the following guidelines have been developed: 1. The data contained in this report will become out-of-date within 6 months of the report’s issue date. Please contact the Antiretroviral Pregnancy Registry (800-258-4263) to ensure you have obtained the most recently published report. 2. The data in Table 4 (pregnancy exposure in the first trimester and outcome by treatment regimen) are the most appropriate for presentation of therapy results. Presentation of results stratified by earliest trimester of exposure is imperative. Retrospectively collected data are useful for detecting patterns of defects, but are subject to biases as described in the report; thus these data must not be compared to background rates in the general population . 3. The Advisory Committee Consensus statement (page 5) must be included with any presentation of these data, including emphasis on the limitations of voluntary prenatal drug exposure registries such as this one. 4. When presenting data from the Registry please present Registry contact information and remind the audience that success of the Registry depends on reporting of exposures by health care professionals. 5. Please contact the Antiretroviral Pregnancy Registry staff if you have any questions, see contact information below. Suggested Citation Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry International Interim Report for 1 January 1989 through 31 January 2008. Wilmington, NC: Registry Coordinating Center; 2008. Available from URL: www.APRegistry.com. REGISTRY COORDINATING CENTER THE ANTIRETROVIRAL PREGNANCY REGISTRY RESEARCH PARK 1011 ASHES DRIVE WILMINGTON, NC 28405 US, CANADA (toll-free): (800) 258-4263 (Telephone) (800) 800-1052 (Fax) INTERNATIONAL: +1-910-256-0238 (Telephone) +1-910-256-0637 (Fax) UK, GERMANY, FRANCE (toll-free): (00800) 5913-1359 (Telephone) (00800) 5812-1658 (Fax) EUROPE: +32-2-714-5028 (Telephone) +32-2-714-5024 (Fax) www.APRegistry.com Note to Patients: This report was developed to provide you and your treating doctor with information to help guide your treatment. Please discuss any concerns or questions with your doctor. TABLE OF CONTENTS FOREWORD.................................................................................................................................................iii EXECUTIVE SUMMARY............................................................................................................................... 1 Background........................................................................................................................................... 1 Data Summary.................................................................................................................................... 2 Supplemental Analyses ...................................................................................................................... 3 Data Limitations .................................................................................................................................. 4 ADVISORY COMMITTEE CONSENSUS ................................................................................................ 5 INTRODUCTION ..................................................................................................................................... 6 REGISTRY (PROSPECTIVE) CASES – PRIMARY ANALYSIS................................................................... 9 Table 1: Population for Analysis − Prospective Registry Cases Enrolled Through 31 January 2008 .................................................................................................................................... 9 Table 2: Maternal Demographics at Registration − Prospective Registry Cases Closed Through 31 January 2008................................................................................................................ 10 Table 3: Summary of Antiretroviral Treatment Classes [1] by Trimester of Earliest Exposure [2] - – Prospective Registry Cases with Follow-up Data Closed Through 31 January 2008 .... 11 Listing 1: Listing of Birth Defect Cases with Didanosine Exposure −−− Prospective Registry Cases with Follow-up Data Closed Through 31 January 2008 .................................................... 14 Table 4: Summary of Pregnancy Outcomes [1] By Antiretroviral Treatment Regimen [2] − Prospective Registry Cases with Follow-up Data Closed Through 31 January 2008 ....... 15 Table 5: Number of Birth Defects [1] By Trimester of Earliest Exposure to Each Drug − Prospective Registry Cases with Follow-Up Data Closed Through 31 January 2008....... 16 Table 6: Summary of Birth Defects [1] By Organ System and Antiretroviral Treatment Regimen - All Prospective Registry Cases with Follow-up Data Closed Through 31 January 2008 .. 17 Table 7: Confidence Intervals for Birth Defects [1] − All Prospective Registry Cases with Follow- up Data Closed Through 31 January 2008 ....................................................................... 18 RETROSPECTIVE REPORTS ................................................................................................................... 19 REPORTS FROM CLINICAL STUDIES IN PREGNANCY......................................................................... 19 Table 8: Maternal Demographics at Registration − Reports from Clinical Studies in Pregnancy with Follow-up Data Closed 31 January 2008................................................................... 22 Table 9: Summary of Treatment Classes [1] by Trimester of Earliest Exposure [2] − Reports from Clinical Studies in Pregnancy with Follow-Up Data Closed Through 31 January 2008 .................................................................................................................................. 22 Table 10: Summary of Pregnancy Outcomes [1] By Antiretroviral Treatment Regimen [2] − Reports from Clinical Studies in Pregnancy with Follow-up Data Closed Through 31 January 2008..................................................................................................................... 24 Table 11: Summary of Clinical Study Reports of Birth Defects [1] By Organ System and Treatment Regimen − First Trimester Exposures. All Reports with Follow-up Data Closed Through 31 January 2008..................................................................................... 25 Table 12: Confidence Intervals for Birth Defects [1] - Reports from Clinical Studies in Pregnancy with Follow-up Data Closed Through 31 January 2008 .................................................... 26 REPORTS FROM THE PUBLISHED LITERATURE .................................................................................. 27 Table 13: European Collaborative Study Data: Summary of Birth Defects by Organ System and Treatment Regimen – First Trimester Exposures. Data Reporting Period December 1984 – March 2007 ........................................................................................................... 28 Table 14: European Collaborative Study Data: Confidence Intervals for Birth Defects by Organ System and Treatment Regimen. ................................................................................... 29 Table 15: United Kingdom and Ireland Surveillance Data: Summary of Birth Defects by Organ System and Treatment Regimen – First Trimester Exposures. ...................................... 30 Table 16: United Kingdom and Ireland Surveillance Data: Confidence Intervals for Birth Defects
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