Safety and efficacy of tenofovir/IQP-0528 combination gels – A dual compartment microbicide for HIV-1 prevention
► Tenofovir/IQP-0528 microbicide combination gels were tested for safety and efficacy. ► Polarized ectocervical and colorectal tissues were used to evaluate these gels. ► Combination gels were safe toward mucosal tissue and blocked HIV infection. ► These gels provide the foundation of a dual compart...
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| Veröffentlicht in: | Antiviral research 2012-11, Vol.96 (2), p.221-225 |
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| creator | Dezzutti, Charlene S. Shetler, Cory Mahalingam, Alamelu Ugaonkar, Shweta R. Gwozdz, Garry Buckheit, Karen W. Buckheit, Robert W. |
| description | ► Tenofovir/IQP-0528 microbicide combination gels were tested for safety and efficacy. ► Polarized ectocervical and colorectal tissues were used to evaluate these gels. ► Combination gels were safe toward mucosal tissue and blocked HIV infection. ► These gels provide the foundation of a dual compartment, combination product microbicide.
Tenofovir (TFV) is a nucleotide reverse transcriptase inhibitor and IQP-0528 is a non-nucleoside reverse transcriptase inhibitor that also blocks virus entry. TFV and IQP-0528 alone have shown antiviral activity as microbicide gels. Because combination therapy will likely be more potent than mono-therapy, these drugs have been chosen to make a combination microbicide gel containing 2.5% TFV/1% IQP-0528. Safety and efficacy testing was done to evaluate five prototype combination gels. The gels retained TZM-bl cell and ectocervical and colorectal tissue viability. Further, the epithelium of the ectocervical and colorectal tissue remained intact after a 24h exposure. The ED50 calculated from the formulations for IQP-0528 was ∼32nM and for TFV was ∼59nM and their inhibitory activity was not affected by semen. The ED50 of TFV in the combination gels was ∼100-fold lower than when calculated for the drug substance alone reflecting the activity of the more potent IQP-0528. When ectocervical and colorectal tissue were treated with the combination gels, HIV-1 p24 release was reduced by ⩾1log10 and ⩾2log10, respectively. Immunohistochemistry for the ectocervical tissues treated with combination gels showed no HIV-1 infected cells at study end. With the increased realization of receptive anal intercourse among heterosexual couples often in conjunction with vaginal intercourse, having a safe and effective microbicide for both mucosal sites is critical. The safety and efficacy profiles of the gels were similar for ectocervical and colorectal tissues suggesting these gels have the potential for dual compartment use. |
| doi_str_mv | 10.1016/j.antiviral.2012.08.004 |
| format | Article |
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Tenofovir (TFV) is a nucleotide reverse transcriptase inhibitor and IQP-0528 is a non-nucleoside reverse transcriptase inhibitor that also blocks virus entry. TFV and IQP-0528 alone have shown antiviral activity as microbicide gels. Because combination therapy will likely be more potent than mono-therapy, these drugs have been chosen to make a combination microbicide gel containing 2.5% TFV/1% IQP-0528. Safety and efficacy testing was done to evaluate five prototype combination gels. The gels retained TZM-bl cell and ectocervical and colorectal tissue viability. Further, the epithelium of the ectocervical and colorectal tissue remained intact after a 24h exposure. The ED50 calculated from the formulations for IQP-0528 was ∼32nM and for TFV was ∼59nM and their inhibitory activity was not affected by semen. The ED50 of TFV in the combination gels was ∼100-fold lower than when calculated for the drug substance alone reflecting the activity of the more potent IQP-0528. When ectocervical and colorectal tissue were treated with the combination gels, HIV-1 p24 release was reduced by ⩾1log10 and ⩾2log10, respectively. Immunohistochemistry for the ectocervical tissues treated with combination gels showed no HIV-1 infected cells at study end. With the increased realization of receptive anal intercourse among heterosexual couples often in conjunction with vaginal intercourse, having a safe and effective microbicide for both mucosal sites is critical. The safety and efficacy profiles of the gels were similar for ectocervical and colorectal tissues suggesting these gels have the potential for dual compartment use.</description><identifier>ISSN: 0166-3542</identifier><identifier>EISSN: 1872-9096</identifier><identifier>DOI: 10.1016/j.antiviral.2012.08.004</identifier><identifier>PMID: 22940075</identifier><identifier>CODEN: ARSRDR</identifier><language>eng</language><publisher>Kidlington: Elsevier B.V</publisher><subject>Adenine - analogs & derivatives ; Adenine - pharmacology ; Adenine - toxicity ; Administration, Mucosal ; Anti-Infective Agents - pharmacology ; Anti-Infective Agents - toxicity ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Biological and medical sciences ; Cell Line ; Cell Survival - drug effects ; Chemoprevention - methods ; Combination microbicide ; Drug Therapy, Combination - methods ; Female ; HIV Infections - prevention & control ; HIV prevention ; HIV-1 - drug effects ; Human immunodeficiency virus 1 ; Human viral diseases ; Humans ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunopathology ; Infectious diseases ; Medical sciences ; Organophosphonates - pharmacology ; Organophosphonates - toxicity ; Pharmacology. Drug treatments ; Pyrimidinedione ; Pyrimidinones - pharmacology ; Pyrimidinones - toxicity ; Rectal microbicide ; Tenofovir ; Tissue Culture Techniques ; Topical gel ; Vaginal Creams, Foams, and Jellies - pharmacology ; Vaginal Creams, Foams, and Jellies - toxicity ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids</subject><ispartof>Antiviral research, 2012-11, Vol.96 (2), p.221-225</ispartof><rights>2012 Elsevier B.V.</rights><rights>2014 INIST-CNRS</rights><rights>Copyright © 2012 Elsevier B.V. All rights reserved.</rights><rights>2012 Elsevier B.V. All rights reserved 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c538t-868dc227deff3dde9f07e959cbce2db80838d6c627ec4d5b7b8a30ec5f9203453</citedby><cites>FETCH-LOGICAL-c538t-868dc227deff3dde9f07e959cbce2db80838d6c627ec4d5b7b8a30ec5f9203453</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0166354212001891$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26679349$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22940075$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dezzutti, Charlene S.</creatorcontrib><creatorcontrib>Shetler, Cory</creatorcontrib><creatorcontrib>Mahalingam, Alamelu</creatorcontrib><creatorcontrib>Ugaonkar, Shweta R.</creatorcontrib><creatorcontrib>Gwozdz, Garry</creatorcontrib><creatorcontrib>Buckheit, Karen W.</creatorcontrib><creatorcontrib>Buckheit, Robert W.</creatorcontrib><title>Safety and efficacy of tenofovir/IQP-0528 combination gels – A dual compartment microbicide for HIV-1 prevention</title><title>Antiviral research</title><addtitle>Antiviral Res</addtitle><description>► Tenofovir/IQP-0528 microbicide combination gels were tested for safety and efficacy. ► Polarized ectocervical and colorectal tissues were used to evaluate these gels. ► Combination gels were safe toward mucosal tissue and blocked HIV infection. ► These gels provide the foundation of a dual compartment, combination product microbicide.
Tenofovir (TFV) is a nucleotide reverse transcriptase inhibitor and IQP-0528 is a non-nucleoside reverse transcriptase inhibitor that also blocks virus entry. TFV and IQP-0528 alone have shown antiviral activity as microbicide gels. Because combination therapy will likely be more potent than mono-therapy, these drugs have been chosen to make a combination microbicide gel containing 2.5% TFV/1% IQP-0528. Safety and efficacy testing was done to evaluate five prototype combination gels. The gels retained TZM-bl cell and ectocervical and colorectal tissue viability. Further, the epithelium of the ectocervical and colorectal tissue remained intact after a 24h exposure. The ED50 calculated from the formulations for IQP-0528 was ∼32nM and for TFV was ∼59nM and their inhibitory activity was not affected by semen. The ED50 of TFV in the combination gels was ∼100-fold lower than when calculated for the drug substance alone reflecting the activity of the more potent IQP-0528. When ectocervical and colorectal tissue were treated with the combination gels, HIV-1 p24 release was reduced by ⩾1log10 and ⩾2log10, respectively. Immunohistochemistry for the ectocervical tissues treated with combination gels showed no HIV-1 infected cells at study end. With the increased realization of receptive anal intercourse among heterosexual couples often in conjunction with vaginal intercourse, having a safe and effective microbicide for both mucosal sites is critical. The safety and efficacy profiles of the gels were similar for ectocervical and colorectal tissues suggesting these gels have the potential for dual compartment use.</description><subject>Adenine - analogs & derivatives</subject><subject>Adenine - pharmacology</subject><subject>Adenine - toxicity</subject><subject>Administration, Mucosal</subject><subject>Anti-Infective Agents - pharmacology</subject><subject>Anti-Infective Agents - toxicity</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiviral agents</subject><subject>Biological and medical sciences</subject><subject>Cell Line</subject><subject>Cell Survival - drug effects</subject><subject>Chemoprevention - methods</subject><subject>Combination microbicide</subject><subject>Drug Therapy, Combination - methods</subject><subject>Female</subject><subject>HIV Infections - prevention & control</subject><subject>HIV prevention</subject><subject>HIV-1 - drug effects</subject><subject>Human immunodeficiency virus 1</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunodeficiencies</subject><subject>Immunodeficiencies. Immunoglobulinopathies</subject><subject>Immunopathology</subject><subject>Infectious diseases</subject><subject>Medical sciences</subject><subject>Organophosphonates - pharmacology</subject><subject>Organophosphonates - toxicity</subject><subject>Pharmacology. Drug treatments</subject><subject>Pyrimidinedione</subject><subject>Pyrimidinones - pharmacology</subject><subject>Pyrimidinones - toxicity</subject><subject>Rectal microbicide</subject><subject>Tenofovir</subject><subject>Tissue Culture Techniques</subject><subject>Topical gel</subject><subject>Vaginal Creams, Foams, and Jellies - pharmacology</subject><subject>Vaginal Creams, Foams, and Jellies - toxicity</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><issn>0166-3542</issn><issn>1872-9096</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc-O0zAQhyMEYsvCK4AvSFySHdtx4lyQqtXCVloJEH-ulmOPF1dJXOy0Um-8A2_Ik-CqpcCJkw_zzcxv_BXFCwoVBdpcrSs9zX7nox4qBpRVICuA-kGxoLJlZQdd87BYZLIpuajZRfEkpTUANG0nHxcXjHU1QCsWRfyoHc57oidL0DlvtNmT4MiMU3AhL7hafXhfgmCSmDD2ftKzDxO5xyGRn99_kCWxWz0cahsd5xGnmYzexNB74y0SFyK5XX0pKdlE3OVqbn5aPHJ6SPjs9F4Wn9_cfLq-Le_evV1dL-9KI7icS9lIaxhrbY7FrcXOQYud6ExvkNleguTSNqZhLZrair7tpeaARriOAa8FvyxeH-dutv2I1uTt-bvUJvpRx70K2qt_K5P_qu7DTnEBVLRNHvDqNCCGb1tMsxp9MjgMesKwTYpyJgUFzrqMtkc0n55SRHdeQ0EdjKm1OhtTB2MKpMrGcufzv1Oe-34rysDLE6CT0YOLejI-_eGa7JTXhwjLI5fV4M5jVMl4nAxaH9HMygb_3zC_AEOVu58</recordid><startdate>20121101</startdate><enddate>20121101</enddate><creator>Dezzutti, Charlene S.</creator><creator>Shetler, Cory</creator><creator>Mahalingam, Alamelu</creator><creator>Ugaonkar, Shweta R.</creator><creator>Gwozdz, Garry</creator><creator>Buckheit, Karen W.</creator><creator>Buckheit, Robert W.</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>5PM</scope></search><sort><creationdate>20121101</creationdate><title>Safety and efficacy of tenofovir/IQP-0528 combination gels – A dual compartment microbicide for HIV-1 prevention</title><author>Dezzutti, Charlene S. ; Shetler, Cory ; Mahalingam, Alamelu ; Ugaonkar, Shweta R. ; Gwozdz, Garry ; Buckheit, Karen W. ; Buckheit, Robert W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c538t-868dc227deff3dde9f07e959cbce2db80838d6c627ec4d5b7b8a30ec5f9203453</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adenine - analogs & derivatives</topic><topic>Adenine - pharmacology</topic><topic>Adenine - toxicity</topic><topic>Administration, Mucosal</topic><topic>Anti-Infective Agents - pharmacology</topic><topic>Anti-Infective Agents - toxicity</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiviral agents</topic><topic>Biological and medical sciences</topic><topic>Cell Line</topic><topic>Cell Survival - drug effects</topic><topic>Chemoprevention - methods</topic><topic>Combination microbicide</topic><topic>Drug Therapy, Combination - methods</topic><topic>Female</topic><topic>HIV Infections - prevention & control</topic><topic>HIV prevention</topic><topic>HIV-1 - drug effects</topic><topic>Human immunodeficiency virus 1</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immunodeficiencies</topic><topic>Immunodeficiencies. Immunoglobulinopathies</topic><topic>Immunopathology</topic><topic>Infectious diseases</topic><topic>Medical sciences</topic><topic>Organophosphonates - pharmacology</topic><topic>Organophosphonates - toxicity</topic><topic>Pharmacology. Drug treatments</topic><topic>Pyrimidinedione</topic><topic>Pyrimidinones - pharmacology</topic><topic>Pyrimidinones - toxicity</topic><topic>Rectal microbicide</topic><topic>Tenofovir</topic><topic>Tissue Culture Techniques</topic><topic>Topical gel</topic><topic>Vaginal Creams, Foams, and Jellies - pharmacology</topic><topic>Vaginal Creams, Foams, and Jellies - toxicity</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dezzutti, Charlene S.</creatorcontrib><creatorcontrib>Shetler, Cory</creatorcontrib><creatorcontrib>Mahalingam, Alamelu</creatorcontrib><creatorcontrib>Ugaonkar, Shweta R.</creatorcontrib><creatorcontrib>Gwozdz, Garry</creatorcontrib><creatorcontrib>Buckheit, Karen W.</creatorcontrib><creatorcontrib>Buckheit, Robert W.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Antiviral research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dezzutti, Charlene S.</au><au>Shetler, Cory</au><au>Mahalingam, Alamelu</au><au>Ugaonkar, Shweta R.</au><au>Gwozdz, Garry</au><au>Buckheit, Karen W.</au><au>Buckheit, Robert W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and efficacy of tenofovir/IQP-0528 combination gels – A dual compartment microbicide for HIV-1 prevention</atitle><jtitle>Antiviral research</jtitle><addtitle>Antiviral Res</addtitle><date>2012-11-01</date><risdate>2012</risdate><volume>96</volume><issue>2</issue><spage>221</spage><epage>225</epage><pages>221-225</pages><issn>0166-3542</issn><eissn>1872-9096</eissn><coden>ARSRDR</coden><abstract>► Tenofovir/IQP-0528 microbicide combination gels were tested for safety and efficacy. ► Polarized ectocervical and colorectal tissues were used to evaluate these gels. ► Combination gels were safe toward mucosal tissue and blocked HIV infection. ► These gels provide the foundation of a dual compartment, combination product microbicide.
Tenofovir (TFV) is a nucleotide reverse transcriptase inhibitor and IQP-0528 is a non-nucleoside reverse transcriptase inhibitor that also blocks virus entry. TFV and IQP-0528 alone have shown antiviral activity as microbicide gels. Because combination therapy will likely be more potent than mono-therapy, these drugs have been chosen to make a combination microbicide gel containing 2.5% TFV/1% IQP-0528. Safety and efficacy testing was done to evaluate five prototype combination gels. The gels retained TZM-bl cell and ectocervical and colorectal tissue viability. Further, the epithelium of the ectocervical and colorectal tissue remained intact after a 24h exposure. The ED50 calculated from the formulations for IQP-0528 was ∼32nM and for TFV was ∼59nM and their inhibitory activity was not affected by semen. The ED50 of TFV in the combination gels was ∼100-fold lower than when calculated for the drug substance alone reflecting the activity of the more potent IQP-0528. When ectocervical and colorectal tissue were treated with the combination gels, HIV-1 p24 release was reduced by ⩾1log10 and ⩾2log10, respectively. Immunohistochemistry for the ectocervical tissues treated with combination gels showed no HIV-1 infected cells at study end. With the increased realization of receptive anal intercourse among heterosexual couples often in conjunction with vaginal intercourse, having a safe and effective microbicide for both mucosal sites is critical. The safety and efficacy profiles of the gels were similar for ectocervical and colorectal tissues suggesting these gels have the potential for dual compartment use.</abstract><cop>Kidlington</cop><pub>Elsevier B.V</pub><pmid>22940075</pmid><doi>10.1016/j.antiviral.2012.08.004</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Antiviral research, 2012-11, Vol.96 (2), p.221-225 |
| issn | 0166-3542 1872-9096 |
| language | eng |
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| subjects | Adenine - analogs & derivatives Adenine - pharmacology Adenine - toxicity Administration, Mucosal Anti-Infective Agents - pharmacology Anti-Infective Agents - toxicity Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Biological and medical sciences Cell Line Cell Survival - drug effects Chemoprevention - methods Combination microbicide Drug Therapy, Combination - methods Female HIV Infections - prevention & control HIV prevention HIV-1 - drug effects Human immunodeficiency virus 1 Human viral diseases Humans Immunodeficiencies Immunodeficiencies. Immunoglobulinopathies Immunopathology Infectious diseases Medical sciences Organophosphonates - pharmacology Organophosphonates - toxicity Pharmacology. Drug treatments Pyrimidinedione Pyrimidinones - pharmacology Pyrimidinones - toxicity Rectal microbicide Tenofovir Tissue Culture Techniques Topical gel Vaginal Creams, Foams, and Jellies - pharmacology Vaginal Creams, Foams, and Jellies - toxicity Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids |
| title | Safety and efficacy of tenofovir/IQP-0528 combination gels – A dual compartment microbicide for HIV-1 prevention |
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