Efficacy of a reduced dose of DARUNAVIR/RTV in a cohort of antiretroviral‐naïve and experienced HIV‐infected patients: a medium‐term follow‐up
Background The currently approved dose of darunavir/ritonavir is 800/100 mg once daily for PI‐naïve patients, and 600/100 mg twice daily for PI‐pretreated patients. However, in DRV‐sensitive patients at baseline in the POWER 1/2 trials, similar rates of HIV RNA suppression (1 log reduction) were ach...
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| Veröffentlicht in: | Journal of the International AIDS Society 2014-11, Vol.17 (4 Suppl 3), p.19822-n/a |
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| creator | Lanzafame, Massimiliano Lattuada, Emanuela Rigo, Fabio Hill, Andrew Vento, Sandro |
| description | Background
The currently approved dose of darunavir/ritonavir is 800/100 mg once daily for PI‐naïve patients, and 600/100 mg twice daily for PI‐pretreated patients. However, in DRV‐sensitive patients at baseline in the POWER 1/2 trials, similar rates of HIV RNA suppression (1 log reduction) were achieved with doses ranging from 400/100 mg once daily to 600/100 mg twice daily. In previously virologically suppressed patients, a reduced dose of DRV (600/100 QD) is non‐inferior to the standard dose (800 mg QD)[1] and DRV concentrations in plasma and CSF are similar in patients receiving the above different doses [1, 2].
Methods
Twelve treatment‐naïve patients were started on darunavir/ritonavir 600/100mg once daily, with TDF/FTC (8) or ABC/3TC (4). Seven patients were switched to darunavir/ritonavir 600/100 mg once daily, with TDF/FTC (2), ABC/3TC (2), NVP (1), AZT/3TC (1). One was on monotherapy with DRV. Seven treatment‐experienced patients were switched to darunavir/ritonavir 600/100 mg once daily, with TDF/FTC (5), ABC/3TC (1), RAL (1).
Results
Of the 12 naïve patients (mean baseline HIV RNA 134,024 log10 copies/mL, range 4,256‐397,932), 11 had HIV RNA |
| doi_str_mv | 10.7448/IAS.17.4.19822 |
| format | Article |
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The currently approved dose of darunavir/ritonavir is 800/100 mg once daily for PI‐naïve patients, and 600/100 mg twice daily for PI‐pretreated patients. However, in DRV‐sensitive patients at baseline in the POWER 1/2 trials, similar rates of HIV RNA suppression (1 log reduction) were achieved with doses ranging from 400/100 mg once daily to 600/100 mg twice daily. In previously virologically suppressed patients, a reduced dose of DRV (600/100 QD) is non‐inferior to the standard dose (800 mg QD)[1] and DRV concentrations in plasma and CSF are similar in patients receiving the above different doses [1, 2].
Methods
Twelve treatment‐naïve patients were started on darunavir/ritonavir 600/100mg once daily, with TDF/FTC (8) or ABC/3TC (4). Seven patients were switched to darunavir/ritonavir 600/100 mg once daily, with TDF/FTC (2), ABC/3TC (2), NVP (1), AZT/3TC (1). One was on monotherapy with DRV. Seven treatment‐experienced patients were switched to darunavir/ritonavir 600/100 mg once daily, with TDF/FTC (5), ABC/3TC (1), RAL (1).
Results
Of the 12 naïve patients (mean baseline HIV RNA 134,024 log10 copies/mL, range 4,256‐397,932), 11 had HIV RNA <20 c/mL after a mean 27.4 months of follow‐up (range 12–33). Mean PK level was 2,920 ng/mL (1,268–4,562). One patient had virological failure after 14 months (HIV RNA 39,300 copies/mL); no mutations were detected and after introduction of DRV/r 600 mg b.i.d., he returned aviremic. All switched patients maintained HIV RNA suppression (<20 c/mL) for a mean of 32.8 months (range 21‐54). PK level was available for one patient only (Ctrough 3,442 ng/mL). Of the treatment‐experienced patients (mean baseline HIV RNA 24,167 log10 copies/mL, range 112–111,426), five maintained HIV RNA suppression for a mean of 46.2 months (range 31–67). One patient interrupted HAART for three months and then restarted it, the latest HIV RNA level being 628 copies/mL after five weeks of therapy. One patient failed after 42 months (HIV RNA 3,930 copies/mL); after intensification (DRV/r 600 twice daily), he returned aviremic. PK levels were available for three patients (mean 2,502 ng/mL; range 844–4,518).
Conclusions
In this pilot study of 26 patients, use of DRV/r at 600/100 mg OD dose led to sustained HIV RNA suppression in 23 patients with acceptable PK exposures to DRV. Large non‐inferiority trials are warranted to establish its efficacy.</description><identifier>ISSN: 1758-2652</identifier><identifier>EISSN: 1758-2652</identifier><identifier>DOI: 10.7448/IAS.17.4.19822</identifier><identifier>PMID: 25397566</identifier><language>eng</language><publisher>Switzerland: International AIDS Society</publisher><subject>Acquired immune deficiency syndrome ; AIDS ; Antiretroviral agents ; Antiretroviral drugs ; Beliefs, opinions and attitudes ; Care and treatment ; Darunavir ; Dosage and administration ; HIV ; HIV patients ; Human immunodeficiency virus ; Immunosuppression ; Methods ; Patients ; Ritonavir</subject><ispartof>Journal of the International AIDS Society, 2014-11, Vol.17 (4 Suppl 3), p.19822-n/a</ispartof><rights>2014 Lanzafame M et al; licensee International AIDS Society</rights><rights>COPYRIGHT 2014 John Wiley & Sons, Inc.</rights><rights>2014. This work is published under http://creativecommons.org/licenses/by/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2014 Lanzafame M et al; licensee International AIDS Society 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4722-7a423a13d9fe17a2b532682cfbc83fc19c386d37c0aff5b27eb389686eed203</citedby><cites>FETCH-LOGICAL-c4722-7a423a13d9fe17a2b532682cfbc83fc19c386d37c0aff5b27eb389686eed203</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4225444/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4225444/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,1411,11541,27901,27902,45550,45551,46027,46451,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25397566$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lanzafame, Massimiliano</creatorcontrib><creatorcontrib>Lattuada, Emanuela</creatorcontrib><creatorcontrib>Rigo, Fabio</creatorcontrib><creatorcontrib>Hill, Andrew</creatorcontrib><creatorcontrib>Vento, Sandro</creatorcontrib><title>Efficacy of a reduced dose of DARUNAVIR/RTV in a cohort of antiretroviral‐naïve and experienced HIV‐infected patients: a medium‐term follow‐up</title><title>Journal of the International AIDS Society</title><addtitle>J Int AIDS Soc</addtitle><description>Background
The currently approved dose of darunavir/ritonavir is 800/100 mg once daily for PI‐naïve patients, and 600/100 mg twice daily for PI‐pretreated patients. However, in DRV‐sensitive patients at baseline in the POWER 1/2 trials, similar rates of HIV RNA suppression (1 log reduction) were achieved with doses ranging from 400/100 mg once daily to 600/100 mg twice daily. In previously virologically suppressed patients, a reduced dose of DRV (600/100 QD) is non‐inferior to the standard dose (800 mg QD)[1] and DRV concentrations in plasma and CSF are similar in patients receiving the above different doses [1, 2].
Methods
Twelve treatment‐naïve patients were started on darunavir/ritonavir 600/100mg once daily, with TDF/FTC (8) or ABC/3TC (4). Seven patients were switched to darunavir/ritonavir 600/100 mg once daily, with TDF/FTC (2), ABC/3TC (2), NVP (1), AZT/3TC (1). One was on monotherapy with DRV. Seven treatment‐experienced patients were switched to darunavir/ritonavir 600/100 mg once daily, with TDF/FTC (5), ABC/3TC (1), RAL (1).
Results
Of the 12 naïve patients (mean baseline HIV RNA 134,024 log10 copies/mL, range 4,256‐397,932), 11 had HIV RNA <20 c/mL after a mean 27.4 months of follow‐up (range 12–33). Mean PK level was 2,920 ng/mL (1,268–4,562). One patient had virological failure after 14 months (HIV RNA 39,300 copies/mL); no mutations were detected and after introduction of DRV/r 600 mg b.i.d., he returned aviremic. All switched patients maintained HIV RNA suppression (<20 c/mL) for a mean of 32.8 months (range 21‐54). PK level was available for one patient only (Ctrough 3,442 ng/mL). Of the treatment‐experienced patients (mean baseline HIV RNA 24,167 log10 copies/mL, range 112–111,426), five maintained HIV RNA suppression for a mean of 46.2 months (range 31–67). One patient interrupted HAART for three months and then restarted it, the latest HIV RNA level being 628 copies/mL after five weeks of therapy. One patient failed after 42 months (HIV RNA 3,930 copies/mL); after intensification (DRV/r 600 twice daily), he returned aviremic. PK levels were available for three patients (mean 2,502 ng/mL; range 844–4,518).
Conclusions
In this pilot study of 26 patients, use of DRV/r at 600/100 mg OD dose led to sustained HIV RNA suppression in 23 patients with acceptable PK exposures to DRV. Large non‐inferiority trials are warranted to establish its efficacy.</description><subject>Acquired immune deficiency syndrome</subject><subject>AIDS</subject><subject>Antiretroviral agents</subject><subject>Antiretroviral drugs</subject><subject>Beliefs, opinions and attitudes</subject><subject>Care and treatment</subject><subject>Darunavir</subject><subject>Dosage and administration</subject><subject>HIV</subject><subject>HIV patients</subject><subject>Human immunodeficiency virus</subject><subject>Immunosuppression</subject><subject>Methods</subject><subject>Patients</subject><subject>Ritonavir</subject><issn>1758-2652</issn><issn>1758-2652</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>BENPR</sourceid><recordid>eNqFksFu1DAQhiMEoqVw5YgiISEuu01sx044VIpKoYsqkLZlr5bXGe-6SuLFTrbsjUfgxmPwELwJT8LstpQtWoFycDzzze9_7Imip2kyFIzlh6PyfJiKIRumRU7IvWg_FVk-IDwj97f-96JHIVwmCSc5Kx5GeySjhcg434--nRhjtdKr2JlYxR6qXkMVVy7AOvK6HH98X05G48PxxSS2LSLazZ3vNnjbWQ-dd0vrVf3zy9dW_fi-BIxXMXxegLfQrsVORxNM2taA7nC7UB0muvAKxRqobN9gtgPfxMbVtbvCXb94HD0wqg7w5GY9iM7fnFwcnw7OPrwdHZdnA80EIQOhGKEqpVVhIBWKTDNKeE60meqcGp0Wmua8okInyphsSgRMaV7wnANUJKEH0dG16qKfohWNtrATufC2UX4lnbLybqa1czlzS8kIyRhjKPDyRsC7Tz2ETjY2aKhr1YLrg0w54SlHDxzR53-hl673LTYnacIFpwnL039RhOSFYAXnyR9qpmqQeLMO3en10bIUhPKEF8Vaa7CDmkEL2IprwVgM3-GHO3j8Kmis3lnwYqtgDqru5sHVfWddG3Yqa-9C8GBurzhN5HqOJc6xTIVkcjPHWPBs-2Fu8d-DiwC7Bq7Q0-o_cvLdqCQb3V_FvQAl</recordid><startdate>201411</startdate><enddate>201411</enddate><creator>Lanzafame, Massimiliano</creator><creator>Lattuada, Emanuela</creator><creator>Rigo, Fabio</creator><creator>Hill, Andrew</creator><creator>Vento, Sandro</creator><general>International AIDS Society</general><general>John Wiley & Sons, Inc</general><scope>24P</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201411</creationdate><title>Efficacy of a reduced dose of DARUNAVIR/RTV in a cohort of antiretroviral‐naïve and experienced HIV‐infected patients: a medium‐term follow‐up</title><author>Lanzafame, Massimiliano ; Lattuada, Emanuela ; Rigo, Fabio ; Hill, Andrew ; Vento, Sandro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4722-7a423a13d9fe17a2b532682cfbc83fc19c386d37c0aff5b27eb389686eed203</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>AIDS</topic><topic>Antiretroviral agents</topic><topic>Antiretroviral drugs</topic><topic>Beliefs, opinions and attitudes</topic><topic>Care and treatment</topic><topic>Darunavir</topic><topic>Dosage and administration</topic><topic>HIV</topic><topic>HIV patients</topic><topic>Human immunodeficiency virus</topic><topic>Immunosuppression</topic><topic>Methods</topic><topic>Patients</topic><topic>Ritonavir</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lanzafame, Massimiliano</creatorcontrib><creatorcontrib>Lattuada, Emanuela</creatorcontrib><creatorcontrib>Rigo, Fabio</creatorcontrib><creatorcontrib>Hill, Andrew</creatorcontrib><creatorcontrib>Vento, Sandro</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of the International AIDS Society</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lanzafame, Massimiliano</au><au>Lattuada, Emanuela</au><au>Rigo, Fabio</au><au>Hill, Andrew</au><au>Vento, Sandro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of a reduced dose of DARUNAVIR/RTV in a cohort of antiretroviral‐naïve and experienced HIV‐infected patients: a medium‐term follow‐up</atitle><jtitle>Journal of the International AIDS Society</jtitle><addtitle>J Int AIDS Soc</addtitle><date>2014-11</date><risdate>2014</risdate><volume>17</volume><issue>4 Suppl 3</issue><spage>19822</spage><epage>n/a</epage><pages>19822-n/a</pages><issn>1758-2652</issn><eissn>1758-2652</eissn><abstract>Background
The currently approved dose of darunavir/ritonavir is 800/100 mg once daily for PI‐naïve patients, and 600/100 mg twice daily for PI‐pretreated patients. However, in DRV‐sensitive patients at baseline in the POWER 1/2 trials, similar rates of HIV RNA suppression (1 log reduction) were achieved with doses ranging from 400/100 mg once daily to 600/100 mg twice daily. In previously virologically suppressed patients, a reduced dose of DRV (600/100 QD) is non‐inferior to the standard dose (800 mg QD)[1] and DRV concentrations in plasma and CSF are similar in patients receiving the above different doses [1, 2].
Methods
Twelve treatment‐naïve patients were started on darunavir/ritonavir 600/100mg once daily, with TDF/FTC (8) or ABC/3TC (4). Seven patients were switched to darunavir/ritonavir 600/100 mg once daily, with TDF/FTC (2), ABC/3TC (2), NVP (1), AZT/3TC (1). One was on monotherapy with DRV. Seven treatment‐experienced patients were switched to darunavir/ritonavir 600/100 mg once daily, with TDF/FTC (5), ABC/3TC (1), RAL (1).
Results
Of the 12 naïve patients (mean baseline HIV RNA 134,024 log10 copies/mL, range 4,256‐397,932), 11 had HIV RNA <20 c/mL after a mean 27.4 months of follow‐up (range 12–33). Mean PK level was 2,920 ng/mL (1,268–4,562). One patient had virological failure after 14 months (HIV RNA 39,300 copies/mL); no mutations were detected and after introduction of DRV/r 600 mg b.i.d., he returned aviremic. All switched patients maintained HIV RNA suppression (<20 c/mL) for a mean of 32.8 months (range 21‐54). PK level was available for one patient only (Ctrough 3,442 ng/mL). Of the treatment‐experienced patients (mean baseline HIV RNA 24,167 log10 copies/mL, range 112–111,426), five maintained HIV RNA suppression for a mean of 46.2 months (range 31–67). One patient interrupted HAART for three months and then restarted it, the latest HIV RNA level being 628 copies/mL after five weeks of therapy. One patient failed after 42 months (HIV RNA 3,930 copies/mL); after intensification (DRV/r 600 twice daily), he returned aviremic. PK levels were available for three patients (mean 2,502 ng/mL; range 844–4,518).
Conclusions
In this pilot study of 26 patients, use of DRV/r at 600/100 mg OD dose led to sustained HIV RNA suppression in 23 patients with acceptable PK exposures to DRV. Large non‐inferiority trials are warranted to establish its efficacy.</abstract><cop>Switzerland</cop><pub>International AIDS Society</pub><pmid>25397566</pmid><doi>10.7448/IAS.17.4.19822</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Acquired immune deficiency syndrome AIDS Antiretroviral agents Antiretroviral drugs Beliefs, opinions and attitudes Care and treatment Darunavir Dosage and administration HIV HIV patients Human immunodeficiency virus Immunosuppression Methods Patients Ritonavir |
| title | Efficacy of a reduced dose of DARUNAVIR/RTV in a cohort of antiretroviral‐naïve and experienced HIV‐infected patients: a medium‐term follow‐up |
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