High level of viral suppression and low switch rate to second-line antiretroviral therapy among HIV-infected adult patients followed over five years: retrospective analysis of the DART trial
In contrast to resource-rich countries, most HIV-infected patients in resource-limited countries receive treatment without virological monitoring. There are few long-term data, in this setting, on rates of viral suppression or switch to second-line antiretroviral therapy. The DART trial compared cli...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Journal article |
| Language: | English |
| Published: |
Public Library of Science
2014
|
| _version_ | 1826297560016355328 |
|---|---|
| author | Kityo, C Gibb, D Gilks, C Goodall, R Mambule, I Kaleebu, P Pillay, D Kasirye, R Mugyenyi, P Walker, A Dunn, D |
| author_facet | Kityo, C Gibb, D Gilks, C Goodall, R Mambule, I Kaleebu, P Pillay, D Kasirye, R Mugyenyi, P Walker, A Dunn, D |
| author_sort | Kityo, C |
| collection | OXFORD |
| description | In contrast to resource-rich countries, most HIV-infected patients in resource-limited countries receive treatment without virological monitoring. There are few long-term data, in this setting, on rates of viral suppression or switch to second-line antiretroviral therapy. The DART trial compared clinically driven monitoring (CDM) versus routine laboratory (CD4/haematology/biochemistry) and clinical monitoring (LCM) in HIV-infected adults initiating therapy. There was no virological monitoring in either study group during follow-up, but viral load was measured in Ugandan participants at trial closure. Two thousand three hundred and seventeen (2317) participants from this country initiated antiretroviral therapy with zidovudine/lamivudine plus tenofovir (n = 1717), abacavir (n = 300), or nevirapine (n = 300). Of 1896 (81.8%) participants who were alive and in follow-up at trial closure (median 5.1 years after therapy initiation), 1507 (79.5%) were on first-line and 389 (20.5%) on second-line antiretroviral therapy. The overall switch rate after the first year was 5.6 per 100 person-years; the rate was substantially higher in participants with low baseline CD4 counts (<50 cells/mm3). Among 1207 (80.1%) first-line participants with viral load measured, HIV RNA was <400 copies/ml in 963 (79.8%), 400-999 copies/ml in 37 (3.1%), 1,000-9,999 copies/ml in 110 (9.1%), and ≥10,000 copies/ml in 97 (8.0%). The proportion with HIV RNA <400 copies/ml was slightly lower (difference 7.1%, 95% CI 2.5 to 11.5%) in CDM (76.3%) than in LCM (83.4%). Among 252 (64.8%) second-line participants with viral load measured (median 2.3 years after switch), HIV RNA was <400 copies/ml in 226 (89.7%), with no difference between monitoring strategies. Low switch rates and high, sustained levels of viral suppression are achievable without viral load or CD4 count monitoring in the context of high-quality clinical care. TRIAL REGISTRATION: ISRCTN13968779. |
| first_indexed | 2024-03-07T04:33:30Z |
| format | Journal article |
| id | oxford-uuid:cf20d1fe-d16c-4163-8ed1-b2ef0147bc03 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T04:33:30Z |
| publishDate | 2014 |
| publisher | Public Library of Science |
| record_format | dspace |
| spelling | oxford-uuid:cf20d1fe-d16c-4163-8ed1-b2ef0147bc032022-03-27T07:40:25ZHigh level of viral suppression and low switch rate to second-line antiretroviral therapy among HIV-infected adult patients followed over five years: retrospective analysis of the DART trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:cf20d1fe-d16c-4163-8ed1-b2ef0147bc03EnglishSymplectic Elements at OxfordPublic Library of Science2014Kityo, CGibb, DGilks, CGoodall, RMambule, IKaleebu, PPillay, DKasirye, RMugyenyi, PWalker, ADunn, DIn contrast to resource-rich countries, most HIV-infected patients in resource-limited countries receive treatment without virological monitoring. There are few long-term data, in this setting, on rates of viral suppression or switch to second-line antiretroviral therapy. The DART trial compared clinically driven monitoring (CDM) versus routine laboratory (CD4/haematology/biochemistry) and clinical monitoring (LCM) in HIV-infected adults initiating therapy. There was no virological monitoring in either study group during follow-up, but viral load was measured in Ugandan participants at trial closure. Two thousand three hundred and seventeen (2317) participants from this country initiated antiretroviral therapy with zidovudine/lamivudine plus tenofovir (n = 1717), abacavir (n = 300), or nevirapine (n = 300). Of 1896 (81.8%) participants who were alive and in follow-up at trial closure (median 5.1 years after therapy initiation), 1507 (79.5%) were on first-line and 389 (20.5%) on second-line antiretroviral therapy. The overall switch rate after the first year was 5.6 per 100 person-years; the rate was substantially higher in participants with low baseline CD4 counts (<50 cells/mm3). Among 1207 (80.1%) first-line participants with viral load measured, HIV RNA was <400 copies/ml in 963 (79.8%), 400-999 copies/ml in 37 (3.1%), 1,000-9,999 copies/ml in 110 (9.1%), and ≥10,000 copies/ml in 97 (8.0%). The proportion with HIV RNA <400 copies/ml was slightly lower (difference 7.1%, 95% CI 2.5 to 11.5%) in CDM (76.3%) than in LCM (83.4%). Among 252 (64.8%) second-line participants with viral load measured (median 2.3 years after switch), HIV RNA was <400 copies/ml in 226 (89.7%), with no difference between monitoring strategies. Low switch rates and high, sustained levels of viral suppression are achievable without viral load or CD4 count monitoring in the context of high-quality clinical care. TRIAL REGISTRATION: ISRCTN13968779. |
| spellingShingle | Kityo, C Gibb, D Gilks, C Goodall, R Mambule, I Kaleebu, P Pillay, D Kasirye, R Mugyenyi, P Walker, A Dunn, D High level of viral suppression and low switch rate to second-line antiretroviral therapy among HIV-infected adult patients followed over five years: retrospective analysis of the DART trial |
| title | High level of viral suppression and low switch rate to second-line antiretroviral therapy among HIV-infected adult patients followed over five years: retrospective analysis of the DART trial |
| title_full | High level of viral suppression and low switch rate to second-line antiretroviral therapy among HIV-infected adult patients followed over five years: retrospective analysis of the DART trial |
| title_fullStr | High level of viral suppression and low switch rate to second-line antiretroviral therapy among HIV-infected adult patients followed over five years: retrospective analysis of the DART trial |
| title_full_unstemmed | High level of viral suppression and low switch rate to second-line antiretroviral therapy among HIV-infected adult patients followed over five years: retrospective analysis of the DART trial |
| title_short | High level of viral suppression and low switch rate to second-line antiretroviral therapy among HIV-infected adult patients followed over five years: retrospective analysis of the DART trial |
| title_sort | high level of viral suppression and low switch rate to second line antiretroviral therapy among hiv infected adult patients followed over five years retrospective analysis of the dart trial |
| work_keys_str_mv | AT kityoc highlevelofviralsuppressionandlowswitchratetosecondlineantiretroviraltherapyamonghivinfectedadultpatientsfollowedoverfiveyearsretrospectiveanalysisofthedarttrial AT gibbd highlevelofviralsuppressionandlowswitchratetosecondlineantiretroviraltherapyamonghivinfectedadultpatientsfollowedoverfiveyearsretrospectiveanalysisofthedarttrial AT gilksc highlevelofviralsuppressionandlowswitchratetosecondlineantiretroviraltherapyamonghivinfectedadultpatientsfollowedoverfiveyearsretrospectiveanalysisofthedarttrial AT goodallr highlevelofviralsuppressionandlowswitchratetosecondlineantiretroviraltherapyamonghivinfectedadultpatientsfollowedoverfiveyearsretrospectiveanalysisofthedarttrial AT mambulei highlevelofviralsuppressionandlowswitchratetosecondlineantiretroviraltherapyamonghivinfectedadultpatientsfollowedoverfiveyearsretrospectiveanalysisofthedarttrial AT kaleebup highlevelofviralsuppressionandlowswitchratetosecondlineantiretroviraltherapyamonghivinfectedadultpatientsfollowedoverfiveyearsretrospectiveanalysisofthedarttrial AT pillayd highlevelofviralsuppressionandlowswitchratetosecondlineantiretroviraltherapyamonghivinfectedadultpatientsfollowedoverfiveyearsretrospectiveanalysisofthedarttrial AT kasiryer highlevelofviralsuppressionandlowswitchratetosecondlineantiretroviraltherapyamonghivinfectedadultpatientsfollowedoverfiveyearsretrospectiveanalysisofthedarttrial AT mugyenyip highlevelofviralsuppressionandlowswitchratetosecondlineantiretroviraltherapyamonghivinfectedadultpatientsfollowedoverfiveyearsretrospectiveanalysisofthedarttrial AT walkera highlevelofviralsuppressionandlowswitchratetosecondlineantiretroviraltherapyamonghivinfectedadultpatientsfollowedoverfiveyearsretrospectiveanalysisofthedarttrial AT dunnd highlevelofviralsuppressionandlowswitchratetosecondlineantiretroviraltherapyamonghivinfectedadultpatientsfollowedoverfiveyearsretrospectiveanalysisofthedarttrial |