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The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes-A randomized clinical trial.
Atuhaire, Patience; S Brummel, Sean; Mmbaga, Blandina Theophil; Angelidou, Konstantia; Fairlie, Lee; Violari, Avy; Theron, Gerhard; Mukuzunga, Cornelius; Mawlana, Sajeeda; Mubiana-Mbewe, Mwangelwa; Naidoo, Megeshinee; Makanani, Bonus; Mandima, Patricia; Nematadzira, Teacler; Suryavanshi, Nishi; Mbengeranwa, Tapiwa; Loftis, Amy; Basar, Michael; McCarthy, Katie; Currier, Judith S; Fowler, Mary Glenn.
Afiliación
  • Atuhaire P; Makerere University -John Hopkins University Research Collaboration (MUJHU CARE LTD) CRS, Kampala, Uganda.
  • S Brummel S; Harvard School of Public Health, Boston, Massachusetts, United States of America.
  • Mmbaga BT; Kilimanjaro Christian Medical Centre (KCMC), Moshi, Tanzania.
  • Angelidou K; Harvard School of Public Health, Boston, Massachusetts, United States of America.
  • Fairlie L; Wits RHI Shandukani Research Centre CRS, Johannesburg, South Africa.
  • Violari A; Soweto IMPAACT CRS, Johannesburg, South Africa.
  • Theron G; FAM-CRU CRS, Cape Town, South Africa.
  • Mukuzunga C; Malawi CRS, Lilongwe, Malawi.
  • Mawlana S; Durban Paediatric HIV CRS, Durban, South Africa.
  • Mubiana-Mbewe M; George CRS, Lusaka, Zambia.
  • Naidoo M; Umlazi CRS, Durban, South Africa.
  • Makanani B; Blantyre CRS, Blantyre, Malawi.
  • Mandima P; St Marys CRS, Harare, Zimbabwe.
  • Nematadzira T; Seke North CRS, Harare, Zimbabwe.
  • Suryavanshi N; Byramjee Jeejeebhoy Medical College (BJMC) CRS, Pune, India.
  • Mbengeranwa T; Harare Family Care CRS, Harare, Zimbabwe.
  • Loftis A; UNC, Chapel Hill, North Carolina, United States of America.
  • Basar M; Frontier Science, Amherst, Massachusetts, United States of America.
  • McCarthy K; FHI 360, Durham, North Carolina, United States of America.
  • Currier JS; UCLA center for Clinical AIDS Research and Education, Los Angeles, California, United States of America.
  • Fowler MG; Departments of Pathology and Epidemiology, Johns Hopkins University, Baltimore, Maryland, United States of America.
PLoS One ; 15(1): e0228003, 2020.
Article en En | MEDLINE | ID: mdl-31999753
BACKGROUND: Given well documented challenges faced by pregnant women living with HIV taking lifetime ART, it is critical to understand the impact of short-term ART exposure followed by treatment interruption on maternal health outcomes. METHODS: HIV+ breastfeeding (BF) and Formula Feeding (FF) women with CD4 counts > 350 cells/mm3, enrolled in the 1077BF/1077FF PROMISE trial were followed to assess the effect of ART during pregnancy and breastfeeding respectively. The first analysis compared ART use limited to the antepartum period (AP-only) relative to women randomized to Zidovudine. The second analysis included women with no pregnancy combination ART exposure; and compared women randomized to either ART or no ART during postpartum (PP-only). Both analyses included follow-up time beyond breastfeeding period. The primary outcome was progression to AIDS and/or death. Secondary outcomes included adverse events and HIV-related events. RESULTS: 3490 and 1137 HIV+ women were enrolled from 14 sites in Africa and India from April 2011 through September 2014 in cohort AP-only and PP-only, respectively. Most were Black African (96%); median age was 27 years; 97% were WHO Clinical Stage I; and most had a screening CD4 count ≥500 cells/mm3 (78%). The rate of progression to AIDS and/or death was similar and low across all comparison arms (AP comparison, HR = 1.14, 95%CI (0.44, 2.96), p-value = 0.79). In the PP-only cohort, the rate of WHO stage 2-3 events was lower for women randomized to ART(HR = 0.65, 95% CI 0.42, 1.01, p-value = 0.05). CONCLUSION: The incidence of AIDS and/or death was low in pregnant/postpartum HIV+ women with highCD4 cell counts for all comparison arms. This provides some reassurance that there were limited consequences for short term ART interruption in this group of asymptomatic HIV+ women during up to 4 years of follow up; and underscores that even short term ART exposure postpartum may reduce the risk of WHO grade 2-3 disease progression.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Evaluación de Resultado en la Atención de Salud / Terapia Antirretroviral Altamente Activa / Salud Materna Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2020 Tipo del documento: Article País de afiliación: Uganda Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Evaluación de Resultado en la Atención de Salud / Terapia Antirretroviral Altamente Activa / Salud Materna Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2020 Tipo del documento: Article País de afiliación: Uganda Pais de publicación: Estados Unidos