title: Virological Response and Drug Resistance 1 and 2 Years Post-Partum in HIV-Infected Women Initiated on Life-Long Antiretroviral Therapy in Malawi.
abstract: The objective of this study was to determine the virological response and the possible emergence of drug resistance at 1 and 2 years postpartum in HIV-positive pregnant women enrolled under the Option B approach and meeting the criteria for treatment. In the study, women with baseline CD4(+) <350/mm(3) received a combination of stavudine, lamivudine, and nevirapine during pregnancy (from week 25 of gestation) and continued it indefinitely after delivery. HIV-RNA was measured at 12 and 24 months postpartum. Drug resistance mutations were assessed in those with HIV-RNA >50 copies/ml. Baseline resistance mutations were assessed in the entire cohort. A total of 107 women were studied. At baseline, resistance mutations were seen in 6.6% of the women. At 12 months, 26.7% of the women had >50 copies/ml and among them 12.9% had virological failure (HIV-RNA >1,000 copies/ml). At 24 months, detectable HIV-RNA was seen in 28.3% of the women and virological failure in 10.1% of the women. Resistance mutations (mainly non-nucleoside reverse transcriptase inhibitors mutations) were seen in 40% of the women with detectable HIV-RNA. Baseline mutations did not correlate with virological failure or the emergence of resistance at later time points. Virological failure 2 years postpartum and emergence of resistance were rare in this cohort of HIV-infected women. These findings are reassuring in the light of the new strategies for the prevention of mother-to-child HIV transmission, recommending life-long antiretroviral therapy administration.
authors.affiliation: 1 Department of Biomedicine and Prevention, University of Rome Tor Vergata , Rome, Italy .
authors.forename: Sandro
authors.initials: S
authors.lastname: Mancinelli
authors.affiliation: 2 Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità , Rome, Italy .
authors.forename: Clementina Maria
authors.initials: CM
authors.lastname: Galluzzo
authors.affiliation: 2 Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità , Rome, Italy .
authors.forename: Mauro
authors.initials: M
authors.lastname: Andreotti
authors.affiliation: 1 Department of Biomedicine and Prevention, University of Rome Tor Vergata , Rome, Italy .
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Liotta
authors.affiliation: 3 DREAM Program , Community of S. Egidio, Blantyre, Malawi .
authors.forename: Haswel
authors.initials: H
authors.lastname: Jere
authors.affiliation: 3 DREAM Program , Community of S. Egidio, Blantyre, Malawi .
authors.forename: Jean-Baptiste
authors.initials: JB
authors.lastname: Sagno
authors.affiliation: 2 Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità , Rome, Italy .
authors.forename: Roberta
authors.initials: R
authors.lastname: Amici
authors.affiliation: 2 Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità , Rome, Italy .
authors.forename: Maria Franca
authors.initials: MF
authors.lastname: Pirillo
authors.affiliation: 1 Department of Biomedicine and Prevention, University of Rome Tor Vergata , Rome, Italy .
authors.forename: Paola
authors.initials: P
authors.lastname: Scarcella
authors.affiliation: 4 Department of Human Sciences, LUMSA University, Rome, Italy .
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Marazzi
authors.affiliation: 2 Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità , Rome, Italy .
authors.forename: Stefano
authors.initials: S
authors.lastname: Vella
authors.affiliation: 1 Department of Biomedicine and Prevention, University of Rome Tor Vergata , Rome, Italy .
authors.forename: Leonardo
authors.initials: L
authors.lastname: Palombi
authors.affiliation: 2 Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità , Rome, Italy .
authors.forename: Marina
authors.initials: M
authors.lastname: Giuliano
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D024882:Drug Resistance, Viral / Q000235:genetics; D005260:Female; D005865:Gestational Age; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects* / Q000235:genetics / Q000254:growth & development; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D019259:Lamivudine / Q000627:therapeutic use*; D008295:Malawi; D009154:Mutation; D019829:Nevirapine / Q000627:therapeutic use*; D049590:Postpartum Period; D011247:Pregnancy; D012367:RNA, Viral / Q000037:antagonists & inhibitors / Q000096:biosynthesis; D018119:Stavudine / Q000627:therapeutic use*; D019562:Viral Load / Q000187:drug effects
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral; D019259:Lamivudine; D019829:Nevirapine; D018119:Stavudine