treatment of sero discordant couples implications for young people
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TREATMENT OF SERO-DISCORDANT COUPLES: IMPLICATIONS FOR YOUNG PEOPLE. JJ KUMWENDA (FRCP-UK). SYNOPSIS OF HPTN 052.

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Presentation Transcript
synopsis of hptn 052
SYNOPSIS OF HPTN 052
  • A randomized clinical trial to evaluate the effectiveness of Antiretroviral Therapy plus HIV primary care versus HIV primary care alone to prevent the sexual transmission of HIV-1 in sero-discordant couples.
study objectives
STUDY OBJECTIVES
  • Primary objective: To compare the rate of HIV infection among partners of HIV infected participants in two study arms
    • ARM 1: Antiretroviral therapy plus HIV primary care at time of enrolment
    • ARM 2: HIV primary care alone until the participant has two consecutive measurements of CD4 cell count below 250 cells/mm3 or develops an AIDS defining illness.
study objectives1
STUDY OBJECTIVES
  • Evaluate the optimal time to begin antiretroviral therapy in order to reduce illness and death among people infected with HIV/AIDS.
secondary objectives
Secondary objectives
  • Determine long term safety of ART
  • Characterize the pattern and rates of ART drug resistance
  • Assess factors associated with adherence to therapy
  • Evaluate effectiveness of couples counselling and characterize patterns of sexual behaviour in couples in both arms
study design
Study design
  • Phase 3, two arms, randomized controlled multicenter clinical trial
  • Study population: HIV-1 sero-discordant couples in which the HIV infected partner is ART naive and has CD4 cell between 350 and 550 cells/mm3
  • Sample size: 1750 sero-discordant couples
  • Study arms: two arms, assigned 1:1 ratio.
    • ARM 1: ART at enrolment plus HIV primary care
    • ARM 2: HIV primary care alone until participant’s CD4 cell count falls below 250 on two consecutive times or develops an AIDS defining illness
participating sites
PARTICIPATING SITES
  • Botswana: Gaborone
  • Brazil: 2 sites Porto Alegre and Rio de Janeiro
  • India: Chennai and PUNE
  • Kenya: Kisumu
  • Malawi: Blantyre and Lilongwe
  • South Africa: Johannesburg and Soweto
  • Thailand: Chiang Mai
  • USA: Massachusetts Boston
  • Zimbabwe: Harare
results
Results
  • 1763 couples were enrolled from April 2005 to May 2010
  • 97% were heterosexual
  • Mean age was 33 years
  • Mean CD4 cell count at entry 436 cells/mm3 (364-522)
dsmb findings in relation to hiv transmission
DSMB FINDINGS IN RELATION TO HIV TRANSMISSION
  • 39 cases of HIV transmission among previously uninfected partners
  • 28 transmissions were linked (i.e. The virus found in the infected partner did come from the index case)
  • 11 transmissions were not linked (virus found in the infected partner came from someone other than the partner registered in the study) or were still being analysed
  • 27 transmissions in the delayed arm versus 1 in the immediate arm
  • Over 96% reduction in HIV transmission in the immediate arm
  • HIV incidence as a whole in the study was lower than what was expected
dsmb transmission in relation to benefits of starting art early
DSMB TRANSMISSION IN RELATION TO BENEFITS OF STARTING ART EARLY
  • 105 cases of ill health in total
  • 65 cases in delayed arm versus 40 in immediate arm
  • 17 cases of extrapulmonary TB in delayed arm compared to 3 in immediate arm
  • Deaths were 10 in immediate arm versus 13 in delayed arm
issues when conducting 052
ISSUES WHEN CONDUCTING 052
  • Difficult to enrol young people (most go for HIV testing as couples but break up immediately if results are sero-discordant
  • Difficult to keep sero-discordant couples together. Required constant counselling
  • Keeping to schedule of events was a huge task
issues related to young people
ISSUES RELATED TO YOUNG PEOPLE
  • HIV incidence highest in the 20-30 age group especially in women
  • 4.9% HIV prevalence in 15-24 year age group in Malawi more in girls 6.8% compared to 3.1% in boys
  • Trans-generational sex seems an important risk factor in girls
  • Only 42% Overall Knowledge in the adolescent age group about HIV prevention
what to with 052 results
What to with 052 results
  • Malawi to follow WHO recommendation to increase CD4 cell count threshold to 350 for initiating ART
  • Preparation underway to do district-wide door to door testing for couples. Uptake for HIV testing improves significantly on home testing
  • Increasing treatment threshold to 550 as was in 052 has both policy and resource implications
  • Governments normally follow WHO lead.
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