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TREATMENT OF SERO-DISCORDANT COUPLES: IMPLICATIONS FOR YOUNG PEOPLE

TREATMENT OF SERO-DISCORDANT COUPLES: IMPLICATIONS FOR YOUNG PEOPLE. JJ KUMWENDA (FRCP-UK). SYNOPSIS OF HPTN 052.

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TREATMENT OF SERO-DISCORDANT COUPLES: IMPLICATIONS FOR YOUNG PEOPLE

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  1. TREATMENT OF SERO-DISCORDANT COUPLES: IMPLICATIONS FOR YOUNG PEOPLE JJ KUMWENDA (FRCP-UK)

  2. 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.

  3. 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.

  4. STUDY OBJECTIVES • Evaluate the optimal time to begin antiretroviral therapy in order to reduce illness and death among people infected with HIV/AIDS.

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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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