TREATMENT OF SERO-DISCORDANT COUPLES: IMPLICATIONS FOR YOUNG PEOPLE

Presentation Transcript

JJ KUMWENDA (FRCP-UK)

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.

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.

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

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

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

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

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

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

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.