Watch a short film about SPARTAC online

Transcription

1 Watch a short film about SPARTAC online Short course of treatment for people with recent HIV infection slows damage to immune system: results from the SPARTAC study A 48 week course of antiretroviral medication taken in the early stages of HIV infection slows the damage to the immune system and delays the need for long term therapy by 65 weeks. These are the results of SPARTAC (Short Pulse Anti-Retroviral Therapy at HIV Seroconversion); the largest randomised controlled trial ever undertaken in recent HIV infection. The study ran between 2003 and 2011 across eight countries. This leaflet tells you more about the study, the results and what they mean.

2 How HIV is currently treated? Scientists and doctors are always looking for better ways to treat people living with HIV. HIV is a virus that affects a person s immune system by killing the CD4 cells that help to protect the body against illnesses. During early infection, HIV spreads quickly and over time the virus will destroy enough CD4 cells for the immune system to fail. According to current standards of care, anti-hiv treatment, called anti-retroviral therapy (ART), is not usually prescribed until late stage disease, once biological tests (CD4 count) show that the immune system is failing. Once a person starts ART it is a long-term commitment for life. ART must be taken every single day, is expensive and can have side effects. Why is SPARTAC important? Improve current management of recent HIV infection Although doctors and scientists know how to manage late stage HIV infection, there is still a lot of research to be done to understand how to best manage the very early stages of HIV infection. The SPARTAC study aimed to test two new possible treatment strategies for early HIV infection: could giving people recently infected with HIV a short period of 12 or 48 weeks of ART delay the need to starting long-term ART? A significant delay would shorten the overall time a person has to take ART in their lifetime. Robust evidence to inform treatment guidelines There are no conclusive current national and international guidelines on how to treat recent HIV infection as there is no strong evidence on which to base recommendations. The SPARTAC study was conducted in resource-limited and resource-rich settings amongst men and women, and designed to provide robust results.

3 SPARTAC enrolled participants from Australia, Brazil, Italy, Ireland, Spain, South AFrica, Uganda and the UK. How were the participants chosen? The SPARTAC team recruited enough participants to ensure that, if there really was a benefit of early treatment, then we would be able to detect it. 366 adults mainly heterosexual women and men who have sex with men took part from 35 clinical sites in 8 countries. Only people with confirmed recent HIV infection (laboratory evidence of recent infection or a negative HIV test up to 6 months before a positive one) were eligible to participate. All those eligible were fully informed about what it meant to be part of the study before deciding to enrol. All participants had access to treatment according to national treatment guidelines in case they needed it. Woman picking up medicines at an HIV clinic, Masaka, Uganda.

4 How was the clinical trial run? SPARTAC participants were allocated into one of three treatment strategy groups randomly, like the roll of dice. The three groups were: a short-course of ART for 12 weeks; a short-course of ART for 48 weeks; no early ART (the current standard of care for people recently infected with HIV). The SPARTAC team followed up participants for an average of 4 years, regularly measuring the number of CD4 cells and the amount of virus in the blood. The team compared how the 3 groups fared in terms of how long it took before the participants had to start long-term treatment, which is usually when the CD4 count falls below 350 cells per mm 3 of blood. As soon as CD4 counts fell below 350 cells per mm 3 blood, long-term treatment was offered. Participants with recent HIV infection (within 6 months) Randomisation (like the roll of dice) People who needed treatment straight away were not eligible to join and were treated outside of the trial No early ART (123 people) 12 weeks of treatment (120 people) 48 weeks of treatment (123 people) CD4 cell count confirmed below 350 cells per mm 3 blood, or started long-term treatment

5 What did the results show? SPARTAC is the largest clinical randomised trial to have looked at treatment in recent HIV infection and enrolled both men and women in resource-poor and resource-rich settings. Collecting measurements over an average period of 4 years has allowed the SPARTAC team to obtain robust evidence on the impact a short course of ART in recent HIV infection has on the progression of HIV disease, compared to participants who received the current standard of care of no early treatment. Summary Giving people recently infected with HIV 48 weeks of treatment had some advantages, compared to no early treatment: It delayed the time to needing long-term treatment, though not much longer than the time already spent on 48 weeks of treatment (average of 65 weeks). Overall the group had healthier immune systems (an average of 138 more CD4 cells per mm 3 blood) and lower amounts of virus in the blood. These advantages were greater the closer the 48 weeks of treatment was started to the time of HIV infection. There was no effect found in giving people recently infected with HIV 12 weeks of treatment, compared to no early treatment. There was no evidence of harm of early treatment in terms of deaths, adverse events and the effectiveness of long-term treatment later on. What s the science behind these findings? More research is needed to understand why 48 weeks of treatment given to participants recently infected with HIV had certain advantages. Our findings suggest that it may be due to 48 weeks of treatment reducing the amount of hidden virus in the body (viral reservoir size). HIV attacks the immune system and can stay hidden in certain cells that fight infection. When these cells are activated HIV is released.

6 What do the results mean for HIV treatment? The SPARTAC results contribute to scientific research looking for better ways to treat people with recent HIV infection. 48 weeks of treatment during this stage of infection could be an option. Informing treatment guidelines: benefits versus costs The benefits found in giving 48 weeks of treatment early in HIV infection will have to be considered against the extra financial and strategic cost of increased testing and treatment. However, doctors, healthworkers and patients should be aware of the SPARTAC clinical trial findings and may wish to consider the option of 48 weeks of treatment given at recent infection if appropriate. Preventing the spread of HIV National and international guidelines are supporting a more proactive approach to HIV testing in order to put in place proven strategies to reduce the risk of further transmission of HIV. Recent HIV infection is estimated to be responsible for 30% of new HIV transmissions. People who have recently become infected with HIV often don t know it (symptoms are rare) and have very high levels of virus in their blood, making them especially high risk to pass on the virus to their partners. The lower amounts of virus in the body seen in the group taking 48 weeks of treatment could be a more cost effective and manageable way to significantly reduce the risk of passing on the virus compared to other prevention strategies. The additional individual benefits - a healthier immune system and delay in starting long-term ART - is unique in HIV prevention strategies and could be more important in resource-poor countries where people with HIV are often co-infected with tuberculosis. The SPARTAC team plan to look at this more closely. Prevention represents the very best investment that any government can make. It can yield significant savings by avoiding future treatment costs. UK Lords Select Committee on HIV and AIDS, 2011

7 More research is needed SPARTAC has thrown up more questions on what the best strategy is for treating people recently infected with HIV: Treat as close to the time of infection as possible? The SPARTAC results suggest a greater benefit of 48 weeks of early treatment the closer the treatment was started to the time of HIV infection. The participants who were enrolled closer to the time of HIV infection tended to have faster declines in the number of CD4 cells, indicating greater damage to their immune systems, if they did not receive treatment. It was amongst this group that the 48 weeks of early treatment appeared to have a bigger benefit in delaying the need to start long-term treatment. However, we are not sure why these people were coming to see a clinician so early after infection it may be that they felt unwell. More research focusing on people in the very early stages of infection, a challenging group to identify, needs to be done to confirm this observation. Start long-term treatment earlier? Although previous studies have shown that treating a person with early stage HIV infection reduces the risk of this person infecting a sexual partner, more research needs to be done to see if giving people in the early stages of HIV infection life-long treatment is beneficial to the individual. ART has side effects and must be taken every day to prevent the virus from mutating and becoming resistant to the medicines, so the potential benefits of taking early treatment must be weighed against these disadvantages. Does 48 weeks of early treatment have long-term benefits? The higher numbers of CD4 cells and lower amount of virus in the blood of the participants given 48 weeks of early treatment are promising but more research needs to be done to see whether these benefits are maintained and keep people well in the years ahead. The SPARTAC team plan to do this by continuing to follow up participants that took part in the SPARTAC study.

8 Find out more To find out more about SPARTAC send us an or visit our website for a comprehensive set of FAQs and video interviews with SPARTAC participants and staff. spartac@imperial.ac.uk Watch our online films Experiences from the SPARTAC clinical trial and When to start? HIV treatment s unanswered question on our website. The SPARTAC clinical trial was an international collaboration by leading research and academic institutions. Thank you to all SPARTAC staff and volunteers. Thank you to the Wellcome Trust for funding the SPARTAC study and Abbott Laboratories for donating lopinavir/ritonavir for use in the SPARTAC study. Printed Front page image credit: Frank Herdolt.