Of course antiretroviral treatment of one heterosexual partner decreases the chances of transmission to the other regular partner. We aleady knew this from previous trials. People living with the virus have a right to treatment anyway. Why all the hype?
Thanks to the people at SEA-AIDS for sharing the news about the trial. And thanks to the author of the following opinion piece for questioning its significance.
[him] moderator
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Spotlight: Treating PLHIV with ARVs Protects Partners from Infection
CNS
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THIS FINDING WAS STATISTICALLY SIGNIFICANT AND MEANS THAT EARLIER INITIATION OF ANTIRETROVIRALS LED TO A 96 PERCENT REDUCTION IN HIV TRANSMISSION TO THE HIV-UNINFECTED PARTNER
FINDINGS RESULT FROM NIH-FUNDED INTERNATIONAL STUDY
(CNS): Men and women infected with HIV reduced the risk of transmitting the virus to their sexual partners by taking oral antiretroviral medicines when their immune systems were relatively healthy, according to findings from a large-scale clinical study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The clinical trial, known as HPTN 052, was slated to end in 2015 but the findings are being released early as the result of a scheduled interim review of the study data by an independent data and safety monitoring board (DSMB). The DSMB concluded that it was clear that use of antiretrovirals by HIV-infected individuals with relatively healthier immune systems substantially reduced transmission to their partners. The results are the first from a major randomized clinical trial to indicate that treating an HIV-infected individual can reduce the risk of sexual transmission of HIV to an uninfected partner.
“Previous data about the potential value of antiretrovirals in making HIV-infected individuals less infectious to their sexual partners came largely from observational and epidemiological studies,” said NIAID Director Anthony S. Fauci, M.D. “This new finding convincingly demonstrates that treating the infected individual—and doing so sooner rather than later—can have a major impact on reducing HIV transmission.”
Led by study chair Myron Cohen, M.D., director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill, HPTN 052 began in April 2005 and enrolled 1,763 couples, all at least 18 years of age. The vast majority of the couples (97 percent) were heterosexual, which precludes any definitive conclusions about effectiveness in men who have sex with men. The study was conducted at 13 sites in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe. The U.S. site collected only limited data because of difficulties enrolling participants into the study. However, data from one serodiscordant couple at the site was included in the DSMB’s analysis. At the time of enrollment, the HIV-infected partners (890 men, 873 women) had CD4+ T-cell levels—a key measure of immune system health—between 350 and 550 cells per cubic millimeter (mm³) within 60 days of entering the study. The HIV-uninfected partners had tested negative for the virus within 14 days of entering the study.
The investigators randomly assigned the couples to either one of two study groups. In the first group, the HIV-infected partner immediately began taking a combination of three antiretroviral drugs. In the second group (the deferred group), the HIV-infected partners began antiretroviral therapy when their CD4 counts fell below 250 cells/mm³ or an AIDS-related event, such as Pneumocystis pneumonia, occurred. Throughout the study, both groups received HIV-related care that included counseling on safe sex practices, free condoms, treatment for sexually transmitted infections, regular HIV testing, and frequent evaluation and treatment for any complications related to HIV infection. Each group received the same amount of care and counseling.
In its review, the DSMB found a total of 39 cases of HIV infection among the previously uninfected partners. Of those, 28 were linked through genetic analysis to the HIV-infected partner as the source of infection. Seven infections were not linked to the HIV-infected partner, and four infections are still undergoing analysis. Of the 28 linked infections, 27 infections occurred among the 877 couples in which the HIV-infected partner did not begin antiretroviral therapy immediately. Only one case of HIV infection occurred among those couples where the HIV-infected partner began immediate antiretroviral therapy. This finding was statistically significant and means that earlier initiation of antiretrovirals led to a 96 percent reduction in HIV transmission to the HIV-uninfected partner. The infections were confirmed by genetic analysis of viruses from both partners.
Additionally, 17 cases of extrapulmonary tuberculosis occurred in the HIV-infected partners in the deferred treatment arm compared with three cases in the immediate treatment arm, a statistically significant difference. There were also 23 deaths during the study. Ten occurred in the immediate treatment group and 13 in the deferred treatment group, a difference that did not reach statistical significance.
The study was designed to evaluate whether antiretroviral use by the HIV-infected individual reduced HIV transmission to the uninfected partner and potentially benefited the HIV-infected individual as well. Additionally, the study was designed to evaluate the optimal time for a person infected with HIV to initiate antiretrovirals in order to reduce HIV-related sickness and death. Based on their analysis, the DSMB recommended that the deferred study arm be discontinued and that the study participants be informed of the trial’s outcome.
“We want to thank the study participants for making such an important contribution in the fight against HIV/AIDS. We think that these results will be important to help improve both HIV treatment and prevention,” said Dr. Cohen.
Study participants are being informed of the results. Individuals who became HIV-infected during the course of the study were referred to local services for appropriate medical care and treatment. HIV-infected participants in the deferred treatment group will be offered antiretroviral therapy. The study investigators will continue following the study participants for at least one year.
The study was conducted by the HIV Prevention Trials Network, which is largely funded by NIAID with additional funding from the National Institute on Drug Abuse and the National Institute of Mental Health, both part of the NIH. Additional support was provided by the NIAID-funded AIDS Clinical Trials Group. The antiretroviral drugs used in the study were made available by Abbott Laboratories, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/Viiv Healthcare and Merck & Co., Inc.
The 11 HIV drugs that were used in various combinations included the following:
- atazanavir (300 mg once daily)
- didanosine (400 mg once daily)
- efavirenz (600 mg once daily)
- emtricitabine/tenofovir disoproxil fumarate (200 mg emtricitabine/300 mg tenofovir disoproxil fumarate once daily)
- lamivudine (300 mg once daily)
- lopinavir/ritonavir 800/200 mg once daily (QD) or lopinavir/ritonavir 400/100 mg twice daily (BID)
- nevirapine (200 mg taken once daily for 14 days followed by 200 mg taken twice daily)
- ritonavir (100 mg once daily, used only to boost atazanavir)
- stavudine (weight-dependent dosage)
- tenofovir disoproxil fumarate (300 mg once daily)
- zidovudine/lamivudine (150 mg lamivudine/300 mg zidovudine taken orally twice daily)
In an ongoing international clinical study called Strategic Timing of Antiretroviral Therapy, NIAID is examining the optimal time for asymptomatic HIV-infected individuals to begin antiretrovirals.
CNS - www.citizen-news.org
Online at: http://www.citizen-news.org/2011/05/treating-hiv-infected-people-with.html
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Responses to ART/HIV prevention trial results: More spin than rigour
Tim France
The spin and commentary being created today around the recent trial results that show (although not for the first time) that antiretroviral treatment (ART) reduces HIV transmission is missing some pretty important considerations. I'll try to outline what I see as the main three here, but there are others too….
1. Half of the people living with HIV don't know it
Let's just be clear: there are 33 million people thought to be currently living with HIV in the world. Of those, only about half know their HIV status. The first big obstacle to realizing the potential of the 'new' research findings lies in the other 16 million people or so having an HIV test and sticking around for the results. After 30 years of the HIV response so far, we have reached 50% of PLHIV knowing their status. Increasing that number is going to be extremely challenging and the latest results will not change that.
2. Most people living with HIV don't need ART to stay well, because they already are
People who know they are living with HIV don't usually take ART until their immune system gets to a particular stage of decline, which is measured by the level of a specific type of white blood cell called CD4s. In early 2010, WHO issued a new recommendation that ART treatment should begin when CD4 counts get below 350. Normal CD4 levels are up to about 1000. People living with HIV mostly remain well until their immune systems enter this kind of decline, and so taking ART sooner (i.e. as soon as you know you are HIV-positive) likely has no therapeutic benefit for the individual taking it; they would be taking a drug, potentially for years, that has no direct benefit to them other than making them less infectious to others. That is going to be a hard thing to convince many people to do, especially when there are other options around for them to "with dignity and confidence, take additional steps to protect their loved ones from HIV," to quote Michel Sidibe, the head of UNAIDS today.
3. If all people living with HIV were to take ART, it would potentially divert drugs from those that need ART to stay well/alive
When WHO changed the CD4 threshold for starting ART to <350 (from <200), that threw projections of how much ART would be required out of kilter because more people living with HIV were suddenly 'eligible' for ART. Now imagine we effectively remove the threshold for starting ART: the number of people 'needing' ART would go from about 10 million to about 33 million, decreasing the current estimated ART coverage from about 50% of those who need it to about 16% (i.e. 5.2 m out of 33.3 m). Who would have priority access to the available drugs? Those who need them to prevent transmission, or those who need them to stay alive? We have been through a decade or so of unprecedented investment and attention to a health issue: expanding ART availability. Despite that, we have managed to reach only half of those people who need ART to stay alive. That proportion is only going to go down if you now introduce another 20 million people living with HIV into the global ART equation.
Besides these three considerations, other reasons for not spinning these research results as if they are a "serious game changer" (again quoting Sidibe's frothing) is that doing so could inadvertently decrease emphasis on safe sex approaches, driving other STDs and unwanted pregnancies. It also sends a message that using condoms or delaying sexual debut is somehow less than taking dignified and confident steps to protect loved ones. It may also generate a false sense of security that HIV is no longer a risk we need to worry about because there are drugs to take care of that. We also have no idea what widespread use of ART in this context would do to driving emergence of drug resistance.
So why all the excitement and focus on merely the potential positives of this new data? In my view it's because the HIV response desperately needs some good news right now. The current financial crisis and the responses of donors are highlighting the fragility of the amazing gains that have been made against HIV in the past decades. As Sarah Bosely (of The Guardian) said today, the results "will give a massive boost to organisations such as UNAIDS which are arguing, in a time of financial constraint, that there is an urgent need to get AIDS drugs to more people who need them."
In the science and health fields, responding in a biased and selective way to results such as these, and avoiding reference to any of the obvious realities that will hinder their implementation, will only damage organizations that should be cultivating the opposite reputation: one of balance, scientific objectivity and accountability.
http://globalhealthsushi.posterous.com/responses-to-arthiv-prevention-trial-results
