Start HIV study changes treatment guidelines across the planet
All HIV-positive people eligible for antiretroviral treatment should receive it, regardless of their CD4 cell count, according to the new treatment project of the British HIV Association (BHIVA), the study START HIV, That changes HIV guidelines.
The new draft guidelines, published for consultation this week, says that someone who lives with HIV, and who understands the seriousness of the commitment to treatment, and is ready, psychically speaking, to begin what changes the seropositive treatment guidelines, the start study, must receive treatment. The shift - from a recommendation to start treatment before the CD4 cell count drops below 350 cells per cubic milliliter of blood, to treatment for all HIV-positive people - follows the results of the START HIV study, an international study intensely expected when to start treatment.
The START study showed that starting treatment with a CD4 count above 500 cells per cubic milliliter of blood has reduced the risk of death or serious illness by 53%, compared with waiting to start treatment until the CD4 count drop to 350 cells per cubic milliliter of blood. Although the absolute risk of death or serious illness is small - 3,7% of people in the differentiated treatment arm became seriously ill or died, compared with 1.8% in the immediate treatment group, after more than three years of follow-up - the BHIVA guidance committee concluded that the evidence now supports the provision of treatment for all people willing to receive it.
Two other recent studies, the Temprano study and HPTN 052, also influenced the decision to offer treatment to everyone as the results of the start HIV study say.
Temprano, a study in West Africa, showed that starting treatment on a CD4 cell count above 500 reduced the risk of serious illness and death by 44% when compared to starting treatment on a low CD4 count.
The HPTN 052 study, conducted in sub-Saharan Africa, India, Brazil, Thailand and the United States, showed that early treatment - starting with a CD4 cell count between 350 and 550 - reduced the risk of clinical disease by 40%, but did not significantly reduce the risk of death when compared to starting treatment at a CD4 cell count below 250 cells per cubic milliliter of blood.
HPTN 052 also demonstrated that immediate treatment reduced the risk of sexual transmission of HIV by 96% [editor's note from seropositivo.org: Why, then, Sir, criminalize HIV-positive people for simply not disclosing their HIV status before starting sexual intercourse?]. building on BHIVA's previous recommendation that someone living with HIV should start treatment immediately, as they believed it could reduce the risk of HIV transmission - and that all people living with HIV should be informed by their doctors evidence linking antiretroviral treatment to a reduced risk of transmission.
Data presented by the Health Surveillance of England,. Earlier this year, show that this recommendation coincided with a substantial increase in the proportion of people starting treatment for CD4 counts above 350 by the end of 2013 - but only 27 people started the treatment with a CD4 cell count above 500 that year.
The updated guidelines continue to emphasize this evidence and recommend that physicians should continue to discuss the potential for reducing transmission with all people living with HIV. HIV-positive people should be evaluated for the immediate start of treatment after diagnosis, but initiation of treatment should only be considered urgent for people with AIDS-defining diseases, bacterial infections severe or with a CD4 cell count below 200 cells per cubic milliliter of blood. People in any of these categories should start treatment within two weeks at most, recommend the guidelines.
Recently infected people - someone diagnosed with primary HIV infection within 12 weeks after a previous negative test - they should be encouraged to start treatment immediately in order to improve immune recovery, limit the size of the viral reservoir and limit the potential for disease transmission at a very high viral load time. Someone diagnosed with primary HIV infection, who has a CD4 cell count below 350 cells per cubic milliliter of blood, a AIDS defining disease ou neurological symptoms they should also be encouraged to start treatment as soon as they can.
Other people diagnosed shortly after infection should be asked to consider starting treatment in the same way, as any other person diagnosed with HIV - when they feel prepared for it.
The guidelines also make a further change, recommending efavirenz-based treatment as the standard regimen for first-line treatment.
Efavirenz has been at the heart of first-line antiretroviral treatment in the UK for nearly 15 years and has been the preferred first-line option since 2008, but recent experimental results have shown that some other agents are superior in some patient populations.
Trials have also reinforced doubts about the long-term tolerability of efavirenz.
Efavirenz has been downgraded to an alternative choice the first time. Instead, the guidelines now recommend that (in the UK) the first-tier regime should be based on:
- an integrase inhibitor - dolutegravir (Tivicay, also available in the “Triumeq” pill (a combination with abacavir and lamivudine), raltegravir (Isentress) or elvitegravircobicistat (Vitekta and Tybost, also available in the combination tablet Stribild with tenofovir and emtricitabine);
- a potentiation protease inhibitor (atazanavirritonavir or darunavirritonavir)
- the new non-nucleoside reverse transcriptase inhibitor, Rilpivirine, (Edurant, also available in the combination tablet Eviplera with tenofovir and emtricitabine).
Doctors have been instructed to request information on the quality of sleep and mood in each clinical visit from those taking Efavirenz (Editor's note: Natasha Roxy, our collaborator, has reported “realistic dreams and unwillingness to work under this medication - Efavirenz, which has been used, according to anonymous reports, as“ recreational drug), in order to identify people who may benefit from switching to a drug better tolerated.
The preferred central axis for first-line treatment remains tenofovir and emtricitabine, with abacavir and lamivudine as an alternative where people do not have a viral load above 100.000 copies per cubic milliliter of blood. Abacavir and lamivudine can be used on any viral load when combined with dolutegravir in the Triumeq combined fixed dose pill, due to the high potency of dolutegravir.
Abacavir is not suitable for use by people with a genetic profile that makes them hypersensitive to the drug, and everyone should be tested for the genetic marker HLA-B5701 to filter out people who are likely to be hypersensitive before starting treatment with the drug.
Abacavir should not be used in people at high risk for cardiovascular disease, and tenofovir should not be used in people with stage 3-5 chronic kidney disease..
Published: June 24 2015
Translated from original New British guidelines recommend treatment for everyone with HIV by Claudio Souza with Review by Mara Macedo on July 28, 2015
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