/HIV: treatment taken only four days a week is also effective
Hiv: Treatment Taken Only Four Days A Week Is Also

HIV: treatment taken only four days a week is also effective

A French study, the results of which were presented in South Africa at the international AIDS conference, seems to show that reducing the number of antiretroviral drugs does not reduce the effectiveness of treatment against HIV.

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If antiretroviral treatments give very good results in the management of HIV, the treatment protocols remain heavy and restrictive for people affected by the virus. Treatments are started as soon as possible after the discovery of seropositivity and must be taken daily and for life. However, the recommendations could change: it may soon be possible to reduce the number of doses without reducing the effectiveness of the drugs.

These are the results of a French study, presented in Durban (South Africa) within the framework of the XXIst international conference on AIDS, which give hope for an evolution of the protocols.

Three days of respite per week and identical efficiency

Triple antiretroviral therapy taken only four days a week instead of seven kept a viral load below 50 copies in 96 of the 100 patients in the ANRS 162-4D study. Despite this stop, the virus was therefore “muzzled” as with a treatment taken continuously. The results were presented by Dr Pierre de Truchis, infectious disease specialist at Raymond Poincaré hospital in Garches. The ANRS (National Agency for Research on AIDS and Hepatitis) launched this prospective non-randomized trial in 2014 (all patients received the same treatment regimen), which was carried out in several clinical centers. The aim was to evaluate the effectiveness of antiretroviral treatment taken four consecutive days out of seven, in HIV + patients who have been successfully therapeutic for four years, with a viral load of less than 50 copies / mL.

After 48 weeks, 96% of patients were still following the 4/7 day regimen, with a viral load still below 50 copies. Only three patients had a re-detectable viral load at the fourth week of the study (with 785 cp / mL, 124 cp / mL and 969 cp / mL, respectively). In these patients, the viral load fell below the detection threshold with the return to a 7/7 day treatment regimen, without the appearance of resistance. Only one patient left the study on his own at week four.

The objectives of this “therapeutic break” are also to reduce side effects, reduce treatment costs and improve acceptability and adherence to treatment.

Several trials currently underway in the world pursue the same goals. If the ANRS evaluated in trial 162-4D the interest of reducing the number of doses, other studies are interested in the effects of a reduction in doses or try to spare classes of molecules. In France, the ANRS 165 DARULIGHT trial evaluates the benefit of a half-dose of drug (Darunavir) per day, the ANRS 167 LAMIDOL trial that of a Lamivudine-Dolutegravir dual therapy. The ANRS 163 ETRAL trial is studying the value of another dual therapy, Etravirine-Raltegravir.

A protocol well accepted by patients

Along with the evaluation of therapeutic results, patient compliance was studied by self-administered questionnaires, blood drug assays, and intake counting using electronic pill organizers in a subgroup of patients. Again, no problems to report. “The analysis of the adherence studies showed that the 4/7 day program was very well followed and accepted by the patients. In more than 90% of cases, the intake conforms to the prescription“, Commented Dr Pierre de Truchis.

A larger study expected

According to Prof. Jean-François Delfraissy, director of ANRS, “these results encourage us to pursue our objectives of improving the quality of life under treatment and to respond to a strong demand from certain patients to undergo less drug pressure ”.

When, then, will there be lighter protocols for HIV + people? These encouraging results have yet to be confirmed by a randomized trial (where two groups of patients will be compared), on a larger scale, and over a longer period. The ANRS QUATUOR trial will start at the end of 2016 with this objective. 640 patients should be recruited from several hospitals, half of whom will receive treatment for 48 weeks for 4/7 days and the other half for 7/7 days. If similar results were observed in both groups, all patients in the trial would switch to treatment for 4/7 days for an additional 48 weeks.

The trial will seek to clarify another important point: to demonstrate that the benefits for patients in the “light” group are real (fewer side effects, better compliance, etc.), and that theTheir quality of life is improved.