The WAVES study shows that elvitegravir optimized for atazanavir scheme brings better results for women with HIV
Translator's note the study name is WAVES, an acronym for Women Antiretroviral Efficacy and Safety meaning, in free translation: Women, the efficacy and safety of antiretroviral therapy. Once established this, good read
A study of antiretroviral treatment specifically for women with HIV found that a single tablet therapeutic regimen containing the integrase inhibitor elvitegravir suppressed the virus better than a therapeutic regimen containing ritonavir and enhanced by atazanavir, according to a poster presented at the Eighth conference AIDS Society International on HIV, pathogenesis, treatment and prevention (IAS 2015) last month in Vancouver, Canada. This study is important in part because it demonstrates that even more women in clinical trials are feasible.
Most research to date suggests that men and women respond equally well to modern antiretroviral therapy (ART), but women with HIV have been underrepresented in most clinical trials and the patient's gender-related influence influence on treatment effectiveness or tolerability, can be difficult to define.
Kathleen Squires, of Thomas Jefferson University in Philadelphia, and fellow researchers performed the WAVES a study to compare the safety and efficacy of two antiretroviral regimens commonly used and widely recommended in women living with HIV. He is one of the few clinical trials not related to pregnancy antiretroviral treatment 3 phase multinational noting for all women.
The WAVES included 575 women living with HIV and who had not previously taken HIV treatment. Women were living in North America, Europe, Russia, Africa and Asia; most of Russia (33%), Uganda (28%) and the United States (20%). Almost half were black, about 43% were white, about 5% were of Asian descent and the average age of 35 years. Demographics and other baseline characteristics were balanced between treatment arms and reflect the global nature of the study, according to the researchers.
Participants in this double-blind study were randomly assigned to receive one of the following treatments:
- A schema a single tablet once daily containing elvitegravir, cobicistat as a potentiator and tenofovir / emtricitabine (Stribild).
- A regimen of a daily pill of ritonavir enhanced by atazanavir (Reyataz) plus tenofovir / emtricitabine (drugs from Truvada, the PrEP drug).
The vast majority of women (78%) had asymptomatic HIV infection and the median CD4 cell count, approximately 350 cells / mm3. Most had pretreatment viral load <100.000 copies / ml. They had normal renal function (estimated GFR> 70 ml / min), which is important because tenofovir can cause renal toxicity in susceptible individuals.
Women who became pregnant had the option to continue their assigned treatment, as none of the drugs have been shown to be harmful to pregnant women or the developing fetus.
The primary end point was the proportion of women to achieve undetectable viral load, or HIV RNA below OF 50 copies / ml at Week 48ª treatment. Safety was assessed throughout the study.
- By menos87% of women who Stribild and 81% of people who atazanavir is amplified they had an undetectable viral load after 48 weeks, showing that Stribild was statistically superior.
- Among women with high initial viral load, response rates were 90% and 78%, respectively. The average increase of CD4 cells were similar in both arms (221 212 vs cells / mm3, respectively).
- Treatment failure rates were comparable in the arms Stribild and atazanavir (9 12% vs.%, respectively). Drug treatment to emerging resistance was detected in three women (1%) who experienced virologic failure with respect to Atazanavir resistance, but none in the Stribild arm.
The two systems were generally safe and well tolerated, with most side effects in light level. In total, 29 women (10%) discontinued treatment at baseline in Stribild and 45 arm (16%) did so in the study arm with Atazanavir, these five women taking Stribild and 19 on atazanavir arm were discarded due to adverse events.
The decreased renal function, as measured by EGFR were small and similar in Stribild and atazanavir (For more on eGFR click here (Opens another site and another window of your browser).
Changes of Bone Mineral Density in the hip and spine were also comparable in the two arms of the study. Total cholesterol increased more in Stribild arm, but HDL total did not differ significantly.
”[Elvitegravir / cobicistat / tenofovir / emtricitabine] was superior to [atazanavir / ritonavir / tenofovir / emtricitabine] at week 48, and demonstrated its safety and efficacy for treating HIV-1 infection in women,” concluded the researchers. "Recruitment and retention of women in a large multinational study is feasible."
Translated by Claudio Souza Original in English, written by Liz Highleyman protocols for Aidsmap in collaboration with hivandhepatitis.com: WAVES shows elvitegravir boosted by atazanavir regimen beats for women with HIV Published: August 06 2015 reviewed by Mara Macedo on August 07 2015
K Squires et al. Elvitegravir (EVG) / cobicistat (COBI) / emtricitabine (FTC) / tenofovir disoproxil fumarate (TDF) is higher to ritonavir (RTV) boosted atazanavir (ATV) plus FTC / TDF in treatment naïve women with HIV-infection 1 (WAVES Study). 8th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2015), Vancouver, abstract MOLBPE08, 2015.
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