RESUMEN
OBJECTIVES: Maraviroc (MVC) is a suitable drug for aviraemic subjects on antiretroviral treatment (ART) developing toxicity. Its prescription requires prior tropism testing. It is unknown if proviral DNA genotypic tropism testing is reliable for guiding MVC initiation in aviraemic subjects, so this study was carried out to address this issue. METHODS: PROTEST was a phase 4, prospective, single-arm clinical trial carried out in 24 HIV care centres in Spain. MVC-naïve HIV-1-infected patients with HIV-1 RNA < 50 copies/mL on stable ART during the previous 6 months who required an ART change because of toxicity and who had R5 HIV, as determined by proviral DNA genotypic tropism testing, initiated MVC with two nucleoside reverse transcriptase inhibitors (NRTIs) and were followed for 48 weeks. Virological failure was defined as two consecutive viral load measurements > 50 copies/mL. RESULTS: Tropism results were available for 141 of 175 (80.6%) subjects screened: 60% had R5 and 85% of these (n = 74) were finally included in the study. Previous ART included protease inhibitors (PIs) in 62% of subjects, nonnucleoside reverse transcriptase inhibitors (NNRTIs) in 36%, and integrase inhibitors (INIs) in 2%. Main reasons for treatment change were dyslipidaemia (42%), gastrointestinal symptoms (22%) and liver toxicity (15%). MVC was given alongside tenofovir (TDF)/emtricitabine (FTC) (54%) and abacavir (ABC)/lamivudine (3TC) (40%) in most patients. Eighty-four per cent of patients maintained a viral load < 50 copies/mL to week 48, whereas 16% discontinued treatment: two withdrew informed consent, one had an R5 to X4 shift between screening and baseline, one was lost to follow-up, one developed an adverse event (rash), two died from non-study-related causes, and five developed protocol-defined virological failure. CONCLUSIONS: Initiation of MVC plus two NRTIs in aviraemic subjects based on genotypic tropism testing of proviral HIV-1 DNA is associated with low rates of virological failure for up to 1 year.
Asunto(s)
ADN Viral/genética , Genotipo , VIH-1/fisiología , Provirus/genética , Tropismo Viral , Adulto , Antagonistas de los Receptores CCR5/uso terapéutico , Ciclohexanos/uso terapéutico , Femenino , Técnicas de Genotipaje , VIH-1/genética , VIH-1/aislamiento & purificación , Humanos , Quimioterapia de Mantención/métodos , Masculino , Maraviroc , Persona de Mediana Edad , Estudios Prospectivos , España , Resultado del Tratamiento , Triazoles/uso terapéuticoRESUMEN
OBJECTIVES: To determine the frequency of pregnancies among HIV-infected women in a sanitary area. To evaluate the proportion of women not receiving anti-retroviral treatment to decrease vertical transmission and the reasons why this treatment was not administered. PATIENTS AND METHODS: Point prevalence study performed on all women followed for 1997 at the HIV Infection Unit in a 360-bed hospital. The following variables were obtained: social class, civil status and place of residence, risk factors for HIV infection, obstetric antecedents (pregnancies, number of term pregnancies, living newborns) as well as prescription or not of anti-retroviral therapy during pregnancy. RESULTS: Out of 85 women included in the study, 51 (60%) reported to have had a pregnancy and 17 of these (33%) had interrupted the pregnancy at some time. No significant differences were found between pregnancy or abortion and the analyzed socio-demographic variables or risk factors for HIV infection. Only 12% of women with a full length pregnancy received anti-retroviral therapy. Of women with term pregnancy who were not treated, most (63%) did not know they were infected before delivery and an additional 10% refused therapy. Forty-four percent of women with children continued with pregnancy despite knowing they were infected. Vertical transmission occurred in a 13% of cases in which no therapy was instituted and in no case in which zidovudine was administered during pregnancy. CONCLUSIONS: The frequency of pregnancies among HIV-infected women is high in our area and a substantial number of women do not know they are infected. These data support the serological study to HIV in all pregnant women and the necessity of a higher level of information in order that the seropositive women be aware of the responsibility she takes when she decides to go on with her pregnancy.