Objetivos: Describir la forma en que se establecen normativamente el consentimiento informado (CI) y las directivas anticipadas (DA) en países latinoamericanos en relación a la asistencia en salud y la investigación, y su análisis desde la bioética. Métodos: Se realizó un análisis comparativo de las normativas vigentes de los 21 países latinoamericanos respecto al CI y las DA. Se confeccionaron reportes de extracción de datos que fueron diseñados antes de iniciar el proceso de investigación para cada país. Se analizaron cualitativamente similitudes y diferencias respecto a variables predefinidas. Se realizaron tablas para sintetizar la información donde fue posible. Resultados: Dieciocho países latinoamericanos prevén una norma específica para el uso del CI en el ámbito clínico. Seis países han incorporado normativas respecto al uso del CI en la virtualidad. Respecto al uso del CI en investigación, 20 países latinoamericanos prevén una norma específica para este ámbito. En el caso de la exposición académica, son 6 países los que nombran esta situación en la normativa. Siete países latinoamericanos cuentan con normativa para establecer DA. Conclusiones: América Latina ha presentado una notable evolución en torno a normar dos de los más importantes instrumentos del ejercicio de la autonomía, como los son el CI y las DA. La legislación sobre ambos instrumentos no garantiza mayor autonomía en salud, pero su existencia como reguladora de acciones para la toma de decisiones constituye el primer paso para su ejercicio.

HIV-1 subtype B is the most frequent strain in Peru. However, there is no available data about the genetic diversity of HIV-infected patients receiving highly active antiretroviral therapy (HAART) here. A group of 267 patients in the Peruvian National Treatment Program with virologic failure were tested for genotypic evidence of HIV drug resistance at the Instituto Nacional de Salud (INS) of Peru between March 2008 and December 2010. Viral RNA was extracted from plasma and the segments of the protease (PR) and reverse transcriptase (RT) genes were amplified by reverse transcriptase polymerase chain reaction (RT-PCR), purified, and fully sequenced. Consensus sequences were submitted to the HIVdb Genotypic Resistance Interpretation Algorithm Database from Stanford University, and then aligned using Clustal X v.2.0 to generate a phylogenetic tree using the maximum likelihood method. Intrasubtype and intersubtype recombination analyses were performed using the SCUEAL program (Subtype Classification by Evolutionary ALgo-rithms). A total of 245 samples (91%) were successfully genotyped. The analysis obtained from the HIVdb program showed 81.5% resistance cases (n=198). The phylogenetic analysis revealed that subtype B was predominant in the population (98.8%), except for new cases of A, C, and H subtypes (n=4). Of these cases, only subtype C was imported. Likewise, recombination analysis revealed nine intersubtype and 20 intrasubtype recombinant cases. This is the first report of the presence of HIV-1 subtypes C and H in Peru. The introduction of new subtypes and circulating recombinants forms can make it difficult to distinguish resistance profiles in patients and consequently affect future treatment strategies against HIV in this country.

El estudio tuvo como objetivo determinar la resistencia transmitida (RT) del virus de la inmunodeficiencia humana (VIH) en pacientes procedentes de nueve departamentos del Perú. Para ello, se realizó un estudio descriptivo en 132 adultos que aceptaron participar mediante un consentimiento informado. Se colectaron muestras de sangre para realizar el recuento de células CD4/CD8, determinar la carga viral y la genotipificación del VIH. Se recabó información socioepidemiológica de los participantes mediante encuestas. Los resultados revelaron una frecuencia de RT de 9,8% (13/132). Los resultados del estudio ayudarán a mejorar los programas de intervención y monitoreo de la resistencia a los antirretrovirales en el país.

HIV-1 genetic diversity and resistance profile might change according to the risky sexual behavior of the host. To show this, we recruited 134 individuals between the years 2015 and 2017 identified as transgender women sex workers (TWSW, n = 73) and Heterosexual Military Officers (HET-MO, n = 61). After obtaining informed consent, we collected a blood sample to perform the HIV genotyping, CD4 cell count, and viral load. We used bioinformatics approaches for detecting resistance mutations and recombination events. Epidemiological data showed that both groups reported sexually transmitted diseases and they were widespread among TWSW, especially syphilis and herpes virus (35.6%). Illegal drugs consumption was higher among TWSW (71.2%), whereas condom use was inconsistent for both HET-MO (57.4%) and TWSW (74.0%). TWSW showed the shortest time exposition to antiretroviral therapy (ART) (3.5 years) and the lowest access to ART (34.2%) that conducted treatment failure (>4 logs). HIV-1 sequences from TWSW and HET-MO were analyzed to determine the genetic diversity and antiretroviral drug resistance. Phylogeny analysis revealed 125 (93%) cases of subtype B, 01 subtype A (0.76%), 07 (5.30%) BF recombinants, and 01 (0.76%) AG recombinant. Also, TWSW showed a higher recombination index (9.5%, 7/73) than HET-MO (1.5%, 1/68). HET-MO only showed acquired resistance (26.23%, 16/61), whereas TWSW showed both acquired as transmitted resistance (9.59% for each). In conclusion, TWSW and HET-MO showed significant differences considering the epidemiological characteristics, genetic diversity, recombination events, and HIV resistance profile.

HIV genetic diversity in female sex workers (FSW) has been previously described in Peru; however this information is not yet available for male sex workers (MSW). Therefore, purified peripheral blood mononuclear cell DNA from 147 HIV-infected subjects identified as MSW and FSW was used to amplify a 460-bp fragment corresponding to the p24-p7 region of the gag gene. The PCR product was digested with restriction enzymes to identify genetic polymorphism. Later, a random group of samples (n = 19) was sequenced to perform phylogenetic analysis, intragenic recombination analysis, and deleterious mutations leading to a nonfunctional protein in conservative regions of the Gag protein. RFLP analysis revealed 11 genetic variants for AluI and five for MspI. A group of nonsex workers (NSW) used for comparison showed different RFLP genetic variant distributions. Of interest, nine cases of mixed genetic variants were observed for MSW, one case for FSW, and none for NSW. Phylogenetic analysis revealed that all HIV-1 species were subtype B. Intragenic recombination analysis showed a B/C recombination case from an FSW (boostrap = 1000; p value < 0.05). Of interest, deleterious mutations were observed in three cases of conservative D2 zinc domains for Gag 3/19 and one case of the high homology region (1/19). This study shows that gag of HIV circulating from MSW has high genetic polymorphism involving deleterious mutations in conserved domains from the p24-p7 gag region.