Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials.

OBJECTIVES: The single-tablet regimen rilpivirine, emtricitabine and tenofovir alafenamide (RPV/FTC/TAF) for treatment of HIV-1-infected adults was approved based on bioequivalence. We assessed the clinical efficacy, safety and tolerability of switching to RPV/FTC/TAF from either RPV/FTC/tenofovir disoproxil fumarate (TDF) or efavirenz (EFV)/FTC/TDF. METHODS: We conducted two distinct randomized, double-blind, active-controlled, noninferiority trials in participants taking RPV/FTC/TDF (Study 1216) and EFV/FTC/TDF (Study 1160). Each study randomized virologically suppressed (HIV-1 RNA < 50 copies/mL) adults (1:1) to switch to RPV/FTC/TAF or continue their current regimen for 96 weeks. We evaluated efficacy as the proportion with HIV-1 RNA < 50 copies/mL using the Food and Drug Administration snapshot algorithm and prespecified bone and renal endpoints at week 96. RESULTS: We randomized and treated 630 participants in Study 1216 (RPV/FTC/TAF, n = 316; RPV/FTC/TDF, n = 314) and 875 in Study 1160 (RPV/FTC/TAF, n = 438; EFV/FTC/TDF, n = 437). In both studies, the efficacy of switching to RPV/FTC/TAF was noninferior to that of continuing baseline therapy at week 96, with respective percentages of patients with HIV RNA < 50 copies/mL being 89.2% versus 88.5% in Study 1216 [difference 0.7%; 95% confidence interval (CI) -4.3 to +5.8%] and 85.2% versus 85.1% in Study 1160 (difference 0%; 95% CI -4.8 to +4.8%). No participant on RPV/FTC/TAF developed treatment-emergent resistance versus two on EFV/FTC/TDF and one on RPV/FTC/TDF. Compared with continuing baseline therapy, significant improvements in bone mineral density and renal tubular markers were observed in the RPV/FTC/TAF groups (P < 0.001). CONCLUSIONS: Switching to RPV/FTC/TAF from RPV/FTC/TDF or EFV/FTC/TDF was safe and effective and improved bone mineral density and renal biomarkers up to 96 weeks with no cases of treatment-emergent resistance.

[Most of the complaints in gynecology and obstetrics care are generated by perceptions stemming from unavoidable results]. / La mayoría de las quejas por atención ginecológica y obstétrica se generan por percepciones derivadas de resultados inevitables.

UNLABELLED: The annual rises in the cost of claims suffered by some countries had led to increases in: costs of the attention; malpractice premiums; health personnel stress level; risks for the patients with difficult problems, and lack of opportune attention. The intricate interaction between clinical state, responses variability and medical procedures flaws makes impossible stop unavoidable outcomes (UO). Though UO are not derived from negligence or inability, patients and relatives can see it as a malpractice result. OBJECTIVE: To determine the proportion of complaints generated by UO related perceptions (UORP) and their distribution in obstetric and gynecologic stages of care. MATERIAL AND METHODS: A search for claims derived from gynecologic or obstetric care was undertaken in the Medical Arbitrition National Commission (CONAMED) database, those presented between Jun. 1, 1996, and Nov. 30, 1998, were chosen. Some claims were derived directly from UORP (D-UORP claims), others were derived indirectly (UORP clamis); claims were grouped for stage of the attention in which they were originated; non D-UORP claims were grouped also by motives. RESULTS: In 625 claims (98.6% of total) was possible obtain precise information as required for the study. 79% of complaints were derived from UORP; 17% from perceptions generated for medical activities unrelated to UO (MAU-UO claims) and 4% by perception originated from care system (CS claims). 46% of complaints concerned surgical treatment, 27% medical treatment, 14% initial study, 2.1% delivery, in 10% a specific stage of the attention was not mentioned. The motives of the non D-UORP complaints were: 1) I-UORP claims; a) opportunity of the action, when the patient referred delay or inopportuneness as cause of the complaint (17%, overall); b) Professional quality, when questioned de outcomes or medical criteria (23%); 2) MAU-UO claims: a) Professional capacity when patient questions ability, or complaint of error in diagnosis (failure to diagnose or incorrect diagnosis), wrong removal, unnecessary treatment or other actions outside of the norm (13%); b) Improper information (3%); c) Inappropriate manner (0.8%); 3) CS claims: a) Resources (1%); b) Accessibility (2.9%). COMMENTS: The damage risk attributable to medical negligence is very low among patients who had received obstetrical or gynecological care, most of the complaints are UORP generated. In obstetrical care--from 1997 national statistics and described results--a benefit was procured to 1,705,161 persons and were produced 17 possible wrong attentions by professional capacity, five by improper information and one by inappropriate manner; the rest, 123 complaints, were derived from perceptions induced by UO. Undoubtedly there is low complaint registration, however, even at worst the wrong attention effect is lower than the impact attained if the possibility of economic benefit search through medical demands is not totally canceled. The damage risk derived from cost of claims is greater, as suffered on many countries. Medical associations in countries without professional liability problems must accomplish negotiations so that the legislation does not establish compensations by medical care results, the request may be based in: a) the deleterious consequences derived from cost of claims; and, b) the low probability of affecting the patients interests, in Mexico complaints derived from perceptions about the professional capacity are one in 103,022 obstetrical care attentions, the improper information derived one in 316,989 and the inappropriate manner generated one in 1,373,620. These organizations and other health related could assume the commitment to abate the foreseeable complaints and to do research on feasible forms to forecast UO, technically this must be long-range and though international collaboration.

[Lawsuits against gynecologists-obstetricians in the National Commission of Medical Arbitration]. / Demandas contra ginecoobstetras en la Comisión Nacional de Arbitraje Médico.

UNLABELLED: The study of claims motives is relevant since Obstetrics and Gynecology (O&G) is one of the specialties that it is involved with greater frequency in demands in the Medical Arbitration National Commission (CONAMED). OBJECTIVE: In order to know the causes by those which the patients have attended to be complained of the attention provided by a Obstetrician/Gynecologist (OG). MATERIAL AND METHODS: Between June 1, 1996, and November 30, 1998, there were 635 demands reported to the CONAMED for obstetrical or gynecological care, 375 (60%) derived from obstetrical care; claims were grouped by motives and for stage of the attention in which they were originated. RESULTS: There were more than 17 different causes of claim, the most frequent were: complications (20%), care not opportune (16%), accidents (15%), improper actions (15%), diagnostic error (10%). Claims were derived from: Surgical procedures (45%), medical treatment (27%) and diagnosis (13%). 15 (2.4%) of claims were generated from vaginal delivery, but only 9 (1.4%) were obstetrician related. Obstetric surgical procedures account for 23% of claims. CONCLUSIONS: OG are more claimed because work harder, more than one million vaginal and more than 500,000 cesarean deliveries are performed yearly in Mexico. The rates of reported claims are low, one per 10,000 deliveries attended; one per 275,000 vaginal deliveries, one per 8,400 obstetric surgical procedures. It all points OG claims as a probabilistic problem, risk related.

Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. Study 006 Team.

BACKGROUND: Efavirenz is a nonnucleoside reverse-transcriptase inhibitor of human immunodeficiency virus type 1 (HIV-1). We compared two regimens containing efavirenz, one with a protease inhibitor and the other with two nucleoside reverse-transcriptase inhibitors, with a standard three-drug regimen. METHODS: The study subjects were 450 patients who had not previously been treated with lamivudine or any nonnucleoside reverse-transcriptase inhibitor or protease inhibitor. In this open-label study, patients were randomly assigned to one of three regimens: efavirenz (600 mg daily) plus zidovudine (300 mg twice daily) and lamivudine (150 mg twice daily); the protease inhibitor indinavir (800 mg every eight hours) plus zidovudine and lamivudine; or efavirenz plus indinavir (1000 mg every eight hours). RESULTS: Suppression of plasma HIV-1 RNA to undetectable levels was achieved in more patients in the group given efavirenz plus nucleoside reverse-transcriptase inhibitors than in the group given indinavir plus nucleoside reverse-transcriptase inhibitors (70 percent vs. 48 percent, P<0.001). The efficacy of the regimen of efavirenz plus indinavir was similar (53 percent) to that of the regimen of indinavir, zidovudine, and lamivudine. CD4 cell counts increased significantly with all combinations (range of increases, 180 to 201 cells per cubic millimeter). More patients discontinued treatment because of adverse events in the group given indinavir and two nucleoside reverse-transcriptase inhibitors than in the group given efavirenz and two nucleoside reverse-transcriptase inhibitors (43 percent vs. 27 percent, P=0.005). CONCLUSIONS: As antiretroviral therapy in HIV-1-infected adults, the combination of efavirenz, zidovudine, and lamivudine has greater antiviral activity and is better tolerated than the combination of indinavir, zidovudine, and lamivudine.