Patient-Reported Outcomes in ATLAS and FLAIR Participants on Long-Acting Regimens of Cabotegravir and Rilpivirine Over 48 Weeks

The phase 3 ATLAS and FLAIR studies demonstrated that maintenance with Long-Acting (LA) intramuscular cabotegravir and rilpivirine is non-inferior in efficacy to current antiretroviral (CAR) oral therapy. Both studies utilized Patient-Reported Outcome instruments to measure treatment satisfaction (HIVTSQ) and acceptance (ACCEPT general domain), health status (SF-12), injection tolerability/acceptance (PIN), and treatment preference. In pooled analyses, LA-treated patients (n = 591) demonstrated greater mean improvements from baseline than the CAR group (n = 591) in treatment satisfaction (Week 44, + 3.9 vs. +0.5 HIVTSQs-points; p /= 97% of LA group participants with recorded data preferred LA treatment compared with prior oral therapy. These results further support the potential of a monthly injectable option for people living with HIV seeking an alternative to daily oral treatment

Evaluation of a strict protocol approach in managing women with severe disease due to hypertension in pregnancy: A before and after study

BACKGROUND: To evaluate whether the introduction of a strict protocol based on the systemic evaluation of critically ill pregnant women with complications of hypertension affected the outcome of those women. METHOD: Study group: Indigent South African women managed in the tertiary hospitals of the Pretoria Academic Complex. Since 1997 a standard definition of women with severe acute maternal morbidity (SAMM), also referred to as a Nearmiss, has been used in the Pretoria Academic Complex. All cases of SAMM and maternal deaths (MD) were entered on the Maternal Morbidity and Mortality Audit System programme (MaMMAS). A comparison of outcome of severely ill women who had complications of hypertension in pregnancy was performed between 1997–1998 (original protocol) and 2002–2003 (strict protocol). Data include women referred from outside the Pretoria Academic Complex area to the tertiary hospitals. RESULTS: Between 1997–1998 there were 79 women with SAMM and 18 maternal deaths due to complications of hypertension, compared with 91 women with SAMM and 13 maternal deaths in 2002–2003. The mortality index (MI) declined from 18.6% to 12.5% (OR 0.62, 95% CI 0.27–1.45). Statistically significant fewer women had renal failure (RR 0.37, 95% CI 0.21 – 0.66) and cerebral complications (RR 0.52, 95%CI 0.34 – 0.81) during the second period, and liver dysfunction (RR 0.27 95%CI 0.06 – 1.25) tended to be lower. However, there tended to be an increase in the number of women, who had immune system failure (RR 4.2 95%CI 0.93 – 18.94) and respiratory failure (RR 1.42 95%CI 0.88 – 2.29) although it did not reach significance. Cardiac failure remained constant (RR 0.84 95%CI 0.54 – 1.30). CONCLUSION: The strict protocol approach based on the systemic evaluation of severely ill pregnant women with complications of hypertension and an intensive, regular feedback mechanism has been associated with a reduction in the number of patients with renal failure and cerebral compromise

Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 Infection.

BACKGROUND: Long-acting injectable regimens may simplify therapy for patients with human immunodeficiency virus type 1 (HIV-1) infection. METHODS: We conducted a phase 3, randomized, open-label trial in which adults with HIV-1 infection who had not previously received antiretroviral therapy were given 20 weeks of daily oral induction therapy with dolutegravir-abacavir-lamivudine. Participants who had an HIV-1 RNA level of less than 50 copies per milliliter after 16 weeks were randomly assigned (1:1) to continue the current oral therapy or switch to oral cabotegravir plus rilpivirine for 1 month followed by monthly injections of long-acting cabotegravir plus rilpivirine. The primary end point was the percentage of participants who had an HIV-1 RNA level of 50 copies per milliliter or higher at week 48 (Food and Drug Administration snapshot algorithm). RESULTS: At week 48, an HIV-1 RNA level of 50 copies per milliliter or higher was found in 6 of 283 participants (2.1%) who received long-acting therapy and in 7 of 283 (2.5%) who received oral therapy (adjusted difference, -0.4 percentage points; 95% confidence interval [CI], -2.8 to 2.1), a result that met the criterion for noninferiority for the primary end point (margin, 6 percentage points). An HIV-1 RNA level of less than 50 copies per milliliter at week 48 was found in 93.6% who received long-acting therapy and in 93.3% who received oral therapy (adjusted difference, 0.4 percentage points; 95% CI, -3.7 to 4.5), a result that met the criterion for noninferiority for this end point (margin, -10 percentage points). Of the participants who received long-acting therapy, 86% reported injection-site reactions (median duration, 3 days; mild or moderate severity, 99% of cases); 4 participants withdrew from the trial for injection-related reasons. Grade 3 or higher adverse events and events that met liver-related stopping criteria occurred in 11% and 2%, respectively, who received long-acting therapy and in 4% and 1% who received oral therapy. Treatment satisfaction increased after participants switched to long-acting therapy; 91% preferred long-acting therapy at week 48. CONCLUSIONS: Therapy with long-acting cabotegravir plus rilpivirine was noninferior to oral therapy with dolutegravir-abacavir-lamivudine with regard to maintaining HIV-1 suppression. Injection-site reactions were common. (Funded by ViiV Healthcare and Janssen; FLAIR ClinicalTrials.gov number, NCT02938520.)

Caring for the medically ill pregnant woman

No Abstract.Obstetrics & Gynaecology Forum Vol. 17 (2) 2007: pp.33-3

Current status of HPV screening

No Abstract

Gynaecological critical incidents. An audit of current gynaecological practice at Kalafong hospital over a six months period: research article

Aim: To identify critical incidents in the gynaecological practice at Kalafong hospital. Setting: Kalafong Hospital, a level 2 & 3 urban hospital in Atteridgeville, Tshwane. Method: A critical incident can be defined as any cause or action that leads to extra morbidity in the patient as well as any intervention that when it was performed could have led to serious morbidity or mortality in the gynaecological wards. Critical incidents were collected at the daily audit meeting. Results: The Dept of Gynaecology at Kalafong Hospital had a critical incident rate of 7, 98% over a six-months period. The Emergency Admission group had an overall critical incident rate of 5, 09% compared to the Elective Admission group, which had an overall critical incident rate of 15%. This unexpected difference can be explained by the large contribution of the Oncology patients. There was 29 out of 51 or 56, 86% of critical incidents from patients suffering from a gynecological oncological problem. The complication rate for elective surgery group is higher than the emergency group. Deaths accounted for 26, 60% of the critical incidents and 2, 15% of all admissions. The death rate is almost six times higher in the elective admission group (6, 76% versus 0, 24%), which can be accounted for by the fact that almost all oncology patients are counted as elective admissions. Conclusion: The system is usable. It became clear that a better database is necessary to determine more specific critical incident rates. O & B Forum Vol.14(2) 2004: 24-2