UN Report: 131 million people in Latin America and the Caribbean cannot access a healthy diet

Cristina Mitchell

19 Jan 2023

The study’s independent Data and Safety Monitoring Board (DSMB) determined that the regimen was not effective in preventing HIV infection compared to placebo among study participants. No safety issues with the vaccine regimen were identified.

In light of the DSMB’s determination, the Mosaico clinical trial will be discontinued. Participant notifications and further analyses of the data are underway. Throughout the trial, study investigators have ensured that any individuals who contracted HIV received prompt HIV treatment and care.

“We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. “Though there have been significant advances in prevention since the beginning of the global epidemic, 1.5 million people acquired HIV in 2021 alone, underscoring the high unmet need for new options and why we have long worked to tackle this global health challenge. We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine. We are grateful to our Mosaico partners and the study investigators, staff and participants.”

Mosaico, a Phase 3 study of Janssen’s investigational HIV vaccine regimen, began in 2019, and completed vaccinations in October 2022. The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain and the United States.

The study evaluated an investigational vaccine regimen containing a mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV) administered during four vaccination visits over one year. A mix of soluble proteins (Clade C/Mosaic gp140, adjuvanted with aluminum phosphate) was also administered at visits three and four.

The Mosaico DSMB analysis, based on the data available to date, indicated that the regimen does not protect against HIV and the study is not expected to meet its primary endpoint. No safety issues with the vaccine regimen were identified. In light of this, the study will be discontinued, and further analyses are underway.

The DSMB’s determination follows the primary analysis of the Phase 2b Imbokodo study, which was announced in August 2021 and found that a similar investigational HIV vaccine regimen did not provide sufficient protection against HIV in a population of young women in sub-Saharan Africa. The investigational vaccine regimen used in the Imbokodo study was found to have a favorable safety profile.

The Mosaico study was led by a global public-private partnership including the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), the HIV Vaccine Trials Network (HVTN), the U.S. Army Medical Research and Development Command (USAMRDC), and Janssen Vaccines & Prevention B.V. Since 2005, Janssen Vaccines & Prevention B.V. has been participating as a sub-grantee in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526, AI096040 and AI128751 (Principal Investigator, Prof. Dan Barouch).

Read also: Johnson and Johnson may eye deals that boost eye care, surgical robots businesses: CEO Joaquin Duato

Many patients with cataract have levels of corneal or
refractive astigmatism sufficient to impact clinical outcomes after cataract
surgery. Astigmatism management at the time of cataract surgery results in
better postoperative visual outcomes, higher satisfaction with vision, greater
spectacle independence, and improvement in patients' vision-related quality of
life compared to patients in whom astigmatism management is not attempted
during cataract surgery. Moreover, astigmatism management during cataract
surgery is a cost-effective approach compared to postoperative vision
correction with spectacles.

The surgical management of astigmatism requires the
integration of multiple steps throughout the preoperative period to achieve an
optimal outcome. The toric intraocular lens (IOL) power must be properly
calculated and selected. Toric IOL stability has been implicated as a potential
source of postoperative rotational malposition.

The Tecnis Toric II (Model ZCU) IOL is an ultraviolet
light-absorbing posterior chamber lens designed to compensate for the spherical
aberration of the average cornea and correct astigmatism. The IOL incorporates
a proprietary wavefront-designed toric aspheric optic with a square posterior
optic edge that provides a 360⁰ barrier to reduce cell migration across the
posterior capsule. The edge of the optic is frosted to reduce potential edge
glare effects.

A post-market study was conducted by Chang et al to
determine the rotational stability of these frosted haptic IOLs. Short-term
rotational stability, defined as 1-day and 1-week postoperatively, and clinical
performance of the Tecnis Toric II (Model ZCU) IOL from this were described in
a previous publication. In this study, short- and long-term lens rotation,
visual acuity, manifest refraction, and patient and surgeon satisfaction were
evaluated over a 3-month period following implantation.

A post-market, prospective, multi-center, single-arm,
open-label study conducted at seven clinical sites in the United States. Two
hundred and two eyes of 133 subjects with unilateral or bilateral cataracts and
corneal astigmatism were implanted with the Tecnis Toric II IOL, Models ZCU150
to 600. Lens axis misalignment/ rotation, visual acuity, manifest refraction,
and surgeon and patient satisfaction were evaluated 3 months postoperatively.
Lens rotation was determined with operative and postoperative visit photographs
and was analyzed by two independent masked analysts.

Mean absolute lens rotation was 0.82° ± 1.00° and 0.94° ±
0.71° at 1 day (n = 189 eyes) and 3 months (n = 185 eyes), respectively.
Absolute lens rotation was ≤5° in 98.9% and 100% of eyes at 1 day and 3 months,
respectively.

At 3 months, postoperative monocular uncorrected and
corrected distance visual acuities were 0.004 ± 0.115 LogMAR (20/20) and −0.066
± 0.092 LogMAR (20/17), mean spherical equivalent was −0.25 D ± 0.35 D and
residual refractive cylinder was +0.27 D ± 0.33 D. Surgeons were satisfied/very
satisfied with overall clinical outcomes and rotational stability in 99% of
eyes, and with uncorrected distance vision in 98.5% of eyes.

Rotational stability of toric IOLs following implantation is
critical to good visual outcomes, particularly with higher magnitude of
astigmatism. For each 10° of toric IOL rotation, the residual cylinder is equal
to about one-third of the corneal cylinder, creating an under correction of the
astigmatic refractive error. Most modern toric IOLs show a relatively low
amount of misalignment. The original Tecnis toric IOLs (model ZCT) was the
first to meet the ANSI standard for rotational stability for toric IOLs
(>90% of eyes having ≤5° axis change between consecutive visits three months
apart), with ≥93% of toric first eyes having a ≤ 5°axis change. However, 3–5°
of rotation still amounts to a loss of approximately 10–15% of the
astigmatism-reducing effect of a toric IOL, with amounts obviously higher for
the outlying values of lens rotation.

The novel validated photographic technique for assessing
lens position provides evidence that this new toric IOL design with frosted
haptics can help to increase surgical success, patient satisfaction, and
surgeon confidence in a toric IOL approach for cataract patients with
astigmatism. This study, while not a head to head comparison to other toric options,
provides confirmation that this improved lens design yields robust technical
and clinical outcomes that address past reports of rotational instability with
the original Tecnis Toric IOL. This improved toric design is now incorporated
into other IOL designs giving physicians presbyopia-correcting options for
their patients with clinically significant levels of astigmatism. The ongoing
improvements and continued success of toric IOLs is critical to meeting the
needs of a greater proportion of the growing presbyopic population in the US
and abroad.

Source: Chang et
al; Clinical Ophthalmology 2022:16 https://doi.org/10.2147/OPTH.S389304

UK: According to a research article published in Ophthalmologica,
researchers have pointed out that following pars plana vitrectomy (PPV), drop
regimen of one-week dexamethasone 0.1%/antibiotic and one-month ketorolac is as
effective as an anti-inflammatory. This regime is safer for Ocular hypertension
(OHT) compared to standard care one-month dexamethasone 0.1%.

It is already known that postoperative steroid/antibiotic drop
regimens effectively suppress inflammation and infection following Pars Plana
Vitrectomy. However, steroid induces OHT frequently. This requires additional
treatment and more frequent hospital visits in the postoperative period.

To address the concern mentioned above, a cohort-control study was
conducted led by Orlans et al. to assess the safety and efficacy of a novel
post-PPV drop regimen.

The study points are:

· The relevant electronic case notes were reviewed between December
2020-April 2021 of those patients who underwent PPV.

· The study was conducted at Vitreoretinal Service, St. Thomas'
Hospital, London, UK

· The intervention cohort had 58 (28 %) patients given postoperative
drops of one-week dexamethasone 0.1%/antibiotic QDS and one-month g. ketorolac
TDS.

· Standard care controls included 151 (72 %) patients who received
one-month g. dexamethasone 0.1%/antibiotic QDS.

· Total of 209 eyes from 192 patients were included.

· IOP≥30 mmHg two weeks postoperatively was the primary outcome measured
by the researchers.

· Secondary outcomes were rates of anterior uveitis, cystoid macular
oedema, endophthalmitis, and the number of eye hospital visits.

· Similarities were reported between baseline and <72hr postoperative
IOPs between groups.

· IOP ≥ 30 mmHg at the two-week postoperative visit (primary outcome
measure) occurred in none of the intervention groups but in 21 (14%) of the
controls.

· The difference in IOP change distribution between the two groups was
highly significant.

· There was no significant difference reported in secondary outcomes
between the groups.

· There were no cases of endophthalmitis in either cohort.

· The intervention cohort had fewer all-cause eye hospital visits in the
three months immediately following PPV.

The novel regimen used in the study reduced rate of subsequent OHT, a
lesser need for additional topical antihypertensive treatment, and fewer
patient visits to the eye hospital in the postoperative period.

Further reading:

Orlans HO, Yazdouni S, Williamson TH, Wong RS, Laidlaw DAH. A novel
postoperative drop regimen reduces the risk of ocular hypertension following
pars plana vitrectomy. Ophthalmologica. 2022 Dec 23. DOI: 10.1159/000528037

This was warned yesterday by epidemiologist-health worker Carlos Féliz Cuello, who advised the public not to stay at home if they experience the first symptoms of profuse diarrhea that causes cholera because the patient requires special hydration, which cannot be obtained simply by drinking water or other energy drinks that people are accustomed to consuming in case of diarrhea. He claims that cholera causes rapid electrolyte loss and dehydration, which can lead to death in less than three days if not treated properly.

The specialist recalled that cholera is a poverty-related disease that manifests itself in areas where there is no drinking water, they do not receive it through pipes, they consume water sold in bulk, they live in overcrowded conditions, and they lack adequate education on food handling and cooking. “All of these are social, economic, and environmental factors that facilitate the development of this bacterium that is acquired through food and water contamination,” he explained. He stated that to avoid the presence of outbreaks of this disease from time to time, countries must be concerned about changing the living conditions of the people who live in these vulnerable areas because otherwise, all they are doing is applying temporary palliative measures, as is currently happening in the country in sectors such as La Zurza, where an outbreak has been registered.

He stated that the cases that are reported are those in which people notify when their care mechanisms, such as drinking a lot of water, teas, and hydrating drinks, have already failed and they arrive at health centers in complicated conditions. He explained that the cholera disease’s profuse diarrhea quickly dehydrates, causing the kidneys to stop working and the circulatory, cardiac, and respiratory systems to shut down.

Living a healthy lifestyle is key to fighting off chronic illnesses like heart disease, stroke, and arthritis. It is also important to practise a healthy lifestyle to protect yourself against acute diseases and infections such as the common cold,...

PAHO issues alert on outbreaks of avian influenza in birds in ten countries of the Americas

Cristina Mitchell

17 Jan 2023

Pharmaceutical companies AbbVie and Eli Lilly have withdrawn from Britain's voluntary medicines pricing agreement, an industry body said on Monday. Reuters Health Information

sales — for its manufacturer AbbVie after coming just a few hundred million short of the $20 billion benchmark for three years in a row. However, while this news was no-doubt greeted warmly by the company, AbbVie’s fourth-quarter 2021