Dr David Margolis, ViiV Healthcare, USA

An injectable antiretroviral therapy (ART) consisting of two drugs (cabotegravir and rilpivirine) administered every four or eight weeks may be as effective as a daily oral dose of the drugs in maintaining viral suppression in patients with HIV, according to a new phase 2 trial published in The Lancet.

In the study, patients were given injectable ART as a maintenance therapy over 96 weeks once they had achieved viral suppression after 20 weeks of daily oral medication.

In Uganda many patients have complained of not being comfortable in swallowing the ARV drugs with some reports indicating some patients abandon treatment along the way.

However, reports suggest that the potential for a long-acting injectable ART could ease the burden faced by people living with HIV of having to take daily oral medication lifelong to manage the disease. Phase 3 trials are ongoing and are needed to confirm the results, and further trials will be needed in wider groups of patients to generalise the findings.

The trial is presented at the International AIDS Society meeting in Paris, France.

An estimated 36.7 million people worldwide are living with HIV, and advances in ART have led to improved survival and quality of life for people with HIV. However, current treatment requires taking a daily dose of medication lifelong, and poor compliance can result in treatment failure or the emergence of drug-resistant mutations. Long-acting injectable drugs potentially offer a more convenient way of managing the disease.

“Adherence to medication remains an important challenge in HIV treatment. Long-acting injectable ART could provide some patients with a more convenient approach to manage HIV infection that avoids daily oral dosing, and the need to keep, store, and transport medications as they go about their daily lives,” explains author of the LATTE-2 study Dr David Margolis, ViiV Healthcare, USA.

“The introduction of single tablet medication represented a leap forward in ART dosing, and long-acting antiretroviral injections may represent the next revolution in HIV therapy by providing an option that circumvents the burden of daily dosing. The results through to 96 weeks with this two-drug regimen are encouraging, and we now need further research, including the ongoing phase 3 trial, to confirm these findings,” Dr Margolis adds.

HIV injectable drugs

According to the report, the  trial began with an induction phase in order to identify any potential adverse events to the drugs before administering a long-acting injectable. 309 participants were included in the initial induction phase of the trial, during which they were given daily oral doses of cabotegravir (30mg) and abacavir-lamivudine (600mg-300mg) over 20 weeks.

The majority of participants tolerated the drugs and reached viral suppression (plasma HIV-1 RNA less than 50 copies per mL) and was therefore eligible to enter the maintenance phase.

286 participants were included in the maintenance phase, where they were randomly assigned to receive injectable cabotegravir plus rilpivirine at 4-week intervals (115 patients), at 8-week intervals (115 patients) or continue on the daily oral dose of cabotegravir and abacavir-lamivudine (56 patients).

32 weeks after randomisation, viral suppression was maintained in 91% (51/56) of patients in the oral medication group, 94% (108/115) in the 4-week group, and 95% (109/115) in the 8-week group.

At 96 weeks, viral suppression was maintained in 84% (47/56) of patients in the oral medication group, 87% (100/115) in the 4-week group, and 94% (108/115) in the 8-week group.

Pain at the site of the injection was the most commonly reported adverse event (97% of patients in the 4-week group, and 96% in the 8-week group). Most reactions were mild or moderate and lasted an average of 3 days. In total, 2 of 230 (<1%) patients receiving the injectable two-drug regimen discontinued due to injection intolerance.

Other adverse events reported included nasopharyngitis, diarrhoea, and headache, and rates were similar in all three groups. A total of 11 patients (4%) developed an adverse event during the maintenance phase which led to withdrawal from the study: 8 patients (7%) in the 4-week group, two (2%) in the 8-week group, and one (2%) in the oral treatment group. Two deaths occurred during the study: one from a motor vehicle accident, and the other following an epileptic seizure which was not thought to be due to the treatment.

The trial was done at 50 sites in the USA, Germany, Canada, Spain, France and Germany. Although it included patients from five countries, most (91%) of the participants were male. Also, participants were only eligible for the trial if they had a CD4+ cell count of at least 200 cells per mm3, which does not necessarily represent the global population living with HIV. Further research in more diverse groups of patients is now needed.

Professor Joe Eron, University of North Carolina at Chapel Hill, USA, author of the study, says: “The results of LATTE-2 show that a long-acting injectable antiretroviral regimen has the potential to be both highly effective and well tolerated over a long period of time. These data provide a strong foundation for the ongoing and planned phase 3 trials which will hopefully lead to an effective, well tolerated alternative to daily antiretroviral therapy.”

Writing in a linked Comment, Professor Mark A. Boyd, University of Adelaide, Adelaide, Australia, and Professor David A. Cooper from the Kirby Institute, University of New South Wales, Sydney, Australia, say:

“While injectable ART might be attractive for some or perhaps many people living with HIV (….), there will inevitably be a trade-off between the convenience of not having to adhere to oral therapy and the inconvenience and discomfort associated with injectable long-acting ART. It is possible that injectable ART will be more attractive the less one must be injected. This is particularly the case in the current era when oral therapy is administered as one pill, once daily, and (at least in Australia) people living with HIV can be dispensed anywhere from 2 to 6 months’ supply of ART at a time. This scenario, compared with having to seek health care to be injected on a monthly basis, might make the injectable option seem less convenient than conventional oral therapy for some people. This is compounded by the fact that health-care systems are generally not configured to facilitate regular, recurrent injections in a timely and convenient way to people who are well. Changing this will take innovation, political will, and time.”

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RT Hon. Dr Ruhakana Rugunda addressing the delegates in Paris

NEW YORK, 22 APRIL 2016.
H.E. Mogens Lykketoft, President of the 70th Session of the UN General Assembly,
Their Excellencies, Heads of State and Government,
H.E. Ban Ki-Moon, UN Secretary General,
Excellencies,
Distinguished Delegates,
Ladies and Gentlemen,

I am honoured and privileged to convey warm fraternal greetings and best wishes from H.E. Yoweri Kaguta Museveni, President of the Republic of Uganda, to Their Excellencies on this historic occasion of the signing of the Paris Agreement on Climate Change. H.E the President was desirous of attending this event but has not been able to do so due to other equally important State commitments. H.E the President delegated me to represent him. I wish to start my remarks in the capacity of Uganda as the Chairperson of the Africa Group for this month.

Mr. President,
The adoption of the Paris Agreement in December 2015 marked the end of a long process of diplomatic engagement and jostling over measures to include in the global package for addressing challenges arising from the effects of climate change. The Paris Agreement was a major milestone in our determination and commitment to take concrete actions to hold the increase in global average temperature to well below 2°C above the pre-industrial levels and to pursue efforts to limit the temperature increase to 1.5°C above the pre-industrial levels.

Mr. President,
This Signing Ceremony of the Paris Agreement opens a new chapter in our global efforts to put into action the undertakings we agreed in Paris. The fact that many countries worldwide will today sign the Agreement sends a strong message of our collective resolve and firm commitment to implement that Agreement. All of us must commit ourselves to carrying this bold step forward by ratifying and eventually domesticating the said Agreement in order to give it the necessary legal effect under our respective national legislation. We re-affirm our commitment to implementing the various relevant measures and actions; as spelt-out in the Agreement.

Mr. President,
Despite all these on-going efforts, African countries are confronted with some real challenges in terms of gaps especially in areas of financing the various climate change priority initiatives; strengthening institutional and human capacities to effectively respond to these challenges; and accessing the vital necessary technologies critical for climate change mitigation and adaptation. This is the context in which we urge our developed country partners that have the required means, to come-in and partner with us in addressing these gaps; consistent with the relevant provisions of the Paris Agreement and the Addis Ababa Action Agenda on financing climate change. They should significantly mobilise and provide new and additional scaled-up financial flows; support enhancement of scientific and technological innovations; and increase assistance for human resource and institutional capacity-building to enable us to fully implement robust climate change actions. We believe that such support can contribute to significant gains in investments in green economy; restoration of our degraded ecosystems and strengthened community resilience to the impacts of climate change and disaster risks.

On the part of Africa, we are committed to promoting regional partnerships for addressing transboundary climate change challenges; including through pooling of resources, available capacities and skills; and sharing of relevant information and data. This is important for efficiency and cost effectiveness in the utilisation of the available limited resources.

Mr. President,
In my national capacity, I am happy to report that Uganda has taken a number of actions to operationalise some of the relevant commitments under the said Agreement. We have fully integrated measures to address the effects of climate change in our long-term national aspiration “Uganda Vision 2040”; and the Second National Development Plan (FY 2015/16-FY 2019/20). The re-elected NRM Government, to be sworn-in on 12th May 2016, has prioritised climate change among issues to address over the next five years.

In this regard, building a sustainable green economy, including through focus on increased use of renewable sources of energy, restoration of degraded ecosystems and demarcation of critical wetlands and forest boundaries, will form a cornerstone of policy-action to be undertaken. Climate change measures are being mainstreamed in various sectoral policies, plans, programmes and projects of Government Ministries, Departments and Agencies (MDAs). Government is investing in the strengthening of institutional capacity of MDAs to deal with the effects of climate change. It is also committed to mobilising to the extent possible domestic resources, capacities, and skills needed to address climate change.

Uganda, in accordance with her relevant national laws, has initiated the necessary process of ratifying and domesticating the Agreement.

Mr. President,
In conclusion, I wish to underscore the seriousness of the effects of climate change and the urgent need to take effective concerted global action to address them. Any piecemeal or selective approach, in my view, will neither secure nor guarantee a safer planet for the present and future generations. It will not respond to the plight of the most vulnerable communities in poor countries and their yearning for salvation from extinction. These groups must be supported to survive, prosper and spur socio-economic transformation without leaving any one behind.

Mr. President,
I thank you for your kind attention.

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Kamuntu also advised Ugandans to have a drastic shift in their mindset if the nation is to avert the negative effects of Climate Change

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We have heard that she went to Paris with the trophies she won in Kampala during the recent PAM music awards. Namubiru has gone to Paris to do two things: to show the trophies to her hubby and to have arrest with her family.

The Birowoozo singer flew to Paris today aboard Turkish Airways. Namubiru will return to Uganda soon for her concerts.

Iryn Namubiru is the first Ugandan female singer to win the top PAM awards in the history of Uganda.

By Christine Kate

The post Iryn Namubiru in Paris, capital city of Fance first appeared on Uganda Multimedia News & Information.

We have heard that she went to Paris with the trophies she won in Kampala during the recent PAM music awards. Namubiru has gone to Paris to do two things: to show the trophies to her hubby and to have arrest with her family.

The Birowoozo singer flew to Paris today aboard Turkish Airways. Namubiru will return to Uganda soon for her concerts.

Iryn Namubiru is the first Ugandan female singer to win the top PAM awards in the history of Uganda.

By James Okello

The post Iryn Namubiru in Paris, capital city of Fance first appeared on Uganda Multimedia News & Information.