A reduced tenofovir (Viread) dose of 150mg daily appears to be a safe and effective treatment for people with HIV who have moderate renal impairment, investigators from Thailand report in the online edition of Clinical Infectious Diseases. The 150mg daily dose provided comparable drug exposure to the currently recommended dose of 300mg every 48 hours. Moreover, treatment with the reduced dose maintained viral suppression.

“This is the first report assessing alternative dosing of TDF [tenofovir] in HIV-infected adults with moderate renal dysfunction. Our data demonstrate that reducing the approved TDF dose of 300mg every 48 hours in adults with a creatinine clearance between 30 to <50ml/min to 150mg once daily provides comparable exposure over a 48 hour period when receiving an NNRTI [non-nucleoside reverse transcriptase inhibitor]- or lopinavir/ritonavir-based regimen,” comment the authors. “The preservation of virological suppression and lack of adverse events was reassuring.”

Tenofovir is a widely used antiretroviral. The standard dose is 300mg once daily, in combination with other anti-HIV drugs. The drug is secreted through the kidneys. A pharmacokinetic study involving HIV-negative people with renal impairment showed that individuals with creatinine clearance below 50ml/min had significantly higher blood levels of tenofovir. It was therefore calculated that a tenofovir dose of 300mg every 48 hours for people with moderate renal impairment – creatinine clearance between 30-49ml/min – would provide similar drug exposure to that observed in people with normal renal function receiving the standard 300mg daily dose.

But many people find dosing every 48 hours confusing and inconvenient. Lower strength tenofovir pills (150, 200, 250mg) have recently been approved. Investigators hypothesised that, for adults with moderate renal impairment, treatment with 150mg once daily would provide similar drug exposure to the currently recommended dose of 300mg every 48 hours.

They therefore designed a phase I, open label, pharmacokinetic study involving 40 people living with HIV who had creatinine clearance between 30 to <50 ml/min, who were taking a tenofovir dose of 300mg every 48 hours. All were virologically suppressed; half were taking a combination based on an NNRTI, the other 50% a lopinavir/ritonavir-containing regimen.

Tenofovir blood levels were intensively sampled over a 48-hour period, and intracellular tenofovir exposure was also monitored in peripheral blood mononuclear cells. The study participants then switched to the 150mg daily tenofovir dose. After two weeks, the pharmacokinetic analysis was repeated.

The participants had a median age of 56 years and an average weight of 51kg. Median creatinine clearance was 43.9 min/ml, and median serum creatinine was 1.3mg/dl. All had an undetectable viral load and median CD4 count was 502 cells/mm³.

Mean plasma tenofovir concentrations were essentially similar for the 300 and 150mg doses, regardless of whether participants were taking the drug in combination with an NNRTI or ritonavir-boosted lopinavir.

Overall, people taking lopinavir/ritonavir had higher tenofovir levels in plasma than people taking an NNRTI. This was observed with both the 300 and 150mg tenofovir doses.

Intracellular tenofovir concentrations were comparable between the 300 and 150mg doses.

“The data reported demonstrates that switching TDF to 150mg once daily in HIV-infected adults with moderate renal function impairment leads to comparable exposure to the current recommended 300mg, every 48 hours,” conclude the authors. “This daily dose option for this subpopulation of patients may be preferable to simplify their regimen and facilitate drug adherence but renal function should continue to be closely monitored in these patients.”

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TODAY was a day many local residents thought they would never see – and sadly, a few didn’t – with the official opening of a dialysis service unit in the Nambucca Valley.

Tears and smiles as new dialysis unit opens in Nambucca Valley: PHOTOS

TODAY was a day many local residents thought they would never see – and sadly, a few didn’t – with the official opening of a dialysis service unit in the Nambucca Valley.

More than 100 people, including mayor Rhonda Hoban, Oxley MP Melinda Pavey and health service representatives, were on hand for an at times emotional ceremony to celebrate the new building.

The centre, the dialysis chairs and medical staff have come about after a significant investment by the local health service and through a long-running grassroots community fundraising campaign.

Located at the Nambucca Healthcare Centre, the service is the culmination of a 20-year lobbying campaign that was driven by a frustration that local people requiring dialysis had to travel to Coffs Harbour and sometimes further afield, for treatment.

At the forefront of the campaign has been Rona Freeman, who gave a short and heartfelt speech at the opening as did a current patient, Eric Day.

“It’s been a long hard road with many hoops and hurdles and there were a lot of knockers over the years,” said Rona, who’s son Paul was forced to travel for dialysis before his passing.

Dr Mark Smith from Nambucca Healthcare Centre recalled that Paul had told his mum “I don’t want to do this anymore”, and that had sparked her drive to see a service established locally so that renal patients would one day not have to travel for treatment.

“Rona made a promise to her son and she kept it,” Dr Smith said.

While the campaign had been long and in danger of flagging, it ‘grew legs’ at a public meeting in Nambucca in September 2011.

Key stakeholders steadily came onboard, the fundraising ante was upped, and the political will to deliver a local dialysis service became irresistible.

“It’s not the size of the dog in the fight, it’s the size of the fight in the dog,” Rona said, only half-jokingly.

Today’s ceremony marked the official opening for Nambucca Healthcare Centre’s Stage II building, which was constructed in 2014 and began operation in January.

The Nambucca Valley Dialysis Unit was brought to fruition through funding via the Nambucca Valley Dialysis Fund, and a partnership hosting arrangement between Nambucca Healthcare Centre and the Mid North Coast Local Health District, which was represented by chief executive Stewart Dowrick.

The unit began as a three-chair pilot program in May last year in the existing Stage I NHC building while a purpose built facility was constructed (Stage II). The unit was moved across to the new completed facility in December and increased to six patients in January this year.

“We are now looking forward to increasing to operation six days a week in order to provide local treatment for six more patients who currently travel out of the local area to Coffs Harbour, said NHC’s Sheree Smith. 

Just last month, radiology practice Active Medical Imaging also began operation from the Stage II building to provide comprehensive quality medical imaging services in the Nambucca Valley.

The range of services available includes fully digital x-ray, high resolution ultrasound and low dose technology CT, utilising leading edge equipment to provide significant reductions in radiation dose. The partnership arrangement includes collaboration with some of the State’s top university teaching radiologists in partnership with local medical service providers.

“It’s been a credit to everyone here today that we have come so far,” Sheree said. 

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LAHORE: As the country faces a threat of ‘chronic kidney disease epidemic’, the fact that Punjab has no rules and regulations for promotion of nephrologists highlights the apathy of the government.

According to the latest statistics, nearly 21 million people in Pakistan have either stage 3 or 4 Chronic Kidney Disease (CKD) and there are only 145 qualified nephrologists.

“Punjab being the largest province faces a gruesome situation as kidney failure incidents have assumed alarming proportions,” an official told Dawn.

He said a batch of nine qualified nephrologists, which was produced a few weeks ago for the first time by any public hospital of Punjab, was recruited (on a regular basis) as senior registrars. “They have become a rolling stone as the government has no rules for their promotion in higher grade. Besides, there are few designated nephrology sections all over the province,” he said.

He said it was quite disturbing for highly-educated persons (nephrologists) who were forced to work without promotions in the public hospitals.

He said the health department recently conveyed to them to “bring rules and get promotions otherwise wait for an indefinite period.” When they pleaded their case, he said, the officials got annoyed and ‘directed’ them to visit them next time with a copy of the rules.

Although they later tried to present Shaikh Zayed Hospital’s model of rules for promotion for the nephrologists, the health department was reluctant to adopt it in letter and spirit.

The official said the nephrology services were already facing a grim situation in Punjab as there were only six FCPS accredited public teaching institutions. They are Shaikh Zayed Hospital, Fatima Jinnah Medical College/Sir Ganga Ram Hospital, Lahore, Allama Iqbal Medical College/Jinnah Hospital, King Edward Medical University Lahore, Punjab Medical College/Allied Hospital Faisalabad and Nishtar Medical College, Multan.

Similarly, he said, there were only six seats of consultant nephrologists at the district level hospitals of Punjab and four positions of assistant professors and one each of associate professor and professor at the teaching hospitals. “SZH is the only institution in Punjab which has been producing the nephrologists for the last 30 years,” he added.

Some nephrologists have managed to establish a new nephrology unit at Mayo Hospital with the help of a charity organisation. It is said to be the first designated nephrology unit of the health department which is training FCPS doctors. Recently, it produced a batch of nine nephrologists which injected hope that the patients would continue to get trained practitioners of the neglected specialty.

The Punjab Public Service Commission (PPSC) advertised the nine posts of senior registrars and these nephrologists got recruited first time on a regular basis in various tertiary-care hospitals. Dr Muzzamil Riaz Malik and Dr Irfan Elahi were posted at Mayo Hospital, Dr Salman Tahir Shafi at Jinnah Hospital, Dr Aurangzaib Afzal at Lahore General Hospital, Dr Poonam at Banazir Bhutto Hospital Rawalpindi, Dr Samee and Dr Yousaf at Nishtar Medical College Multan, Dr Irfan Rasool at DHQ Hospital Faisalabad and Dr Bilal Chaudhry at Allied Hospital, Faisalabad.

They were happy to join their new job but soon realised that there was no mechanism for promotion. Dr Shahid Anwar has been working as assistant professor at FJMC/SGH on an ad hoc basis for the last five years. Neither his service has been regularised nor has his post been sent to the PPSC for regular recruitment.

Similarly, Dr Zahid Rafique has been working as senior registrar for the last seven years as the post of assistant professor of nephrology does not exist due to absence of rules of promotion.

There is only one post of SR Nephrology in Jinnah Hospital Lahore which had been recently advertised via the PPSC. Dr Arslan Khalid is working there as an assistant professor on an ad hoc basis. At the Allama Iqbal Medical College, the post of an associate professor is vacant for the last many years and there is no post of professor of nephrology. Dr Hafiz Ijaz, who is the professor of medicine, is heading the nephrology department.

At Mayo Hospital, Dr Muhammad Anees has been working as assistant professor of nephrology without designated unit for the last 11 years. He has not been promoted as associate professor of nephrology on a regular basis.

Published in Dawn, May 22nd, 2015

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