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The East African : May 26th 2014
The EastAfrican OUTLOOK MAY 24-30,2014 S CI E N C E HIV viral load testing still too costly Docto≥s say pointof-ca≥e testing is essential, especially in the ≥u≥al a≥eas By MIRIAM GATHIGAH Special Correspondent A s Africa scales up antiretroviral therapy, there are concerns that the absence of routine viral load testing will hamper provision of treatment to the millions of HIVinfected people who need it. “Routine viral load testing helps find people whose treatment is failing before they become resistant to antiretrovirals,” said Teri Roberts, diagnostics adviser at Médecins sans Frontières (MSF). Viral load testing, the gold stand- ard in antiretroviral therapy (ART) monitoring, measures HIV levels in the blood, an indicator of the drugs’ success. The World Health Organisation recommends viral load monitoring six months after starting ART, then again at 12 months, and every 12 months thereafter. But a viral load test, although routine in developed countries, is scarce and expensive in Africa. “A viral load test in Kenya is $25 while a similar test in a clinic in Asia costs about $11,” said Roberts. An MSF study found that point- of-care viral load testing remains largely unavailable in Africa. Blood samples are sent for testing at a central laboratory. Point-of-care testing is essential to decentralise care in rural Africa, bringing diagnostics closer to the patient and speeding clinical decisions. Though point-of-care tests are twice as expensive as tests in central laboratories, MSF recommends a mix-and-match combination of solutions that work in a big urban context or in a poor rural district. Health experts worry that many women on ARV treatment have nev- POOLED TESTING An MSF study on viral load testing in seven African countries assessed options to reduce costs and improve access, such as pooled testing at district level in Malawi and Zimbabwe. In pooled testing, blood samples from five people are mixed and only one test conducted. If it shows a high viral load, individual testing follows. In Malawi, sample pooling using dried-blood spots collected through easy fingerpricking reduced by 30 per cent the number of tests required in a rural district with more than 30,000 patients on treatment, saving $207,000 per year. “The drugs could be failing due to social issues such as stigma.” Dorothy Mbori-Ngacha, senior HIV specialist, Unicef er had a viral load test, or it came too late. “We may have highly infectious mothers on ARVs, because they have acquired resistance but this is not picked up for lack of proper moni- A nurse takes a blood sample to test for HIV. Picture: File toring,” said Roberts. Dr Dave Muthama from the Eliza- beth Glaser Paediatric Aids Foundation said that “CD4 count does not drop immediately when drugs fail; the CD4 count may remain high for a while and by the time treatment failure is detected, a lot of harm will have been done.” Doctors are calling on African governments to help overcome these challenges. “While Asia manufactures its own machines and reagents, Africa imports everything,” said Dr John Ong’ech, assistant director at Kenyatta National Hospital. “We need to explore the option of having locally manufactured viral load testing reagents and machines.” Locally manufactured products will also encounter pitfalls in the form of royalty payments for intellectual property rights which, according to MSF, can account for up to 65 per cent of the manufacturing cost of the tests. Dorothy Mbori-Ngacha, senior HIV specialist for East and Southern Africa at Unicef, said the fund Quick the≥apy doesn’t wo≥k in p≥ostate cance≥ ≥elapse By DREW ARMSTRONG Special Correspondent MEN WHOSE prostate cancer comes back in blood tests get no benefit from starting hormone therapy right away, compared with waiting for the disease to progress, a study has found. In a look at 2,012 men whose prostate cancer relapsed, those who delayed hormone treatment, also known as chemical castration, were no more likely to die over five and 10 years than those who started therapy immediately, researchers at the Harvard School of Public Health found. The results were released on Wednesday ahead of the annual meeting of the American Society of Clinical Oncology (Asco) later this month. The findings mean that men whose cancer only shows up in an early blood test, and not in scans or examinations, may wait before starting therapy, which comes with significant side ef- fects such as impotence, the researchers said. “For both groups and both outcomes, the sur- vival is very similar,” said Xabier Garcia-Albeniz, an epidemiologist at Harvard School of Public Health in Boston and a study author. Every year, about 60,000 men in the US have prostate cancer that relapses and shows up in blood tests before it becomes evident in scans or symptoms, said Peter Yu, president-elect of Asco. The researchers said more work needs to be done and the study may not have accounted for differences in doctors’ decisions to treat patients based on risk factors not accounted for in the study. Prostate cancer is often slow growing, mean- ing that many patients may delay therapy. The new study will open discussion between patients and their doctors about what to do, Yu said. “Up to now we’ve not had clear evidence that delaying treatment until there are clear signs of disease is the safe thing to do,” he said. The side effects of androgen deprivation thera- py include impotence, bone weakness, hot flashes, mental dullness and loss of muscle mass. “None of those by themselves are extremely serious in most patients, but cumulatively they really impact most men’s quality of life,” said William Oh, a physician and the chief of haematology and medical oncology at Mount Sinai Hospital in New York. In the study, 85.1 per cent of men who started treatment immediately survived over five years, compared with 87.2 per cent who delayed therapy. Over 10 years, 71.6 per cent of men in both groups were alive. When prostate cancer is detected, it can be treated with surgery or localised radiation. About one-third of men relapse, Dr Oh said, and doctors use a blood test for a protein called prostate-specific antigen, or PSA, as an early screening tool to see if the cancer has returned. and UNITAID, a global health initiative, are trying “to eliminate market monopoly in order to create a competitive market” and make viral load testing technology affordable. For quicker and cheaper relay- ing of results, MSF recommends using mobile phones and electronic health technologies. Roberts stressed the need to push the biggest buyers — the United States President’s Emergency Plan for Aids Relief (Pepfar) and the Global Fund to Fight HIV/ Aids, Tuberculosis and Malaria purchase nine out of 10 tests — to adopt pooled procurement and get even cheaper prices for all. But Dr Ong’ech said this may be difficult, because procurement laws differ across countries and even within countries. Viral load testing helps keep people on first line ARVs, which cost a fraction of the second and third line drugs. EAC states to ha≥monise thei≥ laws on diagnostics By CHRISTABEL LIGAMI Special Correspondent ACCESS TO safe and effective medical devices for diagnosis and treatment of communicable and non-communicable diseases in East Africa is expected to increase with implementation of new guidelines. The region’s health experts have finalised the draft for the “Strengthening and Harmonisation of the Regulation of Medical Devices and Diagnostics” project, which will be implemented by all the partner states over the next three years at a cost of $10 million. It will establish and harmonise the required capacity of medical devices and diagnostics in the region, in tandem with the existing national medicines regulatory authorities (NMRAs) under the co-ordination of the EAC Secretariat. “The regulatory setup for medi- cal devices and diagnostics in EAC is weak and inefficient,” said Dr Stanley Sonoiya, Principal Health Officer at the EAC. “Weak regulation allows poor quality products to be marketed and inefficiency causes unnecessary delays and increases costs to manufacturers and consumers.” In the first year, the EAC Sec- retariat will facilitate a regionwide assessment of the existing policies and laws on regulation of medical devices and diagnostics, compared to the internationally accepted regulatory model of the Global Harmonisation Task Force (GHTF)/ International Medical Device Regulators Forum (IMDRF). The findings and recommendations of the assessment will guide the formulation of new national laws. The health ministries in the EAC will draft and present Bills to their national legislatures for debate and passing; the new laws are expected to be effective in a year or two. “This will pave the way for the establishment of infrastructure for regulation. New staff will be recruited. Training of newly recruited staff and retraining of existing staff will be conducted,” said Dr Sonoiya. 25 Dr Stanley Sonoiya, the EAC Principal Health Officer.
May 19th 2014
June 2nd 2014