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1 October News

  1. Donald Kaye, Section Editor

Health Officials Race to Prevent Congo Yellow Fever Disaster

1 July 2016 (Reuters [Tim Cocks])—It is the stuff of a disaster movie: an outbreak of yellow fever in Congo's capital city, full of unvaccinated people mostly huddled together in slums with too few drains and the kind of sticky, fetid climate that mosquitoes love.

Kinshasa's 12 million people—twice as many as there are doses of yellow fever vaccine anywhere in the world—are largely unprotected against this easily preventable illness, which has killed at least 353 in Democratic Republic of Congo and neighboring Angola.

And though the mosquito-borne virus has yet to gain momentum in Africa's third largest metropolis, officials in Congo's government and the World Health Organization are racing to avoid a repeat of the kind of urban epidemics that decimated Western cities like New York and Philadelphia in centuries past.

With 3 weeks to go before they start a vaccination campaign for 11.6 million people against the hemorrhagic virus in 3 Congolese provinces, and only 1.3 million doses of the vaccine on their way to Congo, time is not on their side.

There are currently just 6 million doses of vaccine in the world, and the method of making more, using chicken eggs, takes about a year. As an emergency measure, health officials have decided to split the doses into fifths, enabling them to cover more people, although only for a year rather than a lifetime.

Yellow fever was once a big killer in the West, wiping out about a tenth of the population of New York and Philadelphia in the 18th century. Then, 80 years ago, a vaccine was created and the virus was quickly eradicated in the rich world.

In Africa it mainly persists in remote rural areas, and not since the 1970s has it threatened a major city.

The current outbreak, with 3464 suspected cases so far, about a third of them in Congo, began in Angola in December. Hitching a ride on popular trade routes from the capital Luanda, it jumped the border into Congo, then to its megacity capital.

Unlike the Ebola virus, which has killed 11 300 people in West Africa since 2013, yellow fever initially spreads slowly, as the mosquitoes carrying it don't travel more than 100 meters from where they are born, health officials said. That may give some breathing space for the response.

And, as with Ebola, a worry is that airplanes can carry the virus to other more distant cities.

Asia has never had yellow fever, despite being home to the mosquitoes that spread it. But this year 11 Chinese expatriates working in Angola contracted it and brought it back to China.

Copyright © 2016 Reuters Limited. All rights reserved.

Editorial comment. The yellow fever epidemic has been smoldering in Angola since January. Cases have been imported into the neighboring Democratic Republic of Congo and a few cases into Kenya. There is now an established outbreak in the Democratic Republic of Congo, with the threat of a major epidemic. A major concern is that Chinese nationals working in Angola will bring the virus back to China where the potential of bites from Aedes aegypti exists with the spread of yellow fever to China.

Shortage of Syringes Hampers Congo's Fight Against Yellow Fever

5 July 2016 (Reuters [Aaron Ross])—A shortage of syringes is hampering plans to vaccinate people in Democratic Republic of Congo against a yellow fever epidemic despite the arrival of more than 1 million doses of vaccine, health officials said.

Congo's government declared a yellow fever epidemic last month in the capital Kinshasa and 2 other provinces near the border with Angola.

The World Health Organization (WHO) says some 1400 suspected cases of the hemorrhagic virus in Congo have resulted so far in 82 deaths and it is particularly concerned about conditions in Kinshasa, a city of 12 million with poor health services and a climate conducive to mosquitoes.

The WHO plans to begin a vaccination campaign in the province of Kwango near the Angolan border on July 20 but the United Nations body's spokesman in Congo, Eugene Kabambi, said the country had only about 4 million syringes but needed 10 million.

Health officials are reluctant to begin the vaccination campaign in only one zone in densely populated Kinshasa for reasons of public safety and order.

“If we only organize in Kisenso, there will be huge crowds coming to Kisenso to obtain the vaccine and that could become unmanageable,” Kabambi said, referring to the first zone officials plan to target in the capital city. “So we're going to wait a little to obtain more (syringes).”

Health officials plan to administer a fifth of the standard dose in Kinshasa due to the shortage of the vaccine. The lower dosage provides temporary protection against the disease but does not confer lifelong immunity.

Copyright © 2016 Reuters Limited. All rights reserved.

US Food and Drug Administration Approves Gilead's Epclusa (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C

28 June 2016 (Business Wire)—Gilead Sciences, Inc. today announced that the US Food and Drug Administration (FDA) has approved Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), the first all-oral, pan-genotypic, single-tablet regimen for the treatment of adults with genotype 1–6 chronic hepatitis C virus (HCV) infection. Epclusa is also the first single-tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin (RBV). Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with RBV for patients with decompensated cirrhosis (Child-Pugh B or C).

The FDA granted Epclusa a Priority Review and Breakthrough Therapy designation, which is given to investigational medicines that may offer major advances in treatment over existing options.

Epclusa's approval is supported by data from 4 international phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4. In the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 1035 patients with genotype 1–6 chronic HCV infection, without cirrhosis or with compensated cirrhosis received 12 weeks of Epclusa. The ASTRAL-4 study randomized 267 patients with genotype 1–6 HCV infection, with decompensated cirrhosis (Child-Pugh B), to receive 12 weeks of Epclusa with or without RBV or 24 weeks of Epclusa. The primary endpoint for all studies was sustained virologic response (SVR12).

Of the 1035 patients treated with Epclusa for 12 weeks in the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 1015 (98%) achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis receiving Epclusa with RBV for 12 weeks achieved a high SVR12 rate (94%) compared to those who received Epclusa for 12 weeks or 24 weeks (83% and 86%, respectively).

Headache and fatigue were the most common adverse reactions (≥10%) experienced by HCV-infected patients treated with Epclusa in ASTRAL-1, ASTRAL-2, and ASTRAL-3 and occurred at a similar or higher frequency in placebo-treated patients. In the 87 HCV-infected patients with decompensated cirrhosis treated with Epclusa and RBV in the ASTRAL-4 study, fatigue, anemia, nausea, headache, insomnia, and diarrhea were the most common adverse reactions (≥10%). Two and 4 patients treated with Epclusa and Epclusa with RBV, respectively, discontinued treatment due to adverse events.

Epclusa should not be administered with RBV in patients for whom RBV is contraindicated.

France's Sanofi Partners US Army to Speed up Zika Vaccine

6 July 2016 (Reuters [Matthias Blamont and Ben Hirschler])—French drugmaker Sanofi said it had struck a research and development deal with the US Army to speed up the development of a vaccine against the mosquito-borne Zika virus.

Sanofi is the only major drugmaker working on a vaccine against Zika, although more than a dozen smaller biotech firms and other groups are also active in the field.

The tie-up with the Walter Reed Army Institute of Research (WRAIR) in the United States gives Sanofi access to a promising new vaccine, made from inactivated virus, which has already produced impressive results in mice.

The vaccine is one of the furthest advanced in development and could be ready for testing on humans in October.

Sanofi said the WRAIR, a biomedical research facility administered by the US Department of Defense, would transfer virus vaccine technology to Sanofi Pasteur, the company's vaccines division.

The US National Institute of Allergy and Infectious Diseases will conduct the phase 1 trials during the technology transfer and then Sanofi will be in charge of clinical and regulatory development.

A single dose of the WRAIR's experimental vaccine was shown to give 100% protection in mice against the Zika virus.

Sanofi is developing another Zika vaccine based on its own know-how in battling established mosquito-borne diseases such as dengue, Japanese encephalitis, and yellow fever.

However, that vaccine will take longer to develop and Sanofi said earlier this year it did not expect to start clinical trials on its in-house Zika candidate until 2017.

Copyright © 2016 Reuters Limited. All rights reserved.

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This Article

  1. Clin Infect Dis. 63 (7): i-ii. doi: 10.1093/cid/ciw503
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