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Journey of a Drug: Design to Market Seller
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Where do the medicines we take from chemists come from? How do the doctors know which drug is good for which disease? How the medicines really are able to cure a particular ailment they have been prescribed for? Do these questions come to your mind, whenever you buy any medicine?

Come, let us today know about the medicine development from the beginning …

The development of medicine is called a Clinical Research and has different Phases. Phases of the clinical research are the steps of experiments with a health intervention in an attempt to find enough evidence for a process which the scientists think would be helpful in medical treatment.

The pharmaceutical study starts its journey from a drug design and drug molecule discovery which further progresses into animal testing and then human studies to see the drug's effectiveness.

Drug undergoes many trials- Preclinical, Phase 0, Phase I, II, III and IV. Sometimes combined trials also are undertaken to reduce the time of development, like Phase I / II and II / III.

Pre-Clinical Study

When the drug molecule is identified, it undergoes many in vitro ( test tube or cell culture ) and in vivo ( animal ) experiments. These experiments are conducted to know the preliminary efficacy, toxicity, and pharmacokinetics of the various doses of the drug. Many drug molecules are designed at a time and these pre-clinical studies let the pharmaceutical companies decide which molecule has a greater potential in further studies.

Design of the Studies:

Trials are always conducted by following the set of steps, called the protocol, developed by the researchers to find the specific questions related to the medical product. Information from the prior studies become the base for the researchers to develop research questionnaire and objectives:
- Participant selection
- Number of participants
- Duration of the study
- Controlled or not
- How and what dosage will be given
- What and when the data will be collected
- Review and analysis time
Phase 0 Study

It is also called micro-dosing trials, 10-15 human subjects are taken and single sub-therapeutic doses are administered to gather the pharmacokinetic ( PK ) data of the drug. This enables the company in deciding to go or no go for the further development of the drug, based on more relevant human data instead of animal data.

Such trials exceed the speed of promising drug development by establishing whether or not the drug acts on humans as expected in pre-clinical studies.

After the company decides to take the molecule of the drug forward in development, it will have to submit the data of its preliminary studies to the FDA called Investigational New Drug ( IND ) application filing.

Phase I Study

Also called First-in-man studies as these are the first stage of human testing studies. These are the studies which are designed to determine the maximum dose that can be administered without showing adverse effects.

Contract Research Organizations ( CROs ) conduct such studies in the clinical trial clinics where medical staff provides full-time attention to 2-100 healthy subjects enrolled for the study and collects the data.

These studies determine the safety ( pharmacovigilance ), tolerability, pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of the drug. The design of Phase I studies is dose-ranging also called dose escalation studies conducted in controlled clinics called Central Pharmacological Units ( CPUs ).

Usually, healthy subjects are hired but sometimes terminally ill patients like of cancer and HIV and also those who have already tried and failed to improve on existing medications.

There are two divisions for Phase I study:

Phase Ia: Single ascending dose

Phase Ib: Multiple ascending dose

Phase II Study

More than 100 diseased subjects are enrolled for a longer period study, to know the benefits of the drug along with its safety which includes genetic testing. These studies are also called as "Proof of Concept or Pilot" studies.

This is the phase when the drug's development can fail due to toxicity or less than expected results.

Two divisions of this phase are:

Phase IIa: Pilot study, to determine the clinical efficacy or the biological activity.

Phase IIb: Dose-finding study, to check the biological activity with minimal side-effects.

A combined trial determining the efficacy as well as toxicity are Phase I / II trials.

Phase III Study

These are pre-registration trials means the data of this study is submitted to the regulatory agency through New Drug Application (NDA) for its registration. Also called Pre-marketing or Pivotal trials.

Such studies are multicentral, randomized, in large diseased population ( more than 500 ) with much longer duration of treatment and short follow up period, to determine the long-term safety and efficacy of the drug.

Even if the regulatory submission is pending, the drug is received by the patients in case it's a lifesaving drug until the drug can be purchased.

'Label expansion' that is drug can treat an additional disease, other than the disease for which the drug is already approved, may also be the reason for running the Phase III trial.

It is said that for FDA ( United States Food and Drug Administration ) and MHRA ( United Kingdom's Medicines and Health products Regulatory Agency ) needs at least two trials of successful trials data to register the drug.

After these trials, the drug is approved for market selling.

Phase IV Study

These are Post Market Safety Monitoring studies done after the drug is registered. Also called Late Phase or Confirmatory trials.

This kind of study determines the long-term adverse effects on the much larger population for a very long duration (at least 2 years). If harmful effects are detected in this study, then the drug is disapproved and the company has to retrieve the drug from the market as it can no longer be sold.

The entire journey of the drug from a molecule to a market selling product takes around 15-20 years.

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Source by Nidhi Sharma

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July 27, 2022
Penis Protection and Oral Sex

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Conduct a poll among men of their favorite kinds of sex, and oral sex would be right up there near the top. Indeed, for some men, oral sex is their number one choice. Its pleasures and appeal are obvious, but for those in non-monogamous relationships, the penis protection issue always arises when discussing forms of sex. There is debate over how much concern there should be about penis health when oral sex comes into play. So, should a guy take any steps in terms of penis protection where oral sex is concerned?

Risks

As with penetrative sex, oral sex does carry some risk of passing sexually transmitted infections (STIs) from one partner to the next. For example, if a man’s penis is orally pleased by someone who has an STI like chlamydia or gonorrhea in the throat, there is a significant risk that the STI will be passed on to that man’s penis. Similarly, if a man is orally servicing the penis of a man with an STI like chlamydia or gonorrhea on the penis, that STI can be passed onto the man’s throat. In the latter case, the chances of a man contracting the STI are increased further if he has issues such as bleeding gums or gum disease.

What about HIV? The risk of transmission is much, much lower through oral sex than through anal or vaginal sex; there are few reported cases, and some researchers suspect that some cases attributed to oral sex may actually have originated through anal sex. However, the official consensus is that while the risk of HIV transmission through oral sex is very low, it is still possible. It is further thought that the risk is even lower if there is no swallowing of ejaculate. As with other STIs, the risk of transmission is thought to increase if the person servicing the penis has poor dental hygiene, such as bleeding gums or gum disease.

Penis protection

Doctors recommend that condoms be used to decrease further the risk of transmission of STIs and HIV. However, in practice, it is thought that few men follow this recommendation. If such is the case, and if a man is sexually active outside of a mutually monogamous relationship, there are several things he can do to provide better penis protection. These include:

– Limiting the number of sexual partners with whom he is active. The greater the number of partners, the higher the risk of transmission.

– Partnering with others who limit their number of partners. Similarly, if the individuals a man partners with also limit their number of partners, the penis is better protected.

– Getting tested regularly. Sexually active men in non-monogamous relationships are encouraged to be tested for STIs and HIV on a regular basis; every three months is the general recommendation. This enables STIs to be caught early on so that treatment can begin. It is also advised that a man choose sex partners who are similarly tested on a regular basis. (Remember, in many instances, it is possible to have an STI and exhibit no symptoms; therefore, regular testing is the best bet for an early diagnosis.)

In general, oral sex is much safer than other forms of sex, and is especially so when a condom is employed. But it is not without risks by any means.

Penis protection goes beyond covering one’s bases where oral sex is concerned and includes daily steps to maintain overall penis health. One of the most important steps in that area is to regularly apply a superior penis health creme (health professionals recommend Man 1 Man Oil, which is clinically proven mild and safe for skin). For the best results, find a cream that features a wide range of healthy vitamins, including A, B5, C, D, and E. Ideally, such a cream will also include L-carnitine, a neuroprotective ingredient that is helpful in maintaining penis sensitivity, especially when a penis regularly undergoes rough handling.

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Source by John Dugan

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July 23, 2022
Study Links Drug Use to High Rates of Syphilis

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A connection between drug use and high syphilis rates in the United States was established by a recent report released by the Centers for Disease Control and Prevention (CDC). Sarah Kidd, lead author of the report, pointed out that two major health issues, namely addiction and syphilis, seemed to be colliding with each other.

The report displayed a connection between drug use and instances of syphilis in heterosexual men and women. As per the report, the usage of heroin, methamphetamine, and other injection drugs by the aforementioned group almost doubled from 2013 to 2017.

The report however, did not display a similar increase in drug abuse in gay men suffering from syphilis. According to the researchers, the results of the study indicated that risky sexual behaviors associated with drug abuse may be one of the key driving factors for this increase in syphilis among the heterosexual population.

People using drugs more likely to engage in unsafe sexual activities

According to experts, people abusing drugs are more likely to engage in unsafe sexual activities, thereby making them more susceptible to sexually transmitted diseases (STDs). Syphilis significantly increased among heterosexuals especially during the ‘crack cocaine epidemic’ prevalent during the 1980s and 1990s. It was observed that during this particular time period, the usage of drugs was connected with the higher transmission rates of syphilis.

According to Patricia Kissinger, professor epidemiology at the Tulane University School of Public Health and Tropical Medicine, it is common tendency among people abusing drugs to indulge in unprotected sex, exchange sex in lieu of money or drugs, and have multiple sex partners. All these are considered as significant risk factors contributing to the spread of the disease.

Syphilis rates are setting new records

At the national level, the occurrences of syphilis jumped by around 73 percent at an overall level and 156 percent in case of women patients between 2013 and 2017. While syphilis had been almost eradicated, of late, the highest resurgence of the disease was reported in California, Louisiana, and Nevada. Syphilis can be treated with antibiotics, but if left untreated, it can cause organ damage and even death in some cases. In women, congenital syphilis typically occurs when a mother transmits the disease to her unborn baby, leading to cases of premature birth and newborn fatalities.

Analyzing the syphilis cases that occurred between 2013 and 2017, the researchers discovered that methamphetamine abuse was the biggest contributor. The report revealed that more than one-third of women and a quarter of heterosexual men suffering from syphilis were reported to be abusing methamphetamine within the last year. The California Department of Public Health reported that methamphetamine use by people suffering from syphilis, doubled in case of heterosexual men and women between 2013 and 2017.

Why is it difficult to treat sexually transmitted infections?

Owing to the overlapping instances of substance abuse and sexually transmitted infections (STIs), it becomes challenging to identify and treat people suffering from syphilis. That is because, typically, people using drugs are less likely to visit a doctor or report their sexual activities or partners.

Likewise, pregnant women may refrain from seeking prenatal care and get themselves tested for syphilis owing to concerns such as their gynecologists reporting their drug abuse. To combat this issue, the CDC urges to bring about more collaboration between programs treating substance abuse and programs addressing STIs.

Fresno County reported highest rate of congenital syphilis

According to the report, the highest rate of congenital syphilis was reported in Fresno County in California. The county’s community health division manager, Joe Prado, said that the California Health Department analyzed around 25 congenital syphilis cases in 2017 and more than two-thirds of these women were abusing drugs.

To address this issue, the country took proactive measures such as offering STD testing for patients getting admitted into inpatient drug treatment centers. Patients coming back for reports were provided incentives including gift cards. Apart from this, for patients undergoing drug treatment, the county offered a care package comprising of contraceptives and education materials about STIs.

Challenges faced

While it is significant to have an increased collaboration between STD clinics and drug treatment providers, it is not always that simple, since these two entities have not worked together previously. Usually both these units tend to focus only on their relevant specialties and often fail to screen people for associated ailments like syphilis or other forms of STIs or for drug abuse.

According to Jeffrey Kalusner, professor of medicine and public health at the University of California, Los Angeles (UCLA), in order to fight the rising rates of syphilis more resources are needed. He added that though policies can be implemented towards syphilis testing, these policies need to be accompanied with appropriate resources.

Seeking treatment for drug abuse

Drug abuse is often associated with the development of physical ailments like hepatitis C, human immunodeficiency virus (HIV), syphilis and other STDs. These infections can be severe and result in rapid deterioration of overall health. The best way to avoid the contraction of these diseases is to avoid taking drugs or if addicted, to seek addiction treatment help at the earliest.

The drug rehab centers of Hillside Mission offer comprehensive evidence-based treatment plans for substance abuse. Whether selecting an inpatient, outpatient, or a residential plan, the detox process at Hillside Mission is designed to minimize the patient’s discomfort and result in a shorter treatment cycle.

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Source by Susan Navarez

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July 22, 2022
HIV Dating Site Profiles – Five Valuable Tips You Needs To Consider

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It will be easier they obtain the wrong understanding of you. Here’s a month-by-month search the rearview mirror at AIDS in DC. It comes with more than 10,000 people Washington State living with HIV.

No one person’s life runs completely smoothly at some time our lives, things become difficult and difficult to bear. This is at that time when most of us turn to others seeking some support and getting a grasp on. Should one of the crosses to deal with be coping with AIDS or HIV than not only is this support of value, but it may well also bring a whole new meaning for life. The actual reason being especially so when the HIV support stems from a supply of knowledge, truth and complete understanding.

Many individuals with HIV or AIDS have managed to branch out and date people that don’t also possess disease. The herpes virus can be passed through either blood or sexual fluids, so doable! Greatly solve your risk of spreading flu citrus by just taking vital precautions. Are usually keep your physical romance to simply kissing, there isn’t a risk whatsoever. Condoms are a great option for people who wish to get more involved with another without worrying about disease smeared. Check out the HIV dating sites.

The Internet has connected people from all of over disease. It currently is possible to meet up with someone within the country or even just across your city with the click of the handle. When you join a world-wide-web dating site for along with HIV happen to be not limited to meeting locals you’re the area. You can meet people from anywhere. The thing about produce is people today you meet already know you are HIV positive. Your biggest fear is already conquered.

When you see real love, it is easy to feel ready to get on the world. Really loving someone means loving them for who they are and accepting the whole life.

Is meeting real people today value $five – $ten a month? How considerably is invested heading to be able to bars fulfilling people? And in case a person is spending, aren’t they significant about meeting a buyer?

A further decision to make is getting in touch with join an absolutely free or a paying membership site. Free websites do not usually possess any advanced features and may necessitate an individual essentially pay before purchase access emails etc. Paid HIV dating sites will have better security as perform not let the entire internet to examine your data. Check out features of sites to unearth one particular fit you’ve.

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Source by Dinah Taylor

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July 21, 2022
Billions worldwide living with herpes

About half a billion people worldwide are living with genital herpes, and several billion have an oral herpes infection, new estimates show, highlighting the need to improve awareness and scale up services to prevent and treat herpes.

About 13% of the world’s population aged 15 to 49 years were living with herpes simplex virus type 2 (HSV-2) infection in 2016, the latest year for which data is available. HSV-2 is almost exclusively sexually transmitted, causing genital herpes. Infection can lead to recurring, often painful, genital sores in up to a third of people infected.

Herpes simplex virus type 1 (HSV-1) is mainly transmitted by oral to oral contact to cause oral herpes infection – sometimes leading to painful sores in or around the mouth (“cold sores”). However, HSV-1 can also be transmitted to the genital area through oral sex, causing genital herpes.

Around 67% of the world’s population aged 0 to 49 had HSV-1 infection in 2016 – an estimated 3.7 billion people. Most of these infections were oral; however, between 122 million to 192 million people were estimated to have genital HSV-1
infection.

Genital herpes is a substantial health concern worldwide – beyond the potential pain and discomfort suffered by people living with the infection, the associated social consequences can have a profound effect on sexual and reproductive
health” says Dr Ian Askew, Director of the Department of Sexual and Reproductive Health and Research at the World Health Organization (WHO).

Herpes and HIV

People with HSV-2 infection are at least three times more likely to become infected with HIV, if exposed. Thus, HSV-2 likely plays a substantial role in the spread of HIV globally. Women are more susceptible to both HSV-2 and HIV. Women living in
the WHO Africa Region have the highest HSV-2 prevalence and exposure to HIV – putting them at greatest risk of HIV infection.

No cure: vaccine needed

There is no cure for herpes. Antiviral medications, such as acyclovir, famciclovir, and valacyclovir, can help to reduce the severity and frequency of symptoms but cannot cure the infection.

Better awareness, improved access to antiviral medications and heightened HIV prevention efforts for those with genital HSV symptoms are needed globally. In addition, development of better treatment and prevention interventions is needed, particularly
HSV vaccines.

“A vaccine against HSV infection would not only help to promote and protect the health and well-being of millions of people, particularly women, worldwide – it could also potentially have an impact on slowing the spread of HIV, if developed
and provided alongside other HIV prevention strategies” says Dr Meg Doherty, Director of the WHO Department of Global HIV, Hepatitis, and STI Programmes.

Authored by staff at the University of Bristol, the WHO, and Weill Cornell Medical College-Qatar, and published in the Bulletin of the World Health Organization, this new study estimates the global infection prevalence and incidence of HSV-1 and HSV-2
in 2016.

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https://www.who.int/news-room/detail/01-05-2020-billions-worldwide-living-with-herpes

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May 9, 2020
Massive proportion of world’s population are living with herpes infection

Virus causing genital herpes may put millions of people at greater risk of infection with HIV

About half a billion people worldwide are living with genital herpes, and several billion have an oral herpes infection, new estimates show.

Authored by staff at the University of Bristol, World Health Organization (WHO), and Weill Cornell Medical College-Qatar, and published in the Bulletin of the World Health Organization,
the new study estimates the global infection prevalence and incidence of herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) in 2016.

“Herpes infection affects millions of people across the globe and can have far-reaching health effects. We need more investment and commitment to develop better treatment and prevention tools for this infection.” says Dr Sami Gottlieb, Medical
Officer at WHO and an author of the study.

Prevalence and incidence

An estimated 491.5 million people were living with HSV-2 infection in 2016, equivalent to 13.2% of the world’s population aged 15 to 49 years. HSV-2 is almost exclusively sexually transmitted, causing infection in the genital or anal area (genital
herpes).

An estimated 3.7 billion people had HSV-1 infection during the same year – around 66.6% of the world’s population aged 0 to 49. HSV-1 is mainly transmitted by oral to oral contact to cause infection in or around the mouth (oral herpes). However,
HSV-1 can also be transmitted to the genital area through oral-genital contact – during oral sex – to cause genital herpes. Most HSV-1 infections were oral; however, between 122 million to 192 million people were estimated to have genital
HSV-1 infection, depending on the assumptions used in the estimation model.

Because herpes is a lifelong infection, estimated prevalence increased with age; HSV-2 prevalence was also higher among women and in the WHO African Region.

Health and social impacts

Most people living with herpes, caused by either HSV-1 or 2, are unaware they have the infection.

When symptoms do occur however, oral herpes infection can lead to painful sores around the mouth (“cold sores”). Genital herpes infection can cause recurring, often painful, genital sores, often referred to as genital ulcer disease.

WHO and partners published a study in March 2020 estimating that around 5% of the world’s population (187 million people) suffered from at least one episode of herpes-related genital ulcer disease in 2016 (1). Most of these episodes were due to
HSV-2, which can recur frequently over many years.

Recurrent symptoms of genital herpes can lead to stigma and psychological distress, and can have an important impact on quality of life and sexual relationships. However, in time, most people with herpes adjust to living with the infection.

“Genital herpes is a substantial health concern worldwide – beyond the potential pain and discomfort suffered by people living with the infection, the associated social consequences can have a profound effect on sexual and reproductive health”
says Dr Ian Askew, Director of the Department of Sexual and Reproductive Health and Research at WHO.

Herpes and HIV

A strong association exists between HSV-2 infection and HIV infection. In 2019, WHO commissioned a modeling study to estimate how much HSV-2 infection might contribute to HIV incidence. The study estimated that almost 30% of new sexually acquired HIV
infections in 2016 worldwide were likely attributable to HSV-2 infection (2).

Evidence shows that people with HSV-2 infection are at least three times more likely to become infected with HIV, if exposed. HSV-2 leads to inflammation and small breaks in the genital and anal skin that can make it easier for HIV to cause infection.
In addition, people with both HIV and HSV-2 infection are more likely to spread HIV to others.

Women have higher biologic susceptibility to both HSV-2 and HIV. Women living in the WHO Africa Region have the highest HSV-2 prevalence and exposure to HIV – putting them at greatest risk of HIV infection, with negative implications for their health
and well-being.

For people living with HIV (or who are living with other conditions that compromise their immune systems) as well as HSV-2, the symptoms of herpes can be more severe and more frequent.

Neonatal herpes

Neonatal herpes can occur when an infant is exposed to HSV in the genital tract during delivery. This is a rare condition, occurring in an estimated 10 out of every 100,000 births globally, but can lead to lasting neurologic disability or death. The risk
for neonatal herpes is greatest when a mother acquires HSV infection for the first time in late pregnancy. Women who have genital herpes before they become pregnant are at very low risk of transmitting HSV to their infants.

No cure – better treatment and prevention needed

There is no cure for herpes. At present, antiviral medications, such as acyclovir, famciclovir, and valacyclovir, can help to reduce the severity and frequency of symptoms but cannot cure the infection.

As well as increasing awareness about HSV infection and its symptoms, improved access to antiviral medications and heightened HIV prevention efforts for those with genital HSV symptoms are needed globally.

In addition, development of better treatment and prevention interventions is needed, particularly HSV vaccines. WHO and partners are working to accelerate research to develop new strategies for prevention and control of HSV infections. Such research includes
the development of HSV vaccines and topical microbicides. Several candidate vaccines and microbicides are currently being studied.

“A vaccine against HSV infection would not only help to promote and protect the health and well-being of millions of people, particularly women, worldwide – it could also potentially have an impact on slowing the spread of HIV, if developed
and provided alongside other HIV prevention strategies” says Dr Meg Doherty, Director of the WHO Department of Global HIV, Hepatitis, and STI Programmes.

Related publications

WHO guidelines for the treatment of Genital Herpes Simplex Virus

WHO preferred product characteristics for herpes simplex virus vaccines

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(1) Looker KJ, Johnston C, Welton NJ, et al. The global and regional burden of genital ulcer disease due to herpes simplex virus: a natural history modelling study. BMJ Glob Health. 2020;5(3):e001875. doi: 10.1136/bmjgh-2019- 001875.

(2) Looker KJ, Welton NJ, Sabin KM, et al.Global and regional estimates of the contribution of herpes simplex virus type 2 infection to HIV incidence: a population attributable fraction analysis using published epidemiological data. Lancet Infect Dis.2020;20(2):240-249. doi: 10.1016/S1473-3099(19)30470-0.

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May 9, 2020
New estimates highlight need to step up the response to hepatitis D

Lyon, France, 29 April 2020 – In a study published in the Journal of Hepatology,¹ Professor Anna Maria Geretti and Dr Alexander Stockdale from the University of Liverpool (United Kingdom), in collaboration with researchers
from the World Health Organization (WHO) and the International Agency for Research on Cancer (IARC), estimate that worldwide, hepatitis D virus (HDV) affects nearly 5% of people who have a chronic infection with hepatitis B virus (HBV) and that HDV
co-infection could explain about 1 in 5 cases of liver disease and liver cancer in people with HBV infection..

To map the epidemiology of HDV infection in the world, Professor Geretti and Dr Stockdale joined forces with the WHO Global Hepatitis Programme and IARC, alongside investigators in Germany, Malawi, and the United Kingdom. “Infection with HDV occurs
in about 1 in 22 cases of chronic HBV infection in the world,” Dr Stockdale says. “More high-quality data are needed, but we have identified several geographical hotspots of high prevalence of HDV infection: in Mongolia, the Republic of
Moldova, and countries in Western and Middle Africa.”

“Although it is less common than hepatitis B, hepatitis D is a serious disease that often affects underprivileged and vulnerable populations,” says Dr Meg Doherty, Director of the WHO Global Hepatitis Programme. Those who are more likely to
have HBV and HDV co-infection include people who inject drugs and people with hepatitis C virus or HIV infection. The risk of co-infection also appears to be higher in recipients of haemodialysis, men who have sex with men, and commercial sex workers.
Dr Doherty points out, “This information helps in identifying the groups with HBV among whom we should be looking for HDV.”

HDV (formerly known as the Delta agent) is a small virus – one of the smallest that is known to cause disease in humans – and can replicate only in the presence of HBV, from which HDV borrows some of its structures. Compared with people with
HBV infection alone, those who have a chronic infection with both HBV and HDV have a much higher risk of developing disease in the form of cirrhosis and liver cancer. “HDV is a significant contributor to severe liver disease and liver cancer,”
says IARC scientist Dr Catherine de Martel. “The findings from this study inform our work on the association between viral infections and cancer, which is focused on developing improved prevention strategies.”

Professor Geretti concludes, “HDV has long been neglected, because for decades the prevalence of infection remained uncertain and effective treatment was lacking. Mapping the epidemiology of the infection is just the first step. More efforts are
needed to reduce the global burden of chronic hepatitis B and develop medicines that are safe and effective against hepatitis D and are affordable enough to be deployed on a large scale to those who are most in need.”

¹ Stockdale AJ, Kreuels B, Henrion MYR, Giorgi E, Kyomuhangi I, de Martel C, Hutin Y, Geretti AM (2020). The global prevalence of hepatitis D virus infection: systematic review and meta-analysis. J Hepatol. Published online 23 April 2020;
https://doi.org/10.1016/j.jhep.2020.04.008

For more information, please contact

Véronique Terrasse, Communications Group, at +33 (0)6 45 28 49 52 or terrassev@iarc.fr or IARC Communications, at com@iarc.fr

The International Agency for Research on Cancer (IARC) is part of the World Health Organization. Its mission is to coordinate and conduct research on the causes of human cancer, the mechanisms of carcinogenesis, and to develop scientific strategies for
cancer control. The Agency is involved in both epidemiological and laboratory research and disseminates scientific information through publications, meetings, courses, and fellowships. If you wish your name to be removed from our press release emailing
list, please write to com@iarc.fr.

About University of Liverpool

Founded in 1881 as the original ‘red brick’, the University of Liverpool is one of the UK’s leading research-intensive higher education institutions. Consistently ranked in the top 200 universities worldwide, we are a member of the prestigious
Russell Group and have a global reach and influence that reflects our academic heritage as one of the country’s largest civic institutions. For more information please visit us at www.liverpool.ac.uk

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May 9, 2020
Global leaders unite to ensure everyone everywhere can access new vaccines, tests and treatments for COVID-19

Heads of state and global health leaders today made an unprecedented commitment to work together to accelerate the development and production of new vaccines, tests and treatments for COVID-19 and assure equitable access worldwide.

The COVID-19 pandemic has already affected more than 2.4 million people, killing over 160,000. It is taking a huge toll on families, societies, health systems and economies around the world, and for as long as this virus threatens any country, the entire world is at risk.

There is an urgent need, therefore, while following existing measures to keep people physically distanced and to test and track all contacts of people who test positive, for innovative COVID-19 vaccines, diagnostics and treatments.

“We will only halt COVID-19 through solidarity,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Countries, health partners, manufacturers, and the private sector must act together and ensure that the fruits of science and research can benefit everybody.”

Work has already started. Since January, WHO has been working with researchers from hundreds of institutions to develop and test vaccines, standardize assays and standardize regulatory approaches on innovative trial designs and define criteria to prioritize vaccine candidates. The Organization has prequalified diagnostics that are being used all over the world, and more are in the pipeline. And it is coordinating a global trial to assess the safety and efficacy of four therapeutics against COVID-19.

The challenge is to speed up and harmonize processes to ensure that once products are deemed safe and effective, they can be brought to the billions of people in the world who need them. Past experience, in the early days of HIV treatment, for example, and in the deployment of vaccines against the H1N1 outbreak in 2009, shows that even when tools are available, they have not been equally available to all.

So today leaders came together at a virtual event, co-hosted by the World Health Organization, the President of France, the President of the European Commission, and the Bill & Melinda Gates Foundation. The event was joined by the UN Secretary General, the AU Commission Chairperson, the G20 President, heads of state of France, South Africa, Germany, Vietnam, Costa Rica, Italy, Rwanda, Norway, Spain, Malaysia and the UK (represented by the First Secretary of State).

Health leaders from the Coalition for Epidemic Preparedness Innovations (CEPI), GAVI-the Vaccine Alliance, the Global Fund, UNITAID, the Wellcome Trust, the International Red Cross and Red Crescent Movement (IFRC), the International Federation of Pharmaceutical Manufacturers (IFPMA), the Developing Countries Vaccine Manufacturers’ Network (DCVMN), and the International Generic and Biosimilar Medicines Association (IGBA) committed to come together, guided by a common vision of a planet protected from human suffering and the devastating social and economic consequences of COVID-19, to launch this groundbreaking collaboration. They are joined by two Special Envoys: Ngozi Okonjo-Iweala, Gavi Board Chair and Sir Andrew Witty, former CEO of GlaxoSmithKline.

They pledged to work towards equitable global access based on an unprecedented level of partnership. They agreed to create a strong unified voice, to build on past experience and to be accountable to the world, to communities and to one another.

“Our shared commitment is to ensure all people have access to all the tools to prevent, detect, treat and defeat COVID-19,” said Dr Tedros. “No country and no organization can do this alone. The Access to COVID-19 Tools Accelerator brings together the combined power of several organizations to work with speed and scale.”

Health leaders called on the global community and political leaders to support this landmark collaboration and for donors to provide the necessary resources to accelerate achievement of its objectives, capitalizing on the opportunity provided by a forthcoming pledging initiative that starts on 4 May 2020. This initiative, spearheaded by the European Union, aims to mobilize the significant resources needed to accelerate the work towards protecting the world from COVID-19.

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https://www.who.int/news-room/detail/24-04-2020-global-leaders-unite-to-ensure-everyone-everywhere-can-access-new-vaccines-tests-and-treatments-for-covid-19

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May 9, 2020
WHO public consultation on draft Target Product Profiles for Tuberculosis Preventive Treatment
Tuberculosis (TB) is a major yet preventable global health problem, with an estimated 10 million new cases worldwide in 2018, resulting in more than 1.5 million deaths, making it the leading infectious disease cause of death worldwide. An estimated one fourth of the world’s population is infected with the TB bacterium, of whom 5–10% advance to active TB disease in their lifetime.

Prevention of TB is a crucial component of the World Health Organization (WHO) End TB Strategy that calls for 90% coverage of TB preventive treatment (TPT) among persons living with HIV (PLHIV) and household contacts of infectious TB cases by 2035. The UN high-level meeting on TB, in September 2018, further emphasized the need to strengthen implementation of TPT and called for 30 million people, including 4 million children under 5 years of age to receive TPT by 2022.

However, uptake and scale-up of TPT have been slow, mainly due to the limitations of both diagnostic assays and available regimens (long duration, cost, toxicity, adherence issues, and operational aspects), indicating the need for new short, safe, efficacious and easy-to-take regimens for the treatment of TB infection and prevention of TB disease. The WHO has developed draft Target Product Profiles (TPPs) for TPT to align developers’ performance and operational targets for new TPT regimens with the needs of end-users.

The draft TPPs are now available online for comment.

WHO invites comments or feedback from all stakeholders by 27 April 2020 via this link:
- Access the form here
Based on the comments received on this draft, WHO will prepare the final non-draft TPP (version 1.0), which will be posted on WHO’s website and uploaded into the (WHO) Product Profile Directory by October 2020.

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April 10, 2020
BREAKING: Nigerian Army Arrests Personnel In Viral Video Threatening To Rape, Infect Women With HIV In Warri After SaharaReporters’ Story

The Nigerian Army has arrested two of its troopers, who threatened to rape and infect ladies in Warri, Delta State, with HIV in retaliation for the alleged killing of their colleague.

The slain soldier was alleged to have been killed by a mob after he shot lifeless a person named Joseph Pessu in Warri on Thursday.

Pessu’s killing led to protest by indignant residents of Ugbuwangue, a suburb of Warri, who blocked main roads and burnt tyres to precise their ache.

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In the 26-second lengthy video, the 2 arrested troopers sweared on the individuals of Warri and promised them a tormenting expertise for daring to take the lifetime of their colleague.

Speaking in disjointed Pidgin, one of many troopers stated, “Warri individuals, una don purchase job o. Una kill soldier ba? Your moms, I’ll ensure that I f..ok your moms pores and skin to pores and skin with out condom.

“I’ll ensure that she carry HIV, your daughters will carry HIV, your wives will carry HIV.

“You get mind to kill soldier ba? Dan ubanku.”

VIDEO: Nigerian Soldiers Threaten To Rape Women In Warri, Infect Them With HIV In Retaliation For Killing Colleague @HQNigerianArmy #CoronavirusLockdown #LockDownNigeria #COVID19 #Coronavirus pic.twitter.com/7gsozO3lXb

— Sahara Reporters (@SaharaReporters) April 3, 2020

But reacting to the difficulty in a press release on Friday, the Nigerian Army stated the lads had been arrested at 9 Brigade, Ikeja Military Cantonment, Lagos, including that additional investigations had been ongoing.

The assertion reads, “Soldiers in a viral video utilizing uncouth and uncivilised language purportedly threatening to molest ladies in Warri, Delta State, had been arrested at 9 Brigade, Ikeja Military Cantonment, Lagos State, right now 3 April, 2020 and additional investigation is ongoing.

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“The common public must be assured that the investigations might be swift and truthful in accordance with relevant navy legal guidelines.

“The final result of the investigations will decide essentially the most acceptable disciplinary measures that may be taken within the circumstances.

“The Nigerian Army wishes to reiterate that it would not tolerate any form of irresponsibility and indiscipline on the part of any of its personnel.”

The Nigerian Army place rubbishes an earlier denial by the Delta State Government, who described the video first printed by SaharaReporters as “fake”.

Commissioner for Information within the state, Charles Aniagwu, had stated that the video was concocted and created by disgruntled components bent on pitching the individuals towards the state authorities.

But with the newest improvement, it’s clear info prevailed over sentiment.

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April 4, 2020