Jenna Payesko

Recently, the US Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the oral formulation of Scynexis’ antifungal agent SCY-078 for the treatment of vulvovaginal candidiasis (VVC) and prevention of recurrence.

“These designations from the FDA for the treatment of VVC and prevention of recurrent VVC highlight the significant unmet needs faced by women suffering from these widespread infections,” Marco Taglietti, MD, president, chief executive officer, Scynexis, said in a recent

 “We believe SCY-078 will provide a beneficial treatment option for health care providers and women not satisfied with existing therapies. Moreover, we can now make use of the QIDP and fast track designations across all current SCY-078 development programs, including VVC, invasive candidiasis and invasive 

The novel oral intravenous antifungal agent is a semi-synthetic derivative of the natural product enfumafungin and is the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids.

The biotechnology company also announced that it has completed enrollment for the DOVE study, a phase 2b, dose-finding study for the treatment of VVC; they anticipate the top-line data to be released by July 2018.

The DOVE study, which enrolled more than 180 women with moderate to severe acute VVC, aims to assess the efficacy, safety, tolerability, and pharmacokinetics of 5 different regimens of the oral treatment in order to identify optimal dosing for the phase 3 registration program, which is expected to begin in the fourth quarter of 2018.

“With the recent initiation of [the DOVE study], we are continuing to maximize the value of the SCY-078 platform by advancing the oral formulation of SCY-078,” Dr. Taglietti said in a past statement. “The DOVE study is a critical step towards our goal to provide a treatment option for WC patients, particularly those with recurrent VVC, for which there are currently no approved therapies.”

Current treatments include topical antifungals and the use of prescription oral antifungals, such as fluconazole. 

SCY-078 is also currently in development for the treatment of fungal infections caused by 

The FDA has granted QIPD and fast track designation for the formulations of SCY-078 for indications of invasive candidiasis, 

, and VVC, and additionally, has granted orphan drug designation for the invasive candidiasis and invasive aspergillosis indications. The QIDP designation allows Scynexis to have priority review, eligibility for fast-track status and an additional 5 years of market exclusivity in the US.

A previous version of this article has appeared on 

 / Joe Miller. Feature Picture Caption: This is a Gram-stained photomicrograph of a vaginal discharge specimen. As part of a differential diagnostic study, after its analysis, a diagnosis of genital-vulvovaginal candidiasis (VVC) was determined to be this patient’s malady, which had been caused by an overgrowth of Candida albicans organisms. Note the Gram-positive yeast cells, and the budding cell designated by the arrowhead.

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The FDA has granted QIDP and Fast Track Designations for the oral formulation of SCY-078 for the treatment of vulvovaginal candidiasis.

FDA Grants QIDP & Fast Track Designations for SCY-078 to Treat Vulvovaginal Candidiasis

The US Food and Drug Administration (FDA) accepted for review the new drug application (NDA) for Mayne Pharma Group Limited’s SUBA-Itraconazole capsules for the treatment of 3 systemic fungal infections: histoplasmosis, blastomycosis, and refractory aspergillosis.

The FDA review is expected to be completed at the beginning of 2019.

 has already received approval from the FDA to treat fungal infections; as such, it has been extensively used for that purpose, and, according to HedgePath Pharmaceuticals, Inc., it “has a significant history of safe and effective use in humans.” Mayne Pharma applied their 

 to “the poorly soluble and highly variable” itraconazole to enhance its bioavailability. SUBA-Itraconazole is a “proprietary, patented formulation that enhances solubility and absorption of conventional itraconazole oral formulations,” according to the pharmaceutical company.

“The conventional formulation of oral itraconazole suffers from poor and unpredictable bioavailability resulting in significant inter- and intra-patient variability, which is a frustration to prescribers,” Scott Richards, chief executive officer, Mayne Pharma, said in a 

 “The unique formulation of SUBA-Itraconazole capsules, which has improved bioavailability and significantly reduced variability to existing products, represents a significant innovation.”

The enhancements made via the technology is said to offer a more predictable clinical response and enable a reduction in active drug quantity to deliver the required therapeutic blood levels, according to the press release. Furthermore, the capsules do not need to be taken with food and can be co-administered with drugs that lower gastric acidity without a reduction in itraconazole bioavailability, which increases patient convenience.

The indication for the capsules in the United States is for histoplasmosis, blastomycosis, and refractory aspergillosis—all serious, potentially deadly fungal infections that commonly plague individuals who have a history of having been on immunosuppressant treatment, have had cancer, solid organ or bone marrow transplants, or HIV/AIDS. Due to these underlying conditions, it’s hard to reach target blood levels of itraconazole with the conventional form of the drug.

Mayne Pharma has already received regulatory approval for SUBA-Itraconazole capsules in several countries, including Australia, Argentina, Belgium, Germany, Mexico, Italy, and Spain; they are currently seeking approval in other countries as well.

“The US anti-fungal triazole market has a current value of US $500 million according to IQVA and based on the clear unmet clinical need in serious systemic infections, the addressable market is estimated at US $200 million in which SUBA-itraconazole is expected to perform strongly,” according to Mayne Pharma.

The FDA has accepted for review the NDA for Mayne Pharma’s SUBA-Itraconazole capsules for the treatment of 3 systemic fungal infections.

FDA Accepts NDA for SUBA-Itraconazole Capsules for Treatment of Systemic Fungal Infections

The US Food and Drug Administration (FDA) accepted for review a supplemental Biologics License Application seeking to expand the age indication of the 0.5 mL dose of Sanofi Pasteur’s influenza vaccine (Fluzone Quadrivalent) to include children between 6 and 35 months of age.

The target action date is January 28, 2019, per the Prescription Drug User Fee Act.

“We are one step closer to potentially offering clinicians the option to use 0.5 mL dose of Fluzone Quadrivalent vaccine with all of their eligible pediatric patients 6 months of age and older,” David Greenberg, MD, associate vice president and regional medical head of North American, Sanofi Pasteur, said in a 

This especially hits home as the United States begins to recover from a particularly harsh flu season, where many 

 have been reported for the 2017-2018 season, 5 of them having been reported to the Centers for Disease Control and Prevention during week 15. If this indication is approved, physicians will be able to reserve the vaccine for young children to protect them against the 2019-2020 flu season.

The application is backed by clinical data from a phase 4 safety and immunogenicity study that had been conducted in nearly 2000 children; according to Sanofi Pasteur, data pertaining to this study will be presented at several medical meetings this year.

The vaccine was developed to protect those 6 months of age and older against 4 flu viruses: 2 influenza subtypes, A(H1N1) and A(H3N2) and 2 influenza B lineages, Victoria and Yamagata. A 0.25 mL dose is currently approved for use in children 6 through 35 months of age; a 0.5 mL dose is approved for those 36 months of age and older.

 should not be administered to anyone who has ever experienced a severe allergic reaction to eggs or egg products or after receiving any flu vaccine.

The most common adverse effects include pain at injection site (all ages) and erythema and swelling at the injection site (children). Common systemic reactions include myalgia, malaise, and headache (irritability, abnormal crying, drowsiness, appetite loss, vomiting and fever in young children).

A previous version of this article was published on 

If this indication is approved, physicians will be able to reserve the vaccine for young children to protect them against the 2019-2020 flu season.

Supplemental Biologics License Application for .5 mL Influenza Vaccine in Children 6-35 Months Accepted by FDA

Just days after Grindr—a geosocial networking app geared toward gay and bisexual men to help them meet other men in their area&mdash;revealed a 

new feature which allowed users to opt-in to receive automatic HIV testing reminders

, a data analysis launched by a Norwegian outside research firm found that the app was sharing users’ HIV status with 2 other companies.

 has grown into “the world’s largest social networking app for gay, bi, trans, and queer individuals; it has upwards of 3.6 million daily active users throughout the world. The app was found to have shared personal information (such as HIV status and last tested date) that users included in their profiles to 2 companies that help optimize apps: Apptimize and Localytic.

Grindr has long promoted HIV awareness, offering information about free testing sites and opt-in reminders for semiannual testing. In the app, users can choose to display HIV status ranging from positive to positive and in treatment to negative or negative and on PrEP, an option Grindr intended to help foster open dialogue among users. The app also links to a sexual health FAQ about HIV and how to begin treatment.

Because developers are sending HIV information with users’ GPS data, phone ID, and email, this could identify specific users and their HIV status, which calls into question the company’s users’ privacy policy.

The disclosure of HIV status raises concerns regarding the app’s privacy policy, warning customers that the information that they put in a profile may be revealed. Experts argue that the app should be more specific in its user agreements about how it’s using their data. The company’s policy states: “You may also have the option to provide information concerning health characteristics, such as your HIV status or Last Tested Date. Remember that if you choose to include information in your profile, and make your profile public, that information will also become public.”

, which was confirmed by cybersecurity experts, disclosed that Grindr shared its users’ precise GPS position, gay subculture, sexuality, relationship status, ethnicity and phone ID to other third-party advertising companies, which unlike HIV data, was shared via plain text — a method that can easily be hacked.

“The HIV status is linked to all the other information. That’s the main issue,” Antoine Pultier, a researcher at Norwegian nonprofit SINTEF, told 

. “I think this is the incompetence of some developers that just send everything, including HIV status.”

According to the analysis, the third-parties are not necessarily certified to host medical data.

Grindr insists its sole purpose for sharing highly sensitive health information is an effort to better the app. While it’s not selling data for marketing purposes, it’s offering other companies intimate user information.

“No Grindr user information is sold to third parties,” Scott Chen, chief technology officer, Grindr, told 

. “We pay these software vendors to utilize their services. The limited information shared with these platforms is done under strict contractual terms that provide for the highest level of confidentiality, data security, and user privacy.”

The company claims the contracts with the 2 companies are both standard practice and secure.

“Grindr is a relatively unique place for openness about HIV status,” James Krellenstein, member of AIDS advocacy group ACT UP New York told 

. “To then have that data shared with third parties that you weren’t explicitly notified about and having that possibly threaten your health or safety — that is an extremely egregious breach of basic standards that we wouldn’t expect from a company that likes to brand itself as a supporter of the queer community.”

A previous version of this article was posted on 

, Grindr admitted to sharing the sensitive data in encrypted form to the 2 companies as part of "standard industry practice for rolling out and debugging software." Grindr responded to accusations on its Tumblr page by writing, "It's important to remember that Grindr is a public forum. We give users the option to post information about themselves including HIV status and last test date, and we make it clear in our privacy policy that if you choose to include this information in your profile, the information will also become public." Hours after this statement, the security chief of Grindr told another news website that the company has since changed its policy and "will no longer provide that information to vendors."

On the heels of revealing a new feature promoting HIV testing, a data analysis finds that the app was sharing sensitive information with other companies.

Grindr Found to Be Sharing Users' HIV Status With Other Companies

The CDC has reported that 44% of individuals who are living with HIV are residing in the southern region of the United States; 

HIV diagnosis rates are higher in the South

25th Conference on Retroviruses and Opportunistic Infections (CROI)

, research presented by Johnathan Colasanti, MD, MSPH, from the Emory University School of Medicine, suggested that the implementation of rapid entry programs in an economically and socially disenfranchised population in the South significantly improved time to viral suppression for those with HIV.

“Significant resources and effort were needed to implement this program, suggesting that more data are needed to determine which populations will benefit most from the rapid start of ART in the United States,” Dr. Colasanti said in his 

Data from the test and treat or rapid antiretroviral therapy (ART) approaches have improved linkage to care, rates of viral suppression, and time to viral suppression in South Africa, Haiti, and San Francisco; past data suggests that this may lead to better retention in care. Aside from this study, no rapid entry programs have been reported from the Southern United States.

From May 16, 2016, to July 31, 2016, the feasibility and effectiveness of the rapid entry program was assessed in a large Ryan White-funded clinic in Atlanta, Georgia, which serves a predominantly minority and economically disadvantaged population.

Researchers aimed to enroll patients in the clinic, complete a social needs assessment, provider visit, labs and give an opinion to begin ART within 72 hours of presenting to clinic.

To assess the effectiveness of the program, the researchers compared with intervention group with new enrollees of the clinic from the months preceding the rapid entry program January 1, 2016, to May 15, 2016.

Inclusion criteria included HIV-positive patients, new to the clinic — however, not necessarily new to the diagnosis &mdash; who were viremic at intake and ≥ 16 years old. Researchers followed up with each group of patients at 6 months.

The primary outcome was the time from presentation to clinic for enrollment to viral suppression, while the secondary outcomes included viral suppression <200 c/mL, attending first scheduled provider visit, time to scheduled provider visit, time to first attended provider visit, and time to ART initiation.

A survival analysis was used to compare viral suppression for the groups, while researchers used linear regression models for secondary outcomes.

The sample size included 118 pre-rapid entry program and 91 post-rapid entry program.

Pre-rapid entry program demographics include age 33, 81% male, 86% Black, 60% men who have sex with men, 58% uninsured, an annual income of $8,808, 67% unstably housed, 9% incarcerated in the last 6 months, 42% active substance use, CD4 141 cells/uL and 59% ART naïve. The post-rapid entry program, however, differed in age at 38-years-old.

The median time to viral suppression decreased from 63 days to 45 days post-rapid entry program.

This is the largest, rapid entry cohort described in the US Time to viral suppression, in an economically and socially disenfranchised population in the South.

The findings concluded that through the implementation of a rapid entry program time to first provider appointment, time to initiation of ART, and time to viral suppression all decreased; however, the proportion of patients achieving viral suppression did not decrease.

Viral suppression, significantly improved through implementation of a rapid entry program, was likely due to shortening the time to initial provider visit and ART prescription, the researchers said.

Rapid entry programs are feasible in areas of the country with the greatest number of new infections.

, Dr. Colasanti said that he thinks these programs are critically important in areas like the South, where stigma is so strong and there’s leftover systemic racism and mistrust in the medical system —  the impact of these programs need to be further studied.

“I think it’s up to us to continue to demand from our health systems, from our other state or federal funding sources, that dollars need to be poured into this, really because it’s the right thing to do,” he said.

Implementation of a rapid entry program decreased time to first provider appointment, time to initiation of ART, and time to viral suppression in the Southern United States.

Improving Access to Patient Care & Time to Viral Suppression Using HIV Rapid Entry Programs

In several settings where HIV prevalence is high, fertility rates are also high. Some past research has indicated significantly higher HIV incidence during pregnancy.

, Renee Heffron, PhD, MPH, assistant professor at the University of Washington presented study results that suggested that a woman’s risk of acquiring HIV through sexual intercourse with an HIV-infected male partner increases during pregnancy, with risk being highest during the postpartum period.

“Our findings suggest that biological changes during pregnancy and postpartum may increase HIV risk,” Dr. Heffron said in a press conference at CROI. “This finding has a number of important public health implications. We have tremendous opportunities in antenatal and postnatal care, to promote HIV prevention and care.”

The risk of transmission was observed per sex act, even after accounting for sexual behavior, PrEP, and HIV viral load. Per sex act analyses provide an understanding of absolute and relative risks of HIV transmission; this also sheds light on whether or not increased risk during pregnancy and postpartum can be attributed to biological or sexual changes.

HIV infections that occur during pregnancy or postpartum, not only have negative consequences on women but carry the risk of perinatal HIV transmission to the fetus or newborn through breastfeeding.

The study involved 2751 African serodiscordant couples, enrolling in either of 2 HIV prevention clinical trials: the Partners PrEP Study and the Partners in Prevention HSV/HIV Transmission Study.

HIV uninfected female partners were followed prospectively for ≤48 months to undergo HIV and pregnancy testing either monthly or quarterly, depending on the trial. Sexual frequency and condom use were reported on a monthly basis.

The study time was categorized by reproductive stage as early pregnancy, late pregnancy up to 6 months postpartum or non-pregnant. Researchers utilized a complementary log-log model comparing the probability of male-to-female HIV transmission per sex act by reproductive stage.

Overall, the pregnancy incidence was 12.50 per 100 woman-years (95% CI: 11.52-13.55) and out of the 686 pregnancies that occurred, there were 82 HIV transmissions events.

When determining transmission probabilities per sex act, differences between couples regarding condom use, PrEP use, age, and the male partner’s HIV viral load were considered.

Researchers established that the reference case for HIV transmission probability is a condomless sex act between a 25-year-old woman not using PrEP and a male partner with HIV RNA of 10,000 copies/ml.

A probability was calculated of 1.05 HIV transmissions per 1000 sex acts when the woman was not pregnant, and 2.19 transmissions per 1000 sex acts during the first 13 weeks of pregnancy.

After researchers adjusted for condom use, age, use of PrEP and HIV viral load, the probability of transmission per sex act was significantly higher in late pregnancy (14 weeks to delivery) rising slightly to 2.97 per sex 1000 sex acts, increasing further to 4.18 HIV transmissions per 1000 sex acts for the first 6 postpartum months.

Findings underscore the importance of expanding HIV prevention and testing services for pregnant and postpartum women to prevent sexual transmission and identify acute HIV infections in those living in areas with high HIV prevalence.

“Our data highlight the importance of counseling women on increased risk throughout pregnancy and postpartum, promoting maternal repeat HIV testing, identifying and linking HIV infected partners to ART and care and promoting HIV prevention strategies that women can control themselves without the need of a partner such as oral PrEP during pregnancy and postpartum,” Dr. Heffron stressed.

Currently, the World Health Organization (WHO) recommends including HIV testing as part of a routine component of antenatal, childbirth and postpartum care to couples and partners.

The risk of HIV transmission per sex act steadily increased through pregnancy, with the highest risk occurring during postpartum, suggesting that biological changes during these periods increase the risk.

Researchers note that it’s critical to understand the factors that affect HIV acquisition risk during and after pregnancy, in order to ensure that women are equipped with the best preventive tools.

While further research is needed to better understand biological susceptibility, HIV prevention and testing in antenatal and postpartum care in high-risk settings is warranted to prevent sexual transmission and to identify acute maternal HIV infections, Dr. Heffron concluded.

A previous version of this article can be found on 

Recent research presented at CROI 2018 finds that the risk of female HIV acquisition per sex act steadily increased through pregnancy and was highest during postpartum.

Jenna Payesko

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