Jaime Rosenberg

This article was originally published on 

The FDA has approved sumatriptan nasal spray (Tosymra) for the acute treatment of migraine with or without aura in adults.

Anil Namboodiripad, PhD, president of Promius Pharma, said the nasal spray is formulated using a novel excipient called Intravail to achieve blood levels similar to a 4-mg sumatriptan subcutaneous injection, which results in rapid onset of action.

“For patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options,” said Namboodiripad in a statement. “At Promius, we are committed to developing new ways of improving patient experiences. Tosymra is a mist-like spray that acts rapidly and is well tolerated.”

The most common side effects of the treatment are tingling, dizziness, feeling warm or hot, a burning sensation, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, nasal reactions, abnormal taste, and throat irritation.

Promius warned that the nasal spray can cause serious side effects, including heart attack and other heart problems. Those taking the treatment are encouraged to stop using Tosymra and get emergency medical assistance if they have any symptoms of a heart attack, including nausea or vomiting, discomfort in the center of the chest, or severe tightness, pain, pressure, or heaviness in the chest, throat, neck, or jaw.

Other possible side effects include changes in color or sensation in the fingers and toes, problems with blood circulation in the legs and feet, increased blood pressure, serotonin syndrome, stomach and intestine problems, and seizures.

People with heart problems or a history of heart problems; narrowing of the blood vessels to the legs, arms, stomach, or kidney; uncontrolled high blood pressure; severe liver problems; or hemiplegic or basilar migraine should not use the spray.

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Sumatriptan Nasal Spray Gains FDA Approval for Treatment of Migraine

Reducing the HIV reservoir—a group of cells that are infected with HIV but are not actively producing new HIV&mdash;has proven to be one of the biggest challenges for researchers searching for a cure for the virus. Although adherence to antiretroviral therapy (ART) lowers the rate of HIV proliferation and can result in viral suppression, some infected cells still proliferate and can persist for decades despite treatment.

According to a new study, cellular proliferation generates the majority of infected cells during ART, suggesting that reducing proliferation can decrease the size of the HIV reservoir and work toward a cure. The study provides an answer to the longstanding question facing HIV researchers: Does HIV survive through replication from infected cells that evade treatment or through proliferation from cells that have HIV genes from earlier infection?

“There is debate whether infection remains due to HIV replication within a small population of cells or persistence of memory CD4+ cells with HIV integrated into human chromosomal DNA,” wrote the researchers. “If the latter mechanism predominates, prolonged cellular lifespan and/or cellular proliferation may sustain stable numbers of infected cells.”

When the HIV virus infects a cell, it inserts its DNA into the human chromosome, creating a unique genetic signature. Thus, the researchers assumed that cells arising from viral replication would have unique sequences, whereas those generated from cellular proliferation would have equivalent sequences and thus be part of clonal populations. Using ecologic tools, the researchers studied the abundance of clonal HIV by applying methods to integration site and replication-competent HIV sequence data.

Cellular proliferation predominantly drives HIV persistence on antiretroviral therapy, according to a new study. 

HIV Persistence During Antiretroviral Therapy Caused by Cellular Proliferation

The first study to evaluate population-level roll-out of pre-exposure prophylaxis (PrEP) for HIV in men who have sex with men has demonstrated rapid decline of new HIV infections, researchers reported.

According to the study, rapid, targeted, and high-coverage roll-out of PrEP in New South Wales, Australia, led to a 25% reduction in HIV diagnoses in just 1 year.

“Our results support the population-level effectiveness of PrEP 1 year after rapid implementation at scale,” Andrew Grulich, professor, Kirby Institute, University of New South Wales, and lead author of the study, said in a statement. “PrEP is a highly effective preventive approach when implemented alongside high levels of HIV testing and treatment. Roll-out should be prioritized as a crucial component of HIV prevention in epidemics predominantly affecting men who have sex with men.”

The study recruited 3700 men at high risk of HIV infection who took a daily, single-dose of oral emtricitabine/tenofovir disoproxil fumarate, marketed as Truvada, between March 1, 2016, and October 21, 2016. The men, followed for a year, were tested for HIV at 1 month, 3 months, and every 3 months thereafter.

During the study period, the amount of participants who attended follow-up visits declined, dropping from 88% at 1 months and 90% at 3 months to 76% at 12 months. However, nearly all (97%) participants took the treatment more than once, and median medication possession over the 12 months was 97.8%. Less than one-third (30%) of participants had adherence below 80%, and these participants were also less likely to attend follow-up visits.

By the end of follow-up, just 2 of the men were diagnosed with HIV, both of which were nonadherent to PrEP. With a total of 4100 person-years of follow-up among 3638 patients with a record of at least 1 HIV test after baseline, the HIV incidence was 0.048 per 100 person-years. The researchers observed a 31.5% decline in recent HIV infections and an 18.5% decline in other HIV diagnoses.

“The number of HIV diagnoses in men who has sex with men in New South Wales declined from 295 in the 12 months before PrEP roll-out to 221 in in the 12 months after PrEP roll-out, the lowest annual HIV diagnosis count in men who have sex with men recorded in New South Wales since the beginning of HIV surveillance in 1985,” wrote the researchers.

The first study to evaluate population-level roll-out of pre-exposure prophylaxis (PrEP) for HIV in men who have sex with men has demonstrated rapid decline of new HIV infections.

Population-Level PrEP Roll-Out Effectively Lowers HIV Diagnoses

The association between HIV and an increased risk of cancer is well-documented, with people in the United States having an approximately 

of being diagnosed with cancer compared to the general population. Now, new research is pointing to an increased risk for both first and secondary cancer incidence among the patient population.

The increased risk of cancer is due in part to people living with HIV living longer, thanks to advances like antiretroviral therapy. As these patients live longer, with compromised immune systems, they become more susceptible to both AIDS-defining and non-AIDS—defining cancers.

“The combination of older age, extended duration of immunosuppression, longer latency period for oncogenic viruses, and ongoing environmental exposures such as tobacco and alcohol use, puts people living with HIV at heightened risk for malignancies over time,” wrote the researchers of the study.  

Compromised immune systems, combined with the fact that cancer survivors are more likely to be diagnosed with a second malignancy, puts people living with HIV at an even greater risk of developing a second primary cancer, according to the study of 22,623 patients diagnosed with HIV between January 1, 1990, and December 21, 2010.

Among these patients, there were 4545 incident primary cancers, accounting for 4144 first primary cancers, 372 second primary cancers, 26 third primary cancers, and 3 fourth or later primary cancers. People living with HIV had higher standardized incidence ratios for 14 first primary cancers, including: Kaposi sarcoma, non-Hodgkin lymphoma, cervical cancer, anal cancer, vulvar cancer, Hodgkin lymphoma, eye and orbit cancer, lip cancer, penile cancer, liver cancer, miscellaneous cancer, testicular cancer, tongue cancer, and lung cancer.

The increased risk of cancer is due in part to people living with HIV living longer, thanks to advances like antiretroviral therapy.