Tivicay approved in Europe in new dispersible tablet for children with HIV

ViiV’s Tivicay is to become available in Europe in a new dispersible tablet form to treat children living with HIV.

The joint venture, majority-owned by GlaxoSmithKline with Pfizer and Shionogi as shareholders, said the European Commission had granted a marketing authorisation for the new formulation.

These tablets are used in combination with other antiretroviral agents for treatment of human immunodeficiency virus type-1 infection in paediatric patients.

To be eligible, children must be at least four weeks of old, weighing at least 3kg and must not have been treated with an integrase inhibitor, although it doesn’t matter whether they have been treated with other drugs classes.

This authorisation includes updated dosing recommendations, for Tivicay (dolutegravir) film-coated tablets (10mg, 25mg and 50mg) for children six years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands.

Approval is based on data from the ongoing P1093 and ODYSSEY studies, which are being conducted in collaboration with international paediatric research networks.

P1093 is a a safety, tolerability and dose finding registrational study in paediatric patients aged four weeks to 18 years being conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) network in the USA, Brazil, Thailand, South Africa, Zimbabwe, Kenya and Tanzania.

ViiV Healthcare, the Division of AIDS (DAIDS) at the US National Institutes of Health (NIH) are collaborating in this trial.

ODYSSEY is a randomised control efficacy trial in first and second- line treatment, in paediatric patients aged four weeks to 18 years being conducted by the PENTA network in Europe, South America, Thailand, Uganda, Zimbabwe, and South Africa.

Originally designed to support World Health Organization (WHO) guideline recommendations by WHO weight bands, this study will now also provide data to support revised dosing and continue to 96 weeks.

ViiV Healthcare, the Paediatric European Network for Treatment of AIDS (Penta) and the Medical Research Council (MRC) Clinical Trials Unit at University College London for ODYSSEY are collaborating in this trial.

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ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV

Shots:

  • The approval is based on P1093 & ODYSSEY (Penta20) studies assessing safety, tolerability & dose-finding of Tivicay (5mg) in pediatric patients aged 4wks.-18yrs. while the second study assessed the 1L & 2L treatment in patients of the same age
  • The approval includes updated dosing recommendations for Tivicay film-coated tablets (10/25/50mg) for children aged ≥6yrs. and weighing at least 14kg, bringing these in line with the WHO weight bands
  • Dolutegravir is the first integrase inhibitor used in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least 4wks. and weighing at least 3kg.

Click here ­to­ read full press release/ article | Ref: VIIV Healthcare | Image: Smart Industry News

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Data sets up 2021 filings for Gilead’s twice-a-year HIV drug lenacapavir

Gilead Sciences has the data it was hoping for in a pivotal trial of lenacapavir, an HIV drug that only needs to be dosed by subcutaneous injection every six months, keeping it on course for regulatory filings next year.

Lenacapavir (previously GS-6207) is the first in a new class of class HIV-1 capsid inhibitor that Gilead is hoping will eventually free patients from the need to take daily oral tablets, although initially it is being developed for patients who are failing their current treatment regimen.

The drug is also a key part of Gilead’s plans to defend its $16 billion HIV franchise from rivals which are also developing long-acting injectables, namely ViiV Healthcare with cabotegravir and Merck & Co’s islatravir (MK-8591).

The 36-patient CAPELLA trial tested lenacapavir in highly treatment-experienced HIV patients who had developed resistant to their current drugs, with virus levels rising as a result.

It found that 21 of 24 (88%) of patients on the capsid inhibitor experienced a 0.5 log10 reduction in viral load after 14 days, compared to two of 12 patients (17%) on placebo.

“We look forward to sharing data from longer-term follow-up of CAPELLA study participants next year and submitting these data for regulatory approval,” said the company’s head of virology Diana Brainard.

The FDA granted breakthrough designation to lenacapavir for the treatment of resistant HIV, which has become a niche part of the overall HIV market thanks to much-improved oral drug regimens in recent years.

In time, Gilead wants in time to extend the use of lenacapavir into additional and much larger indications, including the general HIV-positive population as well as for pre-exposure prophylaxis (PrEP) among people who have sex with HIV-positive partners.

Earlier this year Gilead added a lenacapavir arm to its planned prevention study in women at risk of HIV – which is being carried out to expand the label for Descovy after it was approved with a narrower PrEP indication than Truvada last year.

In parallel, Gilead is also planning to carry out a study of lenacapavir for HIV prevention in men and transgender people who have sex with men.

PrEP is already a big market for HIV drugs like its blockbuster brands Descovy (emtricitabine/tenofovir alafenamide) and Truvada (emtricitabine/tenofovir disoproxil fumarate), which accounted for around $1.5 billion and $3 billion of Gilead’s HIV sales last year.

Descovy’s approved indication excluded people who have receptive vaginal intercourse due to a lack of efficacy data in that population, and Gilead wants to shore up the label quickly as Truvada is facing the loss of patent protection. It is thought that around two-thirds of Truvada’s near-$3 billion in 2019 sales came from use as PrEP.

Expanding the use of lenacapavir into the broader population could be complex however as Gilead will need to find another long-acting drug that can be partnered with it to reduce the risk of resistance to the capsid inhibitor.

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ViiV could challenge Gilead with long-acting HIV PrEP shot

GlaxoSmithKline’s HIV joint venture ViiV Healthcare could mount a challenge to Gilead’s HIV pre-exposure prophylaxis (PrEP) medicines after the FDA granted Breakthrough Therapy Designation for its long-acting injectable drug cabotegravir.

In the trial cabotegravir was injected every eight weeks in a formulation that the company hopes will be more appealing than Gilead’s daily Truvada pill.

Offering patients the option of an injection every eight weeks would allow them to take the medicine more discreetly. Trial results show that cabotegravir is more effective at preventing infections than Truvada.

PrEP drugs are taken by HIV-negative people before they have sex and reduce the risk of getting HIV.

The FDA granted the status based on efficacy and safety results of a trial comparing cabotegravir with emtricitabine+tenofovir disoproxil fumarate (FTC/TDF) – the active ingredients in Gilead’s Truvada – in high-risk individuals.

HPTN 08 is, a phase IIb/III randomised, multicentre, double-blinded, clinical trial comparing the two drugs for HIV prevention among 4,566 men who have sex with men and transgender women who have sex with men.

ViiV said the final analysis of HPTN 083 showed the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral Truvada tablets.

Results of the trial were presented at the AIDS 2020 conference in July and the blinded phase of a prevention study in 3,223 sub-Saharan African women was stopped earlier this month after an analysis by the independent safety monitoring board showed cabotegravir was superior to oral FTC/TDF.

Viiv, which is majority owned by GSK with Pfizer and Shionogi as shareholders, plans to use the data from both studies for future filings with regulators.

Breakthrough Therapy status is intended to expedite the development and review of drugs for serious or life-threatening diseases, which may be better than available therapies.

The FDA requires preliminary clinical evidence showing a drug may be a substantial improvement on at least one clinically significant endpoint over available therapies.

It may allow more frequent collaboration with the FDA to discuss a development plan and could pave the way for a faster Priority Review lasting six months.

Gilead has also produced a follow-up to Truvada – Descovy (emtricitabine+tenofovir alafenamide) which is approved by the FDA in PrEP and to help keep the virus at bay in those infected with the virus.

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ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention

Shots:

  • This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population of 4,566 for HIV prevention. The data were presented at the 23rd International AIDS Conference (AIDS 2020)
  • Results: HPTN 083 study showed that cabotegravir was 66% more effective at preventing HIV compared to daily oral FTC/TDF tablets. The HIV incidence rate is 0.41% in the cabotegravir group and 1.22% in the FTC/TDF group
  • A partner HIV prevention study (HPTN 084) in sub-Saharan African women was stopped earlier this month based upon recommendation of the independent DSMB following the superioriority of cabotegravir to oral FTC/TDF tablets. The company plans to use the data from both the HPTN studies for future regulatory submissions

Click here ­to­ read full press release/ article | Ref: ViiV Healthcare | Image: ViiV Healthcare

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Gilead got a boost from a newly approved PrEP drug. Now, a major insurer is dropping coverage

UnitedHealthcare sent a notice to plan members stating that it would no longer cover Descovy to prevent HIV, while Truvada – after it goes generic next month – will be covered for free. Gilead reported that Descovy for PrEP had offset a second-quarter fall in product sales.

ViiV’s twice-monthly injected PrEP drug superior in HIV prevention to Gilead daily pill, analysis shows

The company said Tuesday that a final analysis of its Phase IIb/III study of cabotegravir showed greater efficacy in HIV prevention than Gilead’s Truvada. The study, among men and transgender women who have sex with men, was stopped in May following an interim analysis.