Ultra-long-acting AIDS drugs: Only one injection every four months

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Ultra-long-acting AIDS drugs: Only one injection every four months

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Ultra-long-acting AIDS drugs: Only one injection every four months.

A Promising Future for HIV Prevention: ViiV Healthcare’s CAB-ULA Trial Shows Potential for Long-Acting PrEP.

The fight against HIV continues to make significant strides, with advancements in both treatment and prevention. Pre-exposure prophylaxis (PrEP), a crucial tool in preventing HIV acquisition, currently involves daily oral medications. However, adherence challenges can limit the effectiveness of this approach.

ViiV Healthcare’s recent announcement regarding cabotegravir ultra long-acting (CAB-ULA) offers a potential game-changer. This investigational injectable formulation, presented at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI), demonstrates promising results for long-acting PrEP, potentially requiring only three injections per year.

Current Landscape of PrEP

Daily oral medications like emtricitabine/tenofovir disoproxil fumarate (Truvada) and emtricitabine/tenofovir alafenamide (Descovy) are currently the mainstay of PrEP. These medications boast high efficacy when taken consistently [Li et al., 2019; Bazeley et al., 2019]. However, adherence can be a challenge due to factors like forgetfulness, stigma, and potential side effects [Gardner et al., 2019; Ghunaim et al., 2017]. Studies have shown that adherence rates can vary significantly, with some individuals struggling to maintain consistent daily medication use [Anderson et al., 2016; Herbst et al., 2017]. This inconsistency can compromise the effectiveness of PrEP and leave individuals vulnerable to HIV acquisition.

The Promise of Long-Acting PrEP

Long-acting injectable PrEP offers a potential solution to the adherence challenges associated with daily oral medications. Cabotegravir, a potent integrase inhibitor, has already shown promise in this area. In 2021, the FDA approved cabotegravir (Apretude) in combination with rilpivirine (Rekord) as a long-acting injectable regimen for HIV treatment [ViiV Healthcare, 2021]. Building on this success, ViiV Healthcare’s CAB-ULA formulation aims to further improve convenience and adherence by extending the dosing interval.

ViiV Healthcare’s CAB-ULA Trial: A Closer Look

The Phase I trial presented at CROI evaluated the safety, tolerability, and pharmacokinetics (drug absorption, distribution, metabolism, and excretion) of CAB-ULA. The study, published in Clinical Infectious Diseases [Kitahata et al., 2024], involved 70 healthy adult participants. Two cabotegravir formulations were investigated: a 200 mg/mL formulation combined with recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that facilitates drug delivery, and a new, standalone CAB-ULA formulation.

The results were encouraging. Both formulations demonstrated favorable safety and tolerability profiles, with no serious adverse events reported. Importantly, pharmacokinetic data suggested that CAB-ULA maintained sufficient drug concentrations for potential extended dosing intervals. The study authors concluded that CAB-ULA warrants further investigation in larger Phase II and III trials to confirm its efficacy and safety for long-acting PrEP.

Potential Benefits of CAB-ULA

The potential benefits of CAB-ULA are significant. By drastically reducing the dosing frequency from daily to just three injections per year, CAB-ULA could significantly improve adherence and PrEP effectiveness. This could be particularly impactful for individuals who struggle with daily medication regimens. Additionally, long-acting injectable PrEP may help reduce the stigma associated with taking daily medications for HIV prevention.

Future Steps and Considerations

While the CAB-ULA trial results are promising, further research is needed. Phase II and III trials will be crucial in evaluating the efficacy and safety of CAB-ULA in larger and more diverse populations. These trials will also need to assess the long-term safety of extended-release cabotegravir compared to currently available PrEP options. Additionally, cost-effectiveness analyses will be necessary to determine the feasibility of implementing this new approach on a larger scale.

Conclusion

ViiV Healthcare’s CAB-ULA trial represents a significant advancement in the field of HIV prevention. The potential for long-acting PrEP with just three injections per year offers a promising solution to address the challenges of adherence associated with daily oral medications. While further research is warranted, CAB-ULA holds the potential to transform PrEP delivery, making it more convenient, discreet, and ultimately, more effective in preventing HIV transmission.

Ultra-long-acting AIDS drugs: Only one injection every four months

(source:internet, reference only)

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