ARV drug supplies remain erratic

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The DA’s health spokesperson in Gauteng‚ Jack Bloom‚ has noted his concern about a “reported shortage of the lamivudine HIV/Aids treatment drug” in the province, reports Business Day.

The Health Department confirmed the shortage – after the Treatment Action Campaign raised the issue – saying it was “a matter of low supply” and the drug was only available in a 150g dosage‚ instead of the usual 300g.

“Whilst this should not be a real crisis as a double dose can be taken‚ there have been cases‚ especially in the East Rand‚ where patients have been told that the drug is simply not available‚” said Bloom. “This is inexcusable as any interruption in treatment can lead to dangerous drug resistance. The department needs to tighten up on its drug orders and its communication with clinics and hospitals,” he said.

 

Health-e News reports that Ayanda Mahlangu from Daveyton east of Johannesburg has been without one of her three ARVs for a week as her local Daveyton East and Daveyton Extension clinics run dry of the ARV lamivudine. “I haven’t been taking treatment for a week now,” Mahlangu said. “They (nurses) did not even give me alternatives. They said I must wait until lamivudine becomes available.”

Lamivudine shortages have also been reported at Boksburg’s Tambo Memorial Hospital and the Treatment Action Campaign’s Jabu Mahlangu has alleged the drug has been out of stock since late November. Fellow Daveyton resident Annah Manana was given an alternative combination ARV at her local clinic in lieu of her usual single tablet of lamivudine. While Manana has responded well to the switch, HIV Clinicians Society of Southern Africa CEO Lauren Jankelowitz cautions there is no “one-size fits all” solution for patients who are not able to get lamivudine. She added that a lamivudine shortage would be worrying because many patients on the drug may not have many other treatment options.

Gauteng Department of Health spokesperson Steve Mabona has confirmed a shortage of 300mg tablets of the drug but says smaller dose formulations of the drug are available. “We wish to confirm that, there is a shortage of lamivudine 300mg, however, we do have lamivudine 150mg tablets in stock,” said Mabona, who urged health professionals to consider dispensing a double dose of the smaller, 150mg-formulation in lieu of the usual 300mg tablets.

Mabona said the shortage of higher dose tablets is being addressed. He blamed the fact that some patients were being turned away empty handed from clinics on a miscommunication between district pharmacies and clinics.

 

Meanwhile, after months of erratic supply of its antiretroviral (ARV) Aluvia in South Africa, international pharmaceutical company AbbVie will now allow generic manufacturers to produce the drug to help safeguard supplies, according to an announcement.

Health-e News reports that AbbVie’s new licensing agreement with the international Medicines Patent Pool allows generic ARV manufacturers to obtain a sublicense from the pool to produce a tablet combining the ARVs lopinavir and ritonavir usually sold under the brand name Aluvia.

The new agreement will also allow generic drug makers to combine Aluvia with other ARVs such as atazanavir and darunavir, according to a statement released by the Medicines Patent Pool, an international body that allows drug makers to voluntarily share patents with generic manufacturers in order to increase access to affordable medicines in developing countries

The announcement follows months of Aluvia shortages in South Africa due to the country’s dependence on a single supplier, AbbVie, to produce the drug as AbbVie’s patents prevented other companies from selling the drug in South Africa. The Department of Health had already begun to actively encouraging AbbVie to enter into the new agreement as of November.

Health Minister Dr Aaron Motsoaledi has welcomed the announcement and said the new agreement will allow the Department of Health to procure the combination ARV for a wider range of companies. “This agreement, which the South African government actively encouraged, will significantly help the Ministry of Health to care for its communities living with HIV,” said Motsoaledi in a statement. “(Lopinavir and ritonavir are) are critical for second-line treatment in our country and we need to secure supply of the product, especially as treatment needs increase.”

Second-line treatment is used when people living with HIV may have developed resistance to their initial treatment. According to AbbVie, Aluvia is the most widely used second-line HIV treatment in Africa. According to the pool, some generic pharmaceutical companies have already registered generic formulations of Aluvia for Medicine Control Council approval and that new such applications will be fast tracked.

The new agreement may also pave the way for local production, according to Medicine Patent Pool executive director Greg Perry. “While many African countries are currently able to purchase generic versions of these medicines from India, this licence will now enable manufacturers in other countries where there are patents, such as China and South Africa, to manufacture (the drug) and other ritonavir-based treatments,” said Perry, adding that an expanded supplier base would help safeguard supply of the second-line HIV treatment not only in South Africa but also the continent.

The pool’s announcement follows a similar announcement in November that may pave the way for generic formulations of the hepatitis C treatment daclatasvir to be sold in South Africa. In November, the pool announced that it had signed an agreement with pharmaceutical company Bristol-Myers Squibb to increase access to its hepatitis C medicine daclatasvir, which is currently patented in South Africa. According to the pool, that agreement now allows for generic manufacturers to apply to the pool for a license to sell generic formulations of daclatasvir in South Africa pending Medicine Control Council approval.

Full Business Day report
Health-e News material
Health-e News material


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