Fixed dose combination

African countries are facing serious financial and practical dilemmas over implementing recent World Health Organization (WHO) guidelines urging a shift away from d4T-based combinations for first-line antiretroviral treatment, the 2007 HIV Implementers' Meeting heard last week in Kigali, Rwanda.

JOHANNESBURG- A new version of the second-line antiretroviral (ARV) drug, Kaletra, began arriving in parts of West and Southern Africa this week, thanks to the efforts of the international medical charity, Medecins Sans Frontieres (MSF).

While generic production has brought down the prices of most first-line anti-retrovirals from over U10 000 (R70 000) in 2000 to as little as U150 (R1 050) per patient per year in June this year, prices of newer ARVs and formulations for children are up to 12 times higher.

Foster City, CA, and Johannesburg, South Africa, April 25, 2005 - Gilead Sciences, Inc. (Nasdaq: GILD) and JSE Securities Exchange listed Aspen Pharmacare (APN) today announced that the companies have signed a letter of intent under which they have committed to enter into a non-exclusive licensing and distribution agreement for Gilead's antiretroviral (ARV) products Truvada (emtricitabine and tenofovir disoproxil fumarate) and Viread (tenofovir disoproxil fumarate).

The Medicines Control Council (MCC) has declared a generic version of antiretroviral (ARV) Duovir undesirable and ordered a recall, the manufacturer confirmed on Thursday.

There is an urgent need for local suppliers of anti-retrovirals (ARVs), according to people living with HIV/Aids, pharmacies and manufacturer GlaxoSmithKline. This was highlighted by shortages this week in the supply of ARVs to South Africa. Despite the government's decision to roll out the provision of ARVs, a lack of planning has meant temporary shortages - and could presage future crises if problems are not dealt with. This week, GlaxoSmithKline lost two batches of 300mg Retrovir (AZT) in transit. The pharmaceutical company's spokesperson, Vicki Ehrich, described the loss as a rare short-term hitch, but concurred that an alternative local supplier would be helpful. GlaxoSmithKline, she said, had done its bit by granting a voluntary licence to generic drug manufacturer Aspen Pharmacare for the manufacture and sale of three anti-retrovirals - Epivir (3TC), Retrovir and Combivir - in 2001. Aspen Pharmacare is, however, still awaiting approval from the Medicines Control Council (MCC) to manufacture the drugs. A pharmacist who did not want to be named said her pharmacy was having trouble estimating the demand for the ARVs every month. Aspen's Philip, also citing the ever-increasing infection rate in South Africa, underlined the need to nurture a domestic pharmaceutical industry. It does help to have the medicines available locally. Such a factory would also be at the MCC's doorstep to inspect and monitor quality control. But Treatment Action Campaign spokesperson Mark Heywood attributed the current shortage to the incompetence of pharmacies and suppliers: You can always plan for emergencies. He said local drug manufacturers could be part of a back-up plan should imported supplies fall short. (Source: Jaspreet Kindra, Mail and Guardian, Johannesburg ,12 December 2003 )

The reduction will drop the price of Combivir, an HIV/Aids treatment recommended by the World Health Organisation, to 90 cents a day in 63 developing countries, including South Africa. The pharmaceutical company announced it would also reduce the price of Epivir, commonly known at 3TC and Retrovir, also known as AZT, by 45% and 38% respectively. TAC spokesperson Nathan Geffen said the price reduction was not being made available to pharmacies which was where most patients obtained their medication. Only about a 1 000 people get their medication through the public health system. Most people get their medication in the private sector. Geffen said the only way of keeping prices substantially low was through generic competition. He said GlaxoSmithKline also needed to clarify if it was going to lower the price of Lamibudine. Combivir is made up of AZT and Lamibudine. He said while Glaxo's action was insufficient, the positive side was that the drugs were being offered to employers who were treating their workers who were not part of medical aid plans. Jean-Pierre Garnier, Glaxo's chief executive, emphasised yesterday that this was not its first price cut. Glaxo has said it has trebled sales from two million people treated to six million in the 63 poorest countries between 2001 and 2002. Sales had not increased much since the last price cut, but manufacturing processes had improved. (Source: Sapa, Guardian Newspapers Limited 2003, Sapa,29 April 2003)

US-Based AIDS Healthcare Foundation is planning to file a complaint with the SA Competition Commission against pharmaceutical giant GlaxoSmithKline, in a bid to widen access to AIDS drugs. The attorney representing the foundation in SA, Musa Ntsibande of law firm Strauss Daly, said yesterday that the complaint would argue that Glaxo abused its dominant market position in contravention of the Competition Act, and was engaging in excessive pricing of its drugs to the detriment of the consumer. Glaxo holds the patent for the antiretroviral medicines AZT, Lamivudine (3TC), and a combination of the two (Combivir), which are used to treat HIV-positive patients. Glaxo is opposing a lawsuit brought against it by the foundation in the US, in which the foundation is challenging Glaxo's patent on the drug AZT The foundation's US attorney, Ron Katz, said yesterday that the foundation was challenging Glaxo on the grounds that it had defrauded the US patent office. The foundation was therefore seeking to have the patent declared invalid, he said. The foundation describes itself on its website as the largest specialised provider of HIV medical care in the US. Its presence in SA is confined to a pilot HIV/AIDS treatment project in KwaZulu-Natal, which it established last year in partnership with a local nongovernmental organisation called Netcom SA, to provide antiretroviral medicines. The pilot programme's doctor, Paul Musoke, said that more patients could be treated if the drugs were cheaper.(Source: Tamar Kahn: Business Day, 28 January 2003)

Prices for AIDS drugs will become more affordable with the announcement this weekend of two initiatives aimed at cutting the cost of the most frequently prescribed antiretrovirals. Multinational pharmaceutical company GlaxoSmithKline (GSK) said yesterday it was granting a voluntary licence to local firm Aspen Pharmacare to produce AZT and 3TC - as well as the combination pill Combivir exclusively for the public sector. The deal also obliges Aspen to pay 30% of the net sale price to non-governmental organisations dealing with HIV/AIDS. At the same time Cipla-Medpro, the local associate of Indian pharmaceutical manufacturer Cipla, has submitted a complaint to the Competition Commission alleging that GSK and Boehringer Ingelheim abused their patents. Cipla manufactures Nevirapine, an antiretroviral drug that helps to prevent the mother-to-child transmission of HIV. Cipla-Medpro CEO Jerome Smith said late last night that the complaint might now have to include Aspen Pharmacare. The only real market in SA for antiretroviral drugs has been in the private sector as government has consistently refused to provide the life-prolonging drugs to public sector patients who could not afford them. GSK has kept the lucrative - albeit small - market that includes medical aid schemes and larger buyers, like mining or manufacturing companies like Ford or DaimlerChrysler. The Cipla action is groundbreaking and challenges the way the patents have been used by both companies to keep drug prices high. Cipla has chosen to challenge the patents through the commission initially, but it will use the Patents Acts if necessary. Cipla's complaint says that the patents and licence-holders qualify as a dominant firm in terms of the Competition Act, and claims that they have abused that dominance. James Love, director of the Washington-based consumer project on technology, believes that GSK needs to be challenged further on its drug policy for the private sector, and says that the competition which the Cipla action will bring, will see prices lowered further. (Source: Business Day, 8 October 2001)

None of the rape survivors given antiretroviral drugs by Sunninghill Hospital has become HIV-positive, according to Dr Adrienne Wulfsohn, who heads the Sandton hospital's accident and emergency unit. Sexual-assault survivors who come to Sunninghill's Albertina Sisulu Rape Crisis Centre within 72 hours of being attacked are offered a three-day course of the antiretroviral drug Combivir if they consent to an HIV test and test negative. They are then advised to buy their own Combivir (a combination of AZT and 3TC) for a further 28 days at a cost of R900. Despite the poverty of many patients - most of whom are from Alexandra, Diepsloot and Zevenfontein - it's amazing how many of them manage to raise the money, said Wulfsohn. The crisis centre treats about 50 women and children free of charge each month as part of the Netcare group's service to communities, Wulfsohn pointed out. The cost of fully treating a sexual-assault case is about R8 500. The Netcare clinics in Gauteng offering this service pro bono cost the group about R2,3-million last year, said Wulfsohn. The Medicines Control Council has not approved Combivir for use after sexual assault, so the patients have to sign a consent form which explains that they might still get HIV. (Source: Health-E, 3 July 2001)